Names and pronunciation
(er′-duh-fih′-tih-nib) Balversa
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Drug reference
(er′-duh-fih′-tih-nib) Balversa
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Func. class.: Antineoplastic-kinase inhibitor
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Chem. class.: Fibroblast growth factor receptor (FGFR) inhibitors
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ACTION: Inhibits the enzymatic activ- ity of FGFR1, FGFR2, FGFR3, and FGFR4
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USES: Locally advanced or metastatic urothelial carcinoma
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SIDE EFFECTS GI: Abdominal pain, nausea, vomiting, anorexia, constipation, diarrhea CNS: Fatigue, fever EENT: Stomatitis, blurred vision, retinal detachment INTEG: Rash, nail discoloration META: Hyperglycemia, hyper-hypophos- phatemia, hypomagnesemia, hyponatre- mia, hypoalbuminemia HEMA: Leukopenia, anemia, thrombocytopenia SYST: Infection
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INTERACTIONS Avoid use with CYP3A4 inducers, inhibitors
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DOSAGE AND ROUTES • Adult: PO 8 mg daily; after 14 to 21 days of treatment, increase to 9 mg daily if serum phosphate level is <5.5 mg/dL and there are no ocular disorders or grade 2 or higher adverse reactions; continue treatment until disease progres- sion or unacceptable toxicity
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Available forms: Tablets 3, 4, 5 mg
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Administer: • Swallow tablets whole, with or without food • If vomiting occurs, do not replace the dose; the next dose should be taken the next day • If a dose is missed, it can be taken as soon as possible on the same day; do not take extra tablets to make up for the missed dose; resume the regular daily schedule on the next day
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Assess: • Ocular disease: Provide dry eye pro- phylaxis with ocular demulcents as needed; perform monthly ophthalmo- logic examinations during the first 4 months of treatment and every 3 months thereafter, and urgently at any time for vi- sual disturbance; examinations should include an assessment of visual acuity, slit-lamp examination, fundoscopy, and optical coherence tomography; an inter- ruption of therapy, discontinuation of therapy, or dose reduction may be neces- sary for ocular adverse reactions • Infection: Assess for infection (fever, flulike symptoms) • Avoid coadministration with agents that alter serum phosphate levels prior to the initial dose increase period (days 14 to 21); monitor phosphate levels monthly for hyperphosphatemia and follow dose modification guidelines when required; in patients with hyperphosphatemia, re- strict phosphate intake to 600 to 800 mg daily; if serum phosphate is >7 mg/dL, consider adding an oral phosphate binder until the serum phosphate level returns to less than 5.5 mg/dL • Pregnancy/breastfeeding: Pregnancy should be avoided during and for at least 1 mo after the last dose; obtain pregnancy testing before use
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Evaluate: • Therapeutic response: decreased pro- gression of cancer
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CLINICAL CONSIDERATIONS
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Patient and caregiver information: • About the reproductive risk and contra- ception requirements during treatment; men with female partners of reproductive potential should also use effective contra- ception during treatment and for 1 mo after the last dose; not to breastfeed during and for 1 mo after last dose • Ophthalmic examinations will be needed periodically
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PHARMACOKINETICS 99.8% protein bound to alpha-1-acid E glycoprotein; half-life 59 hr; 69% excreted in feces (19% unchanged) and 19% in urine (13% unchanged), metabolized by CYP2C9 (39%) and CYP3A4 (20%); an inhibitor of OCT2; peak 2.5 hr
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• Adult: PO 8 mg daily; after 14 to 21 days of treatment, increase to 9 mg daily if serum phosphate level is <5.5 mg/dL and there are no ocular disorders or grade 2 or higher adverse reactions; continue treatment until disease progres- sion or unacceptable toxicity
PDF page 491