Gemcitabine injection is a sterile solution in singledose vials for intravenous use. Gemcitabine is an option for firstline chemotherapy for patients with advanced or metastatic adenocarcinoma of the pancreas and a karnofsky score of at least 50 karnofsky score is a measure of the ability to perform ordinary tasks. All generic versions have an ap rating, which means the u. Increased toxicity with infusion time greater than 60 minutes or dosing more frequently than once weekly.
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 in combination with carboplatin is recommended using gemcitabine mgm 2 administered on days 1 and 8 of each 21day cycle as a 30minute intravenous infusion. Gemcitabine gemzar gemcitabine gemzar is a chemotherapy regimen for pancreatic cancer. Gemcitabine is often prescribed to treat ovarian cancer, breast cancer, nonsmall cell lung cancer, pancreatic cancer, and other types. Mar 16, 2019 gemcitabine in combination with carboplatin is recommended using gemcitabine mgm 2 administered on days 1 and 8 of each 21day cycle as a 30minute intravenous infusion. Webmd provides common contraindications for gemcitabine intravenous.
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. Tell your doctor about the allergy and what signs you had. It is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Gemcitabine hydrochloride supplier based in usa buy api. Gemzar gemcitabine for injection, usp, is available in sterile singleuse vials individually packaged in a carton containing. Gemzar is a nucleoside metabolic inhibitor indicated. The clinical formulation is supplied in a sterile form for intravenous use only. Dacogen decitabine forinjection, for intravenous use initial u. Gemcitabine, hcl cas 122111039 calbiochem empirical formula hill notation. Jul 02, 2018 table 9 presents the incidence of selected adverse reactions, occurring in. Gemcitabine side effects, dosage, interactions drugs. These cancers include breast cancer, ovarian cancer, nonsmall cell lung cancer, pancreatic cancer, and bladder cancer.
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. Each cell line was treated with gemcitabine up to 3 mm for 24, 48, and 72 h 24. Hyaluronic acid ha drug conjugates with distinct linkers conjugating both dox. This page also discusses gemcitabine uses in children and some offlabel uses of the drug. Eligible patients can register for valuable savings offers for nearly 40 brand name medications. Learn more about medicare prescription drug plans and savings with goodrx. Food and drug administration considers them equivalent to brandname gemzar. Gemcitabine 1 g powder for solution for infusion summary. Gemzar gemcitabine for injection powder, lyophilized, for solution for intravenous use initial u. After gemcitabine, carboplatin will be given on day 1 consistent with a target area under curve auc of 4. Gemcitabine was discovered and developed by scientists at the pharmaceutical company eli lilly. However, if after dose reduction to 75% on day 8, their blood count on day 15 is still inadequate i. Gemcitabine dosage and administration ovarian cancer. Dosage reduction guidelines for gemzar for myelosuppression on day of treatment in.
Use of a multidrug regimen gemcitabine, 5fluorouracil, irinotecan. Here, we identify gemcitabine gem and doxorubicin dox as a synergistic drug pair in vitro for. If you need information about a lilly product or want to report an adverse event or product complaint, you may call us. Nov 09, 2018 gemcitabine is a cancer medicine that interferes with the growth and spread of cancer cells in the body.
Identification of the substancemixture and of the companyundertaking product name. When gemcitabine is used to treat lung cancer, it is usually given on certain. This emedtv web page describes how gemcitabine is used for treating breast cancer, ovarian cancer, nonsmall cell lung cancer, and pancreatic cancer. As with fluorouracil and other analogues of pyrimidines, the drug replaces one of the building blocks of nucleic acids, in this case cytidine, during dna replication. Patients with a known hypersensitivity to gemcitabine 4 warnings and precautions scheduledependent toxicity.
