Epirubicin Hydrochloride (Page 7 of 7)

Preparation & Administration Precautions

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Procedures normally used for proper handling and disposal of anticancer drugs should be considered for use with Epirubicin Hydrochloride Injection. Several guidelines on this subject have been published.1 to 8

Protective measures

The following protective measures should be taken when handling Epirubicin Hydrochloride Injection:

  • Personnel should be trained in appropriate techniques for reconstitution and handling.

  • Pregnant staff should be excluded from working with this drug.

  • Personnel handling Epirubicin Hydrochloride Injection should wear protective clothing: goggles, gowns and disposable gloves and masks.

  • A designated area should be defined for syringe preparation (preferably under a laminar flow system), with the work surface protected by disposable, plastic-backed, absorbent paper.

  • All items used for reconstitution, administration or cleaning (including gloves) should be placed in high-risk, waste-disposal bags for high temperature incineration.

Spillage or leakage should be treated with dilute sodium hypochlorite (1% available chlorine) solution, preferably by soaking, and then water. All contaminated and cleaning materials should be placed in high-risk, waste-disposal bags for incineration. Accidental contact with the skin or eyes should be treated immediately by copious lavage with water, or soap and water, or sodium bicarbonate solution. However, do not abrade the skin by using a scrub brush. Medical attention should be sought. Always wash hands after removing gloves.

Incompatibilities

Prolonged contact with any solution of an alkaline pH should be avoided as it will result in hydrolysis of the drug. Epirubicin Hydrochloride Injection should not be mixed with heparin or fluorouracil due to chemical incompatibility that may lead to precipitation.

Epirubicin Hydrochloride Injection can be used in combination with other antitumor agents, but it is not recommended that it be mixed with other drugs in the same syringe.

Preparation of Infusion Solution

Epirubicin Hydrochloride Injection is provided as a preservative-free, ready-to-use solution.

Epirubicin Hydrochloride Injection should be administered into the tubing of a freely flowing intravenous infusion (0.9% sodium chloride or 5% glucose solution). Patients receiving initial therapy at the recommended starting doses of 100 to 120 mg/m2 should generally have epirubicin infused over 15 to 20 minutes. For patients who require lower epirubicin starting doses due to organ dysfunction or who require modification of epirubicin doses during therapy, the epirubicin infusion time may be proportionally decreased, but should not be less than 3 minutes. This technique is intended to minimize the risk of thrombosis or perivenous extravasation, which could lead to severe cellulitis, vesication, or tissue necrosis. A direct push injection is not recommended due to the risk of extravasation, which may occur even in the presence of adequate blood return upon needle aspiration. Venous sclerosis may result from injection into small vessels or repeated injections into the same vein (see PRECAUTIONS). Epirubicin Hydrochloride Injection should be used within 24 hours of first penetration of the rubber stopper. Discard any unused solution.

HOW SUPPLIED

Epirubicin Hydrochloride Injection is available in glass single-use vials containing 2 mg epirubicin hydrochloride per mL as a sterile, preservative-free, ready-to-use solution in the following strengths:

50 mg/25 mL (2 mg/mL) single-use vial NDC 10139-061-25

200 mg/100 mL (2 mg/mL) single-use vial NDC 10139-061-01

Store refrigerated between 2ºC and 8ºC (36ºF and 46ºF). Do not freeze. Protect from light. Discard unused portion.

Manufactured by:

Intas Pharmaceuticals Ltd.
Plot No. 457/468 Sharkhej – Bavla Highway
Matoda – 382 210
Ahmedabad, Guarat, India

Mfg. Lic. No.: Guj/Drugs/1026
10 1127 0 604041

Manufactured for:

GeneraMedix Inc.
50 Allen Road
Liberty Corner, NJ 07938

August 2006
PI06100.01

REFERENCES

  1. ONS Clinical Practice Committee. Cancer Chemotherapy Guidelines and Recommendations for Practice. Pittsburgh, PA: Oncology Nursing Society; 1999: 32 to 41.

  2. Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. Washington, DC: Division of Safety, Clinical Center Pharmacy Department and Cancer Nursing Services, National Institutes of Health; 1992 US Dept of Health and Human Services. Public Health Service Publication NIH 92-2621.

  3. AMA Council on Scientific Affairs. Guidelines for Handling Parenteral Antineoplastics. JAMA 1985; 253(11):1590 to 1592.

  4. National Study Commision on Cytotoxic Exposure – Recommendations for Handling of Cytotoxic Agents. 1987. Available from Louis P. Jeffrey, ScD., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, MA 02115.

  5. Clinical Oncology Society of Australia, Guidelines and Recommendations for Safe Handling of Antineoplastic Agents. Med J Australia 1983; 1:426 to 428.

  6. Jones RB, Frank R, Mass T. Safe Handling of Chemotherapeutic Agents: A Report from the Mount Sinai Medical Center. CA-A Cancer J for Clin 1983; 33:258 to 263.

  7. American Society of Hospital Pharmacists. ASHP Technical Assistance Bulletin on Handling Cytotoxic and Hazardous Drugs. AM J Hosp Pharm 1990; 47:1033 to 1049.

  8. Controlling Occupational Exposure to Hazardous Drugs (OSHA Work-Practice Guidelines). Am J Health-Syst Pharm1996; 53:1669 to 1685.

EPIRUBICIN HYDROCHLORIDE
epirubicin hydrochloride injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10139-061
Route of Administration INTRAVENOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
epirubicin hydrochloride (epirubicin) epirubicin 2 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
sodium chloride
water
hydrochloric acid
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10139-061-01 100 mL (100 MILLILITER) in 1 VIAL, GLASS None
2 NDC:10139-061-25 25 mL (25 MILLILITER) in 1 VIAL, GLASS None
Labeler — GeneraMedix, Inc.

Revised: 11/2007 GeneraMedix, Inc.

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