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Letermovir: Pediatric drug information

Letermovir: Pediatric drug information
2025© UpToDate, Inc. and its affiliates and/or licensors. All Rights Reserved.
For additional information see "Letermovir: Drug information" and "Letermovir: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Prevymis
Brand Names: Canada
  • Prevymis
Therapeutic Category
  • Antiviral Agent
Dosing: Pediatric
Cytomegalovirus, prophylaxis in allogeneic hematopoietic cell transplant recipients

Cytomegalovirus (CMV), prophylaxis in allogeneic hematopoietic cell transplant (HCT) recipients: Note: Initiate between day 0 and day 28 post transplant and typically continue through 100 days post-HCT; may continue through day 200 in patients at risk for late CMV infection/disease. Duration may vary based on immune reconstitution and discontinuation of immunosuppressive therapy; consult institutional protocols (Ref).

Infants ≥6 months and Children <12 years:

IV:

6 to <7.5 kg: IV: 40 mg once daily.

7.5 to <15 kg: IV: 60 mg once daily.

15 to <30 kg: IV: 120 mg once daily.

≥30 kg: IV: 480 mg once daily.

Oral:

6 to <7.5 kg: Oral pellets: Oral: 80 mg once daily.

7.5 to <15 kg: Oral pellets: Oral: 120 mg once daily.

15 to <30 kg: Oral pellets, tablets: Oral: 240 mg once daily.

≥30 kg: Oral pellets, tablets: Oral: 480 mg once daily (Ref).

Children ≥12 years and Adolescents:

15 to <30 kg:

IV: 120 mg once daily.

Oral: Oral pellets, tablets: 240 mg once daily.

≥30 kg: IV, Oral: 480 mg once daily (Ref).

Cytomegalovirus, prophylaxis in kidney transplant recipients

Cytomegalovirus (CMV), prophylaxis in kidney transplant recipients:

High-risk recipients (donor CMV seropositive/recipient CMV seronegative [D+/R-]):

Children ≥12 years and Adolescents, weighing ≥40 kg: IV, Oral: 480 mg once daily beginning between day 0 and 7 post kidney transplant; continue through day 200 post transplantation.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Pediatric

Infants ≥6 months, Children, and Adolescents:

eGFR >10 mL/minute/1.73 m2:

Oral: No dosage adjustment necessary.

IV: No dosage adjustment necessary; use with caution and monitor serum creatinine closely in patients with eGFR <50 mL/minute/1.73 m2 due to potential accumulation of IV vehicle (hydroxypropyl betadex).

eGFR ≤10 mL/minute/1.73 m2: Oral, IV: There are no specific dosage adjustments provided in the manufacturer's labeling; data are insufficient to make dosage recommendations.

ESRD on dialysis: Oral, IV: There are no specific dosage adjustments provided in the manufacturer's labeling; data are insufficient to make dosage recommendations.

Dosing: Liver Impairment: Pediatric

Infants ≥6 months, Children, and Adolescents: Oral, IV:

Mild or moderate impairment: No dosage adjustment necessary.

Severe impairment: Use is not recommended.

Dosing: Adult

(For additional information see "Letermovir: Drug information")

Cytomegalovirus, prophylaxis in hematopoietic cell transplant recipients

Cytomegalovirus, prophylaxis in hematopoietic cell transplant recipients: IV, Oral: 480 mg once daily beginning between day 0 and day 28 postallogeneic hematopoietic cell transplant for cytomegalovirus (CMV)-seropositive recipients; continue through day 100 post transplantation (Ref). Use may be continued through day 200 post transplantation in patients at risk for late CMV infection and disease.

Cytomegalovirus, prophylaxis in kidney transplant recipients

Cytomegalovirus, prophylaxis in kidney transplant recipients: IV, Oral: 480 mg once daily beginning between day 0 and 7 post kidney transplant for high-risk recipients (donor CMV seropositive/recipient CMV seronegative); continue through day 200 post transplantation (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Note: The Cockcroft-Gault equation should be used to estimate renal function.

CrCl >10 mL/minute:

Oral: No dosage adjustment necessary.

IV: No dosage adjustment necessary; use with caution and closely monitor serum creatinine in patients with CrCl <50 mL/minute due to potential accumulation of IV vehicle (hydroxypropyl betadex).

CrCl ≤10 mL/minute: There are no specific dosage adjustments provided in the manufacturer's labeling; data are insufficient to make dosage recommendations. Closely monitor serum creatinine due to potential accumulation of IV vehicle (hydroxypropyl betadex).

ESRD on dialysis: There are no specific dosage adjustments provided in the manufacturer's labeling; data are insufficient to make dosage recommendations.

Dosing: Liver Impairment: Adult

Mild or moderate impairment (Child-Pugh class A or B): No dosage adjustment necessary.

Severe impairment (Child-Pugh class C): Use is not recommended.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Reported adverse reactions are for adults.

>10%:

Cardiovascular: Cardiac abnormality (13%; including atrial fibrillation [3%], tachycardia [4%]), peripheral edema (14%)

Gastrointestinal: Abdominal pain (12%), diarrhea (26%), nausea (27%), vomiting (19%)

Hematologic & oncologic: Decreased platelet count (<25,000 cells/mcL: 27%; 25,000 to <50,000 cells/mcL: 17%; 50,000 to <100,000 cells/mcL: 20%) (table 1)

Letermovir: Adverse Reaction: Decreased Platelet Count

Drug (Letermovir)

Placebo

Indication

Number of Patients (Letermovir)

Number of Patients (Placebo)

Comments

27%

21%

Prophylaxis of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant

373

192

<25,000 cells/mcL

20%

30%

Prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant

373

192

50,000 to <100,000 cells/mcL

17%

18%

Prophylaxis of CMV infection and disease in adult CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant

373

192

25,000 to <50,000 cells/mcL

Nervous system: Fatigue (13%), headache (14%)

Respiratory: Cough (14%)

1% to 10%: Hematologic & oncologic: Decreased hemoglobin (<6.5 g/dL: 2%)

<1%: Hypersensitivity: Hypersensitivity reaction

Contraindications

Concomitant administration with pimozide or ergot alkaloids; concomitant administration with pitavastatin and simvastatin when coadministered with cyclosporine.

Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to letermovir or any component of the formulation; concomitant administration with bosentan, lovastatin, and rosuvastatin when coadministered with cyclosporine.

Warnings/Precautions

Disease-related concerns:

• Hepatic impairment: Use is not recommended in patients with severe impairment (Child-Pugh class C).

• Renal impairment: Use with caution and closely monitor serum creatinine in patients with CrCl <50 mL/minute; accumulation of IV vehicle, hydroxypropyl betadex, may occur. Data are insufficient to make dosage recommendations in patients with CrCl ≤10 mL/minute or in patients on dialysis.

Dosage form specific issues:

• Injection: Contains hydroxypropyl betadex; use injection only in patients unable to take oral therapy.

Other warnings/precautions:

• Appropriate use: Not active against other herpes viruses besides cytomegalovirus (CMV) (Marschall 2012). Additional prophylaxis targeting herpes simplex virus (HSV) in HSV-positive transplant recipients receiving letermovir may be necessary (ASBMT [Tomblyn 2009]; Limaye 2023; Marty 2017).

