Zanubrutinib

What is Zanubrutinib?

• Zanubrutinib (Brukinsa) is a kinase inhibitor used to treat adults with mantle cell lymphoma (MCL).

Zanubrutinib development series

What are the uses of this medicine?

• This medicine is used to treat adults with mantle cell lymphoma (MCL) who have received at least one prior treatment for their cancer.

How does this medicine work?

• Upon administration, zanubrutinib inhibits the activity of BTK and prevents the activation of the B-cell antigen receptor (BCR) signaling pathway.
• This prevents both B-cell activation and BTK-mediated activation of downstream survival pathways, which leads to the inhibition of the growth of malignant B-cells that overexpress BTK.
• BTK, a member of the Src-related BTK/Tec family of cytoplasmic tyrosine kinases, is overexpressed in B-cell malignancies; it plays an important role in B-lymphocyte development, activation, signaling, proliferation and survival.

Who Should Not Use this medicine ?

• This medicine have no usage limitations.

What drug interactions can this medicine cause?

• Co-administration with a moderate or strong CYP3A inhibitor may increase the risk of Brukinsa toxicities.Reduce Brukinsa dosage when co-administered with moderate or strong CYP3A inhibitors.
• Co-administration with a moderate or strong CYP3A inducer may reduce Brukinsa efficacy.Avoid co-administration of Brukinsa with moderate or strong CYP3A inducers.

Is this medicine FDA approved?

• It was approved for use in the United States in 2019.

How should this medicine be used?

Recommended Dosage

• The recommended dose of Brukinsa is 160 mg taken orally twice daily or 320 mg taken orally once daily until disease progression or unacceptable toxicity.

Dosage Modification for Use in Hepatic Impairment The recommended dose of Brukinsa for patients with severe hepatic impairment is 80 mg orally twice daily.

Administration

• Take Brukinsa exactly as your healthcare provider tells you to take it.
• Do not change your dose or stop taking Brukinsa unless your healthcare provider tells you to.
• Your healthcare provider may tell you to decrease your dose, temporarily stop, or completely stop taking Brukinsa if you develop certain side effects.
• Take Brukinsa with or without food.
• Swallow Brukinsa capsules whole with a glass of water. Do not open, break, or chew the capsules.
• If you miss a dose of Brukinsa, take it as soon as you remember on the same day. Return to your normal schedule the next day.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Capsules: 80 mg

This medicine is available in fallowing brand namesː

• Brukinsa

What side effects can this medication cause?

The most common side effects of this medicine include:

• decreased white blood cells
• decreased platelet count
• rash
• diarrhea
• upper respiratory infection
• decreased red blood cells (anemia)
• bruising
• cough

Brukinsa may cause serious side effects, including:

• Bleeding problems (hemorrhage)
• Infections
• Decrease in blood cell counts
• Heart rhythm problems (atrial fibrillation and atrial flutter)

What special precautions should I follow?

• Brukinsa may cause hemorrhage. Monitor for bleeding and manage appropriately.
• Monitor patients for signs and symptoms of infection, including opportunistic infections, and treat as needed.
• Grade 3 or 4 cytopenias, including neutropenia (27%), thrombocytopenia (10%), and anemia (8%) based on laboratory measurements, were reported in patients treated with Brukinsa. Monitor complete blood counts during treatment and treat using growth factor or transfusions, as needed.
• Second primary malignancies, including non-skin carcinoma, have occurred in 9% of patients treated with Brukinsa monotherapy. Advise patients to use sun protection.
• This medicine can cause cardiac arrhythmias. Monitor for atrial fibrillation and atrial flutter and manage appropriately.
• This medicine Can cause fetal harm. Advise women of the potential risk to a fetus and to avoid pregnancy.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Brukinsa can cause fetal harm when administered to pregnant women.
• There are no available data on Brukinsa use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.

Can this medicine be used in children?

• Safety and effectiveness in pediatric patients have not been established.

What are the active and inactive ingredients in this medicine?

• Active ingredient: zanubrutinib
• Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate.

Who manufactures and distributes this medicine?

• Distributed and Marketed by: BeiGene USA, Inc. San Mateo, CA 94403
• Brukinsa™ is a trademark owned by BeiGene, Ltd.

What should I know about storage and disposal of this medication?

• Distributed and Marketed by: BeiGene USA, Inc. San Mateo, CA 94403

Brukinsa™ is a trademark owned by BeiGene, Ltd.

• Dailymed label info on Zanubrutinib
• FDA Zanubrutinib

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