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تعداد آیتم قابل مشاهده باقیمانده : 1 مورد

Pomalidomide: Drug information

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

For abbreviations, symbols, and age group definitions show table
ALERT: US Boxed Warning
Pregnancy:

Pomalidomide is contraindicated in pregnancy. Pomalidomide is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting pomalidomide treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping pomalidomide treatment. Pomalidomide is only available through a restricted distribution program called the Pomalyst Risk Evaluation and Mitigation Strategy (REMS). Information about the POMALYST REMS program is available at www.pomalystrems.com or by calling the REMS Call Center at 1-888-423-5436.

Thromboembolic events:

Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in patients with multiple myeloma treated with pomalidomide. Prophylactic antithrombotic measures were employed in clinical trials. Thromboprophylaxis is recommended, and the choice of regimen should be based on assessment of the patient's underlying risk factors.

Brand Names: US
  • Pomalyst
Brand Names: Canada
  • APO-Pomalidomide;
  • JAMP-Pomalidomide;
  • NAT-Pomalidomide;
  • Pomalyst;
  • REDDY-Pomalidomide;
  • SANDOZ Pomalidomide
Pharmacologic Category
  • Angiogenesis Inhibitor;
  • Antineoplastic Agent
Dosing: Adult
Kaposi sarcoma

Kaposi sarcoma: Note: Patients received thromboprophylaxis with low-dose aspirin throughout treatment (Ref). In patients with AIDS-related Kaposi sarcoma, continue highly active antiretroviral therapy (HAART). ANC should be ≥1,000/mm3 and platelets ≥75,000/mm3 prior to initiating new cycles of therapy.

Oral: 5 mg once daily on days 1 to 21 of 28-day cycles (Ref); continue until disease progression or unacceptable toxicity.

Multiple myeloma, relapsed/refractory

Multiple myeloma, relapsed/refractory: Note: ANC should be ≥500/mm3 and platelets ≥50,000/mm3 prior to initiating new cycles of therapy. Thromboprophylaxis is recommended (regimen should be based on assessment of the patient’s underlying risk factors). Institute appropriate management if at risk for tumor lysis syndrome.

Oral: 4 mg once daily on days 1 to 21 of 28-day cycles (in combination with dexamethasone); continue until disease progression or unacceptable toxicity (Ref).

Off-label combinations: Oral: 4 mg once daily on days 1 to 21 of 28-day cycles (in combination with elotuzumab and dexamethasone) until disease progression or unacceptable toxicity (Ref) or 4 mg once daily on days 1 to 21 of 28-day cycles (in combination with daratumumab and dexamethasone) until disease progression (Ref) or 4 mg once daily on days 1 to 21 of 28-day cycles (in combination with daratumumab/hyaluronidase and dexamethasone) until disease progression or unacceptable toxicity (Ref) or 4 mg once daily on days 1 to 21 of 28-day cycles (in combination with isatuximab and dexamethasone) until disease progression (Ref).

Missed doses: May administer a missed dose if within 12 hours of usual dosing time. If >12 hours, skip the dose for that day and resume usual dosing the following day. Do not take 2 doses to make up for a skipped dose.

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

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Kenar D. Jhaveri, MD; Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Altered kidney function: Oral:

CrCl ≥15 mL/minute: No dosage adjustment necessary (Ref).

CrCl <15 mL/minute: Administer 75% to 100% of the usual indication-specific dose depending on patient-specific factors (Ref). Note: Pharmacokinetic evaluations (using data extrapolated from dialysis-dependent patients on nondialysis days) suggest increased pomalidomide exposure (Ref); however, studies in patients with multiple myeloma and severe kidney impairment suggest that 100% of the dose can be administered with acceptable tolerability, although with frequent grade ≥3 adverse events that may necessitate dose adjustment (Ref).

Augmented renal clearance (measured urinary CrCl ≥130 mL/minute/1.73 m2):

Note: Augmented renal clearance (ARC) is a condition that occurs in certain critically ill patients without organ dysfunction and with normal serum creatinine concentrations. Young patients (<55 years of age) admitted post trauma or major surgery are at highest risk for ARC, as well as those with sepsis, burns, or hematologic malignancies. An 8- to 24-hour measured urinary CrCl is necessary to identify these patients (Ref).

Oral: No dose adjustment necessary (Ref).

Hemodialysis, intermittent (thrice weekly): Dialyzable (exact % unknown):

Note: Pharmacokinetic evaluations suggest increased pomalidomide exposure (Ref); however, studies in patients with multiple myeloma and severe kidney impairment, including those on dialysis, suggest that 100% of the dose can be administered with acceptable tolerability, although with frequent grade ≥3 adverse events that may necessitate dose adjustment (Ref).

Oral: Administer 75% to 100% of the usual indication-specific dose depending on patient-specific factors. When a scheduled dose falls on a dialysis day, administer after dialysis (Ref).

Peritoneal dialysis: Oral: No data available. Dose as for patients with CrCl <15 mL/minute (Ref).

CRRT:

Note: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Recommendations are based on high-flux dialyzers and effluent flow rates of 20 to 25 mL/kg/hour (or ~1,500 to 3,000 mL/hour), unless otherwise noted. Close monitoring of response and adverse reactions (eg, hematological toxicity) due to drug accumulation is important.

Oral: No data available. No dosage adjustment necessary (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration):

Note: Drug clearance is dependent on the effluent flow rate, filter type, and method of renal replacement. Close monitoring of response and adverse reactions (eg, hematological toxicity) due to drug accumulation is important.

Oral: No data available. Administer 75% to 100% of the usual indication-specific dose. When scheduled dose falls on a PIRRT day, administer after PIRRT (Ref).

Dosing: Liver Impairment: Adult

Hepatic impairment prior to treatment:

Kaposi sarcoma:

Mild, moderate, or severe impairment (Child-Pugh class A, B, or C): Initial: 3 mg once daily.

