Daunoxome contains an aqueous solution of the citrate salt of daunorubicin encapsulated within lipid vesicles liposomes composed of a. This medicine often causes a temporary and total loss of hair. Daunorubicin hydrochloride must not be used if the cumulative highest dose of daunorubicin hydrochloride 500600 mgm 2 in adults, 300 mgm 2 in children of 2 years and older, 10mgkg body weight in children under 2 years or another cardiotoxic anthracycline has already been previously administered, as otherwise the danger of lifethreatening. Nov 09, 2018 daunorubicin is a cancer medication that interferes with the growth and spread of cancer cells in the body. Product information daunorubicin injection page 2 of 8 supersedes. It belongs to a group of medicines used to treat acute leukaemia. Clinical pharmacology mechanism of action idarubicin hydrochloride is a dnaintercalating analog of daunorubicin which has an inhibitory effect on nucleic acid synthesis and interacts with the enzyme.
Each 20 mg vial contains 20 mg idarubicin hydrochloride, usp and 200 mg of lactose nf hydrous as an orangered, lyophilized powder. Ndc number 0703523393, 20 mg as base, 4 ml fill in a 6 ml single dose vial. Dosage is based on your medical condition, body size, and response to. Each ml contains 5 mg daunorubicin equivalent to 5. A vesicant is a chemical that causes extensive tissue damage and blistering if it escapes from the vein. Daunorubicin may also be used for purposes not listed in this medication guide. Daunorubicin lipid complex may cause other side effects. The liposome membrane is composed of distearoylphosphatidylcholine dspc, distearoylphosphatidylglycerol dspg, and cholesterol in a 7. This medication must not be given by injection into a muscle or under the skin. Daunorubicin is supplied with 100 mg of mannitol in 20mg vials, from which it is reconstituted with 4 ml of sterile water for injection. Find medication information including related drug classes, side effects, patient statistics and answers to frequently asked questions. Following rapid iv administration, total plasma concentrations of daunorubicin and its metabolites decline in a triphasic manner and plasma concentrations of unchanged daunorubicin decline in a biphasic manner. Because the parent drug daunorubicin is a vesicant this liposomal form is treated with equal caution. Daunorubicin is usually injected into a vein through a specially prepared site on your skin.
Daunorubicin injection storage daunorubicin injection will be stored in the pharmacy or on the ward. The absence of a methoxy group at position 4 of the anthracycline structure gives the compound a high lipophilicity which results in an increased rate of cellular uptake. Product information daunorubicin injection page 1 of 8. After treatment with daunorubicin has ended, normal hair growth should return. Jul 15, 2019 vyxeos daunorubicin and cytarabine liposome for injection is a combination of daunorubicin and cytarabine in a 1. Side effects tell your doctor, nurse or pharmacist as soon as possible if you do not feel well while you are being given daunorubicin injection. Daunorubicin liposomal is given into a vein as an infusion over 1 hour. Vyxeos daunorubicin and cytarabine liposome for injection, for intravenous use. Daunorubicin hydrochloride injection drug information. Daunoxome contains an aqueous solution of the citrate salt of daunorubicin encapsulated within lipid vesicles liposomes composed of a lipid bilayer of distearoylphos. Administer the first consolidation cycle 5 to 8 weeks after the start of the last induction. Consumer information about the medication daunorubicin citrate liposome injection daunoxome, includes side effects, drug interactions, recommended dosages, and storage information.
The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. Common adverse reactions include reversible alopecia,acute nausea. Sep 24, 2009 daunorubicin that exceeds the standard 45 mgm 2 dose for induction should be considered the new standard of care the american authors agreed. Store unopened vials in refrigerator, 2 to 8c 36 to 46f.
