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Daunamac 20 Lyophilized Injection

Generic Name- Daunorubicin hydrochloride

Drug Class- Antineoplastic agent

Daunorubicin is an anthracycline antibiotic that has antineoplastic activity and is used in the therapy of acute leukemia and AIDS related Kaposi sarcoma. It acts by intercalating between DNA base pairs and uncoiling the DNA helix, thereby resulting in inhibition of DNA synthesis and apoptosis of rapidly dividing cells.

Product Description

Daunamac 20 (Daunorubicin hydrochloride for injection) is a single use lyophilized powder available in glass vial for intravenous administration only.

Indications and Usage

  • Daunorubicin is indicated for inducing remissions of acute myelogenous and lymphocytic leukemia in adults and treatment of acute lymphocytic leukemia (ALL) and acute myeloid leukemia (AML) in children, as part of a combination regimen

Dosage and Administration

  • Recommended dose in adults for AML and ALL: 40 – 60 mg/m2 on alternate days for a course of up to three injections for the induction of remissions
  • Recommended dose in children for AML and ALL: 300 mg/m2.for children over 2 years of age and 10 mg/kg, for children under 2 years of age (or below 0.5 m2 body surface area)

Dosage Form and Strengths

  • Supplied as a single vial containing lyophilized powder for intravenous infusion
  • Available as 20mg for injection

Clinical Efficacy

  • Shows potent activity in acute leukemia with better tolerability
  • Offers complete remission rates of 60%-80% and survival rates of 40%-45% in younger adults with AML
  • Achieves a complete response rate of 76% in adults with ALL

Adverse Reactions

  • Common side effects of daunorubicin include bone marrow suppression, nausea, vomiting, diarrhea, mucositis, alopecia, skin rash, red urine and fever

Contraindications

  • It is contraindicated in patients with a known hypersensitivity to daunorubicin

Special Precautions

  • Consider dose reduction in patients with severe renal and hepatic impairment
  • Monitor hematologic status during therapy and determine leukocyte, platelet, and erythrocyte counts prior to and at frequent intervals during therapy to evaluate risk of infections related to bone marrow suppression
  • Evaluate patients with HIV infection and immunosuppression for risk of opportunistic infections
  • Patients should be monitored for the risk of cardio toxicity during or months to years after therapy
  • Monitor for injection site related reactions as extravasations of daunorubicin can cause severe local tissue necrosis, severe cellulitis, thrombophlebitis, or painful induration accompanied by immediate burning sensation at injection site
  • Control systemic infections before beginning therapy, however, treatment of underlying malignancy in addition to other therapy (e.g., antibiotics) may be required in some patients with acute leukemia, before systemic infections can be controlled
  • Daunorubicin may be acceptable in pregnant mothers in some condition, so use with caution and treat accordingly
  • Discontinue nursing because of potential risk to nursing infants
Daunamac 20 Lyophilized Injection - ADMAC Life Science