Zanubrutinib
Mantle-Cell Lymphoma
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Drug Status
Government Approvals
US(FDA), UK(BNF)
WHO Essential Medicine
YES
Known Teratogen
NO
Pharmaceutical Class
Kinase Inhibitor
Controlled Drug Substance
No
Zanubrutinib
Summary
Zanubrutinib is used to treat several types of B-cell malignancies. These include mantle cell lymphoma, Waldenström's macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia, and follicular lymphoma. It is also used when cancer has returned or did not respond to at least two other medications.
Zanubrutinib works by inhibiting a protein called Bruton's tyrosine kinase, which is involved in the growth and survival of cancerous B-cells. By blocking this protein, Zanubrutinib helps to stop the spread of cancer cells and reduce tumor growth.
The usual daily dose for adults is 160 mg taken orally twice daily or 320 mg taken orally once daily. Zanubrutinib can be taken with or without food. There is no established dosage for children.
Common side effects include decreased white blood cell count, decreased platelet count, upper respiratory tract infection, diarrhea, and fatigue. Serious adverse effects can include bleeding, infections, cardiac arrhythmias, and hepatotoxicity.
Zanubrutinib can cause serious bleeding, infections, second primary malignancies, cardiac arrhythmias, and hepatotoxicity. It should not be used by patients who are hypersensitive to Zanubrutinib or any of its components. Patients should inform their healthcare provider of any existing medical conditions.
Indications and Purpose
How does Zanubrutinib work?
Zanubrutinib is a small-molecule inhibitor of Bruton's tyrosine kinase (BTK). It forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK activity. BTK is a signaling molecule in the B-cell antigen receptor and cytokine receptor pathways. By inhibiting BTK, Zanubrutinib disrupts pathways necessary for B-cell proliferation, trafficking, chemotaxis, and adhesion, thereby reducing tumor growth and spread.
Is Zanubrutinib effective?
Zanubrutinib has been shown to be effective in treating various types of B-cell malignancies, including mantle cell lymphoma, Waldenström's macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia, and follicular lymphoma. Clinical trials have demonstrated significant overall response rates and durations of response in patients treated with Zanubrutinib. The medication works by inhibiting Bruton's tyrosine kinase, which is involved in the proliferation and survival of malignant B-cells.
What is Zanubrutinib?
Zanubrutinib is used to treat various types of B-cell malignancies, including mantle cell lymphoma, Waldenström's macroglobulinemia, marginal zone lymphoma, chronic lymphocytic leukemia, and follicular lymphoma. It works by inhibiting Bruton's tyrosine kinase, a protein involved in the growth and survival of cancerous B-cells. By blocking this protein, Zanubrutinib helps to stop the spread of cancer cells and reduce tumor growth.
Directions for Use
For how long do I take Zanubrutinib?
Zanubrutinib is typically taken until disease progression or unacceptable toxicity occurs. The duration of use can vary significantly depending on the individual's response to treatment and the specific condition being treated. Always follow your doctor's guidance regarding the duration of treatment.
How do I dispose of Zanubrutinib?
If you can, bring unused medicines to a drug take-back program or collection site at a pharmacy or hospital. They will dispose of this medicine properly so they don't harm people or the environment. If you can't find a take-back program, you can throw most medicines in the trash at home. But first, take them out of their original containers, mix them with something undesirable like used coffee grounds, seal the mixture in a plastic bag and throw it away.
How do I take Zanubrutinib?
Zanubrutinib should be taken exactly as prescribed by your healthcare provider, either once or twice daily. It can be taken with or without food. Patients should swallow the capsules whole with a glass of water and should not open, break, or chew them. While there are no specific food restrictions, patients should discuss any dietary concerns with their healthcare provider to ensure optimal treatment outcomes.
How long does it take for Zanubrutinib to start working?
Zanubrutinib typically starts working within a few hours, reaching peak plasma concentration quickly. However, the full therapeutic effect may take several weeks to become evident, depending on the condition being treated. Individual factors like overall health and other medications can affect how quickly you notice improvements. It's important to follow your healthcare provider's instructions and be patient as the medicine takes effect.
How should I store Zanubrutinib?
Zanubrutinib should be stored at room temperature, between 20°C to 25°C (68°F to 77°F), with permissible excursions between 15°C to 30°C (59°F to 86°F). It should be kept in its original container, tightly closed, and out of reach of children. The medication should be stored away from excess heat and moisture, and should not be kept in the bathroom. Proper storage ensures the medication remains effective and safe to use.
What is the usual dose of Zanubrutinib?
The usual daily dose for adults taking Zanubrutinib is 160 mg taken orally twice daily or 320 mg taken orally once daily. The medication can be taken with or without food. There is no established dosage for children as the safety and effectiveness of Zanubrutinib in pediatric patients have not been established.
Warnings and Precautions
Can I take Zanubrutinib with other prescription drugs?