• Resistance: Patients may have resistance to letermovir due to mutations in UL56. Cross resistance does not occur in populations with substitutions conferring resistance to CMV DNA polymerase inhibitors such as ganciclovir, cidofovir, and foscarnet.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Packet, Oral:

Prevymis: 20 mg (1 ea, 30 ea); 120 mg (1 ea, 30 ea)

Solution, Intravenous [preservative free]:

Prevymis: 240 mg/12 mL (12 mL); 480 mg/24 mL (24 mL)

Tablet, Oral:

Prevymis: 240 mg, 480 mg

Generic Equivalent Available: US

No

Pricing: US

Pack (Prevymis Oral)

20 mg (per each): $13.72

120 mg (per each): $82.32

Solution (Prevymis Intravenous)

240MG/12ML (per mL): $37.94

480MG/24ML (per mL): $18.97

Tablets (Prevymis Oral)

240 mg (per each): $329.27

480 mg (per each): $329.27

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous:

Prevymis: 240 mg/12 mL (12 mL); 480 mg/24 mL (24 mL)

Tablet, Oral:

Prevymis: 240 mg, 480 mg

Administration: Pediatric

Oral:

Oral pellets: Do not crush or chew pellets. Determine number of oral pellet packet(s) needed for dose. Open packet(s) and empty all contents into a bowl; mix with 1 to 3 teaspoons of soft food (eg, applesauce, yogurt, pudding); food should be at or below room temperature; do not use hot food. Gently mix oral pellets and food together and administer entire mixture. If pellets are left in the container or on the spoon used to prepare and administer oral pellets, add more soft food, stir, and administer to ensure delivery of the entire dose. Mixture must be administered within 10 minutes of preparation; if not administered within 10 minutes, then mixture must be discarded and new dose must be prepared.

Administration via feeding tube: Tube type and size and preparation are based on dose. Dose must be administered within 2 hours of preparation; if mixture is not administered within 2 hours of preparation, discard mixture and prepare new dose.

20 mg oral pellet packets (40 to 80 mg dose):

Gastric tubes (5 French polyurethane NG, any ≥6 French NG, or any 12 French G-tube): Open packets and pour oral pellets into a medicine cup with 3 mL room temperature purified water; do not use hot or cold (refrigerated) water. Allow mixture to stand for 10 minutes; do not shake or swirl; oral pellets will become loose or broken up but will not dissolve. Gently stir mixture with tip of enteral dosing syringe. Draw up entire mixture in enteral dosing syringe; gently invert syringe to keep pellets from settling and administer immediately; do not shake the syringe (may cause air bubbles). Add 2 mL of room temperature purified water to the medicine cup; using same syringe, stir with tip, draw up rinse and administer contents to ensure delivery of entire dose. Flush feeding tube with an appropriate volume of purified water.

120 mg oral pellet packets (120 to 480 mg dose):

Gastric tubes (any ≥8 French NG or ≥12 French G-tube): Open packets and pour oral pellets into a medicine cup with 15 mL room temperature purified water; do not use hot or cold (refrigerated) water. Allow mixture to stand for 10 minutes; do not shake or swirl; oral pellets will become loose or broken up but will not dissolve. Gently stir mixture with tip of enteral dosing syringe. Draw up entire mixture in enteral dosing syringe; gently invert syringe to keep pellets from settling and administer immediately; do not shake the syringe (may cause air bubbles). Add 15 mL of room temperature purified water to the medicine cup; using same syringe, stir with tip, draw up rinse and administer contents to ensure delivery of entire dose. Flush feeding tube with an appropriate volume of purified water.

Tablets: Administer with or without food; swallow tablet whole per the manufacturer.

Administration via feeding tube:

Gastric tubes (eg, NG, G-tube): Crush tablets into a fine powder and disperse in 15 to 30 mL purified water; draw up mixture into enteral dosing syringe and administer via feeding tube (Ref).

Dosage form information: Tablets are film-coated; administration of film-coated tablets via feeding tube may increase the risk of clogging the tube; use caution (Ref).

Parenteral: IV: Infuse over 1 hour through a peripheral or central venous catheter; do not administer as IV bolus. Infuse via a 0.2- or 0.22-micron polyethersulfone in-line filter. Not compatible with polyurethane- or DEHP-containing IV administration sets; refer to manufacturer's labeling for compatible infusion sets.

Administration: Adult

Oral:

Pellets: Do not crush or chew. Mix pellets with 1 to 3 teaspoons of soft food (eg, applesauce, yogurt, pudding); use at or below room temperature food; do not use hot food. Administer mixture within 10 minutes of preparation.

Administration via feeding tube: Tube type and size and preparation are dose dependent. Administer within 2 hours of preparation.

120 mg oral pellet packets (120 to 480 mg dose):

Gastric (any ≥8 French NG or any G-tube) tubes: Open packets and pour pellets into a medicine cup with 15 mL room temperature purified water; do not use hot or cold (refrigerated) water. Allow mixture to stand for 10 minutes; do not shake or swirl; pellets will become loose or broken up but will not dissolve. Gently stir mixture with tip of enteral dosing syringe. Draw up entire mixture in enteral dosing syringe; gently invert syringe to keep pellets from settling and administer immediately; do not shake the syringe (may cause air bubbles). Add 15 mL of room temperature purified water to the medicine cup; using same syringe, stir with tip, draw up rinse mixture and administer contents to ensure delivery of entire dose. Flush feeding tube with an appropriate volume of purified water.

Tablet: Administer with or without food; swallow whole.

IV: Infuse as an IV infusion over 1 hour through a peripheral or central venous catheter; do not administer as IV bolus. Infuse via a 0.2- or 0.22-micron polyethersulfone in-line filter. Not compatible with polyurethane-containing IV administration sets; refer to manufacturer's labeling for compatible infusion sets.

Storage/Stability

Injection: Store intact vials at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light; do not shake intact vials. Diluted solution is stable for ≤24 hours at room temperature or ≤48 hours at 2°C to 8°C (36°F to 46°F), including infusion time.

Oral pellets: Store in original packet at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F).

Tablets: Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Store in original container to protect from moisture.

Use

Prophylaxis of cytomegalovirus (CMV) infection and disease in CMV-seropositive recipients [R+] of an allogeneic hematopoietic stem cell transplant (FDA approved in ages ≥6 months and weighing ≥6 kg and adults); prophylaxis of CMV disease in kidney transplant recipients at high risk (donor CMV seropositive/recipient CMV seronegative [D+/R-]) (FDA approved in ages ≥12 years and weighing ≥40 kg and adults).

Metabolism/Transport Effects

Substrate of CYP2D6 (Minor), CYP3A4 (Minor), OATP1B1/1B3, P-glycoprotein (Major with inducers), P-glycoprotein (Minor with inhibitors), UGT1A1, UGT1A3; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential; Inhibits CYP3A4 (Moderate);

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program

Abemaciclib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Abemaciclib. Management: Monitor for increased abemaciclib toxicities if combined with moderate CYP3A4 inhibitors. Consider reducing the abemaciclib dose in 50 mg decrements if necessary. Risk C: Monitor

Acalabrutinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Acalabrutinib. Management: Reduce acalabrutinib dose to 100 mg once daily with concurrent use of a moderate CYP3A4 inhibitor. Monitor patient closely for both acalabrutinib response and evidence of adverse effects with any concurrent use. Risk D: Consider Therapy Modification

Acrivastine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Acrivastine. Risk C: Monitor

Adagrasib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Adagrasib. Risk C: Monitor

ALfentanil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of ALfentanil. Management: If use of alfentanil and moderate CYP3A4 inhibitors is necessary, consider dosage reduction of alfentanil until stable drug effects are achieved. Frequently monitor patients for respiratory depression and sedation when these agents are combined. Risk D: Consider Therapy Modification

Alfuzosin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Alfuzosin. Risk C: Monitor

Alitretinoin (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Alitretinoin (Systemic). Risk C: Monitor

ALPRAZolam: CYP3A4 Inhibitors (Moderate) may increase serum concentration of ALPRAZolam. Management: Consider alternatives to this combination when possible. If combined, consider an alprazolam dose reduction and monitor for increased alprazolam effects and toxicities (eg, sedation, lethargy). Risk D: Consider Therapy Modification

Amiodarone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Amiodarone. Risk C: Monitor

AmLODIPine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of AmLODIPine. Risk C: Monitor

Apixaban: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Apixaban. Risk C: Monitor

Aprepitant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Aprepitant. Risk X: Avoid

ARIPiprazole Lauroxil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of ARIPiprazole Lauroxil. Risk C: Monitor

ARIPiprazole: CYP3A4 Inhibitors (Moderate) may increase serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy, indication, or dosage form. Consult full interaction monograph for specific recommendations. Risk C: Monitor

