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Balversa

Balversa

Manufacturer:

Janssen-Cilag

Distributor:

DKSH

Marketer:

Janssen-Cilag
Concise Prescribing Info
Contents
Erdafitinib
Indications/Uses
Adults w/ locally advanced or metastatic urothelial carcinoma (mUC), that has susceptible fibroblast growth factor receptors (FGFR) 3 or FGFR2 genetic alterations, & progressed during or following at least 1 line of prior platinum-containing chemotherapy, including w/in 12 mth of neoadjuvant or adjuvant platinum-containing chemotherapy.
Dosage/Direction for Use
Recommended starting dose: 8 mg (as two 4 mg tab) once daily, w/ dose increase to 9 mg (as three 3 mg tab) once daily based on serum phosphate levels (<5.5 mg/dL), tolerability at 14-21 days & no ocular disorders or ≥Grade 2 adverse reactions. Dose reduction schedule: 9 mg (as three 3 mg tab): 1st dose reduction: 8 mg (as two 4 mg tab), 2nd dose reduction: 6 mg (as two 3 mg tab), 3rd dose reduction: 5 mg (as one 5 mg tab), 4th dose reduction: 4 mg (as one 4 mg tab). 8 mg (as two 4 mg tab): 1st dose reduction: 6 mg (as two 3 mg tab), 2nd dose reduction: 5 mg (as one 5 mg tab), 3rd dose reduction: 4 mg (as one 4 mg tab).
Administration
May be taken with or without food.
Special Precautions
May cause ocular disorders, including central serous retinopathy/retinal pigment epithelial detachment (CSR/RPED). Administer dry eye prophylaxis w/ ocular demulcents for dry eye symptoms. Perform mthly ophth exam during first 4 mth of treatment & every 3 mth afterwards, & urgently at any time for visual symptoms. Withhold therapy when CSR occurs & permanently discontinue if it does not resolve w/in 4 wk, or if Grade 4 in severity. Monitor for hyperphosphatemia, & patients w/ or suspected to have CYP2C9*3/*3 genotype. Female & male patients w/ female partners of reproductive potential must use effective contraception during treatment, & for 1 mth after the last dose. Pregnancy & lactation. Ped patients.
Adverse Reactions
Stomatitis, diarrhea, dry mouth, constipation, abdominal pain, nausea, vomiting; decreased appetite; fatigue, pyrexia; onycholysis, dry skin, palmar-plantar erythrodysaesthesia, alopecia, nail discoloration; dry eye, blurred vision, increased lacrimation; dysgeusia; paronychia, UTI, conjunctivitis; oropharyngeal pain, dyspnea; hematuria; musculoskeletal pain, arthralgia; decreased wt. Decreased Hb, platelets, leukocytes & neutrophils; increased phosphate, creatinine, ALT, alkaline phosphatase, AST, Ca, K & fasting glucose, decreased Na, albumin, Mg & phosphate.
Drug Interactions
Increased plasma conc w/ moderate CYP2C9 or strong CYP3A4 inhibitors. Decreased plasma conc w/ strong & moderate CYP2C9 or CYP3A4 inducers. May increase or decrease serum phosphate levels w/ other serum phosphate level-altering agents. May alter plasma conc of CYP3A4 substrates. May increase plasma conc of OCT2 & P-gp substrates.
ATC Classification
L01EX16 - erdafitinib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Balversa FC tab 4 mg
Packing/Price
1 × 14's;1 × 28's;2 × 28's
Form
Balversa FC tab 3 mg
Packing/Price
2 × 28's;2 × 42's
Form
Balversa FC tab 5 mg
Packing/Price
1 × 28's
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