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 0310–7810–30).
300 mg Tablets Available in bottles containing 30 tablets (NDC 0310–7830–30).
. Storage and Handling
Vandetanib tablets should be stored at 25°C (77°F); excursions permitted to 15oC – 30oC (59oF – 86oF) [See USP controlled room temperature].
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published1-4. Vandetanib 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.
17. PATIENT COUNSELING INFORMATION
QT Interval
Vandetanib can prolong the QT interval in a concentration-dependent manner. Torsades de pointes, ventricular tachycardia and sudden death have been reported in patients administered Vandetanib. Patients should be advised that their electrolytes and the electrical activity of their heartbeat (via an ECG) should be monitored regularly during treatment with Vandetanib.
Rash
Patients taking Vandetanib should be told they may be more susceptible to sunburn and to use appropriate sun protection (e.g., sunscreen and/or clothing) while taking Vandetanib and for at least 4 months after drug discontinuation. Patients should consult their physician promptly if they develop a skin rash.
Interstitial lung disease
Patients should be told to contact their physician promptly if they develop sudden onset or worsening of breathlessness, persistent cough or fever.
Diarrhea
Patients should be informed that they may experience diarrhea while taking Vandetanib. Patients should also be advised to use standard anti-diarrheal medications and to seek medical attention if their diarrhea becomes persistent or severe. Patients with diarrhea should contact their physician to have their electrolytes monitored.
Reversible Posterior Leukoencephalopathy Syndrome
Patients should be told to contact their physician promptly if they experience seizures, headaches, visual disturbances, confusion or difficulty thinking.
Pregnancy and Nursing
Patients of childbearing potential must be told to use effective contraception during therapy and for at least four months following their last dose of Vandetanib.
Breast-feeding mothers are advised to discontinue nursing while receiving Vandetanib therapy.
Drug Handling
Vandetanib tablets should not be crushed. Direct contact of crushed tablets with the skin or mucous membranes should be avoided.
17.8 Medication Guide
MEDICATION GUIDE
Vandetanib [van-DEH-tuh-nib]
Tablets
Read this Medication Guide before you start taking Vandetanib and each time you get a refill. There may be new information. This Med |