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.
Related Clinical Trials
A Randomized Phase II Study Comparing Cytarabine + Daunorubicin (7 + 3) vs (Daunorubicin and Cytarabine) Liposome, Cytarabine + Daunorubicin + Venetoclax, Azacitidine + Venetoclax, and (Daunorubicin and Cytarabine) Liposome + Venetoclax in Patients Aged 59 or Younger Who Are Considered High-Risk (Adverse) Acute Myeloid Leukemia As Determined by MYELOMATCH; A MYELOMATCH Clinical Trial
Summary: This phase II MyeloMATCH treatment trial tests whether the standard approach of cytarabine and daunorubicin in comparison to the following experimental regimens works to shrink cancer in patients with high risk acute myeloid leukemia (AML): 1) daunorubicin and cytarabine liposome alone; 2) cytarabine and daunorubicin with venetoclax; 3) azacitidine and venetoclax; 4) daunorubicin and cytarabine li...
A Phase 1b/2, Open-Label, Safety and Efficacy Study of Epcoritamab (GEN3013; DuoBody®-CD3xCD20) in Relapsed/Refractory Chronic Lymphocytic Leukemia and Richter's Syndrome
Summary: The study is a global, multi-center safety and efficacy trial of epcoritamab, an antibody also known as EPKINLY™ and GEN3013 (DuoBody®-CD3xCD20). Epcoritamab will be tested either in Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL) as: * Monotherapy, or * Combination therapy: * epcoritamab + venetoclax * epcoritamab + pirtobrutinib Treatment-naïve (TN) high risk (HR) (CLL): • epcoritam...
A Two-part Phase 1 Open-label Safety and Pharmacokinetic Study of Intravenous RC220 in Combination With Doxorubicin in Adult Patients With Solid Tumours.
Summary: This is a multi-centre, two-part, open-label, phase 1, first in human study of multiple ascending doses of RC220 bisantrene formulation alone and in combination with fixed dose doxorubicin to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) in adult patients with advanced solid tumours where an anthracycline may be considered as a treatment option / or is indicated. ...
Related Latest Advances
Brand Information
Daunorubicin Hydrochloride (daunorubicin hydrochloride)
1DESCRIPTION
Daunorubicin hydrochloride is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of
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 injection 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.
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 injection 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:
6HOW SUPPLIED
DAUNOrubicin Hydrochloride Injection, 5 mg/mL, is available as a deep red sterile liquid in butyl-rubber-stoppered vials as follows:
NDC 42658-021-01 20 mg, 4 mL per vial, single-dose vials; individually-boxed.
NDC 42658-021-02 20 mg, 4 mL per vial, single-dose vials; individually-boxed and then carton of 10.
NDC 42658-019-01 50 mg, 10 mL per vial, single-dose vial; individually-boxed.
To report SUSPECTED ADVERSE REACTION, contact Hisun Pharmaceuticals USA, Inc. at 1-855-554-4786, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
7REFERENCES
- 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.
- National Study Commission on Cytotoxic Exposure Recommendations for Handling Cytotoxic Agents. Available from Louis R 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.
- Jones RB, et al: Safe handling of chemotherapeutic agents: A report from the Mount Sinai Medical Center, Ca
- American Society of Hospital Pharmacists technical assistance bulletin on handling cytotoxic and hazardous drugs.
- OSHA Work Practice Guidelines for Personnel Dealing with Cytotoxic (Antineoplastic) Drugs.
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