Multiple myeloma:

Mild or moderate impairment (Child-Pugh class A or B): Initial: 3 mg once daily.

Severe impairment (Child-Pugh class C): Initial: 2 mg once daily.

Hepatotoxicity during treatment: If liver enzymes are elevated, stop pomalidomide and evaluate; after liver enzymes return to baseline, may consider restarting at a lower dose.

Dosing: Adjustment for Toxicity: Adult

Hematologic toxicities:

Pomalidomide Dose Modifications for Hematologic Toxicities in Kaposi Sarcoma

Toxicity

Severity

Dose modification

Neutropenia

ANC 500 to <1,000/mm3

If day 1 of cycle, withhold pomalidomide until ANC ≥1,000/mm3, then resume pomalidomide at the same dose.

If during the cycle, continue pomalidomide at the current dose.

ANC <500/mm3

Withhold pomalidomide until ANC ≥1,000/mm3, then resume pomalidomide at the same dose.

Neutropenic fever

ANC <1,000/mm3 and a single temperature ≥38.3°C

or

ANC <1,000/mm3 and sustained temperature ≥38°C for >1 hour

Withhold pomalidomide until ANC ≥1,000/mm3, then resume pomalidomide with the dose reduced by 1 mg from the previous dose.

Thrombocytopenia

Platelets 25,000 to <50,000/mm3

If day 1 of cycle, withhold pomalidomide until platelets ≥50,000/mm3, then resume pomalidomide at the same dose.

If during the cycle, continue pomalidomide at the current dose.

Platelets <25,000/mm3

Permanently discontinue pomalidomide.

Permanently discontinue pomalidomide if unable to tolerate a dose of 1 mg once daily.

Pomalidomide Dose Modifications for Hematologic Toxicities in Multiple Myeloma

Toxicity

Severity

Dose modification

Neutropenia

ANC <500/mm3 or neutropenic fever (fever ≥38.5°C and ANC <1,000 /mm3)

Withhold pomalidomide treatment, follow CBC weekly. When ANC returns to ≥500/mm3, resume pomalidomide with the dose reduced by 1 mg from the previous dose.

For each subsequent ANC drop of <500/mm3

Withhold pomalidomide treatment. When ANC returns to ≥500/mm3, resume pomalidomide with the dose reduced by 1 mg from the previous dose.

Thrombocytopenia

Platelets <25,000/mm3

Withhold pomalidomide treatment, follow CBC weekly. When platelets return to ≥50,000/mm3, resume pomalidomide with the dose reduced by 1 mg from the previous dose.

For each subsequent drop <25,000/mm3

Withhold pomalidomide treatment. When platelets return to ≥50,000/mm3, resume pomalidomide with the dose reduced by 1 mg from the previous dose.

Permanently discontinue pomalidomide if unable to tolerate a dose of 1 mg once daily.

Nonhematologic toxicities (Kaposi sarcoma and multiple myeloma):

Grade 2 or 3 skin rash: Consider interrupting or discontinuing pomalidomide.

Angioedema, anaphylaxis, grade 4 rash, skin exfoliation, bullae, or any other severe dermatologic toxicity (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug reaction with eosinophilia and systemic symptoms): Permanently discontinue.

Other grade 3 or 4 toxicities: Withhold pomalidomide treatment until toxicity has resolved to ≤ grade 2, then may restart pomalidomide with the dose reduced by 1 mg less than the previous dose.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

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

>10%:

Cardiovascular: Peripheral edema (25%)

Dermatologic: Skin rash (21%), pruritus (15%)

Endocrine & metabolic: Hypercalcemia (21%), hyperglycemia (11%), hypokalemia (12%), hyponatremia (11%), weight loss (15%)

Gastrointestinal: Constipation (36%), decreased appetite (23%), diarrhea (35%), nausea (36%), vomiting (14%)

Hematologic & oncologic: Anemia (38%; grades 3/4: 23%), leukopenia (13%; grades 3/4: 7%), neutropenia (53%; grades 3/4: 48%), thrombocytopenia (26%; grades 3/4: 22%)

Nervous system: Anxiety (13%), confusion (12%), dizziness (22%), fatigue (≤58%), headache (15%), myasthenia (14%), peripheral neuropathy (21%)

Neuromuscular & skeletal: Arthralgia (17%), asthenia (≤58%), back pain (35%), muscle spasm (21%), musculoskeletal chest pain (23%), musculoskeletal pain (12%), ostealgia (12%)

Renal: Increased serum creatinine (19%), renal failure syndrome (15%)

Respiratory: Cough (17%), dyspnea (36%), epistaxis (17%), pneumonia (28%; includes streptococcal pneumonia), upper respiratory tract infection (37%)

Miscellaneous: Fever (23%)

1% to 10%:

Dermatologic: Hyperhidrosis (7%), night sweats (5%), xeroderma (9%)

Endocrine & metabolic: Dehydration (<10%), hypocalcemia (6%)

Genitourinary: Urinary tract infection (10%)

Hematologic & oncologic: Febrile neutropenia (<10%; grades 3/4: 6%), lymphocytopenia (4%; grades 3/4: 2%)

Infection: Sepsis (<10%)

Nervous system: Chills (10%), insomnia (7%)

Neuromuscular & skeletal: Limb pain (7%), tremor (10%)

Respiratory: Oropharyngeal pain (6%), productive cough (9%)

<1%: Endocrine & metabolic: Weight gain

Frequency not defined:

Cardiovascular: Acute myocardial infarction, angina pectoris, arterial thromboembolism, atrial fibrillation, cardiac failure, cerebrovascular accident, deep vein thrombosis, hypotension, ischemic heart disease, pulmonary embolism, septic shock, syncope, venous thromboembolism

Dermatologic: Cellulitis

Endocrine & metabolic: Hyperkalemia

Gastrointestinal: Abdominal pain, Clostridioides difficile associated diarrhea

Genitourinary: Pelvic pain, urinary retention, urinary tract infection with sepsis

