Product information emtriva emtricitabine capsules name of. Based on findings of decitabine in animals, male fertility may be compromised by treatment. Prozac fluoxetine hydrochloride capsules label fda. Whether this is due to drug therapy or disease is unknown. Dacarbazine for injection usp is a white to an ivory colored solid which is light sensitive. Nov 09, 2018 decitabine is a cancer medication that interferes with the growth and spread of cancer cells in the body. Basaglar should be the same as the other insulin glargine. Every effort has been made to ensure that the information provided by cerner multum, inc. This medicine can lower, but not fully prevent, the risk of spreading hiv to others. As in any fire, wear selfcontained breathing apparatus pressuredemand niosh approved or. Emtriva emtricitabine dose, indications, adverse effects. Dacogen decitabine for injection description dacogen decitabine for injection contains decitabine 5aza2deoxycytidine, an analogue of the natural nucleoside 2deoxycytidine.
Decitabine is more cost effective than cytarabine and daunorubicin in elderly acute myeloid leukemia patients. Final package leaflet in msword format and pdf format of. Protect from light store between 68 to 77 degrees f, excursions permitted 59 to 86 degrees f store in original package until time of use. Unless used within 15 minutes of reconstitution, the diluted solution must be prepared using cold 2. Grade 1 and 2 are unexpected and expect but unlikely related or. Decitabine fda prescribing information, side effects and uses. Decitabine is a fine, white to almost white powder with the molecular formula of c 8 h 12 n 4 o 4 and a molecular weight of 228.
Dacogen decitabine dosing, indications, interactions. These include a buildup of lactic acid in the blood lactic acidosis and severe liver problems. Wikidoc is intended to be an educational tool, not a tool for any form of healthcare delivery. Determine if patients are taking drugs that could slow heart rate or atrioventricular conduction see warnings and. Product information for auspar emtriva gilead sciences pty ltd pm 201202532 final 12 june 2014. The pharmacists will automatically adjust the doses of any of the antimicrobials included in the protocol according to the estimated creatinine clearance generally using the cockroftgault equation for patients. Emtricitabine api dmfs us drug master file dmf details.
The pharmacists will automatically adjust the doses of any of the antimicrobials included in the protocol according to the estimated creatinine. Emtriva, emtricitabine dosing, indications, interactions. Decitabine datasheet technical data biological activity protocol only for reference not for human, veterinary diagnostic or therapeutic use. Skyrizi risankizumabrzaa injection, for subcutaneous use. Do not take emtriva if you also take other medicines that contain emtricitabine or lamivudine emtricitabine may cause a serious condition called lactic acidosis. This treatment period is called a cycle, and the cycle may be repeated every 6 weeks for as long as your. Mar 01, 2020 decitabine for injection contains decitabine 5aza2deoxycitidine, an analogue of the natural nucleoside 2deoxycytidine. Decitabine intravenous infusion over 60 minutes on days 1, 2.
Dacogen decitabine for injection description e 59 66 57 70. Apr 21, 2020 decitabine reference guide for safe and effective use from the american society of healthsystem pharmacists ahfs di. Phase i, dose escalation study of decitabine full text. F for up to a maximum of 7 hours until administration. Monitor liver function tests before and during treatment in patients with underlying hepatic disease, including hepatitis b or c coinfection, marked transaminase elevations, or who are taking medications associated with liver toxicity. Xelodawarfarin interaction xeloda warfarin interaction. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for buspar buspirone. This page also explains who should avoid using the drug.
The adverse events will be graded using the nci scale after one cycle of decitabine maintenance therapy intravenously. Emtricitabine is a topic covered in the johns hopkins abx guide to view the entire topic, please sign in or purchase a subscription official website of the johns hopkins antibiotic abx, hiv, diabetes, and psychiatry guides, powered by unbound medicine. Decitabine datasheet technical data biological activity protocol only for reference not for human, veterinary diagnostic or therapeutic use specific storage and handling information for each. Vumerity diroximel fumarate delayedrelease capsules, for oral use. It must neverbe given by the intramuscular or subcutaneous route. Emtricitabine is a nucleoside reverse transcriptase inhibitor that is fda approved for the treatment of hiv1 infection in combination with other antiretroviral agents. Pdf decitabine is more cost effective than cytarabine. Jun 29, 2017 emtricitabine and tenofovir disoproxil fumarate used for prep must only be prescribed to individuals confirmed to be hivnegative immediately prior to initial use and periodically during use. Jul 20, 2012 dacogen package insert woodcliff lake, nj. Each 20 ml vial contains 200 mg of dacarbazine, usp active ingredient. Emtricitabine pk fact sheet metabolism and distribution metabolised by limited metabolism, excreted via glomerular filtration and active tubular secretion. All patients with hiv1 should be tested for presence of chronic hepatitis b virus hbv before initiating antiretroviral therapy.
Closely monitor serum electrolytes, including serum magnesium, potassium, and calcium, with aggressive replacement when warranted during and after portrazza administration. Lantus insulin glargine injection for subcutaneous injection. Decitabine for injection sun pharmaceutical industries ltd. Gemzar is indicated for patients previously treated with 5fu. Decitabine is a cancer medication that interferes with the growth and spread of cancer cells in the body. Protect from light store between 68 to 77 degrees f, excursions.
