Cerubidine Injection (Daunorubicin Hydrochloride) – Antineoplastic Chemotherapy for Leukemia
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What is Cerubidine injection used for
Cerubidine Injection, containing daunorubicin hydrochloride, is a chemotherapy medication used in the treatment of acute myeloid leukemia (AML) and acute lymphocytic leukemia (ALL). It works by inhibiting DNA and RNA synthesis, thereby preventing the growth of cancer cells.

Brand Name: Cerubidine

Generic Name: Daunorubicin Hydrochloride

Drug Class: Anthracycline Antibiotic / Antineoplastic Agent

Formulation: Injectable Solution (vial)

Strength: 20 mg / vial

Route of Administration: Intravenous (IV)

Availability: Prescription Only (Rx)

Manufacturer: Pfizer Inc. (and other generic manufacturers)

Storage: Refrigerate between 2°C and 8°C. Protect from light.

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Daunorubicin Hydrochloride
An anthracycline chemotherapeutic agent that intercalates DNA and inhibits topoisomerase II, leading to disruption of DNA replication and cell death, primarily in rapidly dividing cancer cells.
Daunomycin

Daunoxome (liposomal form)

Rubidomycin
Generic daunorubicin hydrochloride injection
Cerubidine (Daunorubicin HCl) works by intercalating between DNA base pairs, inhibiting the activity of topoisomerase II, and causing DNA strand breaks. This results in inhibition of nucleic acid synthesis and ultimately leads to apoptosis (programmed cell death) in rapidly dividing malignant cells.
Cerubidine is indicated in the treatment of:

Acute Myeloid Leukemia (AML) – both newly diagnosed and relapsed cases

Acute Lymphocytic Leukemia (ALL) – particularly in children and adolescents

Combination Chemotherapy Regimens – commonly used with cytarabine and other antineoplastics

It is not used as a standalone therapy but rather in combination chemotherapy protocols.
Dosage must be individualized and administered under strict medical supervision.

Patient Type Typical Regimen (Induction)
Adults (AML) 45 mg/m²/day IV for 1–3 days
Pediatric (ALL) 25–45 mg/m²/day IV every 1–2 weeks

Route: Slow intravenous infusion (never intramuscular or subcutaneous)

Cycle Duration: Repeat every 3–6 weeks depending on hematologic recovery

Dilution: In 0.9% sodium chloride (NS) or dextrose solution before infusion

Important: Strict monitoring of cardiac function, blood counts, and liver/kidney function during therapy.

Prescribing and Monitoring Guidelines
Baseline echocardiogram or MUGA scan before initiating therapy

Monitor WBC, RBC, platelet counts during and after cycles

Cumulative lifetime dose of daunorubicin should not exceed 550 mg/m² due to risk of cardiomyopathy

Avoid extravasation – may cause severe local tissue necrosis

Safety Information
Pregnancy Category D: Contraindicated; teratogenic

Breastfeeding: Not recommended; excreted in breast milk

Pediatrics: Use with caution; monitor closely

Cardiac Function: Regular cardiac assessments are mandatory

Handling: Use cytotoxic precautions during reconstitution and administration
Common Serious
Nausea, vomiting, mucositis Congestive heart failure, cardiomyopathy
Alopecia (hair loss) Severe myelosuppression
Injection site reactions Septicemia, secondary malignancies (rare)
Red urine discoloration Hepatic dysfunction, severe tissue necrosis
Fatigue, fever Hypersensitivity reactions, anaphylaxis
Cardiotoxicity: Major limiting factor; irreversible at high cumulative doses

Myelosuppression: Dose-limiting toxicity; monitor CBC regularly

Extravasation Risk: Causes tissue necrosis; use central line when possible

Hepatic/Renal Impairment: Dose adjustments required

Secondary Leukemia Risk: Long-term use may increase the risk
Interacting Drug/Class Clinical Implication
Cyclophosphamide, Adriamycin Increased cardiotoxicity
Live vaccines Avoid due to immunosuppression
Trastuzumab Additive cardiac risk
Hepatotoxic drugs (e.g. methotrexate) Increased risk of liver toxicity
Radiotherapy Enhances toxicity in irradiated tissues
ATC Code: L01DB01

Therapeutic Class: Antineoplastic Agent (Anthracyclines)

Legal Classification: Schedule H / Prescription-only

WHO Essential Medicine: Yes (for leukemia treatment)
CALGB 8811 Study (Cancer and Leukemia Group B):
Showed daunorubicin in combination with cytarabine significantly improves remission rates in AML.
Daunorubicin demonstrated as an effective induction agent in pediatric ALL protocols.

Cardiotoxicity Review (Ewer et al., JCO 2007):
Cumulative dose >550 mg/m² increases cardiomyopathy risk exponentially.

Frequently Asked Questions (FAQs)
Q1. What is Cerubidine used for?
Cerubidine is used for the treatment of acute myeloid and acute lymphocytic leukemia, usually as part of combination chemotherapy.

Q2. How is Cerubidine administered?
It is administered by intravenous infusion, typically in a hospital setting under supervision by oncology specialists.

Q3. What are the major risks with Cerubidine?
The most critical risks include cardiotoxicity, bone marrow suppression, and tissue necrosis if extravasated.

Q4. Is Cerubidine safe during pregnancy?
No. It is contraindicated in pregnancy due to potential teratogenic effects.

Q5. How long does treatment with Cerubidine last?
Treatment duration depends on the protocol, response to therapy, and tolerance, often given in cycles spaced 3–6 weeks apart.
Store vials between 2–8°C in the refrigerator

Do not freeze

Protect from direct light

Handle using cytotoxic safety measures

Dispose of via cytotoxic waste disposal

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