Zanubrutinib

Zanubrutinib is a prescription medication used for the treatment of the following conditions:

• Mantle cell lymphoma
• Waldenström Macroglobulinemia
• Marginal Zone Lymphoma
• Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Zanubrutinib is available under the following different brand names: Brukinsa

Common side effects of Zanubrutinib include:

• diarrhea,
• low platelet or other blood cell counts,
• easy bruising,
• unusual bleeding,
• rash,
• stuffy nose,
• sneezing,
• sore throat, and
• cough

Serious side effects of Zanubrutinib include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• pounding heartbeats,
• fluttering in the chest,
• chest discomfort,
• lightheadedness,
• right-sided upper stomach pain,
• vomiting,
• loss of appetite,
• yellowing of the skin or eyes,
• feeling unwell,
• easy bruising,
• unusual bleeding,
• purple or red spots under the skin,
• pale skin,
• weakness,
• unusual tiredness,
• shortness of breath,
• cold hands and feet,
• fast or irregular heartbeat,
• fever,
• mouth sores,
• skin sores,
• sore throat,
• cough,
• red or pink urine,
• bloody or tarry stools,
• coughing up blood,
• vomit that looks like coffee grounds,
• severe headache,
• vision problems,
• numbness or weakness on one side,
• trouble speaking or understanding anything communicated,
• chills,
• redness or swelling, and
• cough with mucus

Rare side effects of Zanubrutinib include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms include fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheadedness, or passing out. 

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Capsules

• 80 mg

Mantle Cell Lymphoma

Adult dosage

• 160 mg orally twice daily or 320 mg orally every day until disease progression or unacceptable toxicity

Waldenström Macroglobulinemia

Adult dosage

• 160 mg orally twice daily or 320 mg orally every day until disease progression or unacceptable toxicity

Marginal Zone Lymphoma

Adult dosage

• 160 mg orally twice daily or 320 mg orally every day

Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma

Adult dosage

• 160 mg orally twice daily or 320 mg orally every day

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Zanubrutinib has severe interactions with no other drugs.
• Zanubrutinib has serious interactions with at least 47 other drugs.
• Zanubrutinib has serious interactions with at least 121 other drugs.
• Zanubrutinib has serious interactions with the following drugs:
  • acetazolamide
  • anastrozole
  • cyclophosphamide
  • posaconazole

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your healthcare professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• None

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Zanubrutinib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Zanubrutinib?”

Cautions

• Grade 3 or 4 cytopenias (eg, neutropenia, thrombocytopenia, anemia) reported; monitor CBC counts during treatment and treat using growth factors or transfusions, as needed
• Second primary malignancies, including non-skin carcinoma, may occur; the most frequent second primary malignancies included malignant solid tumors, hematologic malignancies and skin cancer (basal cell carcinoma, melanoma, and squamous cell carcinoma of skin); advise to use sun protection; monitor patients for the development of second primary malignancies
• Atrial fibrillation and atrial flutter reported; patients with cardiac risk factors, hypertension, and acute infections may be at increased risk; grade ≥3 events reported with monotherapy; monitor for signs and symptoms of cardiac arrhythmias (eg, palpitations, dizziness, syncope, dyspnea, chest discomfort); manage as appropriate and consider risks and benefits of continued treatment
• Based on animal findings, can cause fetal harm when administered to pregnant females
• Infections
  • Fatal and serious infections (including bacterial, viral, or fungal) and opportunistic infections reported; infections due to hepatitis B virus reactivation have occurred
  • Consider prophylaxis for herpes simplex virus, Pneumocystis jiroveci pneumonia, and other infections according to the standard of care in patients who are at increased risk for infections
  • Monitor and evaluate for fever or other signs and symptoms of infection and treat appropriately
• Hemorrhage
  • Fatal and serious hemorrhagic events have occurred in patients with hematological malignancies treated with monotherapy
  • Bleeding events reported with and without concomitant antiplatelet or anticoagulation therapy; coadministration with antiplatelet or anticoagulant medications may further increase the risk of hemorrhage
  • Monitor for signs and symptoms of bleeding; discontinue therapy if intracranial hemorrhage of any grade occurs; consider benefit-risk of withholding therapy for 3-7 days presurgery and postsurgery depending on the type of surgery and risk of bleeding
• Drug interaction overview
  • Moderate and strong CYP3A4 inhibitors
    • Coadministration with a moderate or strong CYP3A inhibitor increases zanubrutinib plasma levels, which may increase the risk of zanubrutinib toxicities
• Moderate and strong CYP3A4 inducers
  • Coadministration with a moderate or strong CYP3A inhibitor decreases zanubrutinib plasma levels, which may reduce zanubrutinib efficacy

Pregnancy and Lactation

• There are no available data on use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes
• Avoid pregnancy during administration; warn patients of the potential hazard to the fetus if used during pregnancy or if the patient becomes pregnant while taking zanubrutinib
• Pregnancy testing is recommended for females of reproductive potential before initiating therapy
• Contraception
  • Females of reproductive potential: Use effective contraception during treatment and for at least 1 week following the last dose
  • Males: Advise men to avoid fathering a child while receiving zanubrutinib and for at least 1 week following the last dose
• Lactation
  • There are no data on the presence of drug or its metabolites in human milk, its effects on the breastfed child, or milk production
  • Owing to the potential for serious adverse reactions from therapy in a breastfed child, advise lactating women not to breastfeed during treatment and for at least 2 weeks following the last dose