Zanubrutinib Dosage
Medically reviewed by Drugs.com. Last updated on Feb 19, 2024.
Applies to the following strengths: 80 mg
Usual Adult Dose for:
- Mantle Cell Lymphoma
- Marginal Zone Lymphoma
- Chronic Lymphocytic Leukemia
- Waldenstrom's Macroglobulinemia
Additional dosage information:
Usual Adult Dose for Mantle Cell Lymphoma
160 mg orally twice a day or 320 mg orally once a day
Duration of therapy: Until disease progression or unacceptable toxicity
Comments:
- These indications are approved under accelerated approval based on overall response rate; continued approval may depend on verification and description of clinical benefit in confirmatory trials.
Uses:
- For the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy
- For the treatment of patients with relapsed or refractory marginal zone lymphoma who have received at least 1 anti-cluster of differentiation 20 (CD20)-based regimen
Usual Adult Dose for Marginal Zone Lymphoma
160 mg orally twice a day or 320 mg orally once a day
Duration of therapy: Until disease progression or unacceptable toxicity
Comments:
- These indications are approved under accelerated approval based on overall response rate; continued approval may depend on verification and description of clinical benefit in confirmatory trials.
Uses:
- For the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy
- For the treatment of patients with relapsed or refractory marginal zone lymphoma who have received at least 1 anti-cluster of differentiation 20 (CD20)-based regimen
Usual Adult Dose for Chronic Lymphocytic Leukemia
160 mg orally twice a day or 320 mg orally once a day
Duration of therapy: Until disease progression or unacceptable toxicity
Uses:
- For the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma
- For the treatment of patients with Waldenstrom's macroglobulinemia
Usual Adult Dose for Waldenstrom's Macroglobulinemia
160 mg orally twice a day or 320 mg orally once a day
Duration of therapy: Until disease progression or unacceptable toxicity
Uses:
- For the treatment of patients with chronic lymphocytic leukemia or small lymphocytic lymphoma
- For the treatment of patients with Waldenstrom's macroglobulinemia
Renal Dose Adjustments
Mild, moderate, or severe renal dysfunction (CrCl at least 15 mL/min): No adjustment recommended
Comments:
- CrCl estimated by Cockcroft-Gault
Liver Dose Adjustments
Mild to moderate liver dysfunction: No adjustment recommended
Severe liver dysfunction: 80 mg orally twice a day
Comments:
- Safety has not been evaluated in patients with severe liver dysfunction.
- Patients with liver dysfunction should be monitored for adverse reactions associated with this drug.
Dose Adjustments
FOR ADVERSE REACTIONS (Starting Dose: 160 mg orally twice a day or 320 mg orally once a day):
Hematological Toxicities:
- Grade 3 or 4 febrile neutropenia OR platelet count decreased to 25,000 to 50,000/mm3 with significant bleeding OR neutrophil count decreased to less than 500/mm3 (lasting more than 10 consecutive days) OR platelet count decreased to less than 25,000/mm3 (lasting more than 10 consecutive days):
- First occurrence: This drug should be interrupted. Once toxicity has resolved to grade 1 or lower or baseline, this drug should resume at 160 mg orally twice a day or 320 mg orally once a day.
- Second occurrence: This drug should be interrupted. Once toxicity has resolved to grade 1 or lower or baseline, this drug should resume at 80 mg orally twice a day or 160 mg orally once a day.
- Third occurrence: This drug should be interrupted. Once toxicity has resolved to grade 1 or lower or baseline, this drug should resume at 80 mg orally once a day.
- Fourth occurrence: This drug should be discontinued.
Asymptomatic lymphocytosis should not be regarded as an adverse reaction; these patients should continue taking this drug.
Nonhematological Toxicities:
- Severe or life-threatening nonhematological toxicities:
- First occurrence: This drug should be interrupted. Once toxicity has resolved to grade 1 or lower or baseline, this drug should resume at 160 mg orally twice a day or 320 mg orally once a day; the benefit-risk should be evaluated before resuming therapy at the same dosage for grade 4 nonhematological toxicity.
- Second occurrence: This drug should be interrupted. Once toxicity has resolved to grade 1 or lower or baseline, this drug should resume at 80 mg orally twice a day or 160 mg orally once a day.
- Third occurrence: This drug should be interrupted. Once toxicity has resolved to grade 1 or lower or baseline, this drug should resume at 80 mg orally once a day.
- Fourth occurrence: This drug should be discontinued.
FOR USE WITH CYP450 3A INHIBITORS OR INDUCERS (Starting Dose: 160 mg orally twice a day or 320 mg orally once a day):
- Coadministration with a moderate CYP450 3A inhibitor: 80 mg orally twice a day
- Dose should be modified as recommended for adverse reactions.
- Coadministration with a strong CYP450 3A inhibitor: 80 mg orally once a day
- Dose should be interrupted as recommended for adverse reactions.
- Coadministration with a moderate CYP450 3A inducer: Concomitant use should be avoided; if these inducers cannot be avoided, zanubrutinib dose should be increased to 320 mg orally twice a day.
- Coadministration with a strong CYP450 3A inducer: Concomitant use should be avoided.
- After discontinuation of a CYP450 3A inhibitor or moderate CYP450 inducer: Should resume the previous dose of zanubrutinib
Precautions
CONTRAINDICATIONS: None
Safety and efficacy have not been established in patients younger than 18 years.
Consult WARNINGS section for additional precautions.
Dialysis
Monitoring recommended
Comments:
- Patients on dialysis should be monitored for adverse reactions associated with this drug.
Other Comments
Administration advice:
- Administer with or without food.
- Swallow capsules whole with water; do not open, break, or chew the capsules.
- If a dose is missed, take as soon as possible on the same day; return to the normal schedule the following day.
Storage requirements:
- Store at 20C to 25C (68F to 77F); excursions permitted to 15C to 30C (59F to 86F).
Monitoring:
- Cardiovascular: For signs/symptoms of cardiac arrhythmias
- General: For adverse reactions in patients on dialysis or with liver dysfunction
- Hematologic: For signs/symptoms of bleeding; CBC (regularly during therapy)
- Infections/Infestations: For fever or other signs/symptoms of infection
- Oncologic: For development of second primary malignancies
Patient advice:
- Read the US FDA-approved patient labeling (Patient Information).
- Report signs/symptoms of severe bleeding; this drug may need to be interrupted for major surgeries or procedures.
- Report signs/symptoms suggestive of infection.
- You will need periodic blood tests to check blood counts during therapy.
- Because other malignancies (including skin cancer and other solid tumors) have been reported with this drug, use sun protection and have monitoring for development of other cancers.
- Report any signs of palpitations, lightheadedness, dizziness, fainting, shortness of breath, and chest discomfort.
- Female patients of childbearing potential and male patients with partners of childbearing potential: Use effective contraception during therapy and for 1 week after the last dose.
- Do not breastfeed during therapy and for 2 weeks after the last dose.
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