Hepatic: Hepatic failure, hepatoxicity, hyperbilirubinemia, increased serum alanine aminotransferase

Infection: Bacteremia, neutropenic sepsis, viral infection

Nervous system: Altered mental status, falling, impaired consciousness, noncardiac chest pain, vertigo

Neuromuscular & skeletal: Bone fracture, vertebral compression fracture

Respiratory: Bronchospasm, interstitial pulmonary disease, lobar pneumonia, pneumonia due to Pneumocystis jirovecii, pulmonary infection, respiratory failure, respiratory syncytial virus infection

Miscellaneous: Failure to thrive, multiorgan failure, physical health deterioration

Postmarketing:

Dermatologic: Severe dermatological reaction, Stevens-Johnson syndrome, toxic epidermal necrolysis

Endocrine & metabolic: Hyperthyroidism, hypothyroidism

Gastrointestinal: Gastrointestinal hemorrhage

Hematologic & oncologic: Basal cell carcinoma of skin, pancytopenia, squamous cell carcinoma of skin, tumor lysis syndrome

Hepatic: Increased liver enzymes

Hypersensitivity: Anaphylaxis, angioedema, hypersensitivity reaction

Immunologic: Drug reaction with eosinophilia and systemic symptoms, organ transplant rejection

Infection: Herpes zoster infection, reactivation of HBV

Nervous system: Progressive multifocal leukoencephalopathy (Ueno 2020)

Contraindications

Severe hypersensitivity (eg, angioedema, anaphylaxis) to pomalidomide or any component of the formulation; pregnancy.

Canadian labeling: Additional contraindications (not in the US labeling): Hypersensitivity to thalidomide or lenalidomide; breastfeeding; women of childbearing potential not using 2 effective means of contraception; male patients unable to comply with required contraceptive measures.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Neutropenia, anemia, and thrombocytopenia commonly occur, including grades 3 and 4 events. Neutropenic fever has also been reported.

• CNS effects: May cause dizziness and/or confusion; caution patients to avoid tasks that require mental alertness (eg, operating machinery or driving). Avoid concomitant medications that may exacerbate dizziness and confusion.

• Dermatologic reactions: Severe cutaneous reactions, including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction with eosinophilia and systemic symptoms (DRESS), have been reported; may be fatal. DRESS may manifest as a cutaneous reaction (eg, rash, exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications, which may include hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis.

• Hepatotoxicity: Hepatic failure (with fatalities) has been reported; elevated bilirubin and ALT have also been observed.

• Hypersensitivity: Hypersensitivity, including angioedema and anaphylactic reactions, have been reported.

• Interstitial lung disease (ILD): ILD and related events (eg, pneumonitis) have been reported.

• Neuropathy: Peripheral and sensory neuropathy occurred in clinical trials, including some cases of grade 3 neuropathy, although no cases of grade 4 neuropathy were observed.

• Secondary malignancy: Acute myelogenous leukemia (AML) as a secondary malignancy has been reported in patients receiving pomalidomide in the investigational treatment of condition(s) other than multiple myeloma.

• Thromboembolic events: Venous and arterial thromboembolic events such as deep vein thrombosis, pulmonary embolism, myocardial infarction (MI), and stroke have occurred in multiple myeloma patients during pomalidomide therapy. Clinical trials utilized antithrombotic prophylaxis. Arterial thrombotic events also included cerebrovascular ischemia and ischemic heart disease. Advise patients to promptly seek medical attention should symptoms (shortness of breath, chest pain, or arm or leg swelling) occur.

• Tumor lysis syndrome: Patients with a high tumor burden may be at risk for tumor lysis syndrome.

Disease-related concerns:

• Hepatic impairment: Use with caution; pomalidomide is hepatically metabolized and systemic exposure may be increased.

• Multiple myeloma: An increase in mortality was noted in 2 clinical studies in patients with multiple myeloma who received pembrolizumab in combination with a thalidomide analogue and dexamethasone. Pembrolizumab should not be used to treat multiple myeloma in combination with a thalidomide analogue and dexamethasone unless as part of a clinical trial.

Special populations:

• Cigarette smokers: Cigarette smoking may induce CYP1A2-mediated metabolism of pomalidomide, potentially reducing its systemic exposure and efficacy.

Other warnings/precautions:

• Blood donation: Patients should not donate blood during pomalidomide treatment and for 4 weeks after therapy discontinuation.

• REMS program: Due to the embryo-fetal risk, pomalidomide is only available through a restricted distribution program (Pomalyst REMS). Pomalidomide should only be prescribed to patients who can understand and comply with the conditions of the Pomalyst REMS program. Prescribers and pharmacies must be certified with the REMS program.

Dosage Forms: US

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

Capsule, Oral:

Pomalyst: 1 mg, 2 mg, 3 mg [contains fd&c blue #2 (indigotine,indigo carmine)]

Pomalyst: 4 mg [contains fd&c blue #1 (brilliant blue), fd&c blue #2 (indigotine,indigo carmine)]

Generic Equivalent Available: US

No

Pricing: US

Capsules (Pomalyst Oral)

1 mg (per each): $1,369.77

2 mg (per each): $1,369.77

3 mg (per each): $1,369.77

4 mg (per each): $1,369.77

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.

Capsule, Oral:

Pomalyst: 1 mg, 2 mg, 3 mg [contains fd&c blue #2 (indigotine,indigo carmine)]

Pomalyst: 4 mg [contains fd&c blue #1 (brilliant blue), fd&c blue #2 (indigotine,indigo carmine)]

Generic: 1 mg, 2 mg, 3 mg, 4 mg

Prescribing and Access Restrictions

In Canada, pomalidomide is only available through a restricted distribution program called RevAid. Only physicians and pharmacists registered with the program are authorized to prescribe or dispense pomalidomide. Patients must also be registered and meet all conditions of the program. Two negative pregnancy tests with a sensitivity of at least 25 milliunits/mL are required prior to initiating therapy in women of childbearing potential. Further information is available at 1-888-738-2431 or www.RevAid.ca.

