Balversa

— THERAPEUTIC DISORDERS TREATED —
  • Bladder, kidney, and other urologic cancers
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Balversa Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Erdafitinib 3mg, 4mg, 5mg; tabs.

    Pharmacological Class

    Kinase inhibitor.

    How Supplied

    Tabs 3mg—56, 84; 4mg—28, 56; 5mg—28

    Manufacturer

    Janssen Pharmaceuticals, Inc.

    Generic Availability

    NO

    Balversa Indications

    Indications

    Locally advanced or metastatic urothelial carcinoma that has susceptible FGFR3 or FGFR2 genetic alterations, and has progressed during or following at least 1 line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.

    Balversa Dosage and Administration

    Adult

    Confirm presence of FGFR genetic alterations by an FDA-approved test. Swallow whole. Initially 8mg once daily; increase to 9mg once daily at 14–21 days if serum phosphate level <5.5mg/L with no ocular disorders or Grade ≥2 adverse reactions. Continue until disease progression or unacceptable toxicity occurs. Dose modifications for adverse reactions: see full labeling.

    Children

    Not established.

    Balversa Contraindications

    Not Applicable

    Balversa Boxed Warnings

    Not Applicable

    Balversa Warnings/Precautions

    Warnings/Precautions

    Perform ophthalmic exam (include visual acuity, slit lamp, fundoscopy, optical coherence tomography) monthly for the first 4 months then every 3 months thereafter, and as needed. Withhold if central serous retinopathy occurs; permanently discontinue if not resolved within 4 weeks or if Grade 4 severity. Monitor for hyperphosphatemia. Restrict phosphate intake to 600–800mg daily; if serum phosphate is >7.0mg/dL, consider adding oral phosphate binder until level returns to <5.5mg/dL. Withhold, reduce dose, or permanently discontinue based on duration and severity of hyperphosphatemia. Known or suspected CYP2C9*3/*3 genotype: monitor. Severe hepatic impairment: limited data. Severe renal impairment: not studied. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 month after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).

    Balversa Pharmacokinetics

    Absorption

    Median time to achieve peak plasma concentration (tmax) was 2.5 hours (range: 2–6 hours).

    Distribution

    The mean apparent volume of distribution of erdafitinib was 29 L in patients. Erdafitinib protein binding was 99.8% in patients, primarily to alpha-1-acid glycoprotein.

    Metabolism

    Primarily metabolized by CYP2C9 and CYP3A4. 

    Elimination

    Following a single oral dose of radiolabeled erdafitinib, ~69% of the dose was recovered in feces (19% as unchanged) and 19% in urine (13% as unchanged). The mean effective half-life of erdafitinib was 59 hours.

    Balversa Interactions

    Interactions

    Potentiated by strong CYP2C9 or CYP3A4 inhibitors: consider alternatives, if use unavoidable, monitor closely and adjust dose accordingly. May be antagonized by strong CYP2C9 or CYP3A4 inducers: avoid. May be antagonized by moderate CYP2C9 or CYP3A4 inducers: if use is necessary after initial dose increase period, increase to erdafitinib 9mg. Concomitant other serum phosphate level-altering agents may affect serum phosphate levels: avoid before initial dose increase period. Avoid concomitant sensitive CYP3A4 substrates with narrow therapeutic index. May potentiate OCT2 substrates; consider alternatives or reducing the dose of substrates. May potentiate P-gp substrates; if use unavoidable, separate dosing by ≥6hrs before or after substrates.

    Balversa Adverse Reactions

    Adverse Reactions

    Phosphate increased, stomatitis, fatigue, creatinine increase, diarrhea, dry mouth, onycholysis, ALT/AST increased, alkaline phosphatase increased, sodium decreased, decreased appetite, albumin decreased, dysgeusia, hemoglobin decreased, dry skin, magnesium decrease, dry eye, alopecia, palmarplantar erythrodysesthesia syndrome, constipation, phosphate decreased, abdominal pain, calcium increased, nausea, musculoskeletal pain; ocular disorders (eg, central serous retinopathy/retinal pigment epithelial detachment).

    Balversa Clinical Trials

    See Literature

    Balversa Note

    Not Applicable

    Balversa Patient Counseling

    See Literature

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