Medically reviewed by Drugs.com. Last updated on May 29, 2019.
Applies to the following strengths: 10 mg; 50 mg; 100 mg; 10 mg-50 mg-100 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Leukemia
Weekly ramp-up schedule over 5 weeks:
Week 1: 20 mg orally once a day
Week 2: 50 mg orally once a day
Week 3: 100 mg orally once a day
Week 4: 200 mg orally once a day
Week 5: 400 mg orally once a day
Start after the patient has completed the 5-week dose ramp-up schedule and has received the 400-mg dose for 7 days: 400 mg orally once a day until disease progression or unacceptable toxicity
IN COMBINATION WITH RITUXIMAB:
-Start rituximab after the patient has completed the 5-week dose ramp-up schedule and has received the 400-mg dose for 7 days.
-Administer rituximab on Day 1 of each 28-day cycle for 6 cycles at 375 mg/m2 IV for Cycle 1 and 500 mg/m2 IV for Cycles 2 through 6.
-Patients should continue the 400 mg orally once daily for 24 months from Cycle 1 Day 1 of rituximab.
-All dose regimens begin with a 5-week ramp-up schedule to gradually reduce tumor burden and decrease risk of tumor lysis syndrome (TLS).
-Patients should be adequately hydrated during the dose-titration phase to reduce the risk of TLS.
Uses: As monotherapy or in combination with rituximab for the treatment of patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), with or without 17p deletion, who have received at least one prior therapy
Renal Dose Adjustments
-Mild (CrCl 60 to less than 90 mL/min) to moderate (CrCl 30 to less than 60 mL/min) renal impairment: No adjustment recommended.
-Severe renal impairment (CrCl less than 30 mL/min): Data not available
Liver Dose Adjustments
-Mild (total bilirubin and AST greater than upper limit of normal [ULN] OR total bilirubin greater than 1 to 1.5 x ULN) to moderate (total bilirubin greater than 1.5 to 3 x ULN) hepatic impairment: No adjustment recommended.
-Severe hepatic impairment (total bilirubin greater than 3 x ULN): Data not available
If resuming therapy at a reduced dose after dose interruption due to toxicity:
-Restart dose at 300 mg if the dose at interruption was 400 mg.
-Restart dose at 200 mg if the dose at interruption was 300 mg.
-Restart dose at 100 mg if the dose at interruption was 200 mg.
-Restart dose at 50 mg if the dose at interruption was 100 mg.
-Restart dose at 20 mg if the dose at interruption was 50 mg.
-Restart dose at 10 mg if the dose at interruption was 20 mg.
-During the 5-week ramp-up phase, continue the reduced dose for 1 week before increasing the dose.
-For dosing interruptions greater than 1 week during the 5-week ramp-up phase or greater than 2 weeks when at the daily dose of 400 mg, reassess for tumor lysis syndrome (TLS) risk to determine if re-initiation with a reduced dose is necessary (e.g., all or some levels of the dose ramp-up schedule).
-Consider discontinuing treatment for patients who require dose reductions to less than 100 mg for more than 2 weeks.
Blood chemistry changes or symptoms of TLS any occurrence:
-Withhold next day's dose; resume at same dose if resolved within 24 to 48 hours of last dose.
-Resume at reduced dose for any blood chemistry changes requiring more than 48 hours to resolve or following resolution of any events of clinical TLS (laboratory TLS with clinical consequences such as acute renal failure, cardiac arrhythmias, or sudden death and/or seizures).
Grade 3 or 4 non-hematologic toxicities:
-First occurrence: Interrupt dosing; resume at same dose once the toxicity has resolved to Grade 1 or baseline.
-Second and subsequent occurrences: Interrupt dosing and resume at reduced dose after toxicity resolution; larger dose reductions may occur at a physician's discretion.
Grade 3 or 4 neutropenia with infection or fever OR Grade 4 hematologic toxicities (except lymphopenia):
-First occurrence: Interrupt dosing; resume at same dose once the toxicity has resolved to Grade 1 or baseline. Granulocyte-colony stimulating factor (G-CSF) may be administered (if clinically indicated) to reduce the infection risks associated with neutropenia.
-Second and subsequent occurrences: Interrupt dosing and resume at reduced dose after toxicity resolution; larger dose reductions may occur at a physician's discretion. Consider using G-CSF as clinically indicated.
Concomitant use with strong CYP450 3A inhibitors:
-Initiation and ramp-up phase: Contraindicated
-Steady daily dose (after ramp-up phase): Avoid inhibitor use OR reduce dose by at least 75% when concomitant use necessary.
Concomitant use with moderate CYP450 3A or P-gp inhibitors:
-Avoid inhibitor use and consider alternative treatments OR reduce dose by at least 50% when concomitant use necessary.
-Resume dose of this drug that was used prior to initiating the CYP450 3A or P-gp inhibitor 2 to 3 days after discontinuation of the inhibitor.
-Concomitant with strong CYP450 3A inhibitors at initiation and during the titration phase (due to the increased risk of tumor lysis syndrome)
Concomitant use of preparations containing St. John's wort
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 with a meal and water at approximately the same time each day.
-Tablets should be swallowed whole and not chewed, crushed, or broken prior to swallowing.
-A missed dose should be taken as soon as possible if it is within 8 hours of the normal dosing time; otherwise, the missed dose should be skipped and the next dose should be taken at the usual time the following day.
-An additional dose should not be taken if a patient vomits following a dose; the next dose should be taken at the usual time the following day.
-If a patient misses a dose within 8 hours of the time it is usually taken, the patient should take the missed dose as soon as possible on the same day. If a patient misses a dose by more than 8 hours, the patient should not take the missed dose and should resume the usual dosing schedule the following day.
-If a patient vomits following dosing, no additional dose should be taken that day. The next prescribed dose should be taken at the usual time the following day.
-This drug should be kept in the original packaging during the first 4 weeks of treatment.
-This drug should be stored at or below 86 degrees Fahrenheit (30 Celsius).
-The indication for this drug is under accelerated approval based on overall response rate; continued approval may be contingent upon verification and description of clinical benefit in a confirmatory trial.
-Information on FDA-approved tests for the detection of 17p deletions in CLL is available at http://www.fda.gov/CompanionDiagnostics.
-There is no specific antidote for overdosage of this drug; dialysis is unlikely to help.
-HEMATOLOGIC: CBC (during treatment)
-METABOLIC: Tumor burden assessments, including radiographic evaluation (e.g., CT scan); blood chemistry (potassium, uric acid, phosphorus, calcium, and creatinine)
-Avoid eating or drinking products with grapefruit, Seville oranges, and starfruit during treatment.
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
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Other brands: Venclexta