If you experience a serious side effect, you or your doctor may send a report to the food and drug administrations fda medwatch adverse event reporting program online web or by phone 18003321088. A liposomal formulation known as liposomal daunorubicin also exists. When administered to mice thrice weekly intraperitoneally, no carcinogenic effect was noted after 18 months of observation. Tell any doctors, dentists or pharmacists who treat you that you are being treated with daunorubicin. Daunorubicin lipid complex comes as a liquid to be injected intravenously into a vein over 1 hour by a doctor or nurse in a medical facility. The nurse or doctor who give this drug must be carefully trained. Call your doctor if you have any unusual problems while taking this medication. Prescribing information product monograph daunorubicin antimitoticantibiotic 8250 decarie blvd, suite 110 montreal, qc canada, h4p 2p5 date of preparation. It is always given under the supervision of a doctor in a hospital or similar setting with access to sterile equipment for preparation. It is perfectly normal and lasts for only 1 or 2 days after each dose is given. Of note, median doses in both models of daunorubicin were similar to those of doxorubicin across each 100 or 150mgm 2 dose increment. The syringe needle is placed directly into the tubing of a freely flowing iv solution into a vein or central line and the drug is given over several minutes. It belongs to a class of drugs known as anthracyclines and works by slowing or stopping the growth of cancer cells. Cytarabine liposome injection is a sustainedrelease formulation of the active ingredient cytarabine designed for direct administration into the cerebrospinal fluid csf.
Equivalence ratio for daunorubicin to doxorubicin in. It is provided as a deep red sterile liquid in vials for intravenous administration only. Daunorubicin is a cancer medication that interferes with the growth and spread of cancer cells in the body. Daunorubicin hydrochloride solution for injection drug summary. Prescribing information product monograph daunorubicin. The amount of daunorubicin you will receive depends of many factors, including your height and weight, your general health or other health problems. Daunorubicin hydrochloride is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of streptomyces coeruleorubidus. Idarubicin hydrochloride is a dnaintercalating analog of daunorubicin which has an inhibitory effect on nucleic acid synthesis and interacts with the enzyme topoisomerase ii. The name of your medicine is daunorubicin 20 mg powder for i. In this model, the average daunorubicintodoxorubicin ratio, which was based on 150mgm 2 increments, was estimated to be 0. Daunorubicin hydrochloride, when injected subcutaneously into mice, causes fibrosarcomas to develop at the injection site. Parenteral drug products should be inspected visually for particulate.
Nausea, vomiting, constipation, diarrhea, loss of appetite, dry mouth, headache, dryflaking skin, flushing, and increased sweating may occur. The sterile vial contents provide 20 mg of daunorubicin, with 5 mg of daunorubicin per ml. Daunorubicin liposomal is a cancer antineoplastic medication. Cytarabine is an antimetabolite analogue of cytidine with a modified sugar moiety arabinose instead of ribose. It must neverbe given by the intramuscular or subcutaneous route. Daunorubicin is an antineoplastic agent that is fda approved for the treatment of remission induction in acute nonlymphocytic leukemia myelogenous, monocytic, erythroid of adults and for remission induction in acute lymphocytic leukemia of children and adults there is a black box warning for this drug as shown here. Dec 17, 2012 daunorubicin hydrochloride, when injected subcutaneously into mice, causes a fibrosarcomas to develop at the injection site.
Daunorubicin hydrochloride injection must be given into a rapidly flowing intravenous infusion. For more information, go to edit pdf content in word. Daunoxome daunorubicin lipid complex injection chemotherapy. Daunorubicin comes as a solution liquid or as a powder to be mixed with liquid to be injected intravenously into a vein by a doctor or nurse in a medical facility along with other chemotherapy medications. Daunorubicin hydrochloride, when injected subcutaneously into mice, causes a fibrosarcomas to develop at the injection site. Common side effects of daunorubicin include nausea, vomiting, diarrhea, and red. Ask your pharmacist or doctor for a copy of the manufacturers information for the patient. Daunorubicin hydrochloride for injection uses, side. If this medication accidentally leaks into the skinmuscle. Mar 18, 2020 the name of your medicine is daunorubicin 20 mg powder for i. Specifically it is used for acute myeloid leukemia aml, acute lymphocytic leukemia all, chronic myelogenous leukemia cml, and kaposis sarcoma. Idamycin idarubicin hydrochloride for injection, usp. Dailymed vyxeos daunorubicin and cytarabine liposome. Daunorubicin fda prescribing information, side effects and uses.
Very careful handling of this medication is required. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. By stabilizing the complex between dna and topoisomerase ii, daunorubicin inhibits the activity of this enzyme, resulting in singlestrand and doublestrand breaks in dna. Cytarabine is a cell cycle phasespecific antineoplastic agent, affecting cells only during the sphase of cell division. Daunorubicin citrate liposome injection daunoxome side. Because the arabinose sugar sterically hinders the rotation of the molecule within dna, dna replication ceases, specifically during the s phase of the cell cycle. Aug 29, 2018 daunorubicin liposomal is a cancer antineoplastic medication. Word will convert the pdf to editable text and you can then copy and paste that text into your office document. These help by slowing down or stopping the growth of cancerous cells in your body.
