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Maribavir: Drug information

Maribavir: Drug information
(For additional information see "Maribavir: Pediatric drug information" and see "Maribavir: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Livtencity
Brand Names: Canada
  • Livtencity
Pharmacologic Category
  • Antiviral Agent;
  • Benzimidazole Riboside
Dosing: Adult
Cytomegalovirus, refractory, treatment

Cytomegalovirus, refractory, treatment (posttransplant): Oral: 400 mg twice daily (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

Mild, moderate, or severe impairment: No dosage adjustment necessary.

End-stage renal disease, including patients on dialysis: There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Hepatic Impairment: Adult

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

Severe impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer’s labeling (has not been studied).

Dosing: Older Adult

Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Maribavir: Pediatric drug information")

Cytomegalovirus, refractory, treatment

Cytomegalovirus, refractory, treatment; posttransplant: Children ≥12 years and Adolescents weighing ≥35 kg: Oral: 400 mg twice daily.

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

Children ≥12 years and Adolescents:

Mild, moderate, or severe impairment: No dosage adjustment necessary.

End-stage renal disease, including patients on dialysis: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Dosing: Hepatic Impairment: Pediatric

Children ≥12 years and Adolescents:

Mild or moderate impairment: No dosage adjustment necessary.

Severe impairment: There are no dosage adjustments provided in the manufacturer's labeling (has not been studied).

Adverse Reactions

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

>10%:

Gastrointestinal: Diarrhea (19%), nausea (21%), vomiting (14%)

Hematologic & oncologic: Decreased hemoglobin (1% to 32%), decreased platelet count (5% to 18%)

Infection: Infection (23%; including cytomegalovirus disease)

Nervous system: Fatigue (12%), taste disorder (46%)

Renal: Increased serum creatinine (7% to 33%)

1% to 10%: Hematologic & oncologic: Decreased neutrophils (2% to 4%)

Contraindications

There are no contraindications listed in the manufacturer's US labeling.

Canadian labeling: Hypersensitivity to maribavir or any component of the formulation; coadministration with ganciclovir or valganciclovir.

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

Warnings/Precautions

Other warnings/precautions:

• Virologic failure/relapse: Virologic failure due to resistance may occur during and after treatment with maribavir. Virologic relapse posttreatment usually occurs within 4 to 8 weeks after maribavir discontinuation. Some maribavir pUL97 resistance-associated substitutions confer cross-resistance to ganciclovir and valganciclovir. If a patient is not responding to treatment or relapses, check for maribavir resistance.

Dosage Forms: US

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

Tablet, Oral:

Livtencity: 200 mg [contains fd&c blue #1 (brilliant blue)]

Generic Equivalent Available: US

No

Pricing: US

Tablets (Livtencity Oral)

200 mg (per each): $266.78

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.

Tablet, Oral:

Livtencity: 200 mg [contains fd&c blue #1 (brilliant blue)]

Administration: Adult

Oral: Administer with or without food. Tablet may be taken whole, dispersed, or crushed to administer by mouth, or dispersed through an NG or orogastric (OG) tube (≥10 French).

For patients unable to swallow tablets whole, may administer as an oral suspension. Place tablets for prescribed dose in a container and add appropriate volume of drinking water to make a suspension; do not use other liquids. Tablets may also be crushed with a spoon prior to adding water. Swirl container gently to keep particles from settling prior to administration; the mixture will have a bitter taste. After administering the initial suspension, rinse container with 15 mL of drinking water and administer contents; visually inspect container and repeat rinsing of container if particles remain. Oral suspension may be prepared and stored at room temperature for up to 8 hours.

