Caprelsa Generic Name & Formulations
Legal Class
General Description
Pharmacological Class
How Supplied
Manufacturer
Generic Availability
Mechanism of Action
Caprelsa Indications
Indications
Caprelsa Dosage and Administration
Adult
Children
Caprelsa Contraindications
Contraindications
Caprelsa Boxed Warnings
Boxed Warning
Caprelsa Warnings/Precautions
Warnings/Precautions
Hypocalcemia, hypokalemia, hypomagnesemia, QTcF interval >450msec, history of Torsades de pointes, bradyarrhythmias, uncompensated heart failure, recent hemoptysis: not recommended. Ventricular arrhythmias. Recent MI. Monitor electrolytes (esp. K+, Ca++, Mg++), TSH, and ECG for QT prolongation at baseline, 2–4 weeks and 8–12 weeks after starting, then every 3 months, and after dose reductions or dose interruptions >2 weeks; reduce dose as needed. Correct electrolyte disturbances before starting. Maintain serum K+ at least 4mEq/mL. Interrupt therapy and follow-up if acute or worsening pulmonary symptoms, QTcF >500msec, or CTCAE Grade ≥3 toxicity occurs. Monitor for heart failure; consider discontinuing if occurs. Discontinue if confirmed interstitial lung disease, severe ischemic cerebrovascular event, hemorrhage, uncontrolled hypertension, or posterior leukoencephalopathy symptoms (RPLS) occur. Impaired wound healing: withhold for ≥1 week prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Moderate to severe hepatic impairment, severe renal impairment (CrCL <30mL/min): not recommended. ESRD requiring dialysis: not studied. Avoid sun, UV light. Embryo-fetal toxicity. Advise females of reproductive potential and males w. female partners of reproductive potential to use effective contraception during and for 4 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 4 months after the last dose).
REMS
Caprelsa Pharmacokinetics
Absorption
Peak plasma concentrations achieved at a median of 6 hours (range, 4 to 10 hours) after dosing.
Distribution
Plasma protein bound: ~90%.
Elimination
Caprelsa Interactions
Interactions
Caprelsa Adverse Reactions
Adverse Reactions
Caprelsa Clinical Trials
See Literature
Caprelsa Note
Notes
Caprelsa Patient Counseling
See Literature