Administration: Adult

Oral: Administer with or without food. Swallow whole with water; do not break, chew, or open the capsules.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2024 [table 1]).

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 2023; NIOSH 2024; USP-NF 2020).

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and as follows, must be dispensed with this medication:

Pomalyst: https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/204026s034lbl.pdf#page=33

Use: Labeled Indications

Kaposi sarcoma: Treatment of AIDS-related Kaposi sarcoma in adults after failure of highly active antiretroviral therapy (HAART); treatment of Kaposi sarcoma in HIV-negative adults.

Multiple myeloma, relapsed/refractory: Treatment of multiple myeloma (in combination with dexamethasone) in adults who have received at least 2 prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on or within 60 days of completion of the last therapy.

Medication Safety Issues
Sound-alike/look-alike issues:

Pomalidomide may be confused with lenalidomide, thalidomide

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drugs (contraindicated in pregnancy) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Community/Ambulatory Care Settings).

Metabolism/Transport Effects

Substrate of CYP1A2 (Major), CYP2C19 (Minor), CYP2D6 (Minor), CYP3A4 (Minor), P-glycoprotein (Minor); 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 drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Abatacept: Anti-TNF Agents may increase immunosuppressive effects of Abatacept. Risk X: Avoid

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Acrivastine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Alcohol (Ethyl): CNS Depressants may increase CNS depressant effects of Alcohol (Ethyl). Risk C: Monitor

Alizapride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Amisulpride (Oral): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Anakinra: Anti-TNF Agents may increase adverse/toxic effects of Anakinra. An increased risk of serious infection during concomitant use has been reported. Risk X: Avoid

Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor

Articaine: May increase CNS depressant effects of CNS Depressants. Management: Consider reducing the dose of articaine if possible when used in patients who are also receiving CNS depressants. Monitor for excessive CNS depressant effects with any combined use. Risk D: Consider Therapy Modification

Azelastine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of BCG Products. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Benperidol: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Bisphosphonate Derivatives: Angiogenesis Inhibitors (Systemic) may increase adverse/toxic effects of Bisphosphonate Derivatives. Specifically, the risk for osteonecrosis of the jaw may be increased. Risk C: Monitor

Blonanserin: CNS Depressants may increase CNS depressant effects of Blonanserin. Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Risk D: Consider Therapy Modification

Brexanolone: CNS Depressants may increase CNS depressant effects of Brexanolone. Risk C: Monitor

Brimonidine (Topical): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Broccoli: May decrease serum concentration of CYP1A2 Substrates (High risk with Inducers). Risk C: Monitor

Bromopride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Bromperidol: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Buclizine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Buprenorphine: CNS Depressants may increase CNS depressant effects of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Risk D: Consider Therapy Modification

BusPIRone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Canakinumab: Anti-TNF Agents may increase adverse/toxic effects of Canakinumab. Specifically, the risk for serious infections and/or neutropenia may be increased. Risk X: Avoid

Cannabinoid-Containing Products: CNS Depressants may increase CNS depressant effects of Cannabinoid-Containing Products. Risk C: Monitor

Cannabis: May decrease serum concentration of CYP1A2 Substrates (High risk with Inducers). Risk C: Monitor

Certolizumab Pegol: Anti-TNF Agents may increase immunosuppressive effects of Certolizumab Pegol. Risk X: Avoid

Cetirizine (Systemic): May increase CNS depressant effects of CNS Depressants. Management: Consider avoiding this combination if possible. If required, monitor for excessive sedation or CNS depression, limit the dose and duration of combination therapy, and consider CNS depressant dose reductions. Risk D: Consider Therapy Modification

Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Chloral Hydrate/Chloral Betaine: CNS Depressants may increase CNS depressant effects of Chloral Hydrate/Chloral Betaine. Management: Consider alternatives to the use of chloral hydrate or chloral betaine and additional CNS depressants. If combined, consider a dose reduction of either agent and monitor closely for enhanced CNS depressive effects. Risk D: Consider Therapy Modification

Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor

Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid

Chlormethiazole: May increase CNS depressant effects of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider Therapy Modification

Chlorphenesin Carbamate: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor

Ciprofloxacin (Systemic): May increase serum concentration of Pomalidomide. Management: Avoid concomitant use of pomalidomide and ciprofloxacin when possible. If coadministration is considered necessary, consider reducing the pomalidomide dose to 2 mg and monitoring patients for increased pomalidomide effects/toxicities. Risk D: Consider Therapy Modification

Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor

CNS Depressants: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Miscellaneous Oncologic Agents) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing these oncologic agents several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

CYP1A2 Inducers (Moderate): May decrease serum concentration of Pomalidomide. Risk C: Monitor

CYP1A2 Inhibitors (Moderate): May increase serum concentration of Pomalidomide. Risk C: Monitor

CYP1A2 Inhibitors (Strong): May increase serum concentration of Pomalidomide. Management: Avoid when possible. If coadministration is necessary, reduce the pomalidomide dose to 2 mg and monitor for increased pomalidomide effects/toxicities. Risk D: Consider Therapy Modification

Dantrolene: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Daridorexant: May increase CNS depressant effects of CNS Depressants. Management: Dose reduction of daridorexant and/or any other CNS depressant may be necessary. Use of daridorexant with alcohol is not recommended, and the use of daridorexant with any other drug to treat insomnia is not recommended. Risk D: Consider Therapy Modification

Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and immunosuppressants. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

DexmedeTOMIDine: CNS Depressants may increase CNS depressant effects of DexmedeTOMIDine. Management: Monitor for increased CNS depression during coadministration of dexmedetomidine and CNS depressants, and consider dose reductions of either agent to avoid excessive CNS depression. Risk D: Consider Therapy Modification

