See the full prescribing information including boxed warning about not substituting with other daunorubicin andor cytarabinecontaining products. Highlights of prescribing information these highlights do. Since the growth of normal body cells may also be affected by daunorubicin, other effects will also occur. Click on the daunorubicin and cytarabine liposome vyxeos package insert link below for more reported side effects, possible drug interactions, and other prescribing information side effect videos nausea and vomiting diarrhea fatigue bleeding pain anemia neutropenic fever. Each vial contains 200 mg of dacarbazine the active ingredient, citric acid monohydrate and mannitol. Cpx351 cytarabine and daunorubicin liposome for injection versus conventional cytarabine plus. Dec 17, 2012 each ml contains daunorubicin hydrochloride, usp equivalent to 5 mg of daunorubicin, 9 mg sodium chloride, hydrochloric acid to adjust ph, and water for injection, q. Each 10 mg lyophilized vial contains 10 mg of doxorubicin hydrochloride, usp and 50 mg of lactose monohydrate, nf. It is provided as a sterile reddish lyophilized powder in vials for intravenous administration only. Vyxeos daunorubicin and cytarabine acute myeloid leukemia. Daunorubicin hydrochloride injection must be given into a rapidly flowing intravenous infusion.
Cpx351 cytarabine and daunorubicin liposome for injection versus conventional cytarabine plus daunorubicin in older patients with newly diagnosed secondary acute myeloid leukemia. As a precaution, allopurinol administration is usually begun prior to initiating. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each. Daunorubicin hydrochloride may induce hyperuricemia secondary to rapid lysis of leukemic cells. Interrupt empliciti elotuzumab for grade 2 or higher and permanently discontinue for severe infusion reaction. Daunorubicin hydrochloride possesses an antitumor effect against a wide spectrum of animal tumors, either grafted or spontaneous.
Vyxeos should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine, or any of its ingredients. 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. Jan 22, 2020 cerubidine daunorubicin hydrochloride is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of streptomyces coeruleorubidus. History of serious hypersensitivity reactions, including anaphylaxis, to oncaspar or to any of the excipients. Daunorubicin may cause serious or lifethreatening heart problems at any time during your treatment or months to years after your treatment has ended. Doxorubicin hydrochloride for injection, usp patient. Acute myeloid leukemia rydapt is indicated, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation. As a precaution, allopurinol administration is usually begun prior to initiating antileukemic therapy.
It is provided as a deep red sterile liquid in vials for. Carefully swirl the contents of the vial for 5 minutes while gently inverting the vial every 30 seconds. Daunorubicin by injection national library of medicine. Product monograph cerubidine daunorubicin hydrochloride. Ddavp injection desmopressin acetate 4 mcgml has infrequently produced changes in blood pressure causing either a slight elev ation in blood pressure or a transient fall in blood pressure and a compensatory increase in heart rate. Idamycin idarubicin hydrochloride for injection, usp 12 mgm 2 daily for 3 days by slow 10 to 15 min intravenous injection in combination with cytarabine. When reconstituted with 4 ml of sterile water for injection, usp, each ml contains 5 mg daunorubicin activity. Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention 1 indications and usage 1. It has the following structural formula which may be described with the chemical name of 1 s,3 s 3acetyl1,2,3,4,6,11hexahydro3,5,12trihydroxy10methoxy6,11dioxo1.
Daunorubicin injection is a sterile, isotonic, preservative free solution containing daunorubicin hydrochloride. Idamycin idarubicin hydrochloride for injection, usp. History of serious thrombosis with prior lasparaginase therapy. Follow applicable special handling and disposal procedures. Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention 1 indications and usage. Acute myeloid leukemia rydapt is indicated, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia aml who are flt3 mutationpositive, as detected by an fdaapproved test. Serious irreversible myocardial toxicity with delayed congestive. Vyxeos can cause a severe decrease in blood cells red and white blood cells and cells that prevent bleeding, called platelets which can result in serious infection or bleeding and possibly lead to death. Doxorubicin hydrochloride for injection, usp for intravenous use only rx only warnings 1. Vyxeos is a liposomal combination of daunorubicin, an anthracycline topoisomerase inhibitor, and cytarabine, a nucleoside metabolic inhibitor, that is indicated for the treatment of adults with newlydiagnosed therapyrelated acute myeloid leukemia taml or aml with myelodysplasiarelated changes amlmrc.
