A patient experienced diarrhea, nausea, and vomiting after receiving a single iv dose of approximately 290 mglm2, almost 4 times the recommended starting dose. Page 3 of 44 full prescribing information 1 indications and usage 1. Commonly causes low red blood cells, white blood cells, and platelets. Monitor patients and discontinue rituxan infusion for severe reactions 5. May 10, 20 i mplications for p ractice the introduction of the hypomethylating agents azacitidine and decitabine has been a major advancement in the treatment of patients with higherrisk myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid leukemia who are ineligible for more intensive treatments, such as allogeneic stem cell transplantation and induction chemotherapy. The finished product is supplied in a sterile form for reconstitution as a suspension for subcutaneous injection or reconstitution as a solution with further dilution for intravenous infusion. Each 20 ml, single dose, glass vial contains 50 mg decitabine, 68 mg monobasic potassium phosphate potassium dihydrogen phosphate and 11.
Side effect videos fatigue anemia see dailymed package. Azacitidine is the first drug that has been shown in a clinical trial to improve survival in this setting. No formal clinical drug interaction studies with azacitidine have been. The nccn compendium is a derivative work of the nccn guidelines. Mar 27, 2020 vidaza reconstituted for intravenous administration may be stored at 25c 77f, but administration must be completed within 1 hour of reconstitution. If it comes into contact with mucous membranes, flush thoroughly with water. Patients treated is based on the pbrer report of patient exposure, which was calculated based on the global total milligram volume sales divided by the average dose per patient per year, based on us approved indications. Vidaza is believed to exert its antineoplastic effects by causing hypomethylation of dna and direct cytotoxicity on abnormal hematopoietic cells in the bone marrow. Why is dailymed no longer displaying pill images on the search results and drug info pages.
Vidaza is a registered trademark of celgene corporation. Azacitidine for injection, for subcutaneous or intravenous use. Mozobil plerixafor injection, for subcutaneous use. Read all of this leaflet carefully before you start using. At sandoz our work is focused on improving access to medicines, access to medical information and access. Tell all of your health care providers that you take azacitidine. Aug 25, 2019 azacitidine package insert pdf myaza azacitidine for injection contains azacitidine ip, which is a pyrimidine the finished product is supplied in a sterile form for reconstitution as. Reconstituted vidaza should be injected subcutaneously insert the needle at a 4590. O ho oh oh n n n nh 2 o the empirical formula is c8h12n4o5.
Drug interaction studies with azacitidine have not. After completing the rampup schedule on cycle 2 day 28, patients should continue. Renal impairment renal abnormalities ranging from elevated serum creatinine to renal failure and death were reported in. Highlights of prescribing information employ more intensive. Click the orange links and well show you extra information. See full prescribing information for complete boxed warning. What are some things i need to know or do while i take azacitidine. Diversity drives innovation, which in turn drives change and progress. The finished product is supplied in a sterile form for reconstitution and subcutaneous injection only. Azacitidine and its deoxy derivative, decitabine also known as 5aza2. Dacogen decitabine forinjection, for intravenous use initial u. Due to inconsistencies between the drug labels on dailymed and the pill images provided by rximage, we no longer display the rximage pill images associated with drug labels we anticipate reposting the images once we are able identify and filter out images that do not match the information provided in. Azacitidine is designed to slow the production of leukemia cells and help the bone marrow produce more healthy and normal functioning cells.
Vidaza package insert keyword after analyzing the system lists the list of keywords related and the list of websites with related. Feb 18, 2020 you must check to make sure that it is safe for you to take azacitidine with all of your drugs and health problems. Monitor liver chemistries and serum creatinine prior to initiation of therapyand with each cycle5. Dacogen decitabine for injection is a white to almost white sterile lyophilized powder supplied in a clear colorless glass vial. Vidaza azacitidine for injection for sc or iv use initial u. Desferal is not indicated for the treatment of primary hemochromatosis, since phlebotomy is the method of choice for removing excess iron in this disorder.
Vidaza azacitidine 100 mg powder for suspension for injection product information celgene v1. Contraindications known hypersensitivity to the active substance. Good blood cells often start to increase after 3 4 cycles. Click on the azacitidine vidaza package insert below for reported side effects and possible drug interactions. Dacogen decitabine for injection description e 59 66. Vidaza package insert keyword found websites listing. The azacitidine suspension should be prepared immediately before use and administered within 45 minutes. Azacitidine appears to exert its antineoplastic effect by multiple mechanisms, including a direct cytotoxic effect on abnormal hematopoietic cells in the bone marrow through incorporation into dna and rna, and an inhibition of dna methyltransferase, causing. Refer to the obinutuzumab prescribing information for recommended obinutuzumab dosing information. Each ml of the sterile solution contains 20 mg of plerixafor. If unexplained reductions in serum bicarbonate levels to less than 20 mmoll occur, the dose should be reduced by 50 % on the next cycle. Please also see full prescribing information for azactam aztreonam for injection, usp on page 6. Dacogen decitabine for injection description dacogen decitabine for injection contains decitabine 5aza2deoxycytidine, an analogue of the natural nucleoside 2deoxycytidine. Vidazaazacitidinefor injection for sc or iv use initial u.
