Balversa Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Balversa Indications
Indications
Balversa Dosage and Administration
Adult
Children
Balversa Contraindications
Not Applicable
Balversa Boxed Warnings
Not Applicable
Balversa Warnings/Precautions
Warnings/Precautions
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.
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
Balversa Clinical Trials
See Literature
Balversa Note
Not Applicable
Balversa Patient Counseling
See Literature
Images
