The desired dose is withdrawn into a syringe containing 10 ml to 15 ml of 0. Prescribing information product monograph daunorubicin. In clinical trials, serious hypersensitivity occurred in 0. Daunorubicin is supplied with 100 mg of mannitol in 20mg vials, from which it is reconstituted with 4 ml of sterile water for injection. Daunorubicin liposomal is given into a vein as an infusion over 1 hour.
The liposome membrane is composed of distearoylphosphatidylcholine dspc, distearoylphosphatidylglycerol dspg, and cholesterol in a 7. Daunorubicin is used in the treatment of leukemia blood cancer. Daunorubicin fda prescribing information, side effects. A liposomal formulation known as liposomal daunorubicin also exists. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. Daunorubicin fda prescribing information, side effects and uses.
Vyxeos daunorubicin and cytarabine liposome for injection, for intravenous use. 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. Serious or fatal hemorrhagic eventswith associated. Jul 15, 2019 vyxeos daunorubicin and cytarabine liposome for injection is a combination of daunorubicin and cytarabine in a 1. Call your doctor if you have any unusual problems while taking this medication. Daunorubicin hydrochloride for injection uses, side. It must neverbe given by the intramuscular or subcutaneous route. Administer the first consolidation cycle 5 to 8 weeks after the start of the last induction. Severe local tissue necrosis will occur if there is extravasation during administration.
This medication must not be given by injection into a muscle or under the skin. When daunorubicin is used to treat aml, it is usually injected once a day on certain days of your treatment period. It is perfectly normal and lasts for only 1 or 2 days after each dose is given. A vesicant is a chemical that causes extensive tissue damage and blistering if it escapes from the vein. The name of your medicine is daunorubicin 20 mg powder for i. Find medication information including related drug classes, side effects, patient statistics and answers to frequently asked questions. Daunorubicin works by attacking and destroying the abnormal white blood cells which are present in a person with leukaemia. Daunoxome daunorubicin lipid complex injection chemotherapy. Do not interchange with other daunorubicin andor cytarabinecontaining products see full prescribing information for complete boxed war ning. Store unopened vials in refrigerator, 2 to 8c 36 to 46f. These help by slowing down or stopping the growth of cancerous cells in your body.
Daunorubicin hydrochloride injection drug information. Product description what it looks like daunorubicin injection is a clear red solution in a plastic vial. Daunoxome contains an aqueous solution of the citrate salt of daunorubicin encapsulated within lipid vesicles liposomes composed of a lipid bilayer of distearoylphos. 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. Cytarabine is a cell cycle phasespecific antineoplastic agent, affecting cells only during the sphase of cell division. Ask your pharmacist or doctor for a copy of the manufacturers information for the patient. Daunorubicin hydrochloride, when injected subcutaneously into mice, causes a fibrosarcomas to develop at the injection site. Daunorubicin liposomal is a cancer antineoplastic medication. Cytarabine is converted to the triphosphate form within the cell and then competes with cytidine for incorporation into dna. After treatment with daunorubicin has ended, normal hair growth should return. Daunorubicin hydrochloride may induce hyperuricemia secondary to rapid lysis of leukemic cells. Daunoxome contains an aqueous solution of the citrate salt of daunorubicin encapsulated within lipid vesicles liposomes composed of a. 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.
Prescribing information product monograph daunorubicin antimitoticantibiotic 8250 decarie blvd, suite 110 montreal, qc canada, h4p 2p5 date of preparation. 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. Common adverse reactions include reversible alopecia,acute nausea. By stabilizing the complex between dna and topoisomerase ii, daunorubicin inhibits the activity of this enzyme, resulting in singlestrand and doublestrand breaks in dna. In this model, the average daunorubicintodoxorubicin ratio, which was based on 150mgm 2 increments, was estimated to be 0. Dec 17, 2012 daunorubicin hydrochloride, when injected subcutaneously into mice, causes a fibrosarcomas to develop at the injection site. Dailymed daunorubicin hydrochloride injection, solution. 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. Aug 03, 2012 cerubidine daunorubicin must be given into a rapidly flowing intravenous infusion. Each ml contains 5 mg daunorubicin equivalent to 5. The product catalog provides you with a full listing of tevas brand and generic product lines.
It is always given under the supervision of a doctor in a hospital or similar setting with access to sterile equipment for preparation. Daunorubicin has antimitotic and cytotoxic activity. Ndc number 0703523393, 20 mg as base, 4 ml fill in a 6 ml single dose vial. Daunorubicin hydrochloride, when injected subcutaneously into mice, causes fibrosarcomas to develop at the injection site. 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.
Like other medicines, daunorubicin can cause some side effects. Highlights of prescribing information these highlights do. This medicine often causes a temporary and total loss of hair. Administer daunorubicin into a rapidly flowing iv infusion. 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. Daunorubicin must be given only by injection into a vein. Daunorubicin citrate liposome injection daunoxome side. Daunorubicin that exceeds the standard 45 mgm 2 dose for induction should be considered the new standard of care the american authors agreed. Daunorubicin side effects, dosage, interactions drugs. Daunorubicin is usually injected into a vein through a specially prepared site on your skin. If this medication accidentally leaks into the skinmuscle.