Number of Maribavir Tablets and Volume of Drinking Water Needed to Make Suspension for Oral Administration of Dispersed or Crushed Tablets

Recommended dosage (mg)

Number of 200 mg tablets

Volume of drinking water (mL)

400

2

30

800

4

60

1,200

6

90

NG or OG feeding tube (≥10 French): Place a maximum of 2 tablets (400 mg total) into a 50 or 60 mL catheter-tip compatible syringe. Draw 30 mL of drinking water (do not use other liquids) into syringe and hold syringe with tip pointing upward; pull plunger to a higher volume position (for air space in syringe), return cap on syringe (if applicable), and shake well for ~30 to 45 seconds or until tablets are completely dispersed. Once the tablets are completely dispersed in syringe, attach syringe to the NG or OG tube and administer the dispersion before it settles. Flush with 15 mL of water in the same syringe and NG or OG tube; visually inspect syringe and repeat flushing of NG or OG tube if particles remain. For doses of 800 mg or 1,200 mg, repeat until full dose is administered; same syringe, NG or OG tube may be used. Oral suspension may be prepared and stored at room temperature for up to 8 hours.

Administration: Pediatric

Oral: May administer without regard to food; may administer whole, crushed, or dispersed.

Dispersed or crushed tablet if unable to swallow whole tablet: Add appropriate number of tablets to a suitable container; tablets may be crushed or allowed to disperse without crushing; add 30 mL of drinking water for every 400 mg of drug. Swirl container to mix and administer before drug particles settle. Rinse container with 15 mL of drinking water and administer; if drug particles remain in the container repeat container rinse with 15 mL of water and administer.

Orogastric (OG) or nasogastric (NG) administration of dispersed tablet: Using a 50 to 60 mL OG/NG compatible catheter-tipped syringe, remove the plunger, place 400 mg dose (two 200 mg tablets) in syringe, and put plunger back in place. Draw up 30 mL of drinking water into syringe and pull back plunger further to allow air space in the syringe. Cap syringe and shake syringe well for 30 to 45 seconds until tablets disperse completely; administer. Draw up 15 mL drinking water into the syringe and flush the OG/NG tube; repeat 15 mL flush at least one time, and a second time if any drug particles remain in syringe. If dose >400 mg, repeat all steps for each 400 mg dose increment.

Hazardous Drugs Handling Considerations

This medication is not on the NIOSH (2016) list; however, it may meet the criteria for a hazardous drug. Maribavir may cause teratogenicity and reproductive toxicity.

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2016; USP-NF 2020).

Note: Facilities may perform risk assessment of some hazardous drugs to determine if appropriate for alternative handling and containment strategies (USP-NF 2020). Refer to institution-specific handling policies/procedures.

Use: Labeled Indications

Cytomegalovirus, refractory, treatment (posttransplant): Treatment of posttransplant cytomegalovirus infection/disease that is refractory to treatment (with or without genotypic resistance) with ganciclovir, valganciclovir, cidofovir, or foscarnet in adults and pediatric patients ≥12 years of age and weighing ≥35 kg.

Metabolism/Transport Effects

Substrate of CYP1A2 (minor), CYP3A4 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

CarBAMazepine: May decrease the serum concentration of Maribavir. Management: Increase the dose of maribavir to 800 mg twice daily when combined with carbamazepine. Risk D: Consider therapy modification

CycloSPORINE (Systemic): Maribavir may increase the serum concentration of CycloSPORINE (Systemic). Risk C: Monitor therapy

CYP3A4 Inducers (Moderate): May decrease the serum concentration of Maribavir. Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May decrease the serum concentration of Maribavir. Risk X: Avoid combination

Digoxin: Maribavir may increase the serum concentration of Digoxin. Risk C: Monitor therapy

Everolimus: Maribavir may increase the serum concentration of Everolimus. Risk C: Monitor therapy

Fosphenytoin-Phenytoin: May decrease the serum concentration of Maribavir. Management: Increase the dose of maribavir to 1,200 mg twice daily with concomitant use of fosphenytoin or phenytoin. Risk D: Consider therapy modification

Ganciclovir-Valganciclovir: Maribavir may diminish the therapeutic effect of Ganciclovir-Valganciclovir. Risk X: Avoid combination

PHENobarbital: May decrease the serum concentration of Maribavir. Management: Increase the dose of maribavir to 1,200 mg twice daily with concomitant use of phenobarbital. Risk D: Consider therapy modification