Diazoxide Choline: May increase serum concentration of CYP1A2 Substrates (High risk with Inhibitors). Risk X: Avoid

Difelikefalin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Difenoxin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Dihydralazine: CNS Depressants may increase hypotensive effects of Dihydralazine. Risk C: Monitor

Dimethindene (Topical): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Dothiepin: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Doxylamine: CNS Depressants may increase CNS depressant effects of Doxylamine. Risk C: Monitor

DroPERidol: May increase CNS depressant effects of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Risk D: Consider Therapy Modification

Emedastine (Systemic): May increase CNS depressant effects of CNS Depressants. Management: Consider avoiding this combination if possible. If required, monitor for excessive sedation or CNS depression, limit the dose and duration of combination therapy, and consider CNS depressant dose reductions. Risk C: Monitor

Entacapone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Erythropoiesis-Stimulating Agents: May increase thrombogenic effects of Pomalidomide. Risk C: Monitor

Esketamine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Estrogen Derivatives: May increase thrombogenic effects of Pomalidomide. Risk C: Monitor

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Flunarizine: CNS Depressants may increase CNS depressant effects of Flunarizine. Risk X: Avoid

Flunitrazepam: CNS Depressants may increase CNS depressant effects of Flunitrazepam. Management: Reduce the dose of CNS depressants when combined with flunitrazepam and monitor patients for evidence of CNS depression (eg, sedation, respiratory depression). Use non-CNS depressant alternatives when available. Risk D: Consider Therapy Modification

HydrOXYzine: May increase CNS depressant effects of CNS Depressants. Management: Consider a decrease in the CNS depressant dose, as appropriate, when used together with hydroxyzine. Increase monitoring of signs/symptoms of CNS depression in any patient receiving hydroxyzine together with another CNS depressant. Risk D: Consider Therapy Modification

Inebilizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating immunosuppressants if possible. If vaccination occurs less than 2 weeks prior to or during therapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Ixabepilone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Kava Kava: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Ketotifen (Systemic): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Kratom: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents. Risk D: Consider Therapy Modification

Lemborexant: May increase CNS depressant effects of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Risk D: Consider Therapy Modification

Levocetirizine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Lisuride: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Lofepramine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Lofexidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Loxapine: CNS Depressants may increase CNS depressant effects of Loxapine. Management: Consider reducing the dose of CNS depressants administered concomitantly with loxapine due to an increased risk of respiratory depression, sedation, hypotension, and syncope. Risk D: Consider Therapy Modification

Magnesium Sulfate: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Melitracen [INT]: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Mequitazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Metergoline: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Methotrimeprazine: CNS Depressants may increase CNS depressant effects of Methotrimeprazine. Methotrimeprazine may increase CNS depressant effects of CNS Depressants. Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Risk D: Consider Therapy Modification

Methoxyflurane: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Metoclopramide: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

MetyroSINE: CNS Depressants may increase sedative effects of MetyroSINE. Risk C: Monitor

Minocycline (Systemic): May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Moxonidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Mumps- Rubella- or Varicella-Containing Live Vaccines may increase adverse/toxic effects of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nabilone: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Nalfurafine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Noscapine: CNS Depressants may increase adverse/toxic effects of Noscapine. Risk X: Avoid

Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor

Olopatadine (Nasal): May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Opicapone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Opioid Agonists: CNS Depressants may increase CNS depressant effects of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider Therapy Modification

Opipramol: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Orphenadrine: CNS Depressants may increase CNS depressant effects of Orphenadrine. Risk X: Avoid

Oxomemazine: May increase CNS depressant effects of CNS Depressants. Risk X: Avoid

Oxybate Salt Products: CNS Depressants may increase CNS depressant effects of Oxybate Salt Products. Management: Consider alternatives to this combination when possible. If combined, dose reduction or discontinuation of one or more CNS depressants (including the oxybate salt product) should be considered. Interrupt oxybate salt treatment during short-term opioid use Risk D: Consider Therapy Modification

OxyCODONE: CNS Depressants may increase CNS depressant effects of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider Therapy Modification

Paliperidone: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Paraldehyde: CNS Depressants may increase CNS depressant effects of Paraldehyde. Risk X: Avoid

Pembrolizumab: May increase adverse/toxic effects of Thalidomide Analogues. Specifically, mortality may be increased when this combination is used for treatment of refractory multiple myeloma. Risk X: Avoid

Perampanel: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Periciazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid

Pipamperone: May increase adverse/toxic effects of CNS Depressants. Risk C: Monitor

Piribedil: CNS Depressants may increase CNS depressant effects of Piribedil. Risk C: Monitor

Pizotifen: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Pramipexole: CNS Depressants may increase sedative effects of Pramipexole. Risk C: Monitor

Primaquine: May increase serum concentration of CYP1A2 Substrates (High risk with Inhibitors). Risk C: Monitor

Procarbazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Rilmenidine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Rilonacept: Anti-TNF Agents may increase adverse/toxic effects of Rilonacept. Risk X: Avoid

Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ropeginterferon Alfa-2b: CNS Depressants may increase adverse/toxic effects of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased. Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider Therapy Modification

Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification

ROPINIRole: CNS Depressants may increase sedative effects of ROPINIRole. Risk C: Monitor

Rotigotine: CNS Depressants may increase sedative effects of Rotigotine. Risk C: Monitor

Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor

Suvorexant: CNS Depressants may increase CNS depressant effects of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider Therapy Modification

Tacrolimus (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Thalidomide: CNS Depressants may increase CNS depressant effects of Thalidomide. Risk X: Avoid

Tobacco (Smoked): May increase adverse/toxic effects of Pomalidomide. Specifically, the risk for thrombosis may be increased. Tobacco (Smoked) may decrease serum concentration of Pomalidomide. Risk C: Monitor

Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid

Trimeprazine: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Live). Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before or during therapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification

Valerian: May increase CNS depressant effects of CNS Depressants. Risk C: Monitor

