BALVERSA Film-coated tablet (2020)

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Janssen Products LP

Λέξεις κλειδιά

59676-030 59676-040 59676-050

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1. Indications and Usage

BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC), that has: susceptible FGFR3 or FGFR2 genetic alterations, and progressed during ...

2. Dosage and Administration

2.1 Patient Selection Select patients for the treatment of locally advanced or metastatic urothelial carcinoma with BALVERSA based on the presence of susceptible FGFR genetic alterations in tumor specimens ...

3. Dosage Forms and Strengths

Tablets: 3 mg: Yellow, round biconvex, film-coated, debossed with 3 on one side; and EF on the other side. 4 mg: Orange, round biconvex, film-coated, debossed with 4 on one side; and EF on the other side. ...

4. Contraindications

None.

5. Warnings and Precautions

5.1 Ocular Disorders BALVERSA can cause ocular disorders, including central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED) resulting in visual field defect. CSR/RPED was reported in ...

6. Adverse Reactions

The following serious adverse reactions are also described elsewhere in the labeling: Ocular Disorders [see Warning and Precautions (5.1)]. Hyperphosphatemia [see Warning and Precautions (5.2)] ...

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 BALVERSA Table 5 summarizes drug interactions that affect the exposure of BALVERSA or serum phosphate level and their clinical management. Table 5. Drug Interactions that ...

8. Use in Specific Populations

8.6 CYP2C9 Poor Metabolizers CYP2C9*3/*3 Genotype: Erdafitinib plasma concentrations were predicted to be higher in patients with the CYP2C9*3/*3 genotype. Monitor for increased adverse reactions ...

8.1. Pregnancy

Risk Summary Based on the mechanism of action and findings in animal reproduction studies, BALVERSA can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)] ...

8.2. Lactation

Risk Summary There are no data on the presence of erdafitinib in human milk, or the effects of erdafitinib on the breastfed child, or on milk production. Because of the potential for serious adverse reactions ...

8.3. Females and Males of Reproductive Potential

Pregnancy Testing Pregnancy testing is recommended for females of reproductive potential prior to initiating treatment with BALVERSA. Contraception Females BALVERSA can cause fetal harm when administered ...

8.4. Pediatric Use

Safety and effectiveness of BALVERSA in pediatric patients have not been established. In 4 and 13-week repeat-dose toxicology studies in rats and dogs, toxicities in bone and teeth were observed at an ...

8.5. Geriatric Use

Of the 416 patients treated with BALVERSA in clinical studies, 45% were 65 years of age or older, and 12% were 75 years of age or older. No overall differences in safety or effectiveness were observed ...

11. Description

Erdafitinib, the active ingredient in BALVERSA, is a kinase inhibitor. The chemical name is N-(3,5-dimethoxyphenyl)N'(1-methylethyl)N[3-(1-methyl-1H-pyrazol-4-yl)quinoxalin-6-yl]ethane-1,2-diamine. Erdafitinib ...

12.1. Mechanism of Action

Erdafitinib is a kinase inhibitor that binds to and inhibits enzymatic activity of FGFR1, FGFR2, FGFR3 and FGFR4 based on in vitro data. Erdafitinib also binds to RET, CSF1R, PDGFRA, PDGFRB, FLT4, ...

12.2. Pharmacodynamics

Cardiac Electrophysiology Based on evaluation of QTc interval in an open-label, dose escalation and dose expansion study in 187 patients with cancer, erdafitinib had no large effect (i.e., >20 ms) on the ...

12.3. Pharmacokinetics

Following administration of 8 mg once daily, the mean (coefficient of variation [CV%]) erdafitinib steady-state maximum observed plasma concentration (Cmax), area under the curve (AUCtau ...

12.5. Pharmacogenomics

CYP2C9 activity is reduced in individuals with genetic variants, such as the CYP2C9*2 and CYP2C9*3 polymorphisms. Erdafitinib exposure was similar in subjects with CYP2C9*1/*2 and *1/*3 genotypes relative ...

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenicity studies have not been conducted with erdafitinib. Erdafitinib was not mutagenic in a bacterial reverse mutation (Ames) assay and was not clastogenic in an in vitro micronucleus ...

14. Clinical Studies

14.1 Urothelial Carcinoma with Susceptible FGFR Genetic Alterations Study BLC2001 (NCT02365597) was a multicenter, open-label, single-arm study to evaluate the efficacy and safety of BALVERSA in patients ...

16.1. How Supplied

BALVERSA (erdafitinib) tablets are available in the strengths and packages listed below: 3 mg tablets: Yellow, round biconvex, film-coated, debossed with 3 on one side and EF on the other side.Bottle of ...

16.2. Storage and Handling

Store at 20°C-25°C (68°F-77°F); excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature].

17. Patient Counseling Information

Advise the patient to read the FDA-approved patient labeling (Patient Information). FGFR genetic alterations: Advise patients that evidence of a susceptible FGFR3 or FGFR2 mutation or gene fusion ...