Zanubrutinib Dosage

Medically reviewed by Drugs.com. Last updated on Feb 19, 2024.

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 (68C 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.

Frequently asked questions

• What are the names of the BTK inhibitors?

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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