Vedolizumab: Anti-TNF Agents may increase adverse/toxic effects of Vedolizumab. Risk X: Avoid

Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zolpidem: CNS Depressants may increase CNS depressant effects of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider Therapy Modification

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Miscellaneous Oncologic Agents) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Zuranolone: May increase CNS depressant effects of CNS Depressants. Management: Consider alternatives to the use of zuranolone with other CNS depressants or alcohol. If combined, consider a zuranolone dose reduction and monitor patients closely for increased CNS depressant effects. Risk D: Consider Therapy Modification

Reproductive Considerations

[US Boxed Warning]: In females of reproductive potential, obtain two negative pregnancy tests before starting pomalidomide treatment. Females of reproductive potential must use two forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping pomalidomide. Women of childbearing potential should be treated only if they are able to comply with the conditions of the Pomalyst REMS Program. Pregnancy must be avoided for ≥4 weeks prior to beginning therapy. Contraception should be used in females of reproductive potential during treatment, during treatment interruptions, and for ≥4 weeks after pomalidomide is discontinued. Two forms of effective/reliable contraception or total abstinence from heterosexual intercourse must be used by women of reproductive potential even with a history of infertility (unless due to hysterectomy). Reliable methods of birth control include one highly effective method (eg, tubal ligation, IUD, hormonal [birth control pills, injections, hormonal patches, vaginal rings, or implants], or partner's vasectomy) and one additional effective method (eg, male latex or synthetic condom, diaphragm, or cervical cap). Pregnancy tests should be performed 10 to 14 days and 24 hours prior to beginning therapy; weekly for the first 4 weeks and then every 4 weeks (every 2 weeks if menstrual cycle irregular) thereafter and during therapy interruptions for at least 4 weeks after discontinuation. Pomalidomide must be immediately discontinued for a missed period, abnormal pregnancy test, or abnormal menstrual bleeding; refer patient to a reproductive toxicity specialist if pregnancy occurs during treatment.

Pomalidomide is present in the semen of males taking this medication. Males (including those vasectomized) should use a latex or synthetic condom during any sexual contact with women of childbearing age during treatment, during treatment interruptions, and for 4 weeks after discontinuation. Male patients should not donate sperm.

Pregnancy Considerations

[US Boxed Warning]: Pomalidomide is contraindicated in pregnancy. Pomalidomide is a thalidomide analogue. Thalidomide is a known human teratogen that causes severe birth defects or embryo-fetal death. Anomalies observed in humans following exposure to thalidomide include amelia, phocomelia, bone defects, ear and eye abnormalities, facial palsy, congenital heart defects, urinary and genital tract malformations; mortality in ~40% of infants at or shortly after birth has also been reported. Discontinue immediately if a pregnancy occurs during pomalidomide therapy.

Data collection to monitor pregnancy and infant outcomes following exposure to pomalidomide is ongoing. Any suspected fetal exposure should be reported to the FDA via the MedWatch program (1-800-332-1088) and to REMS Call Center (1-888-423-5436).

Breastfeeding Considerations

It is not known if pomalidomide is present in breast milk. Due to the potential for serious adverse reactions in the breastfed infant, breastfeeding is not recommended by the manufacturer.

Monitoring Parameters

CBC with differential and platelets (weekly for the first 8 weeks [multiple myeloma] or every 2 weeks for the first 12 weeks [Kaposi sarcoma]) and then monthly or as clinically necessary thereafter; renal function (ie, serum creatinine, CrCl); LFTs (monthly). Monitor for signs/symptoms of thromboembolism, neuropathy, tumor lysis syndrome (in patients at risk), hypersensitivity, dermatologic reactions, and interstitial lung disease. Consider thyroid function tests (thyroid-stimulating hormone recommended at baseline and every 2 to 3 months during treatment for structurally similar medications [Hamnvik 2011]). Monitor adherence.

Females of reproductive potential: Pregnancy test 10 to 14 days and 24 hours prior to initiating therapy, weekly during the first month, then monthly thereafter in women with regular menstrual cycles or every 2 weeks in patients with irregular menstrual cycles. Pregnancy tests should be continued for at least 4 weeks after discontinuation.

The American Society of Clinical Oncology hepatitis B virus (HBV) screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends HBV screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Pomalidomide induces cell cycle arrest and apoptosis directly in multiple myeloma cells. It enhances T cell- and natural killer (NK) cell-mediated cytotoxicity, inhibits production of proinflammatory cytokines tumor necrosis factor-α (TNF-α), IL-1, IL-6, and IL-12, and inhibits angiogenesis (Zhu 2013).

Pharmacokinetics (Adult Data Unless Noted)

Absorption: Rapid; slowed by food.

Distribution: Vdss: 62 to 138 L; semen distribution is ~67% of plasma levels (following 4 days of 2 mg/day dosing).

Protein binding: 12% to 44%.

Metabolism: Hepatic, primarily via CYP1A2 and CYP3A4; CYP2C19 and CYP2D6 (minor).

Half-life elimination: ~7.5 hours.

Time to peak: 2 to 3 hours.

Excretion: Urine (73%; 2% as unchanged drug); feces (15%; 8% as unchanged drug); Clearance: 7 to 10 L/hour.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Mean systemic pomalidomide exposure was increased by 38% in patients with severe renal impairment requiring dialysis (creatinine clearance [CrCl] <30 mL/minute requiring dialysis) and 40% in patients with end-stage renal disease (ESRD) (CrCl <15 mL/minute) on non-dialysis days.

Hepatic function impairment: Mean systemic pomalidomide exposure was increased by 51%, 58%, and 72% in patients with mild, moderate, or severe hepatic impairment (Child-Pugh class A, B, or C).