Asciminib: May increase serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor

Atazanavir: May increase serum concentration of UGT1A1 Substrates. Management: Do not use UGT1A1 substrates for which small increases in exposure can cause serious adverse effects together with atazanavir, and use caution with any UGT1A1 substrate, even when small changes in exposure are less likely to cause serious adverse effects. Risk D: Consider Therapy Modification

Atogepant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Atogepant. Risk C: Monitor

Atorvastatin: Letermovir may increase serum concentration of Atorvastatin. Management: Limit the atorvastatin dose to 20 mg daily when combined with letermovir. When letermovir is coadministered with cyclosporine, the use of atorvastatin (at any dose) is not recommended. Risk D: Consider Therapy Modification

Avacopan: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Avacopan. Risk C: Monitor

Avanafil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Avanafil. Management: The maximum avanafil dose is 50 mg per 24-hour period when used together with a moderate CYP3A4 inhibitor. Patients receiving such a combination should also be monitored more closely for evidence of adverse effects (eg, hypotension, syncope, priapism). Risk D: Consider Therapy Modification

Avapritinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Avapritinib. Management: Avoid use of moderate CYP3A4 inhibitors with avapritinib. If this combination cannot be avoided, reduce the avapritinib dose to 100 mg daily for the treatment of GIST or to 50 mg daily for the treatment of advanced systemic mastocytosis. Risk D: Consider Therapy Modification

Axitinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Axitinib. Risk C: Monitor

Barnidipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Barnidipine. Risk C: Monitor

Bedaquiline: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Bedaquiline. CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Bedaquiline. Risk C: Monitor

Belumosudil: May increase serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Management: Avoid coadministration of belumosudil with these substrates of OATP1B1/1B3 for which minimal concentration increases can cause serious adverse effects. If coadministration is required, dose reductions of the OATP1B1/1B3 substrate may be required. Risk D: Consider Therapy Modification

Benidipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Benidipine. Risk C: Monitor

Benzhydrocodone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Benzhydrocodone. Specifically, the concentration of hydrocodone may be increased. Risk C: Monitor

Blonanserin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Blonanserin. Risk C: Monitor

Bortezomib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Bortezomib. Risk C: Monitor

Bosentan: May decrease serum concentration of Letermovir. Risk X: Avoid

Bosutinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Bosutinib. Risk X: Avoid

Brexpiprazole: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Brexpiprazole. Management: The brexpiprazole dose should be reduced to 25% of usual if used together with both a moderate CYP3A4 inhibitor and a strong or moderate CYP2D6 inhibitor, or if a moderate CYP3A4 inhibitor is used in a CYP2D6 poor metabolizer. Risk C: Monitor

Brigatinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Brigatinib. Management: Avoid concurrent use of brigatinib with moderate CYP3A4 inhibitors when possible. If such a combination cannot be avoided, reduce the dose of brigatinib by approximately 40% (ie, from 180 mg to 120 mg, from 120 mg to 90 mg, or from 90 mg to 60 mg). Risk D: Consider Therapy Modification

Bromocriptine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Bromocriptine. Management: The bromocriptine dose should not exceed 1.6 mg daily with use of a moderate CYP3A4 inhibitor. The Cycloset brand specifically recommends this dose limitation, but other bromocriptine products do not make such specific recommendations. Risk D: Consider Therapy Modification

Budesonide (Oral Inhalation): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Budesonide (Oral Inhalation). Risk C: Monitor

Budesonide (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Budesonide (Systemic). Management: Avoid the concomitant use of CYP3A4 inhibitors and oral budesonide. If patients receive both budesonide and CYP3A4 inhibitors, they should be closely monitored for signs and symptoms of corticosteroid excess. Risk D: Consider Therapy Modification

Budesonide (Topical): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Budesonide (Topical). Risk X: Avoid

Bulevirtide: May increase serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Management: Coadministration of bulevirtide with OATP1B1/1B3 (also known as SLCO1B1/1B3) substrates should be avoided when possible. If used together, close clinical monitoring is recommended. Risk D: Consider Therapy Modification

Buprenorphine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Buprenorphine. Risk C: Monitor

BusPIRone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of BusPIRone. Risk C: Monitor

Cabozantinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Cabozantinib. Risk C: Monitor

Cannabis: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Cannabis. More specifically, tetrahydrocannabinol and cannabidiol serum concentrations may be increased. Risk C: Monitor

Capivasertib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Capivasertib. Management: If capivasertib is combined with moderate CYP3A4 inhibitors, reduce the capivasertib dose to 320 mg twice daily for 4 days, followed by 3 days off. Monitor patients closely for adverse reactions. Risk D: Consider Therapy Modification

Cariprazine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Cariprazine. CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Cariprazine. Management: Cariprazine dose adjustments are recommended and depend upon whether a patient is initiating a moderate CYP3A4 inhibitor or cariprazine, as well as cariprazine indication. See full mono for details. Some non-US labels contraindicate this combination. Risk D: Consider Therapy Modification

Ceftobiprole Medocaril: May increase serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid

Ceritinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ceritinib. Risk C: Monitor

Cilostazol: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Cilostazol. Management: Decrease the dose of cilostazol to 50 mg twice daily when combined with moderate CYP3A4 inhibitors. Risk D: Consider Therapy Modification

Cisapride: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Cisapride. Management: Consider alternatives to this combination. Prescribing information for some moderate CYP3A4 inhibitors state coadministration with cisapride is contraindicated, while some others recommend monitoring and dose titration. Risk D: Consider Therapy Modification

Clindamycin (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Clindamycin (Systemic). Risk C: Monitor

CloZAPine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of CloZAPine. Risk C: Monitor

Cobimetinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Cobimetinib. Management: Avoid this combination when possible. If concurrent short term (14 days or less) use cannot be avoided, reduce the cobimetinib dose from 60 mg to 20 mg daily. Avoid concomitant use in patients already receiving reduced cobimetinib doses. Risk D: Consider Therapy Modification

Codeine: CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Codeine. Risk C: Monitor

Colchicine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Colchicine. Management: Avoidance, dose reduction, or increased monitoring for colchicine toxicity may be needed and will depend on brand, indication for colchicine use, renal/hepatic function, and use of a P-gp inhibitor. See full monograph for details. Risk D: Consider Therapy Modification

Conivaptan: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Conivaptan. Risk C: Monitor

Copanlisib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Copanlisib. Risk C: Monitor

Crizotinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Crizotinib. Risk C: Monitor

CycloSPORINE (Systemic): Letermovir may increase serum concentration of CycloSPORINE (Systemic). CycloSPORINE (Systemic) may increase serum concentration of Letermovir. Management: Letermovir dose reductions are required during coadministration with cyclosporine which depend on indication, age, and weight. See full mono for details. Monitor for increased cyclosporine concentrations and toxicities during coadministration. Risk D: Consider Therapy Modification

Dabrafenib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Dabrafenib. Risk C: Monitor

Dapoxetine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Dapoxetine. Management: The dose of dapoxetine should be limited to 30 mg per day when used together with a moderate inhibitor of CYP3A4. Risk D: Consider Therapy Modification

Daridorexant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Daridorexant. Management: Limit the daridorexant dose to 25 mg, no more than once per night, when combined with moderate CYP3A4 inhibitors. Risk D: Consider Therapy Modification

Darifenacin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Darifenacin. Risk C: Monitor

Darolutamide: May increase serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor

Dasatinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Dasatinib. Risk C: Monitor

Deflazacort: CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Deflazacort. Management: Administer one third of the recommended deflazacort dose when used together with a strong or moderate CYP3A4 inhibitor. Risk D: Consider Therapy Modification

Delamanid: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Delamanid. Risk C: Monitor

DexAMETHasone (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of DexAMETHasone (Systemic). Risk C: Monitor

DiazePAM: CYP3A4 Inhibitors (Moderate) may increase serum concentration of DiazePAM. Risk C: Monitor

