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.
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.
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: 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.
CrCl ≥15 to <60 mL/minute: There are no dosage adjustments provided in the manufacturer's labeling. Compared to patients with normal renal function, pomalidomide pharmacokinetics were not significantly altered in patients with CrCl between 15 to 60 mL/minute.
Hemodialysis: Administer after hemodialysis on dialysis days. Hemodialysis can remove pomalidomide from circulation.
Kaposi sarcoma: Initial: 4 mg once daily.
Multiple myeloma: Initial: 3 mg once daily.
CrCl <45 mL/minute, including hemodialysis (off-label): Results from a phase II study of pomalidomide (in combination with low-dose dexamethasone for treatment of relapsed/refractory multiple myeloma) suggest that pomalidomide 4 mg once daily (for 21 days of a 28-day treatment cycle) was safe and effective in patients with CrCl <45 mL/minute, including patients requiring hemodialysis (Ref).
The International Myeloma Working Group (IMWG) recommendations (Ref): The IMWG recommends use of the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (preferred) or the Modification of Diet in Renal Disease (MDRD) formula to evaluate renal function estimation in multiple myeloma patients with a stable serum creatinine.
CrCl ≥45 mL/minute: No dosage adjustment required.
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.
Hematologic toxicities:
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. |
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.
Refer to adult dosing.
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)
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.
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.
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)]
No
Capsules (Pomalyst Oral)
1 mg (per each): $1,310.79
2 mg (per each): $1,310.79
3 mg (per each): $1,310.79
4 mg (per each): $1,310.79
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.
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
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.
Oral: Administer with or without food. Swallow whole with water; do not break, chew, or open the capsules.
Hazardous agent (NIOSH 2016 [group 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 2016; USP-NF 2020).
An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/204026s031lbl.pdf#page=33 must be dispensed with this medication
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.
Pomalidomide may be confused with lenalidomide, thalidomide
This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.
Substrate of CYP1A2 (major), CYP2C19 (minor), CYP2D6 (minor), CYP3A4 (minor), P-glycoprotein/ABCB1 (minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential
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.
5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Abatacept: Anti-TNF Agents may enhance the immunosuppressive effect of Abatacept. Risk X: Avoid combination
Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy
Alizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Anakinra: Anti-TNF Agents may enhance the adverse/toxic effect of Anakinra. An increased risk of serious infection during concomitant use has been reported. Risk X: Avoid combination
Antithymocyte Globulin (Equine): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of immunosuppressive therapy is reduced. Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor therapy
Azelastine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Baricitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination
BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination
BCG Products: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of BCG Products. Risk X: Avoid combination
Bisphosphonate Derivatives: Angiogenesis Inhibitors (Systemic) may enhance the adverse/toxic effect of Bisphosphonate Derivatives. Specifically, the risk for osteonecrosis of the jaw may be increased. Risk C: Monitor therapy
Blonanserin: CNS Depressants may enhance the CNS depressant effect 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 enhance the CNS depressant effect of Brexanolone. Risk C: Monitor therapy
Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Brincidofovir: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy
Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Broccoli: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Risk C: Monitor therapy
Bromopride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Buprenorphine: CNS Depressants may enhance the CNS depressant effect 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
Canakinumab: Anti-TNF Agents may enhance the adverse/toxic effect of Canakinumab. Specifically, the risk for serious infections and/or neutropenia may be increased. Risk X: Avoid combination
Cannabinoid-Containing Products: CNS Depressants may enhance the CNS depressant effect of Cannabinoid-Containing Products. Risk C: Monitor therapy
Cannabis: May decrease the serum concentration of CYP1A2 Substrates (High risk with Inducers). Risk C: Monitor therapy
Certolizumab Pegol: Anti-TNF Agents may enhance the immunosuppressive effect of Certolizumab Pegol. Risk X: Avoid combination
Chikungunya Vaccine (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Chikungunya Vaccine (Live). Risk X: Avoid combination
Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy
Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination
Chlormethiazole: May enhance the CNS depressant effect 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 enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy
Ciprofloxacin (Systemic): May increase the 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: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination
Cladribine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination
CloZAPine: Myelosuppressive Agents may enhance the adverse/toxic effect of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor therapy
CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy
Coccidioides immitis Skin Test: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the diagnostic effect of Coccidioides immitis Skin Test. 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 (Adenovirus Vector): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification
COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy
COVID-19 Vaccine (mRNA): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy
COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy
CYP1A2 Inducers (Moderate): May decrease the serum concentration of Pomalidomide. Risk C: Monitor therapy
CYP1A2 Inhibitors (Moderate): May increase the serum concentration of Pomalidomide. Risk C: Monitor therapy
CYP1A2 Inhibitors (Strong): May increase the 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
Daridorexant: May enhance the CNS depressant effect 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 enhance the neutropenic effect 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 enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination
Denosumab: May enhance the immunosuppressive effect 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 enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
DexmedeTOMIDine: CNS Depressants may enhance the CNS depressant effect 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
Difelikefalin: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination
Doxylamine: CNS Depressants may enhance the CNS depressant effect of Doxylamine. Risk C: Monitor therapy