Daily dosing of gemcitabine to pregnant mice increased the incidence of fetal malformation cleft palate, incomplete ossification at doses of 1. Gemcitabine is not recommended for patients who can have potentially curative surgery. It is administered intravenously and is usually given at your. The cancer medication gemzar is now available in both brandname and generic form. Gemcitabine gemzar gemcitabine is a type of chemotherapy drug. 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 and docetaxel in treating patients with metastatic prostate cancer the safety and scientific validity of this study is the responsibility of the study sponsor and investigators. 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. The mechanism of action of gemcitabine is as a nucleic acid synthesis inhibitor. Gemcitabine for injection dosage adjustments for hematological toxicity within a cycle of treatment is based on the granulocyte and platelet counts taken on day 8 of therapy. This patients benefit plan requires prior authorization for certain medications in order for the drug to be covered. Feb 29, 2016 pancreatic cancer ranks as the fourth leading cause of cancerrelated mortality in the usa. Gemcitabine uses, dmf, dossier, manufacturer, supplier.
Gemcitabine was embryotoxic and fetotoxic in rabbits. Patients with a known hypersensitivity to gemcitabine 4 warnings and precautions infusion time and dose frequency. Gemcitabine gemzar cancer information cancer research uk. Gemcitabine fda prescribing information, side effects and uses.
To investigate mechanisms of gemcitabine resistance, the miapaca2 mp cell line was selected for survival under continuous. Gemcitabine has been evaluated against two poorly differentiated thyroid cancer cell lines wro and npa and an anaplastic thyroid cancer cell line aro. I f marrow suppression is detected, gemcitabine for injection dosage should be modified according to guidelines in table 1. Gemcitabine is used to treat cancers of the pancreas, lung, ovary, and breast. Gemzar gemcitabine is a chemotherapy drug used to treat certain types of malignant tumors, including some cases of ovarian cancer, lung cancer, pancreatic cancer, and breast. Find documents on drug safety and administration for healthcare providers, including calculations. Get info of suppliers, manufacturers, exporters, traders of gemcitabine injection for buying in india. These cancers include breast cancer, ovarian cancer, nonsmall cell. Pdf gemcitabine is considered to be a welltolerated and safe cytostatic drug because of the relative. Do not breastfeed while you take gemcitabine and for 1 week after your last dose. Selection was initiated at 20 nm gemcitabine, which corresponds to the approximate ic 50 as determined by 72 hr mtt assay fig.
Dailymed gemcitabine injection, powder, lyophilized, for. For all three cell lines, maximal reduction in cell viability as measured by a tetrazolium dye assay was. Gemcitabine and carboplatin are chemotherapy drugs used to treat several types of cancer, including cancer of the pancreas, bladder, ovaries, and lung. If you have an allergy to gemcitabine or any other part of gemcitabine. Gemzar uses gemcitabine is used alone or with other treatments medications to treat certain types of cancer including breast lung ovarian pancreatic it is a chemotherapy drug that works by slowing or. Increased toxicity with infusion time 60 minutes or dosing more frequently than once weekly. Pdf gemcitabineinduced acute lipodermatosclerosislike reaction.
Pdf a hyaluronic acid conjugate engineered to synergistically and. Schedule dependent synergy of gemcitabine and doxorubicin. Gemcitabine and docetaxel in treating patients with. Indications and usage gemzar is a nucleoside metabolic inhibitor indicated for.
Gemcitabine fda prescribing information, side effects. 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. Gemcitabine is an option for firstline chemotherapy for patients with advanced or metastatic adenocarcinoma of the pancreas and a karnofsky score of at least 50 karnofsky score is a measure. Gemcitabine is a nucleoside analog used as chemotherapy.
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. Gemcitabine combination nano therapies for pancreatic cancer. The product catalog provides you with a full listing of tevas brand and generic product lines. Gemcitabine is a prescription drug that is approved for treating several types of cancer. Gemzar is the registered name of gemcitabine for injection.