Dailymed daunorubicin hydrochloride injection, solution. Idamycin idarubicin hydrochloride for injection, usp 12. Dacarbazine for injection is a colorless to an ivory colored solid which is light sensitive. Monitor for fever and other signs of infection and treat promptly. 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. For induction therapy in adult patients with aml the following dose schedule is recommended. Aug 18, 2019 cabazitaxel package insert pdf product monograph. Cpx351 is a novel liposomal formulation of cytarabine and daunorubicin which has recently been fdaapproved for treatment of acute myeloid leukemia aml.
Severe local tissue necrosis will occur if there is extravasation during administration. Cytomegalovirus immune globulin csl behring warnings cytogam. Page 2 of 9 physical and chemical description daunorubicin r. Daunorubicin hydrochloride and cytarabine liposome national. It must neverbe given by the intramuscular or subcutaneous route. Each ml contains daunorubicin hydrochloride, usp equivalent to 5 mg of daunorubicin, 9 mg sodium chloride, hydrochloric acid to adjust ph, and water for injection, q. Cerubidine fda prescribing information, side effects and uses. The drug should be used with caution in patients with coronary. Consumer information about the medication daunorubicin citrate liposome injection daunoxome, includes side effects, drug interactions, recommended dosages, and storage. It is supplied in the hydrochloride form as a sterile redorange lyophilized powder containing lactose and as a sterile parenteral, isotonic solution with sodium chloride for intravenous use only. Vyxeos daunorubicin and cytarabine liposome last updated.
Contaminated clothing should be destroyed and shoes cleaned thoroughly before reuse see package insert for precautions, general and dosage and administration, preparation of solution for intravenous administration. Daunorubicin hydochloride and daunomycin are other names for daunorubicin. Idamycin idarubicin hydrochloride dosage and administration. Cerubidine daunorubicin is a potent bone marrow suppressant.
Severe local tissue necrosis will occur if there is extravasation during. It is the hydrochloride of 4methoxy 6, 9, 11trihydroxy 7, 8, 9, 10tetrahydro 2, 3, 6tridesoxy 3amino. Cyclophosphamide for injection, usp rx only description cyclophosphamide for injection, usp is a sterile white powder containing cyclophosphamide monohydrate. Dec 05, 2018 cytarabine injection, an antineoplastic, is a sterile solution of cytarabine for intravenous and subcutaneous use which contains no preservative and is available in 20 mgml mg50 ml pharmacy bulk package. Blood uric acid levels should be monitored and appropriate therapy initiated in the event that hyperuricemia develops. The desired dose is withdrawn into a syringe containing 10 ml to 15 ml of 0. The product catalog provides you with a full listing of tevas brand and generic product lines.
Therapy with cerubidine daunorubicin should not be started in patients with preexisting druginduced bone marrow suppression unless the benefit from such treatment warrants the. Cyclophosphamide is a synthetic antineoplastic drug chemically related to the nitrogen mustards. Reconstitute each vial with 19 ml of sterile water for injection using a sterile syringe. Adriamycin therapy is also contraindicated in patients with marked liver impairment, in pregnancy and lactation see precautions, in the presence of generalised infection, and in patients with hypersensitivity to adriamycin andor. Daunorubicin injection must be given in a hospital or medical facility under the supervision of a doctor who is experienced in giving chemotherapy medications for cancer.
Product information adriamycin solution for injection warnings 1. This form may work better than other forms of these drugs and have fewer side effects. Adriamycin must not be given by the intramuscular or subcutaneous route. Daunorubicin belongs to the general group of medicines known as antineoplastics. The sterile 4 ml vial contents provide 20 mg of daunorubicin with 5 mg of daunorubicin per ml. 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 hydrochloride possesses an antitumor effect. Etopophos solutions may be administered at infusion rates up to 3. Rydapt is indicated, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia aml who are flt3 mutationpositive, as detected by a fda approved test see dosage and administration 2. Daunorubicin seems to interfere with the growth of cancer cells, which are eventually destroyed.
