Medullary Thyroid Cancer (MTC)

CAPRELSA is 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.

The recommended daily dose is 300 mg of CAPRELSA taken orally. CAPRELSA treatment should be continued until patients are no longer benefiting from treatment or an unacceptable toxicity occurs.

CAPRELSA may be taken with or without food.

If a patient misses a dose, the missed dose should not be taken if it is less than 12 hours before the next dose.

For Patients who have difficulty swallowing solids

CAPRELSA tablets should not be crushed. If CAPRELSA tablets cannot be taken whole, the tablets can be dispersed in a glass containing 2 ounces of non-carbonated water and stirred for approximately 10 minutes until the tablet is dispersed (will not completely dissolve). No other liquids should be used. The dispersion should be swallowed immediately. To ensure the full dose is received, any residues in the glass should be mixed again with an additional 4 ounces of non-carbonated water and swallowed.

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

Direct contact of crushed tablets with the skin or mucous membranes should be avoided. If such contact occurs, wash thoroughly. Avoid exposure to crushed tablets.

Dosage Adjustment

In the event of corrected QT interval, Fridericia (QTcF) greater than 500 ms, interrupt dosing until QTcF returns to less than 450 ms, then resume at a reduced dose.

For CTCAE (Common Terminology Criteria for Adverse Events) grade 3 or greater toxicity, interrupt dosing until toxicity resolves or improves to CTCAE grade 1, and then resume at a reduced dose.

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

The 300-mg daily dose can be reduced to 200 mg (two 100-mg tablets) and then to 100 mg for CTCAE grade 3 or greater toxicities.

Elderly

No adjustment in starting dose is required for patients over 65 years of age. There are limited data for patients over the age of 75.

Concomitant Strong CYP3A4 Inducers

Avoid the concomitant use of strong CYP3A4 inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentine, phenobarbital). Patients should also avoid taking St. John's Wort. [see WARNINGS AND PRECAUTIONS and DRUG INTERACTIONS]

Patients with Renal Impairment

The starting dose should be reduced 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]

Patients with Hepatic Impairment

Single dose pharmacokinetic data from volunteers with hepatic impairment receiving 800 mg suggest that there were no differences in pharmacokinetics compared to patients with normal hepatic function. There are limited data in patients with liver impairment (serum bilirubin greater than 1.5 times the upper limit of normal). CAPRELSA is not recommended for use in patients with moderate (Child-Pugh B) and severe (Child-Pugh C) hepatic impairment, as safety and efficacy have not been established.

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^oC – 30^oC (59^oF – 86^oF) [See USP controlled room temperature].

Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.^1-4 CAPRELSA tablets should not be crushed. Direct contact of crushed tablets with the skin or mucous membranes should be avoided. If such contact occurs, wash thoroughly as outlined in the references. Personnel should avoid exposure to crushed tablets.

REFERENCES

1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.

2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling Occupational Exposure to Hazardous Drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html

3. American Society of Health-System Pharmacists. ASHP Guidelines on Handling Hazardous Drugs: Am J Health-Syst Pharm. (2006) 63:1172-1193.

4. Polovich, M., White, J. M., & Kelleher, L. O. (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice (2nd. ed.) Pittsburgh, PA: Oncology Nursing Society.

Distributed by: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850. Issued 10-2012

Last reviewed on RxList: 10/18/2012
This monograph has been modified to include the generic and brand name in many instances.