Balversa (Tablets) Instructions for Use

Marketing Authorization Holder

Johnson & Johnson, LLC (Russia)

Manufactured By

Janssen-Cilag S.p.A. (Italy)

ATC Code

L01EN01 (Erdafitinib)

Active Substance

Erdafitinib (Rec.INN registered by WHO)

Dosage Forms

	Balversa	Film-coated tablets, 3 mg: 56 or 84 pcs.
		Film-coated tablets, 4 mg: 14, 28 or 56 pcs.
		Film-coated tablets, 5 mg: 28 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets

28 pcs. – blisters (2 pcs.) – cardboard packs (56 pcs.) – By prescription
42 pcs. – blisters (2 pcs.) – cardboard packs (84 pcs.) – By prescription

Film-coated tablets

14 pcs. – blisters – cardboard packs (14 pcs.) – By prescription
28 pcs. – blisters – cardboard packs (28 pcs.) – By prescription
28 pcs. – blisters (2 pcs.) – cardboard packs (56 pcs.) – By prescription

Film-coated tablets

28 pcs. – blisters – cardboard packs (28 pcs.) – By prescription

Clinical-Pharmacological Group

Antitumor drug. Protein kinase inhibitor

Pharmacotherapeutic Group

Antineoplastic agents; protein kinase inhibitors; fibroblast growth factor receptor tyrosine kinase inhibitors

Pharmacological Action

This medicinal product is subject to additional monitoring, which facilitates the rapid identification of new safety information.

Antitumor agent, protease inhibitor.

Indications

Bladder and urinary tract cancer.

ICD codes

Dosage Regimen

Take Balversa orally once daily at the same time each day.

Swallow tablets whole with a glass of water. Do not chew, crush, or split tablets.

The initial recommended dose is 8 mg (two 4 mg tablets) once daily.

Initiate dose modifications based on serum phosphate levels and tolerability.

Measure serum phosphate levels between 14 and 21 days after initiation.

If serum phosphate level is below 5.5 mg/dL and there are no significant adverse reactions, increase the dose to 9 mg.

Continue treatment until disease progression or unacceptable toxicity occurs.

Manage adverse reactions through dose interruptions, dose reductions, or permanent discontinuation.

For adverse reactions, first interrupt therapy until improvement, then resume at the same dose or a reduced dose.

The recommended dose reductions are: first reduction to 6 mg daily, second reduction to 4 mg daily.

Permanently discontinue Balversa if unable to tolerate 4 mg daily.

Perform comprehensive ophthalmological examinations at baseline, at 1 month, at 3 months, and then every 3 months during treatment.

Immediately refer patients for ophthalmological evaluation if they report blurred vision, loss of vision, or other visual disturbances.

Adverse Reactions

Very commondry eyes, hyperphosphatemia; infectious inflammation of the skin around the nail bed, formation of painful areas in the oral cavity, diarrhea, accumulation of fluid under the retina, which can lead to blurred vision; detachment of one of the layers of retinal cells, which can lead to blurred vision, inflammation of the cornea, retinal detachment, retinal edema, pathological changes in the retina, corneal ulcers, detachment of the vitreous body from the retina, detachment of the macula from the surrounding cell layers, which can lead to blurred vision, detachment of the nail base from the nail bed, decreased appetite, dry mouth, dry skin, hair loss, palmar-plantar syndrome, impaired nail growth, change in nail color, eye inflammation, changes in taste sensations.

Common: nail pain, itching, skin cracks, nail ridging, brittle nails, itchy skin rash (eczema), skin thickening, skin peeling, areas of pathological growth or changes in skin appearance, dryness in the nasal cavity, dryness of mucous membranes, severe dry skin, hemorrhages under the nails, itchy skin rash with round spots (nummular eczema), thinning of the skin, skin reactions, discomfort in the nail area.

Possible blood clot formation, calcium deposition in the skin.

Contraindications

Hypersensitivity to erdafitinib, pregnancy, breastfeeding period, children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Use is contraindicated during pregnancy and breastfeeding.

Women of childbearing potential who are receiving Erdafitinib, or female partners of men who are receiving Erdafitinib, should use highly effective methods of contraception before and during therapy, as well as for 3 months after its completion. Male patients should use highly effective methods of contraception (condoms) during sexual intercourse, and should not act as sperm donors or preserve sperm during erdafitinib therapy and for 3 months after the final dose.

Pediatric Use

Use is contraindicated in children and adolescents under 18 years of age.

Special Precautions

Use with caution in patients with eye diseases.

Patients treated with Erdafitinib have experienced visual impairments, which should be taken into account when driving vehicles and operating machinery. If symptoms of visual impairment appear during treatment, patients should not drive vehicles or operate machinery until this symptom resolves.

Drug Interactions

Concomitant use of erdafitinib with the following groups of drugs should be avoided: strong inducers of CYP3A4 or CYP2C9 isoenzymes (e.g., rifampicin); drugs that change phosphate concentrations (e.g., sevelamer); substrates of the CYP3A4 isoenzyme with a narrow therapeutic index (e.g., sirolimus).

Concomitant use with drugs of the following groups should be done with caution and as prescribed by a doctor: strong inhibitors of the CYP3A4 isoenzyme (e.g., itraconazole); moderate inhibitors of the CYP2C9 isoenzyme (e.g., fluconazole); moderate inducers of the CYP3A4 isoenzyme (e.g., efavirenz) or CYP2C9 (e.g., rifampicin); OAT2 substrates (e.g., metformin); P-glycoprotein substrates (e.g., digoxin).

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.