Applies to the following strength(s): 10 mg ; 50 mg ; 100 mg ; 10 mg-50 mg-100 mg
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Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Chronic Lymphocytic 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
-Maintenance Dose: 400 mg orally once a day
-Duration of Therapy: Until disease progression or unacceptable toxicity is observed.
-Select patients based on the presence of 17p deletions in blood specimens, as detected by an approved test.
-Retest patients without 17p deletion at relapse as acquisition of 17p deletion can occur.
Use: Treatment of patients with chronic lymphocytic leukemia (CLL) with 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; a recommended dose has not been determined.
Liver Dose Adjustments
-Mild (total bilirubin and AST greater than upper limit of normal [ULN] OR total bilirubin greater than 1.0 to 1.5 x ULN) to Moderate (total bilirubin greater than 1.5 to 3.0 x ULN) Hepatic Impairment: No adjustment recommended.
-Severe Hepatic Impairment (total bilirubin greater than 3.0 x ULN): Data not available; a recommended dose has not been determined.
If Resuming Treatment 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 Suggestive 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 of this drug 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 of this drug 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.
Safety and efficacy have not been established in pediatric patients.
Consult WARNINGS section for additional precautions.
Data not available; a recommended dose has not been determined.
-This drug should be taken with a meal and water at approximately the same time each day.
-This drug should be swallowed whole and not chewed, crushed, or broken.
-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.
-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.
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Other brands: Venclexta