Medically reviewed by Drugs.com. Last updated on Feb 28, 2020.
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
Use: For the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy
Renal Dose Adjustments
Mild to moderate renal impairment (CrCl 30 mL/min or greater: No adjustment recommended.
Severe renal impairment (CrCl less than 30 mL/min): Dose adjustment(s) may be required; however, no specific guidelines have been suggested. Monitor for adverse reactions.
Liver Dose Adjustments
Mild to moderate hepatic impairment: No adjustment recommended.
Severe hepatic impairment: 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 once 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)
-Read the patient information for this drug each time you have your prescription filled.
-Inform your healthcare provider of all medications you are taking (including
over-the-counter medications, vitamins, and herbal products).
Frequently asked questions
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
More about zanubrutinib
Other brands: Brukinsa