Daunomycin hydrochloride

What is Daunorubicin hydrochloride?

• Daunorubicin hydrochloride (Cerubidine), also known as daunomycin is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of Streptomyces coeruleorubidus.

Daunorubicin

Daunorubicin ball-and-stick

Daunorubicin-2D-structure

What are the uses of this medicine?

Daunorubicin hydrochloride is approved to be used with other drugs as remission induction therapy to treat:

• Acute lymphoblastic leukemia in adults and children.
• Acute myeloid leukemia in adults.

How does this medicine work?

• Daunorubicin (daw” noe roo’ bi sin) is a parenterally administered, cytotoxic antibiotic which is believed to act by intercalating between DNA base pairs and uncoiling the DNA helix, which results in inhibition of DNA synthesis and apoptosis of rapidly dividing cells.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• who have shown a hypersensitivity to it.

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Especially tell your doctor if you use fallowing medicines:

• azathioprine (Imuran), cyclosporine (Neoral, Sandimmune), methotrexate(Rheumatrex, Trexall), sirolimus (Rapamune), and tacrolimus (Prograf).

Is this medicine FDA approved?

• Daunorubicin was approved for medical use in the United States in 1979.

How should this medicine be used?

Recommended dosage: Adult Acute Nonlymphocytic Leukemia:

• For patients under age 60, daunorubicin hydrochloride 45 mg/m2/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/m2/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/m2/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/m2/day IV infusion daily for 7 days for the first course and for 5 days for subsequent courses.

Pediatric Acute Lymphocytic Leukemia:

• Daunorubicin hydrochloride 25 mg/m2 IV on day 1 every week, vincristine 1.5 mg/m2 IV on day 1 every week, prednisone 40 mg/m2 PO daily.
• In children less than 2 years of age or below 0.5 m2 body surface area, it has been recommended that the daunorubicin hydrochloride dosage calculation should be based on weight (1 mg/kg) instead of body surface area.

Adult Acute Lymphocytic Leukemia:

• Daunorubicin hydrochloride 45 mg/m2/day IV on days 1, 2, and 3 AND vincristine 2 mg IV on days 1, 8, and 15
• prednisone 40 mg/m2/day PO on days 1 through 22, then tapered between days 22 to 29
• L-asparaginase 500 IU/kg/day x 10 days IV on days 22 through 32.

Administration:

* Daunorubicin is given intravenously, typically in a regimen of once daily for 3 days during induction and for two days of subsequent courses. 

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Daunorubicin is available as a solution or a powder for injection in 20 and 50 mg vials [5 mg/mL] generically and under the brand name Cerubidine.

This medicine is available in fallowing brand namesː

• Cerubidine

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• vomiting
• sores in the mouth and throat
• diarrhea
• stomach pain
• hair loss
• red urine

Daunorubicin can cause some serious side effects include:

• redness, pain, swelling, or burning at the site where the injection was given
• rash
• hives
• itching
• difficulty breathing or swallowing
• Daunorubicin may increase the risk that you will develop other cancers

What special precautions should I follow?

• Daunorubicin hydrochloride may induce hyperuricemia secondary to rapid lysis of leukemic cells. Blood uric acid levels should be monitored and appropriate therapy initiated in the event that hyperuricemia develops.
• Daunorubicin hydrochloride is a potent bone marrow suppressant.
• Daunorubicin is associated with a low rate of transient serum enzyme and bilirubin elevations during therapy, but has not been implicated in cases of clinically apparent acute liver injury with jaundice.
• Special attention must be given to the potential cardiac toxicity of daunorubicin hydrochloride, particularly in infants and children.
• Significant hepatic or renal impairment can enhance the toxicity of the recommended doses of daunorubicin hydrochloride; therefore, prior to administration, evaluation of hepatic function and renal function using conventional clinical laboratory tests is recommended.
• Daunorubicin hydrochloride may cause fetal harm when administered to a pregnant woman. Women of childbearing potential should be advised to avoid becoming pregnant.
• There have been reports of secondary leukemias in patients exposed to topoisomerase II inhibitors when used in combination with other antineoplastic agents or radiation therapy.
• Extravasation of daunorubicin hydrochloride at the site of intravenous administration can cause severe local tissue necrosis.

What to do in case of emergency/overdose?

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.

Can this medicine be used in pregnancy?

• Daunorubicin hydrochloride may cause fetal harm when administered to a pregnant woman.
• Women of childbearing potential should be advised to avoid becoming pregnant.

Can this medicine be used in children?

• No appropriate studies with daunorubicin hydrochloride have not been performed in the pediatric population, cardiotoxicity may be more frequent and occur at lower cumulative doses in children.

What are the active and inactive ingredients in this medicine?

Active ingredients:

• DAUNORUBICIN HYDROCHLORIDE

Inactive ingredients:

• SODIUM CHLORIDE
• WATER

Who manufactures and distributes this medicine?

Manufactured by:

• THYMOORGAN PHARMAZIE GmbH,
• Schiffgraben 23, Goslar, Germany

Distributed by:

• West-Ward Pharmaceuticals
• Eatontown, NJ USA

What should I know about storage and disposal of this medication?

• Store unopened vials in refrigerator, 2° to 8°C (36° to 46°F).
• Store prepared solution for infusion at room temperature, 15° to 30°C (59° to 86°F) for up to 24 hours.
• Contains no preservative.
• Discard unused portion.
• Protect from light.
• If daunorubicin hydrochloride contacts the skin or mucosae, the area should be washed thoroughly with soap and water.
• Procedures for proper handling and disposal of anticancer drugs should be considered.

• Dailymed label info on Daunomycin hydrochloride
• FDA Daunomycin hydrochloride