Zanubrutinib can interact with several prescription drugs, particularly those that affect the CYP3A enzyme. Strong CYP3A inhibitors, such as clarithromycin and itraconazole, can increase Zanubrutinib levels, potentially leading to increased side effects. Conversely, strong CYP3A inducers, like rifampin, can decrease its effectiveness. Patients should inform their healthcare provider of all medications they are taking to manage potential interactions and adjust dosages as necessary.
Can Zanubrutinib be taken safely while breastfeeding?
Women are advised not to breastfeed while taking Zanubrutinib and for 2 weeks after the last dose. There is no data on the presence of Zanubrutinib in human milk or its effects on the breastfed child, but due to the potential for serious adverse reactions in nursing infants, breastfeeding should be avoided during treatment.
Can Zanubrutinib be taken safely while pregnant?
Zanubrutinib can cause fetal harm when administered to pregnant women, based on findings in animal studies. Women of reproductive potential should use effective contraception during treatment and for 1 week after the last dose. Men with female partners of reproductive potential should also use contraception during treatment and for 1 week after the last dose. If pregnancy occurs while taking Zanubrutinib, patients should inform their doctor immediately. There is no strong evidence from human studies, but the potential risk to the fetus is significant.
Does Zanubrutinib have adverse effects?
Adverse effects are unwanted or harmful effects that can occur with medication use. For Zanubrutinib, some concerning adverse effects include low blood cell counts, infections, bleeding, and liver problems. These effects can vary in frequency. Serious adverse effects, though rare, may include severe bleeding or liver damage, which require immediate medical attention. It's important to report any new symptoms to your healthcare provider and consult them before stopping the medication.
Does Zanubrutinib have any safety warnings?
Zanubrutinib comes with safety warnings, including the risk of bleeding, infections, and liver problems. Bleeding can occur because the medicine affects blood clotting, so watch for unusual bruising or bleeding. Infections are a risk due to lowered immune function, so report any fever or signs of infection. Liver issues may arise, so symptoms like yellowing of the skin or eyes should be reported immediately. Regular monitoring by your healthcare provider is essential to manage these risks.
Is it safe to drink alcohol while taking Zanubrutinib?
Most people tolerate Zanubrutinib well, and occasional alcoholic drinks should not affect the way this medicine works. There are no well-established interactions between Zanubrutinib and alcohol that would interfere with its mechanism or outcomes. However, it's wise to consume alcohol in moderation and discuss any concerns with your healthcare provider to ensure it aligns with your treatment plan.
Is it safe to exercise while taking Zanubrutinib?
Most people tolerate Zanubrutinib well, and it should not limit your ability to exercise. There is no specific information indicating that this medicine affects exercise capacity, physical strength, or endurance. However, if you experience symptoms like fatigue or dizziness during physical activity, take precautions and consider modifying your exercise routine. Always consult your healthcare provider if you have concerns about exercising while on this medication.
Is it safe to stop Zanubrutinib?
Zanubrutinib is typically used for long-term management of certain chronic conditions, such as specific types of cancer. Stopping it suddenly can lead to a return or worsening of the condition it was treating. There may not be withdrawal symptoms, but the risk of the disease progressing is significant. It's crucial to consult your doctor before stopping Zanubrutinib to discuss any potential risks and to plan a safe discontinuation strategy if needed.
Is Zanubrutinib addictive?
Zanubrutinib has no known potential for dependence or addiction. It is not habit-forming, and there are no behaviors or warning signs associated with physical or psychological dependence on this medicine. You can take it as prescribed without worrying about addiction. Always follow your healthcare provider's instructions for use.
Is Zanubrutinib safe for the elderly?
For elderly patients, no specific dose adjustment is required when taking Zanubrutinib. However, elderly patients may experience higher rates of Grade 3 or higher adverse reactions and serious adverse reactions compared to younger patients. It is important for elderly patients to be closely monitored for side effects and to maintain regular communication with their healthcare provider to ensure safe use of the medication.
What are the most common side effects of Zanubrutinib?
A side effect is an unwanted reaction to a medicine. Common side effects of Zanubrutinib include fatigue, diarrhea, bruising, rash, and low blood cell counts. These effects can vary in frequency and may not be directly related to the medicine. It's important to remember that new symptoms can occur when starting any new medication. Always talk to your healthcare provider before stopping Zanubrutinib to ensure it's safe to do so.
Who should avoid taking Zanubrutinib?
Important warnings for Zanubrutinib include the risk of serious bleeding, infections, cytopenias, second primary malignancies, cardiac arrhythmias, and hepatotoxicity. Patients should be monitored for signs of these conditions. Contraindications include hypersensitivity to Zanubrutinib or any of its components. Patients should inform their healthcare provider of any existing medical conditions, especially liver disease, heart problems, or infections, and discuss any medications they are taking to avoid interactions.
