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.
16. HOW SUPPLIED/STORAGE AND HANDLING
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.
17. PATIENT COUNSELING INFORMATION
SEE FDA-APPROVED PATIENT LABELING (MEDICATION GUIDE)
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QT Prolongation and Torsades de Pointes: Advise patients to contact their healthcare provider in the event of syncope, pre-syncopal symptoms, and cardiac palpitations. Advise patients that their healthcare provider will monitor their electrolytes and ECGs during treatment [see Warnings and Precautions (5.1)].
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Severe skin reactions and Stevens-Johnson Syndrome: Advise patients to contact their healthcare provider in the event of skin reactions or rash. [see Warnings and Precautions (5.2)].
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Interstitial Lung Disease (ILD): Advise patients to contact their health care provider in the event of sudden onset or worsening of breathlessness, persistent cough or fever. [see Warnings and Precautions (5.3)].
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Diarrhea: Advise patients to contact their healthcare provider in the event of diarrhea [see Warnings and Precautions (5.7)].
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Reversible Posterior Leukoencephalopathy Syndrome (RPLS): Advise patients to contact their healthcare provider in the event of seizures, headaches, visual disturbances, confusion or difficulty thinking [see Warnings and Precautions (5.10)].
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Fetal Toxicity: Because Caprelsa can cause fetal harm, advise patients of reproductive potential to use effective contraception during therapy and for at least four months following their last dose of Caprelsa, and to immediately contact their health care provider if pregnancy is suspected or confirmed [see Pregnancy (8.1), Females and Males of Reproductive Potential (8.8)].
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Nursing Infants: Because of the potential for serious adverse reactions in nursing infants from Caprelsa, advise breast feeding mothers to discontinue nursing while receiving therapy [see Nursing Mothers (8.3)].
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Photosensitivity: Advise patients to use appropriate sun protection due to the increased susceptibility to sunburn while taking Caprelsa and for at least 4 months after drug discontinuation [see Warnings and Precautions (5.2)].
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Administration: Advise patients that Caprelsa can be taken with or without food and not to crush Caprelsa tablets [see Pharmacokinetics (12.3)].
MEDICATION GUIDE
Caprelsa® (kap-rel-sah)
(vandetanib)
Tablets
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