Diazoxide Choline: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Diazoxide Choline. Risk C: Monitor

Dienogest: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Dienogest. Risk C: Monitor

DilTIAZem: CYP3A4 Inhibitors (Moderate) may increase serum concentration of DilTIAZem. Risk C: Monitor

Disopyramide: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Disopyramide. Risk C: Monitor

DOCEtaxel: CYP3A4 Inhibitors (Moderate) may increase serum concentration of DOCEtaxel. Risk C: Monitor

Dofetilide: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Dofetilide. Risk C: Monitor

Domperidone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Domperidone. Risk X: Avoid

DOXOrubicin (Conventional): CYP3A4 Inhibitors (Moderate) may increase serum concentration of DOXOrubicin (Conventional). Risk X: Avoid

DroNABinol: CYP3A4 Inhibitors (Moderate) may increase serum concentration of DroNABinol. Risk C: Monitor

Dronedarone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Dronedarone. Risk C: Monitor

Ebastine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ebastine. Risk C: Monitor

Elacestrant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Elacestrant. Risk X: Avoid

Elbasvir and Grazoprevir: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Elbasvir and Grazoprevir. Risk C: Monitor

Eletriptan: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Eletriptan. Risk X: Avoid

Elexacaftor, Tezacaftor, and Ivacaftor: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Elexacaftor, Tezacaftor, and Ivacaftor. Management: When combined with moderate CYP3A4 inhibitors, elexacaftor/tezacaftor/ivacaftor should be given in the morning, every other day. Ivacaftor alone should be given in the morning, every other day on alternate days. Risk D: Consider Therapy Modification

Eliglustat: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Eliglustat. Management: Reduce eliglustat dose to 84 mg daily in CYP2D6 EMs when used with moderate CYP3A4 inhibitors. Avoid use of moderate CYP3A4 inhibitors in CYP2D6 IMs or PMs. Use in CYP2D6 EMs or IMs also taking strong or moderate CYP2D6 inhibitors is contraindicated. Risk D: Consider Therapy Modification

Eltrombopag: May increase serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor

Encorafenib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Encorafenib. Management: Avoid use of encorafenib and moderate CYP3A4 inhibitors when possible. If combined, decrease the encorafenib dose from 450 mg to 225 mg; 300 mg to 150 mg; and 225 mg or 150 mg to 75 mg. Resume prior dose once inhibitor discontinued for 3 to 5 half-lives. Risk D: Consider Therapy Modification

Ensartinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ensartinib. Risk X: Avoid

Entrectinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Entrectinib. Management: Avoid moderate CYP3A4 inhibitors if possible. If needed, reduce entrectinib dose to 50 mg/day if starting dose 200 mg; to 100 mg/day if starting dose 300 mg; to 200 mg if starting dose 400 mg or 600 mg. Risk D: Consider Therapy Modification

Eplerenone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Eplerenone. Management: If coadministered with moderate CYP3A4 inhibitors, the max dose of eplerenone is 25 mg daily if used for heart failure; if used for hypertension initiate eplerenone 25 mg daily, titrate to max 25 mg twice daily. Risk D: Consider Therapy Modification

Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates): Letermovir may increase serum concentration of Ergot Derivatives (Vasoconstrictive CYP3A4 Substrates). Risk X: Avoid

Erlotinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Erlotinib. Risk C: Monitor

Erythromycin (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Erythromycin (Systemic). Risk C: Monitor

Eszopiclone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Eszopiclone. Risk C: Monitor

Etravirine: May decrease serum concentration of Letermovir. Risk X: Avoid

Everolimus: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Everolimus. Risk C: Monitor

Fedratinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Fedratinib. Risk C: Monitor

Felodipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Felodipine. Risk C: Monitor

FentaNYL: CYP3A4 Inhibitors (Moderate) may increase serum concentration of FentaNYL. Management: Consider fentanyl dose reductions when combined with a moderate CYP3A4 inhibitor. Monitor for respiratory depression and sedation. Upon discontinuation of a CYP3A4 inhibitor, consider a fentanyl dose increase; monitor for signs and symptoms of withdrawal. Risk D: Consider Therapy Modification

Fexinidazole: CYP3A4 Inhibitors (Moderate) may decrease active metabolite exposure of Fexinidazole. Management: Avoid use of fexinidazole and moderate CYP3A4 inhibitors when possible. If combined, monitor for reduced fexinidazole efficacy. Risk D: Consider Therapy Modification

Finerenone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Finerenone. Risk C: Monitor

Flibanserin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Flibanserin. Management: Use of flibanserin with moderate CYP3A4 inhibitors is contraindicated. If starting flibanserin, start 2 weeks after the last dose of the CYP3A4 inhibitor. If starting a CYP3A4 inhibitor, start 2 days after the last dose of flibanserin. Risk X: Avoid

Fluticasone (Nasal): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Fluticasone (Nasal). Risk C: Monitor

Fluticasone (Oral Inhalation): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Fluticasone (Oral Inhalation). Risk C: Monitor

Fosamprenavir: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Fosamprenavir. Risk C: Monitor

Fosaprepitant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Fosaprepitant. Risk X: Avoid

Gemfibrozil: May increase serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor

Gepirone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Gepirone. Management: Reduce the gepirone dose by 50% if combined with moderate CYP3A4 inhibitors. Monitor for QTc interval prolongation with combined use. Risk D: Consider Therapy Modification

Gepotidacin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Gepotidacin. Risk C: Monitor

Gilteritinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Gilteritinib. Risk C: Monitor

Glasdegib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Glasdegib. Risk C: Monitor

GlyBURIDE: Letermovir may increase serum concentration of GlyBURIDE. Risk C: Monitor

GuanFACINE: CYP3A4 Inhibitors (Moderate) may increase serum concentration of GuanFACINE. Management: Reduce the extended-release guanfacine dose 50% when combined with a moderate CYP3A4 inhibitor. Monitor for increased guanfacine toxicities when these agents are combined. Risk D: Consider Therapy Modification

Halofantrine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Halofantrine. Risk C: Monitor

HMG-CoA Reductase Inhibitors (Statins): Letermovir may increase serum concentration of HMG-CoA Reductase Inhibitors (Statins). Risk C: Monitor

HYDROcodone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of HYDROcodone. Risk C: Monitor

Ibrutinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ibrutinib. Management: When treating B-cell malignancies, decrease ibrutinib to 280 mg daily when combined with moderate CYP3A4 inhibitors. When treating graft versus host disease, monitor patients closely and reduce the ibrutinib dose as needed based on adverse reactions. Risk D: Consider Therapy Modification

Ifosfamide: CYP3A4 Inhibitors (Moderate) may increase adverse/toxic effects of Ifosfamide. CYP3A4 Inhibitors (Moderate) may decrease active metabolite exposure of Ifosfamide. Risk C: Monitor

Iloperidone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Iloperidone. Risk C: Monitor

Irinotecan Products: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Irinotecan Products. CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Irinotecan Products. Specifically, the serum concentration of SN-38 may be increased. Risk C: Monitor

Isavuconazonium Sulfate: CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Isavuconazonium Sulfate. Specifically, CYP3A4 Inhibitors (Moderate) may increase isavuconazole serum concentrations. Risk C: Monitor

Isradipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Isradipine. Risk C: Monitor

Itraconazole: May increase serum concentration of Letermovir. Letermovir may decrease serum concentration of Itraconazole. Risk C: Monitor

Ivabradine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ivabradine. Risk X: Avoid

Ivacaftor: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ivacaftor. Management: Ivacaftor dose reductions may be required; consult full drug interaction monograph content for age- and weight-specific dosage recommendations. Risk D: Consider Therapy Modification

Ivosidenib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ivosidenib. Management: Avoid use of moderate CYP3A4 inhibitors with ivosidenib whenever possible. If combined, monitor for increased ivosidenib toxicities, including QTc prolongation. Risk D: Consider Therapy Modification

Ixabepilone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ixabepilone. Risk C: Monitor

Lapatinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lapatinib. Risk C: Monitor

Larotrectinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Larotrectinib. Risk C: Monitor

Lefamulin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lefamulin. Management: Monitor for lefamulin adverse effects during coadministration of lefamulin tablets with moderate CYP3A4 inhibitors. Risk C: Monitor

Leflunomide: May increase serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor

Lemborexant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lemborexant. Risk X: Avoid

Leniolisib: May increase serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk X: Avoid

Lercanidipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lercanidipine. Risk C: Monitor

Levamlodipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Levamlodipine. Risk C: Monitor

Levoketoconazole: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Levoketoconazole. Risk C: Monitor

Levomethadone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Levomethadone. Risk C: Monitor

Levomilnacipran: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Levomilnacipran. Risk C: Monitor

Lidocaine (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lidocaine (Systemic). CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Lidocaine (Systemic). Specifically, concentrations of monoethylglycinexylidide (MEGX) may be increased. Risk C: Monitor

Lomitapide: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lomitapide. Risk X: Avoid

Lonafarnib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lonafarnib. Risk C: Monitor

Lovastatin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lovastatin. Risk C: Monitor

Lumacaftor and Ivacaftor: May increase serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors or Inducers). Lumacaftor and Ivacaftor may decrease serum concentration of P-glycoprotein/ABCB1 Substrates (High risk with Inhibitors or Inducers). Risk C: Monitor

Lumateperone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lumateperone. Management: Limit the lumateperone dose to 21 mg once daily when used with a moderate CYP3A4 inhibitor. Risk D: Consider Therapy Modification

Lurasidone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lurasidone. Management: Reduce the lurasidone dose by half when initiating therapy with a moderate CYP3A4 inhibitor. If initiating lurasidone in a patient already receiving a moderate CYP3A4 inhibitor, start lurasidone at 20 mg/day with a max dose of 80 mg/day. Risk D: Consider Therapy Modification

Lurbinectedin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Lurbinectedin. Management: Avoid concomitant use of lurbinectedin and moderate CYP3A4 inhibitors when possible. If combined, reduce the lurbinectedin dose by 50%. Risk D: Consider Therapy Modification

Macitentan: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Macitentan. Risk C: Monitor

Manidipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Manidipine. Risk C: Monitor

Maraviroc: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Maraviroc. Risk C: Monitor

Mavacamten: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Mavacamten. Management: Start mavacamten at 5 mg/day if stable on a moderate CYP3A4 inhibitor, and reduce the mavacamten dose by one dose level if initiating a moderate CYP3A4 inhibitor. Avoid initiating moderate CYP3A4 inhibitors in patients on mavacamten 2.5 mg/day. Risk D: Consider Therapy Modification

Mavorixafor: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Mavorixafor. Risk C: Monitor

Meperidine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Meperidine. Risk C: Monitor

Methadone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Methadone. Management: If coadministration with moderate CYP3A4 inhibitors is necessary, consider methadone dose reductions until stable effects are achieved. Monitor patients closely for respiratory depression and sedation. Risk D: Consider Therapy Modification

MethylPREDNISolone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of MethylPREDNISolone. Risk C: Monitor

Methysergide: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Methysergide. Risk X: Avoid

Midazolam: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Midazolam. Management: Avoid concomitant use of nasal midazolam and moderate CYP3A4 inhibitors. Consider alternatives to use with oral midazolam whenever possible and consider using lower midazolam doses. Monitor patients for sedation and respiratory depression if combined. Risk D: Consider Therapy Modification

Midostaurin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Midostaurin. Risk C: Monitor

MiFEPRIStone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of MiFEPRIStone. Risk C: Monitor

Mirodenafil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Mirodenafil. Risk C: Monitor

Mitapivat: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Mitapivat. Management: When coadministered with moderate CYP3A4 inhibitors, doses of mitapivat should not exceed 20 mg twice daily. Additionally, patients should be monitored for changes in hemoglobin response and increased mitapivat adverse effects. Risk D: Consider Therapy Modification

Mobocertinib: CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Mobocertinib. CYP3A4 Inhibitors (Moderate) may increase serum concentration of Mobocertinib. Management: Avoid use of moderate CYP3A4 inhibitors with mobocertinib when possible. If combined, the mobocertinib dose should be reduced by approximately 50% (ie, from 160 mg to 80 mg, 120 mg to 40 mg, or 80 mg to 40 mg). Monitor QTc interval closely. Risk D: Consider Therapy Modification

Modafinil: May decrease serum concentration of Letermovir. Risk X: Avoid

Nafcillin: May decrease serum concentration of Letermovir. Risk X: Avoid

Naldemedine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Naldemedine. Risk C: Monitor

Nalfurafine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Nalfurafine. Risk C: Monitor

Naloxegol: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Naloxegol. Management: The use of naloxegol and moderate CYP3A4 inhibitors should be avoided. If concurrent use is unavoidable, reduce naloxegol dose to 12.5 mg once daily and monitor for signs of opiate withdrawal (eg, hyperhidrosis, chills, diarrhea, anxiety, irritability). Risk D: Consider Therapy Modification

Neratinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Neratinib. Risk C: Monitor

Nevirapine: May decrease therapeutic effects of Letermovir. Risk X: Avoid

NIFEdipine (Topical): CYP3A4 Inhibitors (Moderate) may increase serum concentration of NIFEdipine (Topical). Risk C: Monitor

NIFEdipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of NIFEdipine. Risk C: Monitor

NiMODipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of NiMODipine. Risk C: Monitor

Nirogacestat: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Nirogacestat. Risk X: Avoid

Nisoldipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Nisoldipine. Risk X: Avoid

Nitrendipine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Nitrendipine. Risk C: Monitor

Olaparib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Olaparib. Management: Avoid use of moderate CYP3A4 inhibitors with olaparib, if possible. If such concurrent use cannot be avoided, the dose of olaparib tablets should be reduced to 150 mg twice daily and the dose of olaparib capsules should be reduced to 200 mg twice daily. Risk D: Consider Therapy Modification

Oliceridine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Oliceridine. Risk C: Monitor

Olmutinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Olmutinib. Risk C: Monitor

Omaveloxolone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Omaveloxolone. Management: Avoid this combination if possible. If coadministration is required, decrease the omaveloxolone dose to 100 mg daily and monitor closely for adverse reactions. If adverse reactions occur, decrease omaveloxolone to 50 mg daily. Risk D: Consider Therapy Modification

OxyCODONE: CYP3A4 Inhibitors (Moderate) may increase serum concentration of OxyCODONE. Serum concentrations of the active metabolite Oxymorphone may also be increased. Risk C: Monitor

P-glycoprotein/ABCB1 Inducers: May decrease serum concentration of Letermovir. Risk X: Avoid

PACLitaxel (Conventional): CYP3A4 Inhibitors (Moderate) may increase serum concentration of PACLitaxel (Conventional). Risk C: Monitor

PACLitaxel (Protein Bound): CYP3A4 Inhibitors (Moderate) may increase serum concentration of PACLitaxel (Protein Bound). Risk C: Monitor

Pacritinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Pacritinib. Risk C: Monitor

Palbociclib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Palbociclib. Risk C: Monitor

Palovarotene: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Palovarotene. Management: Avoid concomitant use of palovarotene and moderate CYP3A4 inhibitors when possible. If combined, decrease palovarotene dose by 50% as described in the full interaction monograph. Monitor for palovarotene toxicities when combined. Risk D: Consider Therapy Modification

Panobinostat: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Panobinostat. Risk C: Monitor

PAZOPanib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of PAZOPanib. Risk C: Monitor

Pemigatinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Pemigatinib. Management: If combined use cannot be avoided, reduce the pemigatinib dose from 13.5 mg daily to 9 mg daily, or from 9 mg daily to 4.5 mg daily. Resume prior pemigatinib dose after stopping the moderate inhibitor once 3 half-lives of the inhibitor has passed. Risk D: Consider Therapy Modification

Pexidartinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Pexidartinib. Management: If combined use cannot be avoided, pexidartinib dose should be reduced as follows: reduce pexidartinib doses of 500 mg or 375 mg daily to 125 mg twice daily; reduce pexidartinib 250 mg daily to 125 mg once daily. Risk D: Consider Therapy Modification

Pimavanserin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Pimavanserin. Risk C: Monitor

Pimecrolimus: CYP3A4 Inhibitors (Moderate) may decrease metabolism of Pimecrolimus. Risk C: Monitor

Pimozide: Letermovir may increase serum concentration of Pimozide. Risk X: Avoid

Piperaquine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Piperaquine. Risk C: Monitor

Pirtobrutinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Pirtobrutinib. Risk C: Monitor

Pitavastatin: Letermovir may increase serum concentration of Pitavastatin. Risk X: Avoid

PONATinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of PONATinib. Risk C: Monitor

Pralsetinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Pralsetinib. Management: If this combo cannot be avoided, decrease pralsetinib dose from 400 mg daily to 300 mg daily; from 300 mg daily to 200 mg daily; and from 200 mg daily to 100 mg daily. Risk D: Consider Therapy Modification

Prazepam: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Prazepam. Risk C: Monitor

Praziquantel: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Praziquantel. Risk C: Monitor

Pretomanid: May increase serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor

QUEtiapine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of QUEtiapine. Risk C: Monitor

Quinidine (Non-Therapeutic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Quinidine (Non-Therapeutic). Risk C: Monitor

QuiNIDine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of QuiNIDine. Risk C: Monitor

QuiNINE: CYP3A4 Inhibitors (Moderate) may increase serum concentration of QuiNINE. Risk C: Monitor

Ranolazine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ranolazine. Management: Limit the ranolazine dose to a maximum of 500 mg twice daily in patients concurrently receiving moderate CYP3A4 inhibitors. Monitor for increased ranolazine effects and toxicities during concomitant use. Risk D: Consider Therapy Modification

Red Yeast Rice: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Red Yeast Rice. Risk C: Monitor

Regorafenib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Regorafenib. CYP3A4 Inhibitors (Moderate) may decrease active metabolite exposure of Regorafenib. Risk C: Monitor

Repaglinide: Letermovir may increase serum concentration of Repaglinide. Management: Monitor for increased repaglinide effects/toxicities (ie, hypoglycemia) if combined with letermovir. When letermovir is coadministered with cyclosporine, the use of repaglinide is not recommended. Risk C: Monitor

Repotrectinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Repotrectinib. Risk X: Avoid

Ribociclib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ribociclib. Risk C: Monitor

Rimegepant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Rimegepant. Management: If taking rimegepant for the acute treatment of migraine, avoid a second dose of rimegepant within 48 hours when used concomitantly with moderate CYP3A4 inhibitors. No dose adjustment needed if using rimegepant for prevention of episodic migraine. Risk D: Consider Therapy Modification

Rivaroxaban: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Rivaroxaban. This warning is more specifically for drugs that are inhibitors of both CYP3A4 and P-glycoprotein. For erythromycin, refer to more specific erythromycin-rivaroxaban monograph recommendations. Risk C: Monitor

Roflumilast-Containing Products: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Roflumilast-Containing Products. Risk C: Monitor

Rosiglitazone: Letermovir may increase serum concentration of Rosiglitazone. Risk C: Monitor

Rupatadine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Rupatadine. Risk C: Monitor

Ruxolitinib (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ruxolitinib (Systemic). Risk C: Monitor

Salmeterol: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Salmeterol. Risk C: Monitor

Saquinavir: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Saquinavir. Risk C: Monitor

SAXagliptin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of SAXagliptin. Risk C: Monitor

Selpercatinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Selpercatinib. Management: Avoid combination if possible. If use is necessary, reduce selpercatinib dose as follows: from 120 mg twice/day to 80 mg twice/day, or from 160 mg twice/day to 120 mg twice/day. Risk D: Consider Therapy Modification

Selumetinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Selumetinib. Management: Avoid concomitant use when possible. If combined, selumetinib dose reductions are recommended and vary based on body surface area and selumetinib dose. For details, see the full drug interaction monograph or selumetinib prescribing information. Risk D: Consider Therapy Modification

Sertindole: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Sertindole. Risk X: Avoid

Sildenafil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Sildenafil. Risk C: Monitor

Silodosin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Silodosin. Risk C: Monitor

Simeprevir: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Simeprevir. Risk X: Avoid

Simvastatin: Letermovir may increase serum concentration of Simvastatin. Risk X: Avoid

Sirolimus (Conventional): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Sirolimus (Conventional). Management: Monitor for increased serum concentrations of sirolimus if combined with a moderate CYP3A4 inhibitor. Lower initial sirolimus doses or sirolimus dose reductions will likely be required. Risk D: Consider Therapy Modification

Sirolimus (Protein Bound): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Sirolimus (Protein Bound). Management: Reduce the dose of protein bound sirolimus to 56 mg/m2 when used concomitantly with a moderate CYP3A4 inhibitor. Risk D: Consider Therapy Modification

Solifenacin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Solifenacin. Risk C: Monitor

Sonidegib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Sonidegib. Management: Avoid concomitant use of sonidegib and moderate CYP3A4 inhibitors when possible. When concomitant use cannot be avoided, limit CYP3A4 inhibitor use to less than 14 days and monitor for sonidegib toxicity (particularly musculoskeletal adverse reactions). Risk D: Consider Therapy Modification

Sparsentan: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Sparsentan. Risk C: Monitor

SUFentanil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of SUFentanil. Risk C: Monitor

SUNItinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of SUNItinib. Risk C: Monitor

Suvorexant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Suvorexant. Management: The recommended dose of suvorexant is 5 mg daily in patients receiving a moderate CYP3A4 inhibitor. The dose can be increased to 10 mg daily (maximum dose) if necessary for efficacy. Risk D: Consider Therapy Modification

Suzetrigine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Suzetrigine. Management: Reduce suzetrigine dose as follows: initiate with 100 mg for 1 dose; then 12 hours after first dose, give 50 mg every 12 hours for doses 2, 3, and 4; then 50 mg every 24 hours for dose 5 and thereafter. Risk D: Consider Therapy Modification

Tacrolimus (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tacrolimus (Systemic). Risk C: Monitor

Tacrolimus (Topical): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tacrolimus (Topical). Risk C: Monitor

Tadalafil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tadalafil. Risk C: Monitor

Tamsulosin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tamsulosin. Risk C: Monitor

Tazemetostat: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tazemetostat. Management: Avoid when possible. If combined, reduce tazemetostat dose from 800 mg twice daily to 400 mg twice daily, from 600 mg twice daily to 400 mg in AM and 200 mg in PM, or from 400 mg twice daily to 200 mg twice daily. Risk D: Consider Therapy Modification

Temsirolimus: CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Temsirolimus. Specifically, concentrations of sirolimus may be increased. Risk C: Monitor

Teriflunomide: May increase serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Risk C: Monitor

Tetrahydrocannabinol and Cannabidiol: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tetrahydrocannabinol and Cannabidiol. Risk C: Monitor

Tetrahydrocannabinol: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tetrahydrocannabinol. Risk C: Monitor

Tezacaftor and Ivacaftor: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tezacaftor and Ivacaftor. Management: If combined with moderate CYP3A4 inhibitors, give tezacaftor/ivacaftor in the morning, every other day; give ivacaftor in the morning, every other day on alternate days. Tezacaftor/ivacaftor dose depends on age and weight; see full Lexi-Interact monograph Risk D: Consider Therapy Modification

Thioridazine: May decrease therapeutic effects of Letermovir. Risk X: Avoid

Thiotepa: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Thiotepa. CYP3A4 Inhibitors (Moderate) may decrease active metabolite exposure of Thiotepa. Risk C: Monitor

Ticagrelor: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ticagrelor. CYP3A4 Inhibitors (Moderate) may decrease active metabolite exposure of Ticagrelor. Risk C: Monitor

