Balversa

/ Janssen

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.
Recommended Dosage and Schedule
The recommended starting dose of Balversa is 8 mg (two 4 mg tablets) orally once daily, with a dose increase to 9 mg (three 3 mg tablets) once daily based on serum phosphate (PO4) levels and tolerability at 14 to 21 days.
Swallow tablets whole with or without food. If vomiting occurs any time after taking Balversa, the next dose should be taken the next day. Treatment should continue until disease progression or unacceptable toxicity occurs.
If a dose of Balversa is missed, it can be taken as soon as possible on the same day. Resume the regular daily dose schedule for Balversa the next day. Extra tablets should not be taken to make up for the missed dose.
Dose Increase based on Serum Phosphate Levels
Assess serum phosphate levels 14 to 21 days after initiating treatment. Increase the dose of BALVERSA to 9 mg once daily if serum phosphate level is < 5.5 mg/dL and there are no ocular disorders or Grade 2 or greater adverse reactions. Monitor phosphate levels monthly for hyperphosphatemia.
For dose modifications for adverse reactions: see prescribing information for full details.
Pediatric Use
Balversa is not indicated for children and adolescents under 18 years old.
Safety and effectiveness of Balversa in pediatric patients have not been established.
See prescribing information for full details.

Treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC), that has: Susceptible FGFR3 or FGFR2 genetic alterations, and Progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

Hypersensitivity to the active substances or to any of the excipients.

Ocular Disorders
Balversa can cause ocular disorders, including central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED) resulting in visual field defect.
Perform monthly ophthalmological examinations during the first 4 months of treatment and every 3 months afterwards, and urgently at any time for visual symptoms. Ophthalmological examination should include assessment of visual acuity, slit lamp examination, fundoscopy, and optical coherence tomography.
Withhold Balversa when CSR occurs and permanently discontinue if it does not resolve within 4 weeks or if Grade 4 in severity. For ocular adverse reactions, follow the dose modification guidelines.
Hyperphosphatemia
Increases in phosphate levels are a pharmacodynamic effect of Balversa. Hyperphosphatemia was reported as adverse reaction in 76% of patients treated with BALVERSA. The median onset time for any grade event of hyperphosphatemia was 20 days (range: 8 –116) after initiating Balversa. Thirty-two percent of patients received phosphate binders during treatment with Balversa.
Monitor for hyperphosphatemia and follow the dose modification guidelines when required.
Embryo-Fetal Toxicity
Based on the mechanism of action and findings in animal reproduction studies, Balversa can cause fetal harm when administered to a pregnant woman.
See prescribing information for full details.

Ocular disorders, hyperphosphatemia. See prescribing information for full details.

Moderate CYP2C9 or strong CYP3A4 Inhibitors
Co-administration of BALVERSA with moderate CYP2C9 or strong CYP3A4 inhibitors increased erdafitinib plasma concentrations.
Increased erdafitinib plasma concentrations may lead to increased drug-related toxicity.
Consider alternative therapies that are not moderate CYP2C9 or strong CYP3A4 inhibitors during treatment with BALVERSA.
If co-administration of a moderate CYP2C9 or strong CYP3A4 inhibitor is unavoidable, monitor closely for adverse reactions and consider dose modifications accordingly.
If the moderate CYP2C9 or strong CYP3A4 inhibitor is discontinued, the BALVERSA dose may be increased in the absence of drug-related toxicity.
Strong CYP2C9 or CYP3A4 Inducers
Co-administration of BALVERSA with strong inducers of CYP2C9 or CYP3A4 may decrease erdafitinib plasma concentrations significantly.
Decreased erdafitinib plasma concentrations may lead to decreased activity.
Avoid co-administration of strong inducers of CYP2C9 or CYP3A4 with BALVERSA.
Moderate CYP2C9 or CYP3A4 Inducers
Co-administration of BALVERSA with moderate inducers of CYP2C9 or CYP3A4 may decrease erdafitinib plasma concentrations.
Decreased erdafitinib plasma concentrations may lead to decreased activity.
If a moderate CYP2C9 or CYP3A4 inducer must be co-administered at the start of Balversa treatment, administer Balversa dose as recommended (8 mg once daily with potential to increase to 9 mg once daily based on serum phosphate levels on Days 14 to 21 and tolerability).
If a moderate CYP2C9 or CYP3A4 inducer must be co-administered after the initial dose increase period based on serum phosphate levels and tolerability, increase balversa dose up to 9 mg.
When a moderate inducer of CYP2C9 or CYP3A4 is discontinued, continue BALVERSA at the same dose, in the absence of drug-related toxicity.
See prescribing information for full details.

Pregnancy
Based on the mechanism of action and findings in animal reproduction studies, Balversa can cause fetal harm when administered to a pregnant woman. There are no available data on Balversa use in pregnant women to inform a drug-associated risk. See prescribing information for full details.
Lactation
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 from erdafitinib in a breastfed child, advise lactating women not to breastfeed during treatment with Balversa and for one month following the last dose.
See prescribing information for full details.