Applies to the following strength(s): 1 mg ; 2 mg ; 3 mg ; 4 mg
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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 until disease progression
-Comments: This drug should be given in combination with dexamethasone; consult the manufacturer product information for dexamethasone dosing when used in combination with pomalidomide.
-Use: Treatment of 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
Avoid in patients with a serum creatinine greater than 3.0 mg/dL.
Liver Dose Adjustments
-Serum bilirubin greater than 2 mg/dL and AST/ALT greater than 3 x upper limit of normal: Not recommended
-Elevated liver enzymes during treatment: Stop treatment; consider a lower dose after enzymes return to baseline values.
-Absolute Neutrophil Count (ANC) less than 500 per mcL or Febrile Neutropenia (fever 38.5 degrees Celsius or more and ANC less than 1,000 per mcL): Interrupt treatment, follow CBC weekly.
-ANC return to 500 per mcL or more: Resume treatment at 3 mg daily.
-For each subsequent drop below 500 per mcL: Interrupt treatment.
-Return to 500 per mcL or more: Resume treatment at 1 mg less than the previous dose.
-Platelets less than 25,000 per mcL: Interrupt treatment, follow CBC weekly.
-Platelets return to more than 50,000 per mcL: Resume treatment at 3 mg daily.
-For each subsequent drop below 25,000 per mcL: Interrupt treatment.
-Return to 50,000 per mcL or more: Resume treatment at 1 mg less than the previous dose.
-TO INITIATE A NEW TREATMENT 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 treatment.
-ANGIOEDEMA, SKIN EXFOLIATION, BULLAE, or ANY OTHER SEVERE DERMATOLOGIC REACTION: Permanently discontinue treatment.
-OTHER GRADE 3 OR 4 TOXICITIES: Hold treatment 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.
US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for this drug. It includes elements to assure safe use and an implementation system. For additional information: www.fda.gov/REMS.
US BOXED WARNING:
-EMBRYOFETAL TOXICITY: Pomalidomide is contradicted in pregnancy. This drug 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 treatment, and they must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after stopping treatment. This drug is only available through a restricted distribution program.
-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.
Data not available
-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.
-Drug 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 treatment initiation, then weekly during first 4 weeks of treatment, 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 treatment, 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 treatment as it may affect how well this drug works.
-Do not donate blood, semen, or sperm during treatment (including during dose interruptions) and for at least one month following the end of treatment.
-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.
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Other brands: Pomalyst