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Caprelsa

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Caprelsa

INDICATIONS

CAPRELSA is indicated for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease.

Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA.

DOSAGE AND ADMINISTRATION

The recommended dose of CAPRELSA is 300 mg taken orally once daily until disease progression or unacceptable toxicity occurs. CAPRELSA may be taken with or without food.

Do not take a missed dose within 12 hours of the next dose. Do not crush CAPRELSA tablets. The tablets can be dispersed in 2 ounces of water by stirring for approximately 10 minutes (will not completely dissolve). Do not use other liquids for dispersion. Swallow immediately after dispersion. Mix any remaining residue with 4 additional ounces of water and swallow.

The dispersion can also be administered through nasogastric or gastrostomy tubes.

Dosage Adjustment

For adverse reactions

The 300 mg daily dose can be reduced to 200 mg (two 100 mg tablets) and then to 100 mg for Common Terminology Criteria for Adverse Events (CTCAE) Grade 3 or greater toxicities.

Interrupt CAPRELSA for the following:

  • Corrected QT interval, Fridericia (QTcF) greater than 500 ms: Resume at a reduced dose when the QTcF returns to less than 450 ms.
  • CTCAE Grade 3 or greater toxicity: Resume at a reduced dose when the toxicity resolves or improves to CTCAE Grade 1.

For recurrent toxicities, reduce the dose of CAPRELSA to 100 mg after resolution or improvement to CTCAE Grade 1 severity, if continued treatment is warranted.

Because of the 19-day half-life, adverse reactions including a prolonged QT interval may not resolve quickly. Monitor appropriately [see WARNINGS AND PRECAUTIONS].

For patients with renal impairment

Reduce the starting dose to 200 mg in patients with moderate (creatinine clearance ≥ 30 to < 50 mL/min) and severe (creatinine clearance < 30 mL/min) renal impairment [see WARNINGS AND PRECAUTIONS and Use In Specific Populations].

For patients with hepatic impairment

CAPRELSA is not recommended for use in patients with moderate and severe hepatic impairment [see Use in Specific Populations].

HOW SUPPLIED

Dosage Forms & Strengths

CAPRELSA 100-mg tablets are white, round, biconvex, film-coated, and intagliated with 'Z 100' on one side and plain on the reverse side.
CAPRELSA 300-mg tablets are white, oval, biconvex, film-coated, and intagliated with 'Z 300' on one side and plain on the reverse side.

100 mg Tablets Available in bottles containing 30 tablets (NDC 0310–7820–30).
300 mg Tablets Available in bottles containing 30 tablets (NDC 0310–7840–30).

Storage And Handling

CAPRELSA tablets should be stored at 25°C (77°F); excursions permitted to 15°C – 30°C (59°F – 86°F) [See USP controlled room temperature].

Procedures for proper handling and disposal of anticancer drugs should be considered. A guideline on this subject has been published.1 Do not crush CAPRELSA tablets.

REFERENCES

“OSHA Hazardous Drugs” (OSHA Technical Manual). OSHA.

Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Issued 03/2014

Last reviewed on RxList: 4/10/2014
This monograph has been modified to include the generic and brand name in many instances.

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Additional Caprelsa Information

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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