Brukinsa Dosage

Generic name: ZANUBRUTINIB 80mg
Dosage form: capsule, gelatin coated
Drug class: BTK inhibitors

Medically reviewed by Drugs.com. Last updated on Mar 8, 2024.

Recommended Dosage

The recommended dosage of BRUKINSA for monotherapy or in combination with obinutuzumab 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 [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

Dosage Modifications for Drug Interactions

Recommended dosage modifications of BRUKINSA for drug interactions are provided in Table 1 [see Drug Interactions (7.1)].

Table 1: Dosage Modifications for Use with CYP3A Inhibitors or Inducers
Coadministered Drug	Recommended BRUKINSA Dosage (Starting Dose: 160 mg twice daily or 320 mg once daily)
* Since clarithromycin 250 mg twice daily acts as a moderate CYP3A inhibitor, it is recommended that patients be administered clarithromycin 250 mg twice daily with 80 mg BRUKINSA twice daily [see Clinical Pharmacology (12.3)]. † Modify or interrupt zanubrutinib dose as recommended for adverse reactions [see Dosage and Administration (2.4)].
Clarithromycin 250 mg twice daily*	80 mg twice daily†
Clarithromycin 500 mg twice daily	80 mg once daily†
Posaconazole suspension 100 mg once daily	80 mg twice daily†
Posaconazole suspension dosage higher than 100 mg once daily Posaconazole delayed-release tablets 300 mg once daily Posaconazole intravenous 300 mg once daily	80 mg once daily†
Other strong CYP3A inhibitor	80 mg once daily†
Moderate CYP3A inhibitor	80 mg twice daily†
Strong CYP3A inducer	Avoid concomitant use.
Moderate CYP3A inducer	Avoid concomitant use. If these inducers cannot be avoided, increase BRUKINSA dose to 320 mg twice daily.

After discontinuation of a CYP3A inhibitor or moderate CYP3A inducer, resume previous dose of BRUKINSA [see Dosage and Administration (2.1,2.2) and Drug Interactions (7.1)].

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 Modifications for Adverse Reaction
Adverse Reaction	Adverse Reaction Occurrence	Dosage Modification (Starting Dose: 160 mg twice daily or 320 mg once daily)
* Evaluate the benefit-risk before resuming treatment at the same dosage for Grade 4 non-hematological toxicity.
Hematological toxicities [see Warnings and Precautions (5.3)]
Grade 3 or Grade 4 febrile neutropenia Platelet count decreased to 25,000-50,000/mm3 with significant bleeding Neutrophil count decreased to <500/mm3 (lasting more than 10 consecutive days) Platelet count decreased to <25,000/mm3 (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 [see Warnings and Precautions (5.5) and Adverse Reactions (6.1)]
Severe or life-threatening 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.*
	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