Tilidine: CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Tilidine. CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tilidine. Risk C: Monitor

Tofacitinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tofacitinib. Risk C: Monitor

Tolterodine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tolterodine. Risk C: Monitor

Tolvaptan: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tolvaptan. Management: Avoid this combination with Samsca brand of tolvaptan. Reduce dose for Jynarque brand: 90 mg AM and 30 mg PM, reduce to 45 mg AM and 15 mg PM; 60 mg AM and 30 mg PM, reduce to 30 mg AM and 15 mg PM; 45 mg AM and 15 mg PM, reduce to 15 mg AM and PM. Risk D: Consider Therapy Modification

Toremifene: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Toremifene. Risk C: Monitor

Trabectedin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Trabectedin. Risk C: Monitor

TraMADol: CYP3A4 Inhibitors (Moderate) may increase serum concentration of TraMADol. CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of TraMADol. Risk C: Monitor

TraZODone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of TraZODone. Risk C: Monitor

Tretinoin (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Tretinoin (Systemic). Risk C: Monitor

Triamcinolone (Systemic): CYP3A4 Inhibitors (Moderate) may increase serum concentration of Triamcinolone (Systemic). Risk C: Monitor

Triazolam: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Triazolam. Management: Consider triazolam dose reduction in patients receiving concomitant moderate CYP3A4 inhibitors. Risk D: Consider Therapy Modification

Trofinetide: May increase serum concentration of OATP1B1/1B3 (SLCO1B1/1B3) Substrates (Clinically Relevant with Inhibitors). Management: Avoid concurrent use with OATP1B1/1B3 substrates for which small changes in exposure may be associated with serious toxicities. Monitor for evidence of an altered response to any OATP1B1/1B3 substrate if used together with trofinetide. Risk D: Consider Therapy Modification

Ubrogepant: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Ubrogepant. Management: Use an initial ubrogepant dose of 50 mg and avoid a second dose for 24 hours when used with moderate CYP3A4 inhibitors. Risk D: Consider Therapy Modification

Udenafil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Udenafil. Risk C: Monitor

UGT1A1 Inducers: May decrease serum concentration of Letermovir. Risk X: Avoid

Valbenazine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Valbenazine. CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Valbenazine. Risk C: Monitor

Vamorolone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Vamorolone. Risk C: Monitor

Vanzacaftor, Tezacaftor, and Deutivacaftor: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Vanzacaftor, Tezacaftor, and Deutivacaftor. Management: Age- and weight-specific dose reductions of vanzacaftor, tezacaftor, and deutivacaftor are recommended. Please see full Interact monograph or labeling for details. Risk D: Consider Therapy Modification

Vardenafil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Vardenafil. Management: Limit Levitra (vardenafil) dose to a single 5 mg dose within a 24-hour period if combined with moderate CYP3A4 inhibitors. Avoid concomitant use of Staxyn (vardenafil) and moderate CYP3A4 inhibitors. Combined use is contraindicated outside of the US. Risk D: Consider Therapy Modification

Vemurafenib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Vemurafenib. Risk C: Monitor

Venetoclax: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Venetoclax. Management: Reduce the venetoclax dose by at least 50% in patients requiring concomitant treatment with moderate CYP3A4 inhibitors. Resume the previous venetoclax dose 2 to 3 days after discontinuation of moderate CYP3A4 inhibitors. Risk D: Consider Therapy Modification

Verapamil: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Verapamil. Risk C: Monitor

Vilazodone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Vilazodone. Risk C: Monitor

VinBLAStine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of VinBLAStine. Risk C: Monitor

VinCRIStine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of VinCRIStine. Risk C: Monitor

Vindesine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Vindesine. Risk C: Monitor

Vinflunine: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Vinflunine. CYP3A4 Inhibitors (Moderate) may increase active metabolite exposure of Vinflunine. Risk C: Monitor

Voclosporin: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Voclosporin. Management: Decrease the voclosporin dose to 15.8 mg in the morning and 7.9 mg in the evening when combined with moderate CYP3A4 inhibitors. Risk D: Consider Therapy Modification

Vorapaxar: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Vorapaxar. Risk C: Monitor

Voriconazole: Letermovir may decrease serum concentration of Voriconazole. Management: If concomitant administration of voriconazole with letermovir cannot be avoided, monitor for reduced voriconazole serum concentrations and efficacy. Risk D: Consider Therapy Modification

Warfarin: Letermovir may decrease serum concentration of Warfarin. Risk C: Monitor

Zanubrutinib: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Zanubrutinib. Management: Decrease the zanubrutinib dose to 80 mg twice daily during coadministration with a moderate CYP3A4 inhibitor. Further dose adjustments may be required for zanubrutinib toxicities, refer to prescribing information for details. Risk D: Consider Therapy Modification

Zopiclone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Zopiclone. Risk C: Monitor

Zuranolone: CYP3A4 Inhibitors (Moderate) may increase serum concentration of Zuranolone. Risk C: Monitor

Pregnancy Considerations

Adverse events were observed in some animal reproduction studies.

Monitoring Parameters

Monitor for cytomegalovirus (CMV) reactivation; serum creatinine (especially in patients with CrCl <50 mL/minute [due to potential accumulation of IV vehicle hydroxypropyl betadex]).

Mechanism of Action

Letermovir inhibits cytomegalovirus (CMV) replication by targeting the CMV DNA terminase complex (pUL51, pUL56, pUL89), which is required for viral DNA processing and packaging. Letermovir affects production of genome unit lengths and alters virion maturation.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: IV: 45.5 L.

Protein binding: 99%.

Metabolism: Hepatic via UGT1A1/1A3 (minor).

Bioavailability: Oral: Healthy subjects (without cyclosporine): 94%; hematopoietic cell transplant (HCT) recipients (480 mg orally once daily without cyclosporine): 35%; HCT recipients (240 mg orally once daily with cyclosporine): 85%; kidney transplant recipients (480 mg once daily without cyclosporine): 56%.

Half-life elimination: 12 hours.

Time to peak: 1.5 to 3 hours.

Excretion: Feces: 93% (70% as unchanged drug); urine: <2%.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Letermovir AUC was approximately 1.9- and 1.4-fold higher in subjects with moderate (eGFR 30 to 59 mL/minute/1.73 m2) and severe (eGFR <30 mL/minute/1.73 m2) renal impairment, respectively, compared to healthy subjects (eGFR ≥90 mL/minute/1.73 m2) (Kropeit 2017b).

Post kidney transplant: AUC was approximately 1.1-, 1.3-, and 1.4-fold higher in subjects with mild (CrCl 60 mL/minute to <90 mL/minute), moderate (CrCl 30 mL/minute to <60 mL/minute), and severe (CrCl 15 mL/minute to <30 mL/minute) renal impairment, respectively (compared to subjects with CrCl ≥90 mL/minute).

Hepatic function impairment: Letermovir AUC was approximately 1.6- and 3.8-fold higher in female subjects with moderate (Child-Pugh class B) and severe (Child-Pugh class C) hepatic impairment, respectively, compared to healthy female subjects (Kropeit 2017a).