Read more about the prescription drug daunorubicin citrate liposome injection. Prior to initiating induction, assess cardiac function and obtain liver and renal function studies. Word will convert the pdf to editable text and you can then copy and paste that text into your office document. Idarubicin hydrochloride is a dnaintercalating analog of daunorubicin which has an inhibitory effect on nucleic acid synthesis and interacts with the enzyme topoisomerase ii. 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.
Severe local tissue necrosis will result if extravasation occurs. This medication is available in an injectable form to be given directly into a vein iv by a healthcare professional. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. Daunorubicin hydrochloride is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of streptomyces coeruleorubidus. Cytarabine is an antimetabolite analogue of cytidine with a modified sugar moiety arabinose instead of ribose. Jun 12, 2015 daunorubicin belongs to a group of drugs called anthracyclines. Daunorubicin forms a complex with dna by intercalation between base pairs. Daunorubicin hydrochloride injection must be given into a rapidly flowing intravenous infusion. Verify drug name and dose prior to preparation and administr ation. For more information, go to edit pdf content in word. 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. Each 20 mg vial contains 20 mg idarubicin hydrochloride, usp and 200 mg of lactose nf hydrous as an orangered, lyophilized powder. Product information daunorubicin injection page 1 of 8. Daunorubicin may also be used for purposes not listed in this medication guide.
Daunorubicin, also known as daunomycin, is a chemotherapy medication used to treat cancer. Daunorubicin 20mg powder for injection summary of product. Of note, median doses in both models of daunorubicin were similar to those of doxorubicin across each 100 or 150mgm 2 dose increment. It is kept refrigerated between 28 degrees c in a dark place to protect it from light. Daunorubicin hydrochloride solution for injection drug summary. Nausea, vomiting, constipation, diarrhea, loss of appetite, dry mouth, headache, dryflaking skin, flushing, and increased sweating may occur. Daunorubicin hydrochloride injection, 5 mg baseml, is available as follows. Blood uric acid levels should be monitored and appropriate therapy initiated in the event that hyperuricemia develops. However, in the postapproval setting, across roughly 80,000 chronic kidney disease patients over a 4 year period. Daunoxome daunorubicin citrate liposome injection is a sterile, pyrogenfree, preservativefree product in a single use vial for intravenous infusion. The nurse or doctor who give this drug must be carefully trained. Daunorubicin injection storage daunorubicin injection will be stored in the pharmacy or on the ward.
Daunorubicin causes the urine to turn reddish in color, which may stain clothes. Idamycin idarubicin hydrochloride for injection, usp. Daunorubicin liposomal side effects, dosage, interactions. Nov 15, 2019 daunorubicin causes the urine to turn reddish in color, which may stain clothes. The amount of daunorubicin you will receive depends of many factors, including your height and weight, your general health or other health problems. 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. Highdose daunorubicin is a new standard in aml medscape. Equivalence ratio for daunorubicin to doxorubicin in. Parenteral drug products should be inspected visually for particulate. The sterile vial contents provide 20 mg of daunorubicin, with 5 mg of daunorubicin per ml. Mar 18, 2020 the name of your medicine is daunorubicin 20 mg powder for i. Daunorubicin lipid complex may cause other side effects. 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. It is provided as a deep red sterile liquid in vials for intravenous administration only.
Dailymed vyxeos daunorubicin and cytarabine liposome. 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. 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. Daunorubicin injection cerubidine side effects, medical.
It must never be given by the intramuscular or subcutaneous route. Product information daunorubicin injection page 2 of 8 supersedes. It belongs to a class of drugs known as anthracyclines and works by slowing or stopping the growth of cancer cells. 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. Common side effects of daunorubicin include nausea, vomiting, diarrhea, and red. As a precaution, allopurinol administration is usually begun prior to initiating antileukemic therapy. Specifically it is used for acute myeloid leukemia aml, acute lymphocytic leukemia all, chronic myelogenous leukemia cml, and kaposis sarcoma. Because the parent drug daunorubicin is a vesicant this liposomal form is treated with equal caution. Aug 29, 2018 daunorubicin liposomal is a cancer antineoplastic medication. Daunorubicin hydrochloride injection drug label and. Daunorubicin belongs to a group of drugs called anthracyclines. Daunorubicin is used to treat leukemia and other cancers. Daunorubicin hydrochloride solution for injection drug.
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. Daunorubicin is a cancer medication that interferes with the growth and spread of cancer cells in the body. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Consumer information about the medication daunorubicin citrate liposome injection daunoxome, includes side effects, drug interactions, recommended dosages, and storage information. 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. Tell any doctors, dentists or pharmacists who treat you that you are being treated with daunorubicin. When administered to mice thrice weekly intraperitoneally, no carcinogenic effect was noted after 18 months of observation. 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. Very careful handling of this medication is required. It belongs to a group of medicines used to treat acute leukaemia. 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.
Dosage is based on your medical condition, body size, and response to. This medication is given by injection into a vein by a health care professional. Cytarabine liposome injection is a sustainedrelease formulation of the active ingredient cytarabine designed for direct administration into the cerebrospinal fluid csf. Nov 09, 2018 daunorubicin is a cancer medication that interferes with the growth and spread of cancer cells in the body.
623 1021 1172 617 1525 633 534 369 791 218 615 1095 619 332 1480 492 1179 1321 1142 812 1154 503 21 742 1496 454 1127 626 536 1398 153 1451 647 119 1315 1020 1117 1149 756 1187 914 1187 37 510 420 70 1359 807 433