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Zydelig is being granted traditional approval to treat patients whose chronic lymphocytic leukemia (CLL) has retu"...
(daunorubicin HCl) Injection
- Cerubidine (daunorubicin) 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.
- 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/m2 in adults, 300 mg/m2 in children more than 2 years of age, or 10 mg/kg in children less than 2 years of age.
- Severe myelosuppression occurs when used in therapeutic doses; this may lead to infection or hemorrhage.
- It is recommended that Cerubidine (daunorubicin) 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.
- Dosage should be reduced in patients with impaired hepatic or renal function.
Cerubidine (daunorubicin hydrochloride) is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of Streptomyces coeruleorubidus. It is provided as a sterile reddish lyophilized powder in vials for intravenous administration only. Each vial contains 21.4 mg daunorubicin hydrochloride (equivalent to 20 mg of daunorubicin), and 100 mg mannitol. It is soluble in water when adequately agitated and produces a reddish solution. It has the following structural formula which may be described with the chemical name of (1S,3S)-3-Acetyl-1,2,3,4,6,11-hexahydro-3,5,12-trihydroxy-10-methoxy-6,11-dioxo-1-naphthacenyl 3-amino-2,3,6-trideoxy-α-L-lyxo-hexopyranoside hydrochloride. Its molecular formula is C27H29NO10•HCl with a molecular weight of 563.99. It is a hygroscopic crystalline powder. The pH of a 5 mg/mL aqueous solution is 4.5 to 6.5. The structural formula is as follows:
What are the possible side effects of daunorubicin (Cerubidine)?
If you experience any of the following serious side effects from daunorubicin, contact your doctor immediately:
- an allergic reaction (including difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
- decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; or fever, chills, or signs of infection);
- congestive heart failure (difficulty breathing, fluid retention, chest pain);
- tissue or vein reactions near the site of administration;
What are the precautions when taking daunorubicin (Cerubidine)?
Before using daunorubicin, tell your doctor or pharmacist if you are allergic to it; or to other anthracyclines (e.g., doxorubicin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (e.g., anemia, low blood cell counts), gout, heart disease (e.g., congestive heart failure, irregular heartbeat), kidney disease, liver disease, radiation treatment (especially to chest area).
Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or...
Last reviewed on RxList: 8/3/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Cerubidine Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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