HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use CAPRELSA safely and effectively. See full prescribing information for CAPRELSA.
Initial U.S. Approval: 2011
WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH
See full prescribing information for complete boxed warning. CAPRELSA can prolong the QT interval. Torsades de pointes and sudden death have been reported in patients receiving CAPRELSA. CAPRELSA should not be used in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Hypocalcemia, hypokalemia and/or hypomagnesemia must be corrected prior to CAPRELSA administration and should be periodically monitored. Drugs known to prolong the QT interval should be avoided. If a drug known to prolong the QT interval must be administered, more frequent ECG monitoring is recommended. Given the half-life of 19 days, ECGs should be obtained to monitor the QT at baseline, at 2-4 weeks and 8-12 weeks after starting treatment with CAPRELSA and every 3 months thereafter. Following any dose reduction for QT prolongation, or any dose interruptions greater than 2 weeks, QT assessment should be conducted as described above. Because of the 19-day half-life, adverse reactions including a prolonged QT interval may not resolve quickly. Monitor appropriately. Only prescribers and pharmacies certified through the restricted distribution program are able to prescribe and dispense CAPRELSA (5.15).
INDICATIONS AND USAGE
CAPRELSA is a kinase inhibitor indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.
Use of CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease should be carefully considered because of the treatment related risks of CAPRELSA.
DOSAGE AND ADMINISTRATION
300 mg once daily (2)
CAPRELSA may be taken with or without food.
Dosage reduction may be necessary in the event of severe toxicities or QTc interval prolongation. (2.1)
The starting dose should be reduced to 200 mg in patients with moderate to severe renal impairment.
DOSAGE FORMS AND STRENGTHS
100 mg and 300 mg tablets (3)
CONTRAINDICATIONS
Do not use in patients with congenital long QT syndrome.
WARNINGS AND PRECAUTIONS
Prolonged QT Interval, Torsades de pointes, and sudden death have been reported. Monitor electrocardiograms and levels of serum potassium, calcium, magnesium and TSH at baseline, 2-4 weeks and 8-12 weeks after starting treatment with CAPRELSA, and every 3 months thereafter and following dose adjustments. Dose reduce as appropriate (2.1, 5.1).
Stevens-Johnson syndrome resulting in death has been observed. Severe skin reactions may prompt permanent discontinuation of CAPRELSA (2.1, 5.2).
Interstitial lung disease, resulting in death has been reported. Interrupt CAPRELSA and investigate unexplained dyspnea, cough, and fever. Appropriate measures should be taken for ILD (2.1, 5.3).
Ischemic cerebrovascular events, hemorrhage, heart failure, diarrhea, hypothyroidism, hypertension, and reversible posterior leukoencephalopathy syndrome, have been observed (2.1, 5.4, 5.5, 5.6, 5.7, 5.8, 5.9, 5.10).
CAPRELSA can cause fetal harm when administered to a pregnant woman. Women should be advised to avoid pregnancy while receiving CAPRELSA and for four months following treatment (5.14, 8.1).
Because of the