"The U.S. Food and Drug Administration today expanded the approved use of Opdivo (nivolumab) to treat patients with advanced (metastatic) squamous non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.
Totect® is indicated for the treatment of extravasation resulting from intravenous anthracycline chemotherapy.
DOSAGE AND ADMINISTRATION
Vial contents must be mixed and diluted before use.
Totect® should be given once daily for 3 consecutive days. The first infusion should be initiated as soon as possible and within the first six hours after extravasation.
The individual dosage is based on calculation of the Body Surface Area (BSA) up to a maximum dose of 2000 mg (each on Day 1 and 2) and 1000 mg (Day 3), corresponding to a BSA of 2 m².
|The recommended dose is:||Maximum daily dose:|
|Day one: 1000 mg/m²||2000 mg|
|Day two: 1000 mg/m²||2000 mg|
|Day three: 500 mg/m²||1000 mg|
The Totect® dose should be reduced by 50% in patients with creatinine clearance values < 40 mL/min.
Directions for Mixing and Final Dilution
Read this entire section carefully before mixing and diluting.
Aseptic technique should be used during preparation.
Caution must be exercised when handling Totect® and preparing the mixed solution. [see HOW SUPPLIED/Storage and Handling] Totect® should not be mixed or administered with any other drug during the infusion.
Preparation of Totect®
Step 1. Each vial of Totect® (dexrazoxane for injection) (500 mg) must first be mixed with 50 mL of the enclosed diluent. The resultant solution contains 10 mg/mL. This resultant solution should be used immediately (within 2 hours) after preparation. It contains no antibacterial preservative.
Step 2. Withdraw the recommended dose from the solution containing 10 mg/mL as prepared in Step 1 and further dilute into an infusion bag containing 1000 mL 0.9% Sodium Chloride. In order to obtain the required dose more than one vial may be needed. Totect® must not be mixed with any other drugs.
The infusion bag should be used immediately after preparation. The product is stable for 4 hours from the time of preparation when stored below 25°C (77°F).
The solution of Totect® is slightly yellow.
Parenteral drug products should be inspected visually for particulate matter prior to administration, whenever solution and container permit. Solutions containing a precipitate should be discarded. Vials are for single use only. Unused solution should be discarded.
Totect® should not be mixed or administered with any other drug during the infusion. Administer as an intravenous infusion over 1 to 2 hours at room temperature and normal light conditions in a large caliber vein in an extremity/area other than the one affected by the extravasation. Cooling procedures such as ice packs, if used, should be removed from the extravasation area at least 15 minutes before Totect® administration in order to allow sufficient blood flow to the area of extravasation. Treatment on Day 2 and Day 3 should start at the same hour (+/- 3 hours) as on the first day.
Dosage Forms And Strengths
Totect® is packaged as an urgent treatment kit for single patient use. Each kit contains 1 or 4 vials of Totect® (dexrazoxane for injection) 500 mg and 1 or 4 vials of 50 mL diluent. Up to 10 vials of each may be needed to complete three days of treatment.
Storage And Handling
Totect® is available as an urgent treatment kit for single patient use. Each kit contains 1 or 4 vials of Totect® (dexrazoxane for injection) 500 mg and 1 or 4 vials of 50 mL diluent. Up to 10 vials of each may be needed to complete 3 days of treatment.
NDC 38423-110-02: Carton of 1 vial of Totect® and 1 vial of diluent for Totect®
NDC 38423-110-04: Carton of 4 vials of Totect® and 4 vials of diluent for Totect®
Store at 25°C (77°F); excursions permitted between 15-30°C (59-86°F) [see USP Controlled Room Temperature]. Protect from light. Keep vials in carton until ready for use.
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-4 Direct contact of Totect® with the skin or mucous membranes prior to and following reconstitution should be avoided. If contact occurs, wash immediately and thoroughly with water.
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
Manufactured for: Apricus Pharmaceuticals USA, Inc. San Diego, California 92130. Apr 2013
Last reviewed on RxList: 5/14/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Totect Information
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