Brand Name
Daunorubicin
View Brand InformationFDA approval date: January 02, 2018
Classification: Anthracycline Topoisomerase Inhibitor
Form: Injection
What is Daunorubicin?
Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia of adults and for remission induction in acute lymphocytic leukemia of children and adults.
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Brand Information
daunorubicin hydrochloride (daunorubicin hydrochloride)
WARNINGS
- Daunorubicin hydrochloride injection must be given into a rapidly flowing intravenous infusion. It must never be given by the intramuscular or subcutaneous route. Severe local tissue necrosis will occur if there is extravasation during administration.
- Myocardial toxicity manifested in its most severe form by potentially fatal congestive heart failure may occur either during therapy or months to years after termination of therapy. The incidence of myocardial toxicity increases after a total cumulative dose exceeding 400 to 550 mg/m
- Severe myelosuppression occurs when used in therapeutic doses; this may lead to infection or hemorrhage.
- It is recommended that daunorubicin hydrochloride be administered only by physicians who are experienced in leukemia chemotherapy and in facilities with laboratory and supportive resources adequate to monitor drug tolerance and protect and maintain a patient compromised by drug toxicity. The physician and institution must be capable of responding rapidly and completely to severe hemorrhagic conditions and/or overwhelming infection.
- Dosage should be reduced in patients with impaired hepatic or renal function.
1DESCRIPTION
Daunorubicin Hydrochloride Injection consists of the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of
C
It is a hygroscopic crystalline powder. The pH of a 5 mg/mL aqueous solution is 3 to 4.
2INDICATIONS AND USAGE
Daunorubicin hydrochloride injection in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia (myelogenous, monocytic, erythroid) of adults and for remission induction in acute lymphocytic leukemia of children and adults.
3CONTRAINDICATIONS
Daunorubicin hydrochloride is contraindicated in patients who have shown a hypersensitivity to it.
4ADVERSE REACTIONS
Dose-limiting toxicity includes myelosuppression and cardiotoxicity (see
4.1Cutaneous
Reversible alopecia occurs in most patients. Rash, contact dermatitis and urticaria have occurred rarely.
4.2Gastrointestinal
Acute nausea and vomiting occur but are usually mild. Antiemetic therapy may be of some help. Mucositis may occur 3 to 7 days after administration. Diarrhea and abdominal pain have occasionally been reported.
4.3Local
If extravasation occurs during administration, severe local tissue necrosis, severe cellulitis, thrombophlebitis, or painful induration can result.
4.4Acute Reactions
Rarely, anaphylactoid reaction, fever, and chills can occur. Hyperuricemia may occur, especially in patients with leukemia, and serum uric acid levels should be monitored.
To report SUSPECTED ADVERSE REACTIONS, contact Meitheal Pharmaceuticals, Inc. at 1-844-824-8426 or FDA at 1-800-FDA-1088 or
5DOSAGE AND ADMINISTRATION
Parenteral drug products should be inspected visually for particulate matter prior to administration, whenever solution and container permit.
5.1Principles
In order to eradicate the leukemic cells and induce a complete remission, a profound suppression of the bone marrow is usually required. Evaluation of both the peripheral blood and bone marrow is mandatory in the formulation of appropriate treatment plans.
It is recommended that the dosage of daunorubicin hydrochloride be reduced in instances of hepatic or renal impairment. For example, using serum bilirubin and serum creatinine as indicators of liver and kidney function, the following dose modifications are recommended:
6Storage and Handling
Store unopened vials in refrigerator, 2° to 8°C (36° to 46°F). Store prepared solution for infusion at room temperature, 20° to 25°C (68° to 77°F) for up to 24 hours. Contains no preservative. Discard unused portion. Protect from light. Retain in carton until time of use.
If daunorubicin hydrochloride contacts the skin or mucosae, the area should be washed thoroughly with soap and water. Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.
7HOW SUPPLIED
Daunorubicin Hydrochloride Injection, 5 mg (base) per mL, is available as follows:
Sterile, Nonpyrogenic.
The container closure is not made with natural rubber latex.
8REFERENCES
- Recommendations for the Safe Handling of Parenteral Antineoplastic Drugs. NIH Publication No. 83-2621. For Sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.
- AMA Council Report. Guidelines for Handling Parenteral Antineoplastics. JAMA. 253 (11): 1590–1592, 1985.
- National Study Commission on Cytotoxic Exposure—Recommendations for Handling Cytotoxic Agents. Available from Louis P. Jeffrey, Sc.D., Chairman, National Study Commission on Cytotoxic Exposure, Massachusetts College of Pharmacy and Allied Health Sciences, 179 Longwood Avenue, Boston, Massachusetts 02115.
- Clinical Oncological Society of Australia: Guidelines and recommendations for safe handling of antineoplastic agents. Med J Australia 1:426–428, 1983.
- Jones RB, et al.: Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center, Ca – A Cancer Journal for Clinicians Sept/Oct, 258–263, 1983.
- American Society of Hospital Pharmacists technical assistance bulletin on handling cytotoxic and hazardous drugs. Am J Hosp Pharm 47:1033–1049, 1990.
- OSHA Work Practice Guidelines for Personnel Dealing with Cyotoxic (Antineoplastic) Drugs. AM J Hosp Pharm 43:1193–1204, 1986.
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9PRINCIPAL DISPLAY PANEL - DAUNOrubicin Hydrochloride Injection 20 mg per 4 mL Carton
NDC 71288-
Rx only
DAUNOrubicin Hydrochloride Injection
20 mg per 4 mL
(5 mg per mL*)
For Intravenous Use Only
4 mL Single Dose Vial
10PRINCIPAL DISPLAY PANEL - DAUNOrubicin Hydrochloride Injection 20 mg per 4 mL Carton
NDC 71288-
Rx only
DAUNOrubicin Hydrochloride Injection
20 mg per 4 mL
(5 mg per mL*)
For Intravenous Use Only
Caution: Cytotoxic Agent
10 x 4 mL Single Dose Vials
