Your activity: 249 p.v.
your limit has been reached. plz Donate us to allow your ip full access, Email: sshnevis@outlook.com

Pomalidomide: Drug information

Pomalidomide: Drug information
(For additional information see "Pomalidomide: Patient drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Special Alerts
REMS Drugs COVID-19 Safety Alert March 2020

Due to challenges with completion of required laboratory testing or imaging studies for REMS drugs because of self-isolation or quarantine during the COVID-19 public health emergency, the FDA is recommending health care providers prescribing and/or dispensing REMS drugs consider whether there are compelling reasons or not to complete these requirements during this public health emergency and weigh with the patient the benefits and risks of continuing treatment in the absence of the laboratory testing and imaging studies. The FDA will not take action against sponsors and others during the public health emergency for failing to adhere to REMS requirements.

Further information may be found at https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-provides-update-patient-access-certain-rems-drugs-during-covid-19.

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 Pomalyst Risk Evaluation and Mitigation Strategy (REMS).

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
  • Pomalyst
Pharmacologic Category
  • Angiogenesis Inhibitor;
  • Antineoplastic Agent
Dosing: Adult
Kaposi sarcoma

Kaposi sarcoma: Note: Patients received thromboprophylaxis with low-dose aspirin throughout treatment (Polizzotto 2016). 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 (Polizzotto 2016); 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 (Richardson 2014; San Miguel 2013).

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 (Dimopoulos 2018a) or 4 mg once daily on days 1 to 21 of 28-day cycles (in combination with daratumumab and dexamethasone) until disease progression (Chari 2017) 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 (Dimopoulos 2021) or 4 mg once daily on days 1 to 21 of 28-day cycles (in combination with isatuximab and dexamethasone) until disease progression (Attal 2019).

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

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 (Dimopoulos 2018b).

The International Myeloma Working Group (IMWG) recommendations (Dimopoulos 2016): 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.

Dosing: Hepatic 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: Older Adult

Refer to adult dosing.

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.

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)]

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

Generic Equivalent Available: US

No

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)]

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

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.

Medication Guide and/or Vaccine Information Statement (VIS)

An FDA-approved patient medication guide, which is available with the product information and at https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/204026s024lbl.pdf#page=33 must be dispensed with this medication

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 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).

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:

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.

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.

Metabolism/Transport Effects

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

Drug Interactions

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

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

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

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

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

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: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants is not recommended. 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

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

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

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

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

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 Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

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

Tocilizumab: May enhance the immunosuppressive effect of Anti-TNF Agents. Risk X: Avoid combination

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

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

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 Celgene Corporation (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

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

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).

Pricing: US

Capsules (Pomalyst Oral)

1 mg (per each): $1,138.14

2 mg (per each): $1,138.14

3 mg (per each): $1,138.14

4 mg (per each): $1,138.14

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.

Brand Names: International
  • Imnovid (AR, AT, BE, BH, CH, CR, CY, DE, DK, DO, EE, ES, FI, FR, GB, GR, GT, HN, HR, IE, IL, IS, LB, LT, LU, MT, NI, NL, NO, PA, PL, PT, RU, SE, SI, SK, SV, TR);
  • Pomalid (AR);
  • Pomalyst (AU, BB, HK, JP, KR, NZ, TW)


For country code abbreviations (show table)
  1. <800> Hazardous Drugs–Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 43-NF 38). Rockville, MD: United States Pharmacopeia Convention; 2020:74-92.
  2. 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]
  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. 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]
  5. 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]
  6. 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]
  7. 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]
  8. Hamnvik OP, Larsen PR, and Marqusee E, “Thyroid Dysfunction From Antineoplastic Agents,” J Natl Cancer Inst, 2011, 103(21):1572-87. [PubMed 22010182]
  9. 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]
  10. 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]
  11. 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]
  12. 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]
  13. 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]
  14. Pomalyst (pomalidomide) [prescribing information]. Summit, NJ: Celgene Corporation; October 2021.
  15. Pomalyst (pomalidomide) [product monograph]. Saint-Laurent, Quebec, Canada: Celgene Inc; February 2021.
  16. 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]
  17. 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]
  18. 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]
  19. 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]
  20. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. https://www.cdc.gov/niosh/docs/2016-161/. Updated September 2016. Accessed October 5, 2016.
  21. 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]
Topic 88099 Version 300.0