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Prescribing Information

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Indication


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.

Important Safety Information, including boxed WARNING

WARNING: QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH

  • 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 with the restricted distribution program are able to prescribe and dispense CAPRELSA.
  • Do not use CAPRELSA in patients with congenital long QT syndrome.
  • Because of the risk of QT prolongation, ECGs and levels of serum potassium, calcium, magnesium, and TSH should be monitored at baseline, at 2-4 weeks and 8-12 weeks after starting treatment with CAPRELSA, and every 3 months thereafter and following dose adjustments.
  • Severe skin reactions (including Stevens-Johnson syndrome), some leading to death, have been reported and may prompt permanent discontinuation of CAPRELSA.
  • Interstitial lung disease (ILD) has been observed with CAPRELSA and deaths have been reported. Interrupt CAPRELSA treatment and investigate unexplained dyspnea, cough, and fever.
  • Ischemic cerebrovascular events, serious hemorrhagic events, and heart failure have been observed with CAPRELSA and some cases have been fatal.
  • Diarrhea has been observed with CAPRELSA. Serum electrolytes and ECGs should be carefully monitored in cases of diarrhea because of the risk of QT prolongation with CAPRELSA. If severe diarrhea develops, CAPRELSA treatment should be stopped until diarrhea improves.
  • Hypothyroidism, hypertension, and reversible posterior leukoencephalopathy syndrome (RPLS) have been observed with CAPRELSA.
  • The concomitant use of known strong CYP3A4 inducers may reduce drug levels of CAPRELSA and should be avoided. The administration of CAPRELSA with antiarrhythmic drugs and other drugs that may prolong the QT interval should be avoided.
  • CAPRELSA exposure is increased in patients with impaired renal function. The starting dose of CAPRELSA should be reduced to 200 mg in patients with moderate to severe renal impairment and the QT interval should be monitored closely.
  • CAPRELSA is not recommended for patients with moderate and severe hepatic impairment, since safety and efficacy have not been established.
  • CAPRELSA can cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid pregnancy while receiving CAPRELSA and for at least 4 months following treatment.
  • The most common adverse drug reactions (>20%) seen with CAPRELSA are diarrhea (57%), rash (53%), acne (35%), nausea (33%), hypertension (33%), headache (26%), fatigue (24%), decreased appetite (21%), and abdominal pain (21%). The most common laboratory abnormalities (>20%) were decreased calcium (57%), increased ALT (51%), and decreased glucose (24%).
  • CAPRELSA REMS Program: Because of the risks of QT prolongation, Torsades de pointes and sudden death, CAPRELSA is available only through the CAPRELSA REMS Program. Only prescribers and pharmacies certified with the restricted distribution program are able to prescribe and dispense CAPRELSA. To learn about the specific REMS requirements and to enroll in the CAPRELSA REMS Program call 1-800-236-9933 or visit www.caprelsarems.com.

Please see the full Prescribing Information for CAPRELSA, including boxed WARNING.


 

Only certified prescribers can prescribe CAPRELSA.

Enroll into the CAPRELSA REMS Program to become certified to prescribe.


CAPRELSA is a registered trademark of the AstraZeneca group of companies.