Many people living with cancer experience nausea, diarrhea and other symptoms from their treatment or disease. The cytotoxic effects of gemcitabine are exerted through incorporation of dfdctp into dna with the assistance of dfdcdp, resulting in inhibition of dna synthesis and induction of apoptosis. Jan 01, 2020 gemcitabine injection is available in sterile singledose vials individually packaged in a carton as follows. Vials of gemzar contain either 200 mg or 1 g of gemcitabine hcl expressed as free base formulated with mannitol 200 mg or 1 g, respectively and sodium acetate 12. Medicare coverage and pricing details for gemcitabine.
Gemcitabine resistant pancreatic cancer cell lines acquire. Gemcitabine, sold under the brand name gemzar, among others, is a chemotherapy medication used to treat a number of types of cancer. Dose modifications for nonhematologic adverse reactions 2. This treatment modality utilizes either frequent or continuous drug delivery. Lenalidomide, a drug that prevents the growth of new blood vessels in tumors, has been approved for treatment of certain blood cancers, but it has not yet been approved for use in combination. Gemzar vials contain no antimicrobial preservatives and are intended for single use only. However, if after dose reduction to 75% on day 8, their blood. Pancreatic cancer ranks as the fourth leading cause of cancerrelated mortality in the usa. Manufacturers package insert 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. 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. Gemcitabine injection is indicated for patients previously treated with. 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, carboplatin, and lenalidomide for treatment of.
Gemcitabine gemzar is an antimetabolite that is effective as monotherapy or in combination with other drugs in a variety of solid tumors. Pfizer rxpathways connects eligible patients to a range of assistance programs to help them access their pfizer prescriptions. You might have it as a treatment for a number of different cancers, including bladder and breast cancer. Follow applicable special handling and disposal procedures. Gemcitabine plus cisplatin versus gemcitabine alone in the.
Mesothelioma patients who do not respond well to platinumbased chemotherapy drugs like cisplatin or carboplatin may do well on gemcitabine instead. Gemcitabine resistance is a stable phenotype in vitro and in vivo. See full prescribing information for gemcitabine for injection, usp. Gemcitabine 38 mgml concentrate for solution for infusion. However, a combined use of gemcitabine plus cisplatin gemcis has shown promising efficacies in pancreatic cancer patients.
Several payment sources exist for cancer drugs in ontario, depending on the drug. Gemcitabine resistant pancreatic cancer cell lines acquire an. When gemcitabine is used to treat ovarian or breast cancer, it is usually given on certain days every 3 weeks. Gemzar gemcitabine for injection powder, lyophilized, for solution for intravenous use.
Treatment consisted of a 2day combination of gemcitabine 300 mg, 5fluorouracil. The empirical formula for gemcitabine hcl is c9h11f2n3o4 hcl. Monitor for myelosuppression, which can be doselimiting. Find out what health conditions may be a health risk when taken with gemcitabine intravenous. 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. Manufacturers package insert 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. As with fluorouracil and other analogues of pyrimidines, the drug replaces one of the. Find here online price details of companies selling gemcitabine injection. Optimizing drug ratio and schedule can improve drug combinat.
Gemcitabine is a cytosine analogue and intravenously administered antineoplastic agent used in the therapy of several forms of advanced, pancreatic, lung, breast, ovarian and bladder cancer. Gemcitabine 1 g powder for solution for infusion summary of. Gemcitabine medicare coverage and copay details goodrx. And gemcitabine has been the standard of care for advanced pancreatic cancer. Cvs caremark administers the prescription benefit plan for. Several payment sources exist for cancer drugs in ontario, depending on the drug, disease indication, and how and where it is delivered. Gemcitabine is one of the main chemotherapy drugs used to treat pancreatic cancer. Cvs caremark administers the prescription benefit plan for the patient identified. Side effects of gemzar gemcitabine hcl, warnings, uses. Gemcitabine destroys quickly dividing cells, such as cancer cells. Highlights of prescribing information these highlights. Dose adjustment for gemzar in combination with carboplatin for subsequent cycles is based upon observed toxicity. Features gemcitabine has been used for pancreatic cancer as the most effective anticancer drug. Gemcitabine, carboplatin, and lenalidomide for treatment.
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