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

  • (AE) United Arab Emirates: Imnovid;
  • (AR) Argentina: Idamida | Imnovid | Lidomid | Pomalid | Pomalidomida eczane | Prontex | Vauximida | Xetrane;
  • (AT) Austria: Imnovid;
  • (AU) Australia: Pomalidomide sandoz | Pomalyst | Pomolide;
  • (BE) Belgium: Imnovid;
  • (BG) Bulgaria: Imnovid;
  • (CH) Switzerland: Imnovid;
  • (CL) Chile: Pomalyst;
  • (CO) Colombia: Ipoprin | Pomalyst;
  • (CZ) Czech Republic: Imnovid;
  • (DE) Germany: Imnovid;
  • (EC) Ecuador: Impedice | Pomalyst | Pomelane | Vauximida;
  • (EE) Estonia: Imnovid;
  • (EG) Egypt: Pomalyst;
  • (ES) Spain: Imnovid;
  • (FI) Finland: Imnovid;
  • (FR) France: Imnovid | Pomalidomide celgene;
  • (GR) Greece: Imnovid;
  • (HK) Hong Kong: Pomalyst;
  • (HR) Croatia: Imnovid;
  • (HU) Hungary: Imnovid;
  • (IE) Ireland: Imnovid;
  • (IN) India: Bdpoma | Ibipolid | Pomahope | Pomalid | Pomalong | Pomavia | Pomcad | Pomide | Pomyelo;
  • (IT) Italy: Imnovid;
  • (JP) Japan: Pomalyst;
  • (KR) Korea, Republic of: Pomalyst;
  • (LB) Lebanon: Imnovid;
  • (LT) Lithuania: Imnovid;
  • (LV) Latvia: Imnovid;
  • (MX) Mexico: Imnovid;
  • (MY) Malaysia: Pomalyst;
  • (NL) Netherlands: Imnovid;
  • (NO) Norway: Pomalyst;
  • (NZ) New Zealand: Pomalyst;
  • (PE) Peru: Pomalid | Pomalyst;
  • (PR) Puerto Rico: Pomalyst;
  • (PT) Portugal: Imnovid;
  • (PY) Paraguay: Pomalyst;
  • (QA) Qatar: Imnovid;
  • (RO) Romania: Imnovid;
  • (RU) Russian Federation: Imatango | Imnovid | Myelodest | Pomalidomide tl;
  • (SA) Saudi Arabia: Imnovid | Pomalidomide spc | Pomalyst;
  • (SE) Sweden: Imnovid;
  • (SG) Singapore: Pomalyst;
  • (SI) Slovenia: Imnovid;
  • (SK) Slovakia: Imnovid;
  • (TH) Thailand: Pomalyst;
  • (TR) Turkey: Imnovid | Pomalem;
  • (TW) Taiwan: Pomalyst;
  • (UA) Ukraine: Pomalid | Pomalidomide vista;
  • (ZA) South Africa: Imnovid
  1. Attal M, Richardson PG, Rajkumar SV, et al; ICARIA-MM Study Group. Isatuximab plus pomalidomide and low-dose dexamethasone versus pomalidomide and low-dose dexamethasone in patients with relapsed and refractory multiple myeloma (ICARIA-MM): a randomised, multicentre, open-label, phase 3 study. Lancet. 2019;394(10214):2096-2107. doi: 10.1016/S0140-6736(19)32556-5. [PubMed 31735560]
  2. Bilbao-Meseguer I, Rodríguez-Gascón A, Barrasa H, Isla A, Solinís MÁ. Augmented renal clearance in critically ill patients: a systematic review. Clin Pharmacokinet. 2018;57(9):1107-1121. doi:10.1007/s40262-018-0636-7 [PubMed 29441476]
  3. Chari A, Suvannasankha A, Fay JW, et al. Daratumumab plus pomalidomide and dexamethasone in relapsed and/or refractory multiple myeloma. Blood. 2017;130(8):974-981. [PubMed 28637662]
  4. Dao K, Chtioui H, Lu Y, et al. Pharmacokinetics of pomalidomide in a patient receiving hemodialysis using a high-cutoff filter. Am J Kidney Dis. 2017;69(4):553-554. doi:10.1053/j.ajkd.2016.10.026 [PubMed 28063733]
  5. Dimopoulos MA, Dytfeld D, Grosicki S, et al. Elotuzumab plus pomalidomide and dexamethasone for multiple myeloma. N Engl J Med. 2018a;379(19):1811-1822. doi:10.1056/NEJMoa1805762 [PubMed 30403938]
  6. Dimopoulos MA, Merlini G, Bridoux F, et al; International Myeloma Working Group. Management of multiple myeloma-related renal impairment: recommendations from the International Myeloma Working Group. Lancet Oncol. 2023;24(7):e293-e311. doi:10.1016/S1470-2045(23)00223-1 [PubMed 37414019]
  7. Dimopoulos MA, Sonneveld P, Leung N, et al. International Myeloma Working Group recommendations for the diagnosis and management of myeloma-related renal impairment. J Clin Oncol. 2016;34(13):1544-1557. doi:10.1200/JCO.2015.65.0044 [PubMed 26976420]
  8. Dimopoulos MA, Terpos E, Boccadoro M, et al; APOLLO trial investigators. Daratumumab plus pomalidomide and dexamethasone versus pomalidomide and dexamethasone alone in previously treated multiple myeloma (APOLLO): an open-label, randomised, phase 3 trial. Lancet Oncol. 2021;22(6):801-812. doi:10.1016/S1470-2045(21)00128-5 [PubMed 34087126]
  9. Dimopoulos M, Weisel K, van de Donk NWCJ, et al. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and renal impairment: results from a phase II trial. J Clin Oncol. 2018b;36(20):2035-2043. doi:10.1200/JCO.2017.76.1742 [PubMed 29394124]
  10. Expert opinion. Senior Renal Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.
  11. Hamnvik OP, Larsen PR, and Marqusee E, “Thyroid Dysfunction From Antineoplastic Agents,” J Natl Cancer Inst, 2011, 103(21):1572-87. [PubMed 22010182]
  12. Hodson L, Ovesen J, Couch J, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Managing hazardous drug exposures: information for healthcare settings, 2023. https://doi.org/10.26616/NIOSHPUB2023130. Updated April 2023. Accessed December 27, 2024.
