Medically reviewed by Drugs.com. Last updated on Feb 20, 2023.
Applies to the following strengths: 80 mg
Usual Adult Dose for:
Additional dosage information:
Usual Adult Dose for Lymphoma
160 mg orally 2 times a day until disease progression or unacceptable toxicity
320 mg orally once a day until disease progression or unacceptable toxicity
- For the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
- For the treatment of adult patients with Waldenström's macroglobulinemia (WM)
- For the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one anti-CD20-based regimen
Renal Dose Adjustments
Mild to severe renal dysfunction: No adjustment recommended.
Liver Dose Adjustments
Mild to moderate hepatic dysfunction: No adjustment recommended.
Severe hepatic dysfunction: Reduce dose to 80 mg orally 2 times a day.
DOSE MODIFICATIONS FOR ADVERSE REACTIONS (starting dose of 160 mg 2 times a day OR 320 mg once a day):
1) GRADE 3 OR HIGHER NONHEMATOLOGICAL TOXICITIES
2) GRADE 3 FEBRILE NEUTROPENIA; GRADE 3 THROMBOCYTOPENIA WITH SIGNIFICANT BLEEDING
3) GRADE 4 NEUTROPENIA (LASTING MORE THAN 10 CONSECUTIVE DAYS)
4) GRADE 4 THROMBOCYTOPENIA (LASTING MORE THAN 10 CONSECUTIVE DAYS):
Below are dose modifications for the reactions 1 through 4 listed above:
- First Occurrence: Interrupt therapy; when toxicity has resolved to Grade 1 or less or baseline resume at 160 mg 2 times a day or 320 mg once a day
- Second Occurrence: Interrupt therapy; when toxicity has resolved to Grade 1 or less or baseline resume at 80 mg 2 times a day or 160 mg once a day
- Third Occurrence: Interrupt therapy; when toxicity has resolved to Grade 1 or less or baseline resume at 80 mg once a day
- Fourth Occurrence: Discontinue therapy
Asymptomatic lymphocytosis should not be regarded as an adverse reaction, and these patients should continue taking this drug.
Dose Modifications for Concomitant use with CYP450 3A Inhibitors or Inducers:
- Strong CYP450 3A inhibitor: 80 mg orally once a day; interrupt dose as recommended for adverse reactions
- Moderate CYP450 3A inhibitor: 80 mg orally 2 times a day; interrupt dose as recommended for adverse reactions
- Moderate or strong CYP450 3A inducer: Avoid concomitant use.
- After discontinuation of a CYP450 3A inhibitor, resume previous dose of this drug.
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Monitor for adverse reactions.
- This drug may be taken with or without food.
- Swallow capsules whole with water; do not open, break, or chew.
- If a dose is missed, it should be taken as soon as possible on the same day with a return to the normal schedule the following day.
- Store at 20C to 25C (68F to 77F); excursions permitted between 15C to 30C (59F to 86F)
- Renal function
- Hepatic function
- Cardiac function
- Secondary primary malignancies
- Read the patient information for this drug each time you have your prescription filled.
- Advise females not to breastfeed during treatment and for at least 2 weeks after the last dose.
- If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
- Advise female patients of reproductive potential to use effective contraception during therapy and for at least 1 after.
- Advise men to avoid fathering a child while receiving this drug and for at least 1 week after.
- Advise patients to to report any signs of palpitations, lightheadedness, dizziness, fainting, shortness of breath, and chest discomfort.
- Advise patients to use sun protection.
- Inform patients to report signs or symptoms of severe bleeding and that this drug may need to be interrupted for major surgeries or procedures.
- Inform patients to report signs or symptoms suggestive of infection.
- Inform your healthcare provider of all medications you are taking (including over-the-counter medications, vitamins, and herbal products).
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