Daunorubicin Hydrochloride 5 mg/mL
Daunorubicin Hydrochloride · INJECTION · Hikma Pharmaceuticals USA Inc.
Daunorubicin hydrochloride is a chemotherapy medication given as an intravenous injection that is used to treat certain types of cancer, including leukemia and lymphoma. It works by interfering with cancer cell growth and division.
Key Facts
- Brand Name
- Daunorubicin Hydrochloride
- Generic Name
- Daunorubicin Hydrochloride
- NDC Code (Product)
0143-9550- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Strength
- 5 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA050731
- Marketing Start
- 01/02/2018
Recall History
Teva Pharmaceuticals USA
Presence of Precipitate; precipitation of drug product
Teva Pharmaceuticals USA
Lack of Assurance of Sterility
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE Daunorubicin hydrochloride 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION Parenteral drug products should be inspected visually for particulate matter prior to administration, whenever solution and container permit. Principles 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: Serum Bilirubin Serum Creatinine Dose Reduction 1.2 to 3 mg% — 25% >3 mg% — 50% — >3 mg% 50% Representative Dose Schedules and Combination for the Approved Indication of Remission Induction in Adult Acute Nonlymphocytic Leukemia In Combination For patients under age 60, daunorubicin hydrochloride 45 mg/m 2 /day IV on days 1, 2, and 3 of the first course and on days 1, 2 of subsequent courses AND cytosine arabinoside 100 mg/m 2 /day IV infusion daily for 7 days for the first course and for …
Warnings
WARNINGS Bone Marrow Daunorubicin hydrochloride is a potent bone marrow suppressant. Suppression will occur in all patients given a therapeutic dose of this drug. Therapy with daunorubicin hydrochloride should not be started in patients with pre-existing drug-induced bone marrow suppression unless the benefit from such treatment warrants the risk. Persistent, severe myelosuppression may result in superinfection or hemorrhage. Cardiac Effects Special attention must be given to the potential cardiac toxicity of daunorubicin hydrochloride, particularly in infants and children. Pre-existing heart disease and previous therapy with doxorubicin are co-factors of increased risk of daunorubicin-induced cardiac toxicity and the benefit-to-risk ratio of daunorubicin hydrochloride therapy in such patients should be weighed before starting daunorubicin hydrochloride. In adults, at total cumulative doses less than 550 mg/m 2 , acute congestive heart failure is seldom encountered. However, rare instances of pericarditis-myocarditis, not dose-related, have been reported. In adults, at cumulative doses exceeding 550 mg/m 2 , there is an increased incidence of drug-induced congestive heart failure. …
Contraindications
CONTRAINDICATIONS Daunorubicin hydrochloride is contraindicated in patients who have shown a hypersensitivity to it.
Drug Interactions
Drug Interactions Use of daunorubicin in a patient who has previously received doxorubicin increases the risk of cardiotoxicity. Daunorubicin hydrochloride should not be used in patients who have previously received the recommended maximum cumulative doses of doxorubicin or daunorubicin hydrochloride. Cyclophosphamide used concurrently with daunorubicin hydrochloride may also result in increased cardiotoxicity. Dosage reduction of daunorubicin hydrochloride may be required when used concurrently with other myelosuppressive agents. Hepatotoxic medications, such as high-dose methotrexate, may impair liver function and increase the risk of toxicity.
Adverse Reactions
ADVERSE REACTIONS Dose-limiting toxicity includes myelosuppression and cardiotoxicity (see WARNINGS section). Other reactions include: Cutaneous Reversible alopecia occurs in most patients. Rash, contact dermatitis and urticaria have occurred rarely. Gastrointestinal 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. Local If extravasation occurs during administration, severe local tissue necrosis, severe cellulitis, thrombophlebitis, or painful induration can result. Acute 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.
Frequently Asked Questions
What is Daunorubicin Hydrochloride used for?
Daunorubicin hydrochloride is a chemotherapy medication given as an intravenous injection that is used to treat certain types of cancer, including leukemia and lymphoma. It works by interfering with cancer cell growth and division.
Is Daunorubicin Hydrochloride a controlled substance?
Daunorubicin Hydrochloride is not classified as a controlled substance by the DEA.
What is the generic name for Daunorubicin Hydrochloride?
The generic name for Daunorubicin Hydrochloride is Daunorubicin Hydrochloride. There are 1 other brand versions of Daunorubicin Hydrochloride.
What is the NDC code for Daunorubicin Hydrochloride 5 mg/mL?
The NDC (National Drug Code) for Daunorubicin Hydrochloride 5 mg/mL is 0143-9550, listed by Hikma Pharmaceuticals USA Inc..