Pricing
Prices are indicative MRP and may vary by pharmacy. Trend compares against the last recorded price.
All price changes →More from Rubicin
Other strengths and forms by Beacon Pharmaceuticals PLC
Indications & Uses
Rubicin is indicated for:
Pharmacology
Daunorubicin has antimitotic and cytotoxic activity, and several mechanisms have been proposed for how it works. It forms complexes with DNA by intercalation between base pairs. It also inhibits topoisomerase II activity by stabilizing the DNA-topoisomerase II complex, which prevents the religation part of the ligation-religation reaction that topoisomerase II catalyzes. The result is single-strand and double-strand DNA breaks. It may also inhibit polymerase activity, affect the regulation of gene expression, and cause free radical damage to DNA. Against a wide spectrum of animal tumors, whether grafted or spontaneous, it has shown an antitumor effect.
Distribution
Daunorubicin is distributed quickly and widely in the tissues. The highest levels are found in the spleen, kidneys, liver, lungs and heart. The drug binds to many cellular components, particularly nucleic acids. There is no evidence that it crosses the blood-brain barrier, but it apparently does cross the placenta.
Metabolism and Elimination
Daunorubicin is extensively metabolized in the liver and other tissues, mainly by cytoplasmic aldo-keto reductases. This produces daunorubicinol, the major metabolite, which has antineoplastic activity. After a dose of Daunorubicin, about 40% of the drug in the plasma is present as daunorubicinol within 30 minutes, and 60% within 4 hours. Further metabolism has been demonstrated through reduction cleavage of the glycosidic bond, 4-O demethylation, and conjugation with both sulfate and glucuronide. Simple glycosidic cleavage of Daunorubicin or daunorubicinol is not a significant metabolic pathway in man. Twenty-five percent of an administered dose is eliminated in an active form by urinary excretion, and an estimated 40% by biliary excretion.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Check all parenteral products visually for particulate matter before giving them.
Representative dose schedules and combination for the approved indication of remission induction in adult acute nonlymphocytic leukemia, in combination: for patients under 60 years of age, Daunorubicin 45 mg/m2/day IV on days 1, 2 and 3 of the first course and on days 1 and 2 of later courses, together with cytosine arabinoside 100 mg/m2/day by IV infusion daily for 7 days in the first course and for 5 days in later courses. For patients aged 60 years and above, Daunorubicin 30 mg/m2/day IV on days 1, 2 and 3 of the first course and on days 1 and 2 of later courses, together with cytosine arabinoside 100 mg/m2/day by IV infusion daily for 7 days in the first course and for 5 days in later courses. This reduction in the Daunorubicin dose is based on a single study and may not be appropriate where optimal supportive care is available.
Representative dose schedule and combination for the approved indication of remission induction in pediatric acute lymphocytic leukemia, in combination: Daunorubicin 25 mg/m2 IV on day 1 every week, Vincristine 1.5 mg/m2 IV on day 1 every week, and prednisone 40 mg/m2 by mouth daily. A complete remission is generally achieved within four such courses of therapy. If the patient is only in partial remission after four courses, one further course, or two if necessary, may be given in an effort to achieve complete remission. In children under 2 years of age or with a body surface area below 0.5 m2, it is recommended that the Daunorubicin dose be calculated by weight (1 mg/kg) rather than by body surface area.
Representative dose schedules and combination for the approved indication of remission induction in adult acute lymphocytic leukemia, in combination: Daunorubicin 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 by mouth on days 1 through 22, then tapered between days 22 and 29; L-asparaginase 500 IU/kg/day IV for 10 days on days 22 through 32.
Or, as directed by the registered physician.
Side Effects
Dose-limiting toxicity includes myelosuppression and cardiotoxicity. Other reactions include the following. Skin: Reversible hair loss occurs in most patients. Rash, contact dermatitis and hives have occurred rarely. Digestive system: Acute nausea and vomiting occur but are usually mild, and anti-sickness treatment may help to some extent. Mouth and gut lining inflammation may occur 3 to 7 days after administration. Diarrhea and abdominal pain have occasionally been reported. At the injection site: If the drug leaks into surrounding tissue during administration, severe local tissue damage, severe cellulitis, vein inflammation or painful hardening of the skin can result. Acute reactions: Rarely, an allergic-type reaction, fever and chills can occur. Raised uric acid levels may occur, especially in patients with leukemia, so blood uric acid should be monitored.
Cautions & Contraindications
Warnings & Precautions
Daunobin therapy requires close patient observation and frequent complete blood-count testing. Cardiac, kidney, and liver function should be checked before each course of treatment. Any systemic infection must be brought under control before starting Daunobin therapy. The medicine may cause a temporary red coloration of the urine after it is given, and patients should be told to expect this. Daunobin 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 damage will occur if the drug leaks outside the vein during administration. Myocardial toxicity, which in its most severe form appears as potentially fatal congestive heart failure, may occur either during therapy or months to years after it ends. The risk of this myocardial toxicity rises once the total cumulative dose passes 400 to 550 mg/m2 in adults, 300 mg/m2 in children older than 2 years, or 10 mg/kg in children younger than 2 years. Severe suppression of bone marrow function occurs at therapeutic doses and may lead to infection or bleeding. Daunobin Hydrochloride should be given only by physicians experienced in leukemia chemotherapy, in facilities with the laboratory and supportive resources needed to monitor how well a patient tolerates the drug and to protect and support a patient affected by its toxicity. The physician and institution must be able to respond quickly and fully to severe bleeding and to overwhelming infection. Dosage should be lowered in patients with impaired liver or kidney function.
Contraindications
This medicine should not be used by anyone who is known to be hypersensitive to Daunorubicin or to any of the other ingredients in this product.
Pregnancy & Breastfeeding
Pregnancy Category D. It isn't known whether Daunorubicin passes into breast milk, but since many medicines do and this drug carries a risk of serious harm to a nursing infant, mothers should be advised to stop breastfeeding while receiving Daunorubicin treatment.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Storage
Keep unopened Daunorubicin vials in the refrigerator, at 2°-8°C, and protect them from light. The vials contain no preservatives, so throw away any portion that is left unused.
If Daunorubicin touches the skin or mucosae, wash the area thoroughly with soap and water. Proper procedures for handling and disposing of anticancer drugs should be considered.
Drug Interactions
Common questions about Rubicin 20 mg/4 ml
What is Rubicin 20 mg/4 ml IV Infusion?
Rubicin 20 mg/4 ml IV Infusion is a medicine that contains Daunorubicin. It is made by Beacon Pharmaceuticals PLC. It belongs to the Cytotoxic Chemotherapy group of medicines.
What is Rubicin used for?
Rubicin is used for: Cancer.
What are the side effects of Rubicin?
Dose-limiting toxicity includes myelosuppression and cardiotoxicity. Other reactions include the following.
Can I take Rubicin during pregnancy or while breastfeeding?
Pregnancy Category D. It isn't known whether Daunorubicin passes into breast milk, but since many medicines do and this drug carries a risk of serious harm to a nursing infant, mothers should be advised to stop breastfeeding while receiving Daunorubicin treatment. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Rubicin?
Keep unopened Daunorubicin vials in the refrigerator, at 2°-8°C, and protect them from light. The vials contain no preservatives, so throw away any portion that is left unused.
Can I take other medicines with Rubicin?
Some medicines can interact with Daunorubicin, for example: Doxorubicin Hydrochloride, Cyclophosphamide, Methotrexate. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Rubicin?
Rubicin is a prescription (Rx) medicine. Take it as your doctor advises.