ALUNBRIG Film-coated tablet (2020)
Βιβλιογραφική αναφορά
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Millennium Pharmaceuticals, Inc.
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1. Indications and Usage
ALUNBRIG is indicated for the treatment of adult patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC) as detected by an FDA-approved test <em>[see Dosage ...
2. Dosage and Administration
2.1 Patient Selection Select patients for the treatment of metastatic NSCLC with ALUNBRIG based on the presence of ALK positivity in tumor specimens <em>[see Clinical Studies (14)]</em>. Information on ...
3. Dosage Forms and Strengths
180 mg: oval, white to off-white film-coated tablets with U13 debossed on one side and plain on the other side 90 mg: oval, white to off-white film-coated tablets with U7 debossed on one side and plain ...
4. Contraindications
None.
5. Warnings and Precautions
5.1 Interstitial Lung Disease (ILD)/Pneumonitis Severe, life-threatening, and fatal pulmonary adverse reactions consistent with interstitial lung disease (ILD)/pneumonitis have occurred with ALUNBRIG. ...
6. Adverse Reactions
The following adverse reactions are discussed in greater detail in other sections of the prescribing information: Interstitial Lung Disease (ILD)/Pneumonitis <em>[see Warnings and Precautions (5.1)]</em> ...
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 ALUNBRIG Strong or Moderate CYP3A Inhibitors Coadministration of ALUNBRIG with a strong or moderate CYP3A inhibitor increased brigatinib plasma concentrations, which may increase ...
8.1. Pregnancy
Risk Summary Based on its mechanism of action and findings in animals, ALUNBRIG can cause fetal harm when administered to a pregnant woman <em>[see Clinical Pharmacology (12.1)]</em>. There are no clinical ...
8.2. Lactation
Risk Summary There are no data regarding the secretion of brigatinib in human milk or its effects on the breastfed infant or milk production. Because of the potential for adverse reactions in breastfed ...
8.3. Females and Males of Reproductive Potential
Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating ALUNBRIG <em>[see Use in Specific Populations (8.1)]</em>. Contraception ALUNBRIG can cause fetal harm ...
8.4. Pediatric Use
The safety and effectiveness of ALUNBRIG in pediatric patients have not been established.
8.5. Geriatric Use
Of the 359 patients enrolled in the ALTA 1L ALUNBRIG arm and in ALTA, 26.7% were 65 and older and 7.5% were 75 and older. No overall differences in safety or effectiveness were observed between patients ...
8.6. Hepatic Impairment
No dose adjustment is recommended for patients with mild hepatic impairment (Child-Pugh A) or moderate hepatic impairment (Child-Pugh B). Reduce the dose of ALUNBRIG for patients with severe hepatic impairment ...
8.7. Renal Impairment
No dose adjustment is recommended for patients with mild or moderate renal impairment [creatinine clearance (CLcr) 30 to 89 mL/min by Cockcroft-Gault]. Reduce the dose of ALUNBRIG for patients with severe ...
11. Description
Brigatinib is a kinase inhibitor. The chemical name for brigatinib is 5-chloro-N<sup>4</sup>-N<sup>2</sup>{2-methoxy-4-[4-(4-methylpiperazin-1-yl)piperidin-1-yl]phenyl}pyrimidine-2,4-diamine. The molecular ...
12.1. Mechanism of Action
Brigatinib is a tyrosine kinase inhibitor with <em>in vitro</em> activity at clinically achievable concentrations against multiple kinases including ALK, ROS1, insulin-like growth factor-1 receptor (IGF-1R), ...
12.2. Pharmacodynamics
Brigatinib exposure-response relationships and the time course of the pharmacodynamic response are unknown. Cardiac Electrophysiology The QT interval prolongation potential of ALUNBRIG was assessed in ...
12.3. Pharmacokinetics
The geometric mean (CV%) steady-state maximum concentration (C<sub>max</sub>) of brigatinib at ALUNBRIG doses of 90 mg and 180 mg once daily was 552 (49%) ng/mL and 1452 (60%) ng/mL, respectively, and ...
13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies have not been performed with brigatinib. Treatment with brigatinib resulted in chromosomal damage in an <em>in vivo</em> mammalian erythrocyte micronucleus in the rat, but was not ...
14. Clinical Studies
TKI-naïve Advanced ALK-positive NSCLC (ALTA 1L Study) The efficacy of ALUNBRIG was demonstrated in a randomized (1:1), open-label, multicenter trial (ALTA 1L, NCT02737501) in adult patients with advanced ...
16.1. How Supplied
180 mg tablets: oval, white to off-white film-coated tablets with U13 debossed on one side and plain on the other side; available in: Bottle of 23 tablets NDC 63020-180-23 Bottle of 30 tablets NDC ...
16.2. Storage and Handling
Store at controlled room temperature 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).
17. Patient Counseling Information
Advise the patient to read the FDA-approved patient labeling (Patient Information). Interstitial Lung Disease (ILD)/Pneumonitis Inform patients of the symptoms and risks of serious pulmonary adverse reactions ...