After reconstitution but before final dilution, each ml of vyxeos will contain 2. 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, solution dailymed. Persistent cytarabine and daunorubicin exposure after. In some cases, health care professionals may use the trade name cerubidine or other names. Daunorubicin hydrochloride is the hydrochloride salt of an anthracycline cytotoxic antibiotic produced by a strain of streptomyces coeruleorubidus. Each ml contains 5 mg daunorubicin equivalent to 5. Cerubidine daunorubicin hydrochloride injection, powder, for solution. Vyxeos daunorubicin and cytarabine liposome for injection, for intravenous use. Cytarabine injection, an antineoplastic, is a sterile solution of cytarabine for intravenous and subcutaneous use which contains no preservative and is available in 20 mgml mg50 ml pharmacy bulk package. Daunorubicin fda prescribing information, side effects and uses.
Suppression will occur in all patients given a therapeutic dose of this drug. A pharmacy bulk package is a container of a sterile preparation for parenteral use that contains many single doses. Sequential administration of dacarbazine 400 milligramsm2 and fotemustine 100 milligramsm2 has been associated with acute lung toxicity, in the form of adult respiratory distress syndrome. Ddavp injection desmopressin acetate 4 mcgml has infrequently produced changes in blood pressure causing either a slight elev ation in blood pressure or a transient fall in blood pressure and a.
Dacarbazine is an anticancer agent designated chemically. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. It is the hydrochloride of 4methoxy 6, 9, 11trihydroxy 7, 8. The current study investigated the pharmacokinetics pk of this liposomal formulation. Dacarbazine for injection is reconstituted and administered intravenously ph 34. The sterile vial contents provide 20 mg of daunorubicin, with 5 mg of daunorubicin per ml. Daunorubicin hydrochloride may also inhibit polymerase activity, affect regulation of gene expression, and produce free radical damage to dna. Explore the mechanism of action for a treatment for certain types of acute myeloid leukemia aml vyxeos daunorubicin and cytarabine, a liposomal encapsulation. It is provided as a deep red sterile liquid in vials for intravenous administration only. Prolonged survival in secondary aml saml starts with vyxeos 1.
Extravasation of etopophos may result in swelling, pain, cellulitis, and necrosis including skin necrosis. Rydapt is indicated, in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid. Daunorubicin is supplied with 100 mg of mannitol in 20mg vials, from which it is reconstituted with 4 ml of sterile water for injection. The drug is therefore not suitable for maintenance therapy. Daunorubicin seems to interfere with the growth of cancer cells.
Vyxeos daunorubicin and cytarabine is a liposomal combination of cytarabine, a nucleoside metabolic inhibitor that exhibits antineoplastic effects during the sphase of cell division, and daunorubicin, an. Cytomegalovirus immune globulin intravenous human cytogam liquid formulation solvent detergent treated description cytogam, cytomegalovirus immune globulin intravenous human cmvigiv, is an immunoglobulin g igg containing a standardized amount of antibody to cytomegalov irus cmv. Daunorubicin hydrochloride and cytarabine liposome is a combination form of daunorubicin hydrochloride and cytarabine contained inside liposomes very tiny particles of fat. Download leaflet view the patient leaflet in pdf format. Daunorubicin is an anthracycline antibiotic which damages dna by intercalating between base pairs resulting in. Vyxeos can cause a severe decrease in blood cells red and white. Vyxeos daunorubicin and cytarabine liposome for injection 44 mg100 mg is. Daunorubicin 20mg powder for injection summary of product. Preparation of vyxeos1 vyxeos daunorubicin and cytarabine. Jan 01, 2017 daunorubicin belongs to the general group of medicines known as antineoplastics. Oncaspar pegaspargase is indicated as a component of a multiagent chemotherapeutic regimen for the treatment of pediatric and adult patients with.
532 735 667 333 122 336 700 398 911 626 1095 683 1255 1374 699 874 977 1229 839 130 987 96 348 96 1587 1013 1001 1274 456 278 918 180 1173 1450 68 506 993 1167 1194 965 1126 1087 804 715 306 224 1229