  13. Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
  14. Jian Y, Chang L, Shi MX, et al. Pomalidomide, bortezomib, and dexamethasone for newly diagnosed multiple myeloma patients with renal impairment. Blood Adv. 2023;7(24):7581-7584. doi:10.1182/bloodadvances.2023011428 [PubMed 37922425]
  15. Lacy MQ, Allred JB, Gertz MA, et al, “Pomalidomide Plus Low-Dose Dexamethasone in Myeloma Refractory to Both Bortezomib and Lenalidomide: Comparison of 2 Dosing Strategies in Dual-Refractory Disease,” Blood, 2011, 118(11):2970-5. [PubMed 21690557]
  16. Lacy MQ, Hayman SR, Gertz MA, et al, “Pomalidomide (CC4047) Plus Low Dose Dexamethasone (Pom/Dex) is Active and Well Tolerated in Lenalidomide Refractory Multiple Myeloma (MM),” Leukemia, 2010, 24(11):1934-9. [PubMed 20827286]
  17. Leleu X, Attal M, Arnulf B, et al, “Pomalidomide Plus Low Dose Dexamethasone is Active and Well Tolerated in Bortezomib and Lenalidomide Refractory Multiple Myeloma: IFM 2009-02,” Blood, 2013,121(11):1968-75. [PubMed 23319574]
  18. Li Y, Wang X, O'Mara E, et al. Population pharmacokinetics of pomalidomide in patients with relapsed or refractory multiple myeloma with various degrees of impaired renal function. Clin Pharmacol. 2017;9:133-145. doi:10.2147/CPAA.S144606 [PubMed 29184451]
  19. Li Y, Xu Y, Liu L, Wang X, Palmisano M, Zhou S. Population pharmacokinetics of pomalidomide. J Clin Pharmacol. 2015;55(5):563-572. doi:10.1002/jcph.455 [PubMed 25556560]
  20. Ovesen JL, Sam­mons D, Connor TH, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. NIOSH list of hazardous drugs in healthcare settings, 2024. https://doi.org/10.26616/NIOSHPUB2025103. Updated December 18, 2024. Accessed December 20, 2024.
  21. Polizzotto MN, Uldrick TS, Wyvill KM, et al. Pomalidomide for symptomatic Kaposi's sarcoma in people with and without HIV infection: a phase I/II study. J Clin Oncol. 2016;34(34):4125‐4131. doi:10.1200/JCO.2016.69.3812 [PubMed 27863194]
  22. Pomalyst (pomalidomide) [prescribing information]. Princeton, NJ: Bristol-Myers Squibb Company; March 2023.
  23. Pomalyst (pomalidomide) [product monograph]. Saint-Laurent, Quebec, Canada: Celgene Inc; January 2024.
  24. Refer to manufacturer's labeling.
  25. Richardson PG, Siegel D, Baz R, et al, “Phase I Study of Pomalidomide MTD, Safety and Efficacy in Patients With Refractory Multiple Myeloma Who Have Received Lenalidomide and Bortezomib,” Blood, 2013, 121(11):1961-7. [PubMed 23243282]
  26. Richardson PG, Siegel DS, Vij R, et al. Pomalidomide alone or in combination with low-dose dexamethasone in relapsed and refractory multiple myeloma: a randomized phase 2 study. Blood. 2014;123(12):1826-1832. [PubMed 24421329]
  27. Richter J, Biran N, Duma N, Vesole DH, Siegel D. Safety and tolerability of pomalidomide-based regimens (pomalidomide-carfilzomib-dexamethasone with or without cyclophosphamide) in relapsed/refractory multiple myeloma and severe renal dysfunction: a case series. Hematol Oncol. 2017;35(2):246-251. doi:10.1002/hon.2290 [PubMed 27018162]
  28. San Miguel J, Weisel K, Moreau P, et al. Pomalidomide plus low-dose dexamethasone versus high-dose dexamethasone alone for patients with relapsed and refractory multiple myeloma (MM-003): a randomised, open-label, phase 3 trial. Lancet Oncol. 2013;14(11):1055-1066. [PubMed 24007748]
  29. Siegel DS, Weisel KC, Dimopoulos MA, et al. Pomalidomide plus low-dose dexamethasone in patients with relapsed/refractory multiple myeloma and moderate renal impairment: a pooled analysis of three clinical trials. Leuk Lymphoma. 2016;57(12):2833-2838. doi:10.1080/10428194.2016.1177181 [PubMed 27267105]
  30. Udy AA, Roberts JA, Boots RJ, Paterson DL, Lipman J. Augmented renal clearance: implications for antibacterial dosing in the critically ill. Clin Pharmacokinet. 2010;49(1):1-16. doi:10.2165/11318140-000000000-00000 [PubMed 20000886]
  31. Ueno H, Kikumto M, Takebayashi Y, et al. Pomalidomide-associated progressive multifocal leukoencephalopathy in multiple myeloma: cortical susceptibility-weighted imaging hypointense findings prior to clinical deterioration. J Neurovirol. 2020;26(3):452-455. doi:10.1007/s13365-020-00845-0 [PubMed 32394398]
  32. United States Pharmacopeia. <800> Hazardous Drugs—Handling in Healthcare Settings. In: USP-NF. United States Pharmacopeia; July 1, 2020. Accessed January 16, 2025. doi:10.31003/USPNF_M7808_07_01
  33. Zhu YX, Kortuem KM, and Stewart AK, “Molecular Mechanism of Action of Immune-Modulatory Drugs Thalidomide, Lenalidomide and Pomalidomide in Multiple Myeloma,” Leuk Lymphoma, 2013, 54(4):683-7. [PubMed 22966948]
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