ly ophthalmological examinations during the first four months oftreatment, every 3 months afterwards, and at any time for visualsymptoms. Withhold BALVERSA when CSR/RPED occurs andpermanently discontinue if it does not resolve within 4 weeks or if Grade4 in severity. (2.3, 5.1)
•Hyperphosphatemia: Increases in phosphate levels are apharmacodynamic effect of BALVERSA. Monitor for hyperphosphatemia and manage with dose modifications when required.(2.3, 5.2)
•Embryo-fetal toxicity: Can cause fetal harm. Advise patients of thepotential risk to the fetus and to use effective contraception (5.3, 8.1,8.3).
ADVERSE REACTIONS
The most common adverse reactions including laboratory abnormalities(≥20%) were phosphate increased, stomatitis, fatigue, creatinine increased,diarrhea, dry mouth, onycholysis, alanine aminotransferase increased, alkalinephosphatase increased, sodium decreased, decreased appetite, albumindecreased, dysgeusia, hemoglobin decreased, dry skin, aspartateaminotransferase increased, magnesium decreased, dry eye, alopecia, palmarplantarerythrodysesthesia syndrome, constipation, phosphate decreased,abdominal pain, calcium increased, nausea, and musculoskeletal pain. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact JanssenProducts, LP. at 1-800-526-7736 (1-800-JANSSEN andwww.BALVERSA.com) or FDA at 1-800-FDA-1088 orwww.fda.gov/medwatch.
DRUG INTERACTIONS
•Strong CYP2C9 or CYP3A4 inhibitors: Consider alternative agents ormonitor closely for adverse reactions. (7.1)
•Strong CYP2C9 or CYP3A4 inducers: Avoid concomitant use withBALVERSA. (7.1)
•Moderate CYP2C9 or CYP3A4 inducers: Increase BALVERSA dose upto 9 mg. (7.1)
•Serum phosphate level-altering agents: Avoid concomitant use withagents that can alter serum phosphate levels before the initial dosemodification period. (2.3, 7.1)
•CYP3A4 substrates: Avoid concomitant use with sensitive CYP3A4substrates with narrow therapeutic indices. (7.2)
•OCT2 substrates: Consider alternative agents or consider reducing thedose of OCT2 substrates based on tolerability. (7.2)
•P-gp substrates: Separate BALVERSA administration by at least 6 hoursbefore or after administration of P-gp substrates with narrow therapeuticindices. (7.2)
USE IN SPECIFIC POPULATIONS
•Lactation: Advise not to breastfeed. (8.2)
See 17 for PATIENT COUNSELING INFORMATION and FDAapproved
patient labeling.
Revised: 04/2019
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FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Patient Selection
2.2 Recommended Dosage and Schedule
2.3 Dose Modifications for Adverse Reactions
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Ocular Disorders
5.2 Hyperphosphatemia
5.3 Embryo-Fetal Toxicity
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
7 DRUG INTERACTIONS
7.1 Effect of Other Drugs on BALVERSA
7.2 Effect of BALVERSA on Other Drugs
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Lactation
8.3 Females and Males of Reproductive Potential
8.4 Pediatric Use
8.5 Geriatric Use
8.6 CYP2C9 Poor Metabolizers
11 DESCR |