Mozobil plerixafor injection is a sterile, preservativefree, clear, colorless to paleyellow, isotonic solution for subcutaneous injection. Given the high drug cost and the substantial number of patients. On cycle 1 day 22, start venclexta according to the 5week rampup schedule see table 1. Desferal is contraindicated in patients with severe renal disease or anuria, since the drug and the iron. Monitor patients with renal impairment for toxicity since azacitidine and its metabolites are primarily excreted by the kidneys 5. Highlights of prescribing information these highlights do. Vidaza fda prescribing information, side effects and uses. Vidaza azacitidine for injection, for subcutaneous or intravenous use initial u. Reconstituted vidaza should be injected subcutaneously insert the needle at a 4590o. Gemzar vials contain no antimicrobial preservatives and are intended for single use only. Biosimilars are an opportunity to help reduce the burden of rising treatment costs. For patients whose baseline counts are wbc package insert pdf myaza azacitidine for injection contains azacitidine ip, which is a pyrimidine the finished product is. Vidaza azacitidine for injection contains azacitidine, which is a pyrimidine nucleoside analog of cytidine. Vidaza 25 mgml powder for suspension for injection.
Subsequently, the efficacy of azacitidine was evaluated in a phase iii trial that randomized 358 patients with higherrisk mds to treatment with azacitidine at the approved dosing regimen or conventional care intensive chemotherapy, lowdose cytarabine. Highlights of prescribing information these highlights do not include all the information needed to use akynzeo safely and effectively. Azacitidine is a synthetic pyrimidine nucleoside analog of cytidine. Ndc, product descriptions, prescribing information, dosage form, size, product materials, therapeutic category, brand name, generic, compares to brand. In 21 patients with cancer, subcutaneous azacitidine administration resulted in auc and cmax values that were dose proportional over a dose range of 25 mgm2 to 100. Please also see full prescribing information for azactam. Vincristine sulfate vincristine sulfate this product information is intended only for residents of the united states. Jul 20, 2017 for patients whose baseline counts are wbc aug 30, 2019 azacitidine package insert pdf august 30, 2019 myaza azacitidine for injection contains azacitidine ip, which is a pyrimidine the finished product is supplied in a sterile form for reconstitution as a.
Vials of vidaza contain 100 mg of azacitidine and 100 mg of mannitol as a sterile lyophilized powder. Fatal infusionrelated reactions within 24 hours of rituxan infusion. Azacitidine 5azacytidine, vidazatm for injectable suspension. Vidaza azacitidine for injection, for subcutaneous or intravenous use. Highlights of prescribing information these highlights do not.
Vidaza azacitidine dose, indications, adverse effects. Vidaza may cause fetal harm when administered to a pregnant woman. Vidaza, innazacitidine european medicines agency europa eu. Imfinzi durvalumab injection, for intravenous use 2 full prescribing information 1 indications and usage 1. See full prescribing information for azacitidine for injection. May 20, 2010 subsequently, the efficacy of azacitidine was evaluated in a phase iii trial that randomized 358 patients with higherrisk mds to treatment with azacitidine at the approved dosing regimen or conventional care intensive chemotherapy, lowdose cytarabine, or bsc. Azacitidine is rapidly absorbed after subcutaneous administration. Oct 16, 2019 azacitidine package insert pdf october 16, 2019 admin science myaza azacitidine for injection contains azacitidine ip, which is a pyrimidine the finished product is supplied in a sterile form for reconstitution as a. Mozobil, a hematopoietic stem cell mobilizer, is indicated in combination with granulocytecolony stimulating factor gcsf to mobilize hematopoietic stem cells hscs to the peripheral blood for collection and subsequent autologous transplantation in patients with nonhodgkins lymphoma and multiple myeloma. Vidaza azacitidine for injection is supplied as lyophilized powder in 100 mg singledose vials.
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. Azacitidine is given to help increase blood cell counts, reduce the risk of infection, reduce the amount of blood transfusions needed. Azactam aztreonam injection in galaxy plastic container pl 2040. Product information vidaza azacitidine 100 mg powder. Newly approved agents for the treatment of myelodysplastic. I mplications for p ractice the introduction of the hypomethylating agents azacitidine and decitabine has been a major advancement in the treatment of patients with higherrisk myelodysplastic syndromes, chronic myelomonocytic leukemia, and acute myeloid leukemia who are ineligible for more intensive treatments, such as allogeneic stem cell transplantation and induction. Highlights of prescribing information these highlights do not include all the information needed to use dacogensafely and effectively. Vidaza is a pyrimidine nucleoside analog of cytidine. Azacitidine is designed to slow the production of leukemia cells and help the bone marrow produce. Women of childbearing potential should be apprised of the potential hazard to a fetus.
Azacitidine 275mgm sc bolus once daily on days 1 to 5, and day 8 25mgml and day 9 i. Azacitidine package insert pdf myaza azacitidine for injection contains azacitidine ip, which is a pyrimidine the finished product is. Severe mucocutaneous reactions, some with fatal outcomes 5. Vidaza may causefetalharm when administered to a pregnant woman. Follow applicable special handling and disposal procedures. Highlights of prescribing information these highlights do not include all the information needed to use vidaza safelyand effectively. Both drugs were first synthesized in czechoslovakia as potential chemotherapeutic agents for cancer. Find patient medical information for azacitidine injection on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Azacitidine can be administered to patients with renal impairment without initial dose adjustment see section 5. Azacitidine and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Dacogen decitabine for injection description e 59 66 57 70.
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