BRUKINSA Capsule (2022)
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Beigene Usa, Inc.
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1. Indications and Usage
1.1 Mantle Cell Lymphoma BRUKINSA is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated ...
2. Dosage and Administration
2.1 Recommended Dosage 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 ...
3. Dosage Forms and Strengths
<u>Capsules:</u> Each 80 mg capsule is a size 0, white to off-white opaque capsule marked with ZANU 80 in black ink.
4. Contraindications
None.
5. Warnings and Precautions
5.1 Hemorrhage Fatal and serious hemorrhagic events have occurred in patients with hematological malignancies treated with BRUKINSA monotherapy. Grade 3 or higher hemorrhage including intracranial and ...
6. Adverse Reactions
The following clinically significant adverse reactions are discussed in more detail in other sections of the labeling: Hemorrhage <em>[see Warnings and Precautions (5.1)]</em> Infections <em>[see Warnings ...
6.1. Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another ...
7. Drug Interactions
7.1 Effect of Other Drugs on BRUKINSA <b>Table 9. Drug Interactions that Affect Zanubrutinib:</b> <b>Moderate and Strong CYP3A Inhibitors</b> <em>Clinical Impact</em> • Co-administration with a moderate ...
8.1. Pregnancy
Risk Summary 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 ...
8.2. Lactation
Risk Summary 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 ...
8.3. Females and Males of Reproductive Potential
Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential prior to initiating BRUKINSA therapy. Contraception Females BRUKINSA can cause embryo-fetal harm when administered ...
8.4. Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
8.5. Geriatric Use
Of the 847 patients in clinical studies with BRUKINSA, 53% were ≥65 years of age, and 20% were ≥75 years of age. No overall differences in safety or effectiveness were observed between younger and older ...
8.6. Renal Impairment
No dosage modification is recommended in patients with mild, moderate, or severe renal impairment (CLcr ≥15 mL/min, estimated by Cockcroft-Gault). Monitor for BRUKINSA adverse reactions in patients on ...
8.7. Hepatic Impairment
Dosage modification of BRUKINSA is recommended in patients with severe hepatic impairment <em>[see Dosage and Administration (2.2)]</em>. The safety of BRUKINSA has not been evaluated in patients with ...
11. Description
BRUKINSA (zanubrutinib) is a kinase inhibitor. The empirical formula of zanubrutinib is C<sub>27</sub>H<sub>29</sub>N<sub>5</sub>O<sub>3</sub> and the chemical name is (<em>S</em>)7(1-acryloylpiperidin-4-yl) ...
12.1. Mechanism of Action
Zanubrutinib is a small-molecule inhibitor of Brutons tyrosine kinase (BTK). Zanubrutinib forms a covalent bond with a cysteine residue in the BTK active site, leading to inhibition of BTK activity. BTK ...
12.2. Pharmacodynamics
BTK Occupancy in PBMCs and Lymph Nodes The median steady-state BTK occupancy in peripheral blood mononuclear cells was maintained at 100% over 24 hours at a total daily dose of 320 mg in patients with ...
12.3. Pharmacokinetics
Zanubrutinib maximum plasma concentration (C<sub>max</sub>) and area under the plasma drug concentration over time curve (AUC) increase proportionally over a dosage range from 40 mg to 320 mg (0.13 to ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been conducted with zanubrutinib. Zanubrutinib was not mutagenic in a bacterial mutagenicity (Ames) assay, was not clastogenic in a chromosome aberration assay in mammalian ...
14. Clinical Studies
14.1 Mantle Cell Lymphoma The efficacy of BRUKINSA was assessed in BGB-3111-206 [NCT03206970], a Phase 2, open-label, multicenter, single-arm trial of 86 previously treated patients with MCL who had received ...
16.1. How Supplied
Package Size Content NDC Number 120-count Bottle with a child-resistant cap containing 120 capsules<br />80 mg, white to off-white opaque capsule, marked with ZANU 80 in black ink 72579-011-02 ...
16.2. Storage and Handling
Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F) [See USP Controlled Room Temperature].
17. Patient Counseling Information
Advise patients to read the FDA-approved patient labeling (Patient Information). Hemorrhage Inform patients to report signs or symptoms of severe bleeding. Inform patients that BRUKINSA may need to be ...