Medically reviewed by Drugs.com. Last updated on May 4, 2018.
Applies to the following strengths: 1 mg; 2 mg; 3 mg; 4 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Multiple Myeloma
4 mg orally once a day on Days 1 to 21 of repeated 28-day cycles in combination with dexamethasone until disease progression
-Consult the manufacturer product information for dexamethasone dosing.
Use: In combination with dexamethasone for patients with multiple myeloma 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
Renal Dose Adjustments
Severe renal impairment requiring dialysis: The recommended starting dose is 3 mg daily (25% dose reduction).
Liver Dose Adjustments
-Mild (Child-Pugh A) or moderate (Child-Pugh B) hepatic impairment: The recommended starting dose is 3 mg daily (25% dose reduction).
-Severe (Child-Pugh C) hepatic impairment: The recommended dose is 2 mg (50% dose reduction).
-Absolute neutrophil count (ANC) less than 500 per mcL or febrile neutropenia (fever 38.5 degrees Celsius or more and ANC less than 1000 per mcL): Interrupt therapy; follow CBC weekly.
-ANC return to 500 per mcL or more: Resume therapy at 3 mg daily.
-For each subsequent drop below 500 per mcL: Interrupt therapy.
-Return to 500 per mcL or more: Resume therapy at 1 mg less than the previous dose.
-Platelets less than 25,000 per mcL: Interrupt therapy; follow CBC weekly.
-Platelets return to more than 50,000 per mcL: Resume therapy at 3 mg daily.
-For each subsequent drop below 25,000 per mcL: Interrupt therapy.
-Return to 50,000 per mcL or more: Resume therapy at 1 mg less than the previous dose.
TO INITIATE A NEW THERAPY CYCLE: Neutrophil count must be at least 500 per mcL and platelet count must be at least 50,000 per mcL.
IF TOXICITIES OCCUR AFTER DOSE REDUCTIONS TO 1 MG: Discontinue therapy.
ANGIOEDEMA, SKIN EXFOLIATION, BULLAE, OR ANY OTHER SEVERE DERMATOLOGIC REACTION: Permanently discontinue therapy.
OTHER GRADE 3 OR 4 TOXICITIES: Hold therapy then restart at 1 mg less than the previous dose when toxicity has resolved to Grade 2 or less at the physician's discretion.
CYP450 1A2, 3A4, and P-GP INHIBITORS: Reduce pomalidomide dose by 50% if medically necessary to co-administer strong inhibitors of CYP450 1A2 in the presence of strong inhibitors of CYP450 3A4 and P-gp; Avoid co-administration of strong CYP450 1A2 inhibitors whenever possible.
The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for this drug. DRUG and/or SHARED SYSTEM. It includes elements to assure safe use and an implementation system. For additional information: http://www.accessdata.fda.gov/scripts/cder/rems/index.cfm
US BOXED WARNING:
-EMBRYOFETAL TOXICITY: This drug is contradicted in pregnancy. It is an analog of thalidomide, a known human teratogen that causes severe birth defects or embryo-fetal death. Females of reproductive potential must have 2 negative pregnancy tests before starting therapy, and they must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping therapy. This drug is only available through a restricted distribution program called POMALYST REMS.
-VENOUS AND ARTERIAL THROMBOEMBOLISM: Deep venous thrombosis (DVT), pulmonary embolism (PE), myocardial infarction, and stroke occur in multiple myeloma patients treated with this drug. Thromboprophylaxis is recommended; the choice of regimen should be based on assessment of a patient's underlying risk factors.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
This drug should be taken after completion of dialysis procedure on hemodialysis days.
-This drug should be taken without food, at least 2 hours before or 2 hours after a meal.
-This drug should be taken at the same time each day.
-This drug should be swallowed whole with water.
-Capsules should not be broken, chewed, opened, or crushed.
-A missed dose may still be taken up to 12 hours after the normally scheduled time; the dose should be skipped if more than 12 hours have elapsed. Two doses should not be taken at the same time to make up for a missed dose.
-Handling and disposal of this drug should be performed in a manner consistent with safe procedures for cytotoxic agents.
-Embryofetal Toxicity: Pregnancy testing (1st test within 10 to 14 days and 2nd test within 24 hours prior to therapy initiation, then weekly during first 4 weeks of therapy, and every 4 weeks in women with regular menstrual cycles or every 2 weeks in women with irregular menstrual cycles thereafter)
-Hematologic: Toxicities (e.g., neutropenia, anemia, thrombocytopenia), CBC (baseline, then weekly for first 8 weeks of therapy, and monthly thereafter), signs of bleeding
-Hepatic: Liver function tests (monthly)
-Hypersensitivity: Serious allergic reactions (e.g., angioedema, skin exfoliation, bullae)
-Oncologic: Second primary malignancies
-Do not smoke during therapy as it may affect how well this drug works.
-Do not donate blood, semen, or sperm during therapy (including during dose interruptions) and for at least one month following the end of therapy.
-Avoid driving and other activities that require alertness (such as operating machinery) until you know how this drug affects you.
-Wash your skin immediately with soap and water and flush mucous membranes thoroughly with water if contact with the powder inside the drug capsule occurs.
-Do not give this drug to another person.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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- Drug class: miscellaneous antineoplastics
Other brands: Pomalyst