Primidone: May decrease the serum concentration of Maribavir. Management: Increase the dose of maribavir to 1,200 mg twice daily with concomitant use of primidone. Risk D: Consider therapy modification

Rifabutin: May decrease the serum concentration of Maribavir. Risk X: Avoid combination

Rosuvastatin: Maribavir may increase the serum concentration of Rosuvastatin. Risk C: Monitor therapy

Sirolimus Products: Maribavir may increase the serum concentration of Sirolimus Products. Risk C: Monitor therapy

St John's Wort: May decrease the serum concentration of Maribavir. Risk X: Avoid combination

Tacrolimus (Systemic): Maribavir may increase the serum concentration of Tacrolimus (Systemic). Risk C: Monitor therapy

Reproductive Considerations

In initial studies, patients who could become pregnant were required to have a negative pregnancy test prior to treatment and use effective contraception during therapy (Maertens 2019; Papanicolaou 2019).

Pregnancy Considerations

Based on ex vivo human placenta perfusion studies, maribavir is expected to cross the placenta (Faure Bardon 2020).

Adverse events were observed in some animal reproduction studies at doses lower than the equivalent recommended human dose. Pregnant patients were excluded from initial studies (Maertens 2019; Papanicolaou 2019).

Breastfeeding Considerations

It is not known if maribavir is present in breast milk.

The initial studies excluded patients who were breastfeeding (Maertens 2019; Papanicolaou 2019). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and the benefits of treatment to the mother.

Monitoring Parameters

Cytomegalovirus DNA levels and assess for resistance as clinically appropriate; assess for resistance in patients not responding to treatment.

Mechanism of Action

Maribavir is a benzimidazole riboside antiviral that competitively inhibits the protein kinase activity of human cytomegalovirus enzyme pUL97, resulting in inhibition of the phosphorylation of proteins.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vss: 27.3 L.

Protein binding: 98%.

Metabolism: Hepatic via CYP3A4 (major) and CYP1A2 (minor) to inactive metabolites.

Half-life elimination: Transplant recipients: 4.32 hours.

Time to peak: 1 to 3 hours.

Excretion: Urine (61% [<2% unchanged]); feces (14% [5.7% unchanged]).

  1. <800> Hazardous Drugs–Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 43-NF 38). Rockville, MD: United States Pharmacopeia Convention; 2020:74-92.
  2. Avery RK, Alain S, Alexander BD, et al; SOLSTICE Trial Investigators. Maribavir for refractory cytomegalovirus infections with or without resistance post-transplant: results from a phase 3 randomized clinical trial. Clin Infect Dis. 2022;75(4):690-701. doi:10.1093/cid/ciab988 [PubMed 34864943]
  3. Faure Bardon V, Peytavin G, Lê MP, et al. Placental transfer of Letermovir & Maribavir in the ex vivo human cotyledon perfusion model. New perspectives for in utero treatment of congenital cytomegalovirus infection. PLoS One. 2020;15(4):e0232140. doi:10.1371/journal.pone.0232140 [PubMed 32353010]
  4. Livtencity (maribavir) [prescribing information]. Lexington, MA: Takeda Pharmaceuticals America Inc; April 2023.
  5. Livtencity (maribavir) [product monograph]. Toronto, Ontario, Canada: Takeda Canada Inc; September 2022.
  6. Maertens J, Cordonnier C, Jaksch P, et al. Maribavir for preemptive treatment of cytomegalovirus reactivation. N Engl J Med. 2019;381(12):1136-1147. doi:10.1056/NEJMoa1714656 [PubMed 31532960]
  7. Papanicolaou GA, Silveira FP, Langston AA, et al. Maribavir for refractory or resistant cytomegalovirus infections in hematopoietic-cell or solid-organ transplant recipients: a randomized, dose-ranging, double-blind, phase 2 study. Clin Infect Dis. 2019;68(8):1255-1264. doi:10.1093/cid/ciy706 [PubMed 30329038]
  8. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. https://www.cdc.gov/niosh/docs/2016-161/default.html. Updated September 2016. Accessed August 30, 2022.
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