pharmacopeia
GET
/api/v1/drug/daunorubicin

Boxed warning

1.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. 2.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 2 in adults, 300 mg/m 2 in children more than 2 years of age, or 10 mg/kg in children less than 2 years of age. 3.Severe myelosuppression occurs when used in therapeutic doses; this may lead to infection or hemorrhage. 4.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. 5.Dosage should be reduced in patients with impaired hepatic or renal function.

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: DNA Polymerase Inhibitors; Topoisomerase 2 Inhibitors; Topoisomerase Inhibitors.

DNA PolymeraseTopoisomeraseTopoisomerase 2

Indications

Sourced from openFDA
  • 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.ICD-10: C95.90

Contraindications

Sourced from openFDA
  • Daunorubicin hydrochloride is contraindicated in patients who have shown a hypersensitivity to it.contraindicated

Dosage & administration

Sourced from openFDA

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 5 days for subsequent courses. For patients 60 years of age and above, daunorubicin hydrochloride 30 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 5 days for subsequent courses.

Warnings & precautions

Sourced from openFDA

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. Based on prior clinical experience with doxorubicin, this limit appears lower, namely 400 mg/m 2 , in patients who received radiation therapy that encompassed the heart. In infants and children, there appears to be a greater susceptibility to anthracycline-induced cardiotoxicity compared to that in adults, which is more clearly dose-related.

Adverse reactions

Sourced from openFDA

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.

Use in specific populations

Sourced from openFDA

Pregnancy Daunorubicin hydrochloride may cause fetal harm when administered to a pregnant woman. An increased incidence of fetal abnormalities (parieto-occipital cranioschisis, umbilical hernias, or rachischisis) and abortions was reported in rabbits at doses of 0.05 mg/kg/day or approximately 1/100th of the highest recommended human dose on a body surface area basis. Rats showed an increased incidence of esophageal, cardiovascular and urogenital abnormalities as well as rib fusions at doses of 4 mg/kg/day or approximately 1/2 the human dose on a body surface area basis. Decreases in fetal birth weight and post-delivery growth rate were observed in mice. There are no adequate and well-controlled studies in pregnant women. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. Women of childbearing potential should be advised to avoid becoming pregnant.

Approval history

Sourced from openFDA
  • Jan 30, 1998NDANDA050731Hikma
  • Jan 24, 2000ANDAANDA065035Meitheal
  • Aug 3, 2017NDANDA209401Jazz Pharms Therap
  • Apr 12, 2019ANDAANDA208759Hisun Pharm Hangzhou

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
3,661 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Febrile Neutropenia62317%
  2. 2Pyrexia2958.1%
  3. 3Acute Myeloid Leukaemia2727.4%
  4. 4Death2396.5%
  5. 5Off Label Use2236.1%
  6. 6Pneumonia2065.6%
  7. 7Myelosuppression2005.5%
  8. 8Sepsis1875.1%
  9. 9Acute Myeloid Leukaemia Recurrent1724.7%
  10. 10Bacterial Infection1674.6%
  11. 11Therapeutic Product Effect Incomplete1554.2%
  12. 12Rash1433.9%
  13. 13Secondary Immunodeficiency1303.6%
  14. 14Neutropenia1293.5%
  15. 15Pancytopenia1233.4%

Literature

View JSON

Recent PubMed references pinned to Daunorubicin as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 2,522 ClinicalTrials.gov registrations naming Daunorubicin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Pharmacogenomics

View JSON

CPIC-curated drug–gene pairs for Daunorubicin. Levels describe the strength of curated evidence and guideline status — never a recommendation to test or to adjust therapy.

  • CBR3CPIC D (provisional)
  • HAS3CPIC D (provisional)
  • SLC28A3CPIC B/C (provisional)ClinPGx 2B

Frequently asked questions

How does Daunorubicin work?
Mechanism-of-action classes: DNA Polymerase Inhibitors; Topoisomerase 2 Inhibitors; Topoisomerase Inhibitors.
What is Daunorubicin used for?
According to FDA labeling, Daunorubicin carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Daunorubicin?
Daunorubicin is classified as Anthracyclines and related substances, Anthracycline Topoisomerase Inhibitor, DNA Polymerase Inhibitors, Topoisomerase 2 Inhibitors, Topoisomerase Inhibitors, Decreased DNA Integrity, Decreased Mitosis, Decreased RNA Integrity.
What are the brand names for Daunorubicin?
Daunorubicin is marketed under brand names including Vyxeos.
What are the contraindications for Daunorubicin?
Daunorubicin labeling lists contraindications including: Daunorubicin hydrochloride is contraindicated in patients who have shown a hypersensitivity to it.. Always consult the full prescribing information and a clinician.
Note. Data for daunorubicin is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients