Applies to the following strength(s): 10 mg ; 15 mg ; 20 mg
The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Multiple Myeloma
-Initial dose: 20 mg orally once every other day for 3 doses per week (on Days 1, 3, 5, 8, 10, 12) in Weeks 1 and 2 of each 21-day cycle for up to 8 cycles
-Duration of therapy: Up to 16 cycles (48 weeks)
-Consider continuing treatment of this drug for an additional 8 cycles (16 cycles total) for patients with clinical benefit who do not experience unresolved severe or medically significant toxicity.
-This drug is administered in combination with bortezomib and dexamethasone. Consult manufacturer product information for the recommended dosing for these two drugs.
Use: Treatment of patients with multiple myeloma who have received at least 2 prior regimens, including bortezomib and an immunomodulatory agent
Renal Dose Adjustments
-No adjustment recommended in the manufacturer product information.
-End stage renal disease: Data not available; dialyzability of drug is unknown.
Liver Dose Adjustments
-Mild liver impairment (bilirubin 1.0 or less x ULN and AST greater than 1.0 to 1.5 x ULN, any AST): Reduce dose to 15 mg orally.
-Moderate liver impairment (bilirubin greater than 1.5 to 3.0 x ULN, any AST): Reduce dose to 10 mg orally.
-Severe liver impairment: Avoid use.
ADVERSE DRUG REACTION MANAGEMENT:
-Reduce dose by 5 mg increments.
-If dosing reduced below 10 mg given 3 times per week, discontinue drug.
-Keep the same treatment schedule (3-week cycle) during dose reduction.
Hemoglobin (Hb) less than 8 g/dL, CTCAE Grade 3:
-Interrupt treatment until Hb 10 g/dL or greater; restart at reduced dose.
CONCOMITANT USE WITH STRONG CYP450 3A INHIBITORS:
-Reduce starting dose to 10 mg orally.
-Moderate Diarrhea (4 to 6 stools/day), CTCAE Grade 2: Interrupt treatment until resolved; restart at same dose.
-Severe Diarrhea (7 stools or more/day), IV fluids or hospitalization required, CTCAE Grade 3: Interrupt treatment until resolved; restart at reduced dose.
-Life-threatening Diarrhea, CTCAE Grade 4: Permanently discontinue drug.
NAUSEA OR VOMITING:
-Severe Nausea, CTCAE Grade 3/4: Interrupt treatment until resolved then restart at reduced dose.
-Severe/Life-threatening Vomiting, CTCAE Grade 3/4: Interrupt treatment until resolved then restart at reduced dose.
-Absolute Neutrophil Count (ANC) 0.75 to 1.0 x 10(9)/L, CTCAE Grade 3: Maintain dose.
-ANC 0.5 to 0.75 x 10(9)/L, CTCAE Grade 3 (2 or more occurrences): Interrupt dose until ANC 1.0 x 10(9)/L or greater then restart at same dose.
-ANC less than 1.0 x 10(9)/L, CTCAE Grade 3 with febrile neutropenia (any grade): Interrupt dose until febrile neutropenia resolves and ANC 1.0 x 10(9)/L or greater then restart at reduced dose.
-ANC less than 0.5 x 10(9)/L, CTCAE Grade 4: Interrupt dose until ANC 1.0 x 10(9)/L or greater then restart at reduced dose.
OTHER GRADE 3/4 ADVERSE REACTIONS:
Grade 3/4 adverse drug reactions other than thrombocytopenia, neutropenia, or gastrointestinal toxicity:
-CTC Grade 2 toxicity recurrence and CTC Grade 3/4: Omit the dose until recovery to CTC Grade 1 or less and restart treatment at a reduced dose.
-CTC Grade 3/4 toxicity recurrence: Consider a further dose reduction once the adverse events have resolved to CTC Grade 1 or less.
-Platelets less than 50 x 10(9)/L, CTCAE Grade 3: Maintain dose; monitor platelet counts at least weekly.
-Platelets less than 50 x 10(9)/L with bleeding, CTCAE Grade 3: Interrupt treatment; monitor platelet counts at least weekly until 50 x 10(9)/L or greater then restart at reduced dose.
-Platelets less than 25 x 10(9)/L, CTCAE Grade 4: Interrupt treatment; monitor platelet counts at least weekly until 50 x 10(9)/L or greater then restart at reduced dose.
US REMS: The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for this drug. It includes a communication plan. For additional information: www.fda.gov/REMS.
US BOXED WARNING:
-SEVERE DIARRHEA: Severe diarrhea occurred in 25% of patients. Monitor for symptoms, institute anti-diarrheal treatment, interrupt and then reduce dose or discontinue this drug.
-CARDIAC TOXICITIES: Severe and fatal cardiac ischemic events, severe arrhythmias, and ECG changes have occurred in patients. Arrhythmias may be exacerbated by electrolyte abnormalities. Obtain ECG and electrolytes at baseline and periodically during treatment as clinically indicated.
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 on each scheduled day at approximately the same time, with or without food.
-A missed dose can be taken up to 12 hours after the specified dose time.
-If vomiting occurs, the patient should not repeat the dose but should take the next usual scheduled dose.
-This drug should be swallowed whole with a cup of water; do not chew, crush, or open capsules.
-Avoid direct contact of the powder in the capsules with the skin or mucous membranes.
-Protect from light; store in original carton.
-Accelerated FDA approval based on progression-free survival. Continued approval may be contingent upon verification and description of clinical benefit in confirmatory trials.
-Preparation, handling, and disposal of this drug should be performed in a manner consistent with safe procedures for cytotoxic agents.
Cardiovascular: ECG (prior to treatment initiation and periodically during treatment)
Hematologic: CBC (prior to treatment initiation and at least weekly during treatment)
Hepatic: Liver function tests (prior to treatment initiation and regularly during treatment)
Metabolism: Electrolytes, hydration status (prior to treatment initiation and periodically during treatment)
-Avoid star fruit, pomegranate, and grapefruit while taking this drug as they may increase the drug amount in your blood to a harmful level.
-Wash skin thoroughly if it comes into direct contact with the powder in the capsules.
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