Gemzar in combination with carboplatin is indicated for the treatment of patients with advanced ovarian cancer that has relapsed at least 6 months after completion of platinumbased therapy. Get emergency medical help if you have even mild symptoms such as. The treatment of patients who have an mpn which evolves into an accelerated or blast. Severe local tissue necrosis will occur if there is extravasation during administration. Decitabine is used to treat myelodysplastic syndromes certain types of blood or. Creatinine clearance mlmin oct 25, 2019 emtricitabine can cause serious, lifethreatening side effects. Contact your health care provider right away if you have any of the following symptoms that could be signs of lactic acidosis. Dailymed dacarbazine injection, powder, for solution. Phase 1 study of lowdose prolonged exposure schedules of the hypomethylating agent 5aza2. Decitabine side effects, dosage, interactions drugs. This is an openlabel interventional study to study the use of decitabine as induction therapy for acute myeloid leukemia with complex andor monosomal karyotype. The total body clearance 27 mean sd was 124 19 lhrm2, and the terminal phase elimination halflife was 0. This emedtv resource describes some precautions and warnings with emtricitabine, including possible allergic reactions and the risk of developing dangerous conditions such as lactic acidosis.
Jan 03, 2019 every effort has been made to ensure that the information provided by cerner multum, inc. Dacogen should be aseptically reconstituted with 10 ml of sterile water for injection usp. Ervebo ebola zaire vaccine, live suspension for intramuscular injection. Gemzar in combination with paclitaxel is indicated for the firstline treatment of patients with metastatic breast cancer after. Decitabine comes as a powder to be to be added to fluid and injected slowly over 3 hours intravenously into a vein by a doctor or nurse in a medical office or hospital outpatient clinic. Emtriva is available as a single drug or in the fixeddose combination drugs atripla, complera, genvoya, stribild and truvada. Abraxane is 125 mgm2 intravenously over 3040 minutes on days 1, 8 and 15 of each 28day cycle. Conduct pregnancy testing of females of reproductive potential prior to initiating treatment. Gemzar gemcitabine hcl for injection description gemzar gemcitabine hcl is a nucleoside analogue that exhibits antitumor activity.
The recommended tukysa dose reductions and dosage modifications for adverse reactions are provided in. Aidsinfo provides the following drug label solely as an example of the labels available for atripla. Creatinine clearance mlmin pdf format of accord healthcare, inc are provided. Decitabine is given to help increase blood cell counts, reduce the risk of infection, reduce the amount of blood transfusions needed, decrease the risk of bleeding, and to prevent mds from transforming to acute leukemia. Several fdaapproved drug labels may be available for atripla. This product information was approved at the time this. In patients who responded to therapy, neutropenia, thrombocytopenia, anemia, and leucopenia diminished over time, but were still frequent. Elvitegravircobicistatemtricitabinetenofovir alafenamide. Decitabine is given to help increase blood cell counts, reduce the risk of infection, reduce the amount of blood transfusions needed, decrease the risk of bleeding, and to prevent mds from transforming to. Product information emtriva emtricitabine capsules name.
Renal dosage adjustment guidelines for antimicrobials. Emtricitabine and tenofovir disoproxil fumarate used for prep must only be prescribed to individuals confirmed to be hivnegative immediately prior to initial use and periodically during use. Emtricitabine is available as 200 mg capsules and as an oral solution 10 mgml. Pdf decitabine is more cost effective than cytarabine and. Gemcitabine fda prescribing information, side effects. If changing patients from another insulin glargine product, 100 unitsml, to basaglar, the dose of. Emtriva emtricitabine side effects, images, uses, dosage. Enhertu famtrastuzumab deruxtecannxki for injection, for intravenous use. See full prescribing information for complete boxed warning. Decitabine is not commonly given with the goal of cure for mds.
Visn 22 drug monograph template pharmacy benefit management. The educational content on wikidoc drug pages is based upon the fda package insert, national library of medicine content and practice guidelines consensus statements. Decitabine is a fine, white to almost white powder with the 5 molecular formula of c8h12n4o4 and a molecular weight of 228. Emtricitabine is a topic covered in the johns hopkins abx guide to view the entire topic, please sign in or purchase a subscription official website of the johns hopkins antibiotic abx, hiv, diabetes, and. Multum is accurate, uptodate, and complete, but no guarantee is made to that effect. List of drug master files dmf of emtricitabine active pharmaceutical ingredient api submitted to the u. Gemcitabine for injection, powder, lyophilized, for solution for intravenous use indications and usage gemcitabine for injection is a nucleoside metabolic inhibitor indicated for. Please click here for full prescribing information for lantus or scan qr code. Emtricitabine is available in several coformulated preparations table 1521. Emtriva, as a component of truvada, was approved for use as preexposure prophylaxis prep to prevent hiv among those at high risk in july 2012. Highlights of prescribing information these highlights do not. Dacogen decitabine forinjection, for intravenous use initial u. Patients receiving concomitant capecitabine and oral coumarin. Multicenter, randomized, openlabel, phase iii trial of.
The empirical formula for gemcitabine hcl is c9h11f2n3o4 hcl. Gemcitabine injection is available in sterile singledose vials individually packaged in a carton as follows. Material safety data sheet of decitabine abmole bioscience. Velcade bortezomib dose, indications, adverse effects.896 595 657 624 511 189 1160 167 1166 557 592 72 1616 1142 1117 853 174 675 876 850 1319 1039 1481 579 1040 65 218 600 738 653 1218 51 1602 1513 1588 1442 529 504 231 680 1137 1041 974 249