What is Brukinsa (zanubrutinib), and what is it used for?
Brand name: Brukinsa
Generic: zanubrutinib
Brukinsa (zanubrutinib) is a prescription medicine used to treat the symptoms of mantel cell lymphoma (MCL) and Waldenström macroglobulinemia, both of which are types of non-Hodgkin lymphoma.
It is not known if Brukinsa is safe and effective in children.
What are the side effects of Brukinsa?
Brukinsa may cause serious side effects including:
- hives,
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- pounding heartbeats,
- fluttering in your chest,
- chest discomfort,
- lightheadedness,
- right-sided upper stomach pain,
- vomiting,
- loss of appetite,
- yellowing of your skin or eyes,
- feeling unwell,
- easy bruising,
- unusual bleeding,
- purple or red spots under your 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 what is said to you,
- chills,
- redness or swelling, and
- cough with mucus
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Brukinsa include:
- diarrhea,
- low platelet or other blood cell counts,
- easy bruising,
- unusual bleeding,
- rash,
- stuffy nose,
- sneezing,
- sore throat, and
- cough
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Brukinsa. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Is Brukinsa addictive?
No information provided
What is the dosage for Brukinsa?
The recommended dosage of Brukinsa is 160 mg taken orally twice daily or 320 mg taken orally once daily until disease progression or unacceptable toxicity.
Brukinsa can be taken with or without food. Advise patients to swallow capsules whole with water. Advise patients not to open, break, or chew the capsules. If a dose of
Brukinsa is missed, it should be taken as soon as possible on the same day with a return to the normal schedule the following day.
Dosage Modification For Use In Hepatic Impairment
The recommended dosage of Brukinsa for patients with severe hepatic
impairment is 80 mg orally twice daily.
Dosage Modifications For Drug Interactions
Recommended dosage modifications of Brukinsa for drug interactions are
provided in the Drug Interactions section below.
Table 1: Dose Modifications for Use With CYP3A Inhibitors or Inducers
Co-administered Drug
Recommended Brukinsa Dose
Strong CYP3A inhibitor
80 mg once daily Interrupt dose as recommended for adverse
reactions.
Moderate CYP3A inhibitor
80 mg twice daily Modify dose as recommended for adverse
reactions.
Moderate or strong CYP3A inducer
Avoid concomitant use.
After discontinuation of a CYP3A inhibitor, resume previous dose of Brukinsa.
Dosage Modifications For Adverse Reactions
Recommended dosage modifications of Brukinsa for Grade 3 or higher adverse reactions are provided in Table 2:
Table 2: Recommended Dosage Modification for Adverse Reaction
Event
Adverse Reaction Occurrence
Dosage Modification (Starting Dose: 160 mg twice daily or 320 mg once daily)
Hematological toxicities
Grade 3 febrile neutropenia Grade 3 thrombocytopenia with significant bleeding Grade 4 neutropenia (lasting more than 10 consecutive days) Grade 4 thrombocytopenia (lasting more than 10 consecutive days)
First
Interrupt Brukinsa Once toxicity has resolved to Grade 1 or lower or baseline: Resume at 160 mg twice daily or 320 mg once daily
Second
Interrupt Brukinsa Once toxicity has resolved to Grade 1 or lower or baseline: Resume at 80 mg twice daily or 160 mg once daily
Third
Interrupt Brukinsa Once toxicity has resolved to Grade 1 or lower or baseline: Resume at 80 mg once daily
Fourth
Discontinue Brukinsa
Non-hematological toxicities
Grade 3 or 4 non-hematological toxicities *
First
Interrupt Brukinsa Once toxicity has resolved to Grade 1 or lower or baseline: Resume at 160 mg twice daily or 320 mg once daily^
Hematological toxicities
Second
Interrupt Brukinsa Once toxicity has resolved to Grade 1 or lower or baseline: Resume at 80 mg twice daily or 160 mg once daily
Third
Interrupt Brukinsa Once toxicity has resolved to Grade 1 or lower or baseline: Resume at 80 mg once daily
Fourth
Discontinue Brukinsa
*Evaluate the benefit-risk before resuming treatment for a Grade 4 non-hematological toxicity.
^ Evaluate the benefit-risk before resuming treatment at the same dose for Grade 4 non- hematological toxicity
Asymptomatic lymphocytosis should not be regarded as an adverse reaction, and these patients should continue taking
Brukinsa.
What drugs interact with Brukinsa?
Effect of Other Drugs on Brukinsa
Table 7: Drug Interactions that Affect Zanubrutinib
Moderate and Strong CYP3A Inhibitors
Clinical Impact
- Co-administration with a moderate or strong CYP3A inhibitor increases zanubrutinib Cmax and AUC which may increase the risk of Brukinsa toxicities.
Prevention or management
- Reduce Brukinsa dosage when co-administered with moderate or strong CYP3A inhibitors.
Moderate and Strong CYP3A Inducers
Clinical Impact
- Co-administration with a moderate or strong CYP3A inducer decreases zanubrutinib Cmax and AUC which may reduce Brukinsa efficacy.
Prevention or management
- Avoid co-administration of Brukinsa with moderate or strong CYP3A inducers.
Brukinsa pregnancy and breastfeeding safety
Pregnancy
- Based on findings in animals, 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.
Breastfeeding
- There are no data on the presence of zanubrutinib or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions from Brukinsa in a breastfed child, advise lactating women not to breastfeed during treatment with Brukinsa and for two weeks following the last dose.
