Highlights of prescribing information perforation can occur. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. The manufacturers package insert should be consulted for detailed information on the usual cautions, precautions, and contraindications of the use of this drug this elililly pdf file on gemzar requires the acrobat reader program on your computer. The recommended dose of gemzar is mgm2 as an intravenous infusion over 30 minutes. Gemcitabine plus cisplatin has been shown to be superior to gemcitabine alone, but this regimen has not been compared head to head with other gemcitabinebased combinations, with chemotherapy for advanced exocrine pancreatic cancer view in chinese. This emedtv web page describes how gemcitabine is used for treating breast cancer, ovarian cancer, nonsmall cell lung cancer, and pancreatic cancer. Treatment should continue until disease progression or unacceptable toxicity occurs see clinical studies 14. Advise pregnant womenof the potential risk to a fetus. Tumor treating fields in combination with gemcitabine or. Pancreatic ductal adenocarcinoma pdac is the eighth leading cause of cancer mortality in men and ninth in women worldwide.
Gemcitabine hcl is a white to offwhite solid with a molecular formula of c 9 h 11 f 2 n 3 o 4 hcl and a molecular weight of 299. Folfirinox leucovorin, 5fu, irinotecan, oxaliplatin or gemcitabine, alone or combined with nabpaclitaxel, are commonly prescribed for unresectable pancreatic. Food and drug administration considers them equivalent to. Gemcitabine is used to treat cancers of the pancreas, lung, ovary, and breast. Gemcitabine hcl for injection description gemzar gemcitabine hcl is a nucleoside analogue that exhibits antitumor activity. Gemcitabine gemcitabine this product information is intended only for residents of the united states. For cisplatin, carboplatin, and paclitaxel dosage adjustment in combination. The cancer medication gemzar is now available in both brandname and generic form. Seventyfour percent of patients in the gemcitabine arm crossedover to receive gemcitabine and platinum combinations at disease progression, possibly limiting this variable. Patients will be enrolled at approximately 150 sites globally. This emedtv resource discusses how the medication works, lists potential side effects, and offers information on how to receive the injection. Learn about dose modifications, prophylaxis options, and drug interactions with nerlynx. Tps465 a randomized phase 2 study of cabiralizumab.
This file contains additional information, probably added from the digital camera or scanner used to create or digitize it. Drug name mechanism of action and pharmacokinetics indications and. You should not breastfeed while you are using gemcitabine, and for at least 1 week after your last dose. Gemcitabine is a prodrug and is metabolized intracellularly to the active diphosphate. Effect of prophylaxis or neratinib dose escalation on neratinibrelated diarrhea and tolerability in patients with her2positive earlystage breast cancer. The recommended dosage of gemzar is mgm2 intravenously over 30 minutes on days 1 and 8 of each 21day cycle in combination with carboplatin auc. However, it is important to use birth control to prevent pregnancy because gemcitabine can harm an unborn baby. Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabinebased therapy napoli1. These cancers include breast cancer, ovarian cancer, nonsmall cell lung cancer, pancreatic cancer, and bladder cancer. The primary endpoint was safety of ttfields in combination with gemcitabine, or gemcitabine plus nabpaclitaxel. Taxol paclitaxel is obtained via a semisynthetic process from taxus baccata.
In vitro the cytotoxic action of gemcitabine is both concentration and time dependent. Jun 20, 2019 gemcitabine hcl is a white to offwhite solid with a molecular formula of c 9 h 11 f 2 n 3 o 4 hcl and a molecular weight of 299. Tps465 a randomized phase 2 study of cabiralizumab nivolumab. Gemzar gemcitabine jemsiteabeen is a drug that is used to treat some kinds of cancer. Gemcitabine gemzar gemcitabine gemzar is a chemotherapy regimen for pancreatic cancer.
Gemcitabine is metabolized intracellularly to two active metabolites, gemcitabine diphosphate dfdcdp and gemcitabine triphosphate dfdctp. Advise females of reproductive potential to use effective contraception while receiving dacogenand for 6 months following the last. Gemcitabine investigated as a drug, mutagen, natural product, and tumorigen. Gemcitabine injection is a sterile solution in singledose vials for intravenous use. This medication is given by injection into a vein by a healthcare professional. The empirical formula for gemcitabine hcl is c9h11f2n3o4 hcl. If the file has been modified from its original state, some details may not fully reflect the modified file. The catalog displays all strengths and sizes along with the description, imprint code, ndc and photo for each product. Gemcitabine comes as a powder to be mixed with liquid to be injected over 30 minutes intravenously into a vein by a doctor or nurse in a medical facility.
Other companies are charging thousands of dollars to set up accounts and give you access to their msds online database. Several payment sources exist for cancer drugs in ontario, depending on the drug, disease indication, and how and where it is delivered. These medicines kill dividing cells, including cancer cells. Mekinist trametinib tablets, for oral use initial u. Dosage may be reduced, delayed or discontinued in patients with bone. Highlights of prescribing information these highlights do not include all the information needed to use mekinist safely and effectively. Sequential intravesical gemcitabine and docetaxel gemdoce has shown safety and efficacy in 2 retrospective, single institution cohorts. It is given over 30 minutes as directed by your doctor. Highlights of prescribing information patients at risk. Identification of the substancemixture and of the companyundertaking product name. Pdf sequential intravesical gemcitabine and docetaxel. Gemcitabine, a pyrimidine analog, is structurally similar to cytarabine, but has a wider spectrum of antitumour activity due to its different cellular pharmacology and mechanism of action.