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Prevymis;
  • (AR) Argentina: Prevymis;
  • (AT) Austria: Prevymis;
  • (AU) Australia: Prevymis;
  • (BE) Belgium: Prevymis;
  • (BG) Bulgaria: Prevymis;
  • (BR) Brazil: Privymtra;
  • (CH) Switzerland: Prevymis;
  • (CO) Colombia: Prevymis;
  • (CZ) Czech Republic: Prevymis;
  • (DE) Germany: Prevymis;
  • (EC) Ecuador: Prevymis;
  • (ES) Spain: Prevymis;
  • (FI) Finland: Prevymis;
  • (FR) France: Prevymis;
  • (GB) United Kingdom: Prevymis;
  • (GR) Greece: Prevymis;
  • (HK) Hong Kong: Prevymis;
  • (HR) Croatia: Prevymis;
  • (HU) Hungary: Prevymis;
  • (IE) Ireland: Prevymis;
  • (IT) Italy: Prevymis;
  • (JO) Jordan: Prevymis;
  • (JP) Japan: Prevymis;
  • (KR) Korea, Republic of: Prevymis;
  • (LB) Lebanon: Prevymis;
  • (LV) Latvia: Prevymis;
  • (MY) Malaysia: Prevymis;
  • (NL) Netherlands: Prevymis;
  • (NO) Norway: Prevymis;
  • (NZ) New Zealand: Prevymis;
  • (PL) Poland: Prevymis;
  • (PR) Puerto Rico: Prevymis;
  • (PT) Portugal: Prevymis;
  • (QA) Qatar: Prevymis;
  • (RO) Romania: Prevymis;
  • (SA) Saudi Arabia: Prevymis;
  • (SE) Sweden: Prevymis;
  • (SG) Singapore: Prevymis;
  • (SI) Slovenia: Prevymis;
  • (SK) Slovakia: Prevymis;
  • (TW) Taiwan: Prevymis;
  • (UA) Ukraine: Prevymis;
  • (ZA) South Africa: Prevymis
  1. Blaszczyk A, Brandt N, Ashley J, Tuders N, Doles H, Stefanacci RG. Crushed tablet administration for patients with dysphagia and enteral feeding: challenges and considerations. Drugs Aging. 2023;40(10):895-907. doi:10.1007/s40266-023-01056-y [PubMed 37707775]
  2. Boullata JI. Guidebook on Enteral Medication Administration. American Society for Parenteral and Enteral Nutrition; 2019.
  3. César T, Le MP, Klifa R, et al. Letermovir for CMV prophylaxis in very high-risk pediatric hematopoietic stem cell transplantation recipients for inborn errors of immunity. J Clin Immunol. 2023;44(1):6. doi:10.1007/s10875-023-01617-1 [PubMed 38117473]
  4. Chen K, Cheng MP, Hammond SP, Einsele H, Marty FM. Antiviral prophylaxis for cytomegalovirus infection in allogeneic hematopoietic cell transplantation. Blood Adv. 2018;2(16):2159-2175. doi:10.1182/bloodadvances.2018016493 [PubMed 30154125]
  5. Chen TT, David AP, Barthelmess EK, MacBrayne CE. Letermovir for cytomegalovirus prophylaxis in pediatric hematopoietic stem cell transplantation. Pediatr Blood Cancer. 2023;70(11):e30608. doi:10.1002/pbc.30608 [PubMed 37548491]
  6. Cheng CN, Li SS, Yeh YH, Shen CF, Chen JS. Letermovir prophylaxis for cytomegalovirus reactivation in children who underwent hematopoietic stem cell transplantation: a single-institute experience in Taiwan. J Microbiol Immunol Infect. 2022;55(2):323-327. doi:10.1016/j.jmii.2022.01.002 [PubMed 35241378]
  7. Daukshus N, Cirincione A, Siver M, et al. Letermovir for cytomegalovirus prevention in adolescent patients following hematopoietic cell transplantation. J Pediatric Infect Dis Soc. 2022;11(7):337-340. doi:10.1093/jpids/piac017 [PubMed 35472147]
  8. FDA Medical Review. https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209939Orig1s000,209940Orig1s000MedR.pdf. Accessed March 31, 2018.
  9. Galaverna F, Baccelli F, Zama D, et al. Letermovir for cytomegalovirus infection in pediatric patients undergoing allogenic hematopoietic stem cell transplantation: a real-life study by the Infectious Diseases Working Group of Italian Association of Pediatric Hematology-Oncology (AIEOP). Bone Marrow Transplant. Published online January 25, 2024. doi:10.1038/s41409-024-02209-2 [PubMed 38272999]
  10. Groll AH, Schulte JH, Antmen AB, et al. Pharmacokinetics, safety, and efficacy of letermovir for cytomegalovirus prophylaxis in adolescent hematopoietic cell transplantation recipients. J Pediatric Infect Dis. 2024;43(3):203-208. doi:10.1097/INF.0000000000004208
  11. Körholz KF, Füller MA, Hennies M, et al. Letermovir for prophylaxis and pre-emptive therapy of cytomegalovirus infection in paediatric allogeneic haematopoietic cell transplant patients. Paediatr Drugs. 2023;25(2):225-232. doi:10.1007/s40272-022-00547-6 [PubMed 36572834]
  12. Kropeit D, McCormick D, Erb-Zohar K, et al. Pharmacokinetics and safety of the anti-human cytomegalovirus drug letermovir in subjects with hepatic impairment. Br J Clin Pharmacol. 2017a;83(12):2678-2686. doi: 10.1111/bcp.13376. [PubMed 28722153]
  13. Kropeit D, Scheuenpflug J, Erb-Zohar K, et al. Pharmacokinetics and safety of letermovir, a novel anti-human cytomegalovirus drug, in patients with renal impairment. Br J Clin Pharmacol. 2017b;83(9):1944-1953. doi: 10.1111/bcp.13292. [PubMed 28345163]
  14. Kuhn A, Puttkammer J, Madigan T, et al. Letermovir as cytomegalovirus prophylaxis in a pediatric cohort: a retrospective analysis. Transplant Cell Ther. 2023;29(1):62.e1-62.e4. doi:10.1016/j.jtct.2022.10.005 [PubMed 36244677]
  15. Letermovir treatment in pediatric participants following allogeneic haematopoietic stem cell transplantation (HSCT) (MK-8228-030). ClinicalTrials.gov identifier: NCT03940586. https://clinicaltrials.gov/study/NCT03940586. Updated January 30, 2024. Accessed February 29, 2024.
  16. Limaye AP, Budde K, Humar A, et al. Letermovir vs valganciclovir for prophylaxis of cytomegalovirus in high-risk kidney transplant recipients: a randomized clinical trial. JAMA. Published online June 6, 2023. doi:10.1001/jama.2023.9106 [PubMed 37279999]
  17. Marschall M, Stamminger T, Urban A, et al. In vitro evaluation of the activities of the novel anticytomegalovirus compound AIC246 (letermovir) against herpesviruses and other human pathogenic viruses. Antimicrob Agents Chemother. 2012;56(2):1135-1137. doi: 10.1128/AAC.05908-11. [PubMed 22106211]
  18. Marty FM, Ljungman P, Chemaly RF, et al. Letermovir prophylaxis for cytomegalovirus in hematopoietic-cell transplantation. N Engl J Med. 2017;377(25):2433-2444. doi:10.1056/NEJMoa1706640 [PubMed 29211658]
  19. Pai VB, Tansmore J, Song E. Pharmacokinetic analysis driven letermovir dosing in pediatric hematopoietic cell transplantation patients with resistant CMV disease. Pediatr Transplant. Published online July 19, 2023. doi:10.1111/petr.14580 [PubMed 37466088]
  20. Prevymis (letermovir) tablets, pellets, and injection [prescribing information]. Rahway, NJ: Merck Sharp & Dohme LLC; August 2024.
  21. Prevymis (letermovir) tablets and injection [product monograph]. Kirkland, Quebec, Canada: Merck Canada Inc; March 2024.
  22. Refer to manufacturer's labeling.
  23. Richert-Przygonska M, Jaremek K, Debski R, et al. Letermovir prophylaxis for cytomegalovirus infection in children after hematopoietic cell transplantation. Anticancer Res. 2022;42(7):3607-3612. doi:10.21873/anticanres.15848 [PubMed 35790275]
  24. Tomblyn M, Chiller T, Einsele H, et al; Center for International Blood and Marrow Research; National Marrow Donor program; European Blood and Marrow Transplant Group; et al. Guidelines for preventing infectious complications among hematopoietic cell transplantation recipients: a global perspective [published correction appears in: Biol Blood Marrow Transplant. 2010;16(2):294]. Biol Blood Marrow Transplant. 2009;15(10):1143-1238. doi: 10.1016/j.bbmt.2009.06.019. [PubMed 19747629]
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