DroPERidol: May enhance the CNS depressant effect 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
Erythropoiesis-Stimulating Agents: May enhance the thrombogenic effect of Pomalidomide. Risk C: Monitor therapy
Esketamine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Estrogen Derivatives: May enhance the thrombogenic effect of Pomalidomide. Risk C: Monitor therapy
Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination
Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Flunarizine: CNS Depressants may enhance the CNS depressant effect of Flunarizine. Risk X: Avoid combination
Flunitrazepam: CNS Depressants may enhance the CNS depressant effect 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 enhance the CNS depressant effect 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 enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy
Influenza Virus Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Kava Kava: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Kratom: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Leflunomide: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect 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 enhance the CNS depressant effect 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
Lisuride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Lofexidine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect 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
Metoclopramide: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
MetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE. Risk C: Monitor therapy
Minocycline (Systemic): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Mumps- Rubella- or Varicella-Containing Live Vaccines: May enhance the adverse/toxic effect of Immunosuppressants (Miscellaneous Oncologic Agents). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination
Nabilone: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Nadofaragene Firadenovec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid combination
Natalizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination
Ocrelizumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy
Ofatumumab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy
Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy
Olopatadine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Opioid Agonists: CNS Depressants may enhance the CNS depressant effect 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
Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Risk X: Avoid combination
Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination
Oxybate Salt Products: CNS Depressants may enhance the CNS depressant effect 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 enhance the CNS depressant effect 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
Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk X: Avoid combination
Pembrolizumab: May enhance the adverse/toxic effect of Thalidomide Analogues. Specifically, mortality may be increased when this combination is used for treatment of refractory multiple myeloma. Risk X: Avoid combination
Perampanel: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Pidotimod: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy
Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk X: Avoid combination
Piribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil. Risk C: Monitor therapy
Pneumococcal Vaccines: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy
Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Poliovirus Vaccine (Live/Trivalent/Oral). Risk X: Avoid combination
Polymethylmethacrylate: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the potential for allergic or hypersensitivity reactions to 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 enhance the sedative effect of Pramipexole. Risk C: Monitor therapy
Procarbazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Promazine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy
Rabies Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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
Rilonacept: Anti-TNF Agents may enhance the adverse/toxic effect of Rilonacept. Risk X: Avoid combination
Ritlecitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination
Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect 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
Ropeginterferon Alfa-2b: CNS Depressants may enhance the adverse/toxic effect 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
ROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole. Risk C: Monitor therapy
Rotigotine: CNS Depressants may enhance the sedative effect of Rotigotine. Risk C: Monitor therapy
Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapy
Ruxolitinib (Topical): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination
Sipuleucel-T: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect 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 Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Miscellaneous Oncologic Agents). Risk C: Monitor therapy
Suvorexant: CNS Depressants may enhance the CNS depressant effect 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 enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination
Talimogene Laherparepvec: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect 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 combination
Tertomotide: Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination
Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Risk X: Avoid combination
Tobacco (Smoked): May enhance the adverse/toxic effect of Pomalidomide. Specifically, the risk for thrombosis may be increased. Tobacco (Smoked) may decrease the serum concentration of Pomalidomide. Risk C: Monitor therapy
Tofacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination
Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Typhoid Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Typhoid Vaccine. Risk X: Avoid combination
Ublituximab: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy
Upadacitinib: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination
Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of immunosuppressants when possible. Patients vaccinated less than 14 days before initiating or during therapy should be revaccinated at least 3 after therapy is complete. Risk D: Consider therapy modification
Vaccines (Live): Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Vaccines (Live). Risk X: Avoid combination
Valerian: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy
Vedolizumab: Anti-TNF Agents may enhance the adverse/toxic effect of Vedolizumab. Risk X: Avoid combination
Yellow Fever Vaccine: Immunosuppressants (Miscellaneous Oncologic Agents) may enhance the adverse/toxic effect of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Miscellaneous Oncologic Agents) may diminish the therapeutic effect of Yellow Fever Vaccine. Risk X: Avoid combination
Zolpidem: CNS Depressants may enhance the CNS depressant effect 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
Zuranolone: May enhance the CNS depressant effect 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
[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.
[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).
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.
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.
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).
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.
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).
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