Gemcitabine for injection may be administered on an outpatient basis. Gemcitabine, sold under the brand name gemzar, among others, is a chemotherapy medication used to treat a number of types of cancer. Many people living with cancer experience nausea, diarrhea and other symptoms from their treatment or disease. The 2000mg dose of gemcitabine in 50 or 100 ml normal saline when administered intravesically for up to 2 h once a week for 6 wk has unremarkable systemic and local side effects. Gemcitabine fda prescribing information, side effects and uses. Information from its description page there is shown below. Prolongation of the infusion time beyond 60 minutes and more frequent than weekly dosing have been shown to increase toxicity see dosage. In the event of toxicity, doses may be delayed, but all treatment must be administered within 16 weeks of the first dose see clinical studies 14. Daily dosing of gemcitabine to pregnant mice increased the incidence of fetal malformation cleft palate, incomplete ossification at doses of 1.
The most common adverse reactions 5% were diarrhea, nausea, abdominal pain. The recommended dose of yervoy ipilimumab is 3 mgkg administered intravenously iv over 90 minutes every 3 weeks for a maximum of 4 doses. See prescribing information for cisplatin administration and hydration guidelines. This doublet has since been adopted as an intravesical. Secondline therapy after nabpaclitaxel plus gemcitabine or. Gemcitabine fda prescribing information, side effects. Gemcitabine was embryotoxic and fetotoxic in rabbits.
Response rate and progressionfree survival were each significantly better with gemox, 26. Gemcitabine 1for injection 1is for intravenous use only. Highlights of prescribing information advanced renal cell. Jan 01, 2020 gemcitabine injection is available in sterile singledose vials individually packaged in a carton as follows. Gemcitabine side effects, dosage, interactions drugs.
Highlights of prescribing information tafinlar with. Secondline therapy after nabpaclitaxel plus gemcitabine. Simple dose reductions may help manage side effects so patients remain on therapy. Tell your doctor about the allergy and what signs you had. Highlights of prescribing information patients at risk of. Gemzar gemcitabine for injection powder, lyophilized, for solution for intravenous use. The dose and timing of your chemotherapy may be changed based on the test results andor other side effects. Indications and usage gemzar is a nucleoside metabolic inhibitor indicated for. Gemcitabine is a cancer medicine that interferes with the growth and spread of cancer cells in the body. Each ml of concentrate for solution for infusion contains 40 mg gemcitabine as. Gemcitabine significantly reduces the number of myeloidderived suppressor cells32 csf1r blockade depletes immunosuppressive tams, which contribute to gemcitabine resistance through upregulation of cytidine deaminase in tumor cells, the enzyme that metabolizes gemcitabine into its inactive form27,33. Gemcitabine is a prescription drug that is approved for treating several types of cancer.
For healthcare professionals nerlynx neratinib tablets. Find documents on drug safety and administration for healthcare providers, including calculations. This page also discusses gemcitabine uses in children and some offlabel uses of the drug. Indcdatodmpdcir indcatom onivyde were diarrhea, vomiting. See actual entry in rtecs for complete information. May 2020 updated adverse effects, dosage with toxicity, administration. Patients continued treatment until disease progression or unacceptable toxicity. When gemcitabine is used to treat lung cancer, it is usually given on certain. Gemcitabine is designed to target and kill cancer cells by inserting itself into the dna of a pancreatic cancer cell, but not allowing cancer dna to. Phase iiiii weekly nabpaclitaxel plus gemcitabine or.
Federal usa law restricts this drug to use by or on the order of a licensed veterinarian. Dailymed gemcitabine injection, powder, lyophilized, for. Gemzar vials contain no antimicrobial preservatives and are intended for single use only. Gemzar gemcitabine for injection usp is a white to offwhite lyophilized powder available in sterile singleuse vials containing 200 mg or 1 g gemcitabine. Please see important safety information and prescribing information, including boxed warning. The recommended daily dose of tarceva for pancreatic cancer is 100 mg taken once daily in combination with gemcitabine. In preclinical studies in mice and rats, decitabine caused adverse developmental outcomes includingembryofetal lethality and malformations. Dose modifications for nonhematologic adverse reactions 2. Gemcitabine powder for solution for infusion belongs to a group of medicines called cytotoxics. Only select registry of toxic effects of chemical substances rtecs data is presented here. The product catalog provides you with a full listing of tevas brand and generic product lines.
Your new online msds binder is a place for you to store the material safety data sheets you need to deploy. List of drug master files dmf of gemcitabine hydrochloride active pharmaceutical ingredient api submitted to the u. Secondary endpoints were compliance with ttfields therapy, progression free survival pfs and overall survival os. Gemzar gemcitabine for injection powder, lyophilized, for solution for intravenous use initial u. Gemzar gemcitabine dose, indications, adverse effects. At diagnosis, only 15% of patients are candidates for curative surgical resection.
Gemcitabine injection is available in sterile singledose vials individually packaged in a carton as follows. Gemzar gemcitabine for injection, usp, is available in sterile singleuse vials individually packaged in a carton containing. Do not breastfeed while you take gemcitabine and for 1 week after your last dose. Follow applicable special handling and disposal procedures. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are. Jul 02, 2018 gemzar gemcitabine for injection usp is a white to offwhite lyophilized powder available in sterile singleuse vials containing 200 mg or 1 g gemcitabine. Gemcitabine hydrochloride api dmfs us drug master file. Gemcitabine is designed to target and kill cancer cells by inserting itself into the dna of a pancreatic cancer cell, but not allowing cancer dna to replicate.