Daunorubicin that exceeds the standard 45 mgm 2 dose for induction should be considered the new standard of care the american authors agreed. Blood uric acid levels should be monitored and appropriate therapy initiated in the event that hyperuricemia develops. Serious or fatal hemorrhagic eventswith associated. Daunorubicin belongs to a group of drugs called anthracyclines.
Daunorubicin must be given only by injection into a vein. Daunorubicin injection cerubidine side effects, medical. In clinical trials, serious hypersensitivity occurred in 0. The product catalog provides you with a full listing of tevas brand and generic product lines. Highdose daunorubicin is a new standard in aml medscape. Daunorubicin is used to treat leukemia and other cancers. Daunorubicin 20mg powder for injection summary of product. This medication is available in an injectable form to be given directly into a vein iv by a healthcare professional. As a precaution, allopurinol administration is usually begun prior to initiating antileukemic therapy.
Daunorubicin liposomal side effects, dosage, interactions. Nov 15, 2019 daunorubicin causes the urine to turn reddish in color, which may stain clothes. Highlights of prescribing information these highlights do. Daunorubicin hydrochloride may induce hyperuricemia secondary to rapid lysis of leukemic cells. It must never be given by the intramuscular or subcutaneous route. Daunorubicin hydrochloride injection drug label and. Daunorubicin has antimitotic and cytotoxic activity. Aug 03, 2012 cerubidine daunorubicin must be given into a rapidly flowing intravenous infusion. Daunorubicin is a powerful vesicant that should be administered into the tubing of a freely flowing iv infusion of either 5% dextrose in water or normal saline.
However, in the postapproval setting, across roughly 80,000 chronic kidney disease patients over a 4 year period. When daunorubicin is employed in association with other anticancer agents, the dosage of each should be reduced so as to minimize the total toxic effect. Cytarabine is converted to the triphosphate form within the cell and then competes with cytidine for incorporation into dna. Daunoxome daunorubicin citrate liposome injection is a sterile, pyrogenfree, preservativefree product in a single use vial for intravenous infusion. Like other medicines, daunorubicin can cause some side effects. This medication is given by injection into a vein by a health care professional. Prior to initiating induction, assess cardiac function and obtain liver and renal function studies. Do not interchange with other daunorubicin andor cytarabinecontaining products see full prescribing information for complete boxed war ning. It is kept refrigerated between 28 degrees c in a dark place to protect it from light. Jun 12, 2015 daunorubicin belongs to a group of drugs called anthracyclines. Mar 19, 2020 daunorubicin hydrochloride must not be used if the cumulative highest dose of daunorubicin hydrochloride 500600 mgm 2 in adults, 300 mgm 2 in children of 2 years and older, 10mgkg body weight in children under 2 years or another cardiotoxic anthracycline has already been previously administered, as otherwise the danger of lifethreatening. Daunorubicin hydrochloride injection, 5 mg baseml, is available as follows. If youre looking to insert the contents of your pdf file into an office file, as opposed to simply inserting the pdf as an attachment, then your best bet is to open that pdf with word 20 or 2016. Severe local tissue necrosis will occur if there is extravasation during administration.
Verify drug name and dose prior to preparation and administr ation. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. When daunorubicin is used to treat aml, it is usually injected once a day on certain days of your treatment period. Daunorubicin liposomal interferes with the growth of cancer cells and slows their growth and spread in the body. The desired dose is withdrawn into a syringe containing 10 ml to 15 ml of 0. Cerubidine daunorubicin in combination with other approved anticancer drugs is indicated for remission induction in acute nonlymphocytic leukemia myelogenous, monocytic, erythroid of adults and for remission induction in acute lymphocytic leukemia of children and adults dosage and administration.
Do not interchange with other daunorubicin andor cytarabinecontaining products vyxeos has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. Daunorubicin side effects, dosage, interactions drugs. Daunorubicin works by attacking and destroying the abnormal white blood cells which are present in a person with leukaemia. Administer daunorubicin into a rapidly flowing iv infusion. Daunorubicin, also known as daunomycin, is a chemotherapy medication used to treat cancer. Daunorubicin fda prescribing information, side effects.
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