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 injection is a nucleoside metabolic inhibitor indicated. The nccn recommends cancer patient participation in clinical trials as the gold standard for treatment. Pfizer rxpathways connects eligible patients to a range of assistance programs to help them access their pfizer prescriptions. Your doctor will determine your exact dosage and schedule. The nccn recommends cancer patient participation in clinical trials as the gold standard.
The clinical formulation is supplied in a sterile form for intravenous use only. 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. In this phase i study, patients with metastatic or unresectable solid tumors and. Bumetanide is a loop diuretic, available in 4 ml and 10 ml vials for intravenous or intramuscular injection as a sterile solution. Gemzar dosage adjustment for hematological toxicity within a cycle of treatment is based on the granulocyte and platelet counts taken on day 8 of therapy. When gemcitabine is used to treat lung cancer, it is usually given on certain. The authors concluded that gemcitabine likely does not cross the bloodbrain barrier. And gemcitabine has been the standard of care for advanced pancreatic cancer.
Gemcitabine plus cisplatin versus gemcitabine alone in the. Gemcitabine hydrochloride monograph for professionals. Gemcitabine injection can suppress bone marrow function manifested by leucopenia, thrombocytopenia and anemia. Gemcitabine can increase your risk of bleeding or infection. Subacute cutaneous lupus erythematosus induced by gemcitabine.
Gemcitabine is sometimes given with other cancer medicines, or when other cancer treatments did not work or have stopped working. Feb 29, 2016 pancreatic cancer ranks as the fourth leading cause of cancerrelated mortality in the usa. Gemcitabine fda prescribing information, side effects and uses. Gemzar gemcitabine hcl side effects, images, uses, dosage. The mechanism of action of gemcitabine is as a nucleic acid synthesis inhibitor. Information for the patient gemcitabine 10 mgml, solution for infusion gemcitabine read all of this leaflet carefully before you are given this medicine because it contains important information for you. The advantages of this drug are a relatively mild sideeffect profile and a radiosensitizing effect. Jun 20, 2019 store diluted gemcitabine injection solution for no more than 24 hours at controlled room temperature of 20 to 25c 68 to 77f see usp controlled room temperature. 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. Gemzar gemcitabine for injection, usp, is available in sterile singleuse vials individually packaged in a carton containing. This patients benefit plan requires prior authorization for certain medications in order for the drug to be covered. Phase i combination study of the parp inhibitor veliparib.
Gemcitabine is metabolized intracellularly to two active metabolites, gemcitabine diphosphate dfdcdp and gemcitabine triphosphate dfdctp. Dec 26, 2019 bumetanide is a loop diuretic, available in 4 ml and 10 ml vials for intravenous or intramuscular injection as a sterile solution. Follow applicable special handling and disposal procedures. Taxol paclitaxel injection is a clear, colorless to slightly yellow viscous solution. Gemcitabine may also be used for purposes not listed in this medication guide. Our cases add to the literature on gemcitabineinduced scle.
Increased toxicity with infusion time 60 minutes or dosing more frequently than once weekly. B activity in bxpc3, panc1, and mia paca2 cells and decreased the level. Side effects of gemzar include pale skin, easy bruising or bleeding, numbness or tingly feeling, weakness, nausea, vomiting, upset stomach, diarrhea, constipation, headache, swelling in your handsanklesfeet. 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 hcl for injection description gemzar gemcitabine hcl is a nucleoside analogue that exhibits antitumor activity. Renal cell carcinoma treatment regimens cancer therapy. Only select registry of toxic effects of chemical substances rtecs data is presented here. Gemcitabine fixeddose rate infusion for the treatment of. 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. However, a combined use of gemcitabine plus cisplatin gemcis has shown promising efficacies in pancreatic cancer patients. Renal cell carcinoma treatment regimens cancer therapy advisor. Gemcitabine injection should be used with extreme caution in patients whose bone marrow reserve may have been compromised by prior irradiation or chemotherapy, or whose marrow function is recovering from previous chemotherapy. Dose modifications recommended gemzar dose modifications for myelosuppression are described table 1 and table 2 see warnings and precautions 5. Endpt durable response rate % pts w cr or pr maintained 6mo.
Monitor for myelosuppression, which can be doselimiting. Multiuse vials are not subject to payment for discarded amounts of drug or biological. Abraxane ah braksane paclitaxel proteinbound particles for injectable suspension albumin bound read this patient information before you start receiving abraxane and before each infusion. Day 8 dosage reduction guidelines for gemzar in combination with carboplatin. Eligible patients can register for valuable savings offers for nearly 40 brand name medications. Gemcitabine is often prescribed to treat ovarian cancer, breast cancer, nonsmall cell lung cancer, pancreatic cancer, and other types. Used in combination with paclitaxel as firstline therapy for metastatic breast cancer in patients who did not respond to previous anthracyclinecontaining chemotherapy or in whom such chemotherapy was contraindicated. See actual entry in rtecs for complete information. Jul 02, 2018 gemcitabine is used to treat cancers of the pancreas, lung, ovary, and breast. Patients with a known hypersensitivity to gemcitabine 4 warnings and precautions infusion time and dose frequency.
Gemcitabine resistant pancreatic cancer cell lines acquire. Gemcitabine fda prescribing information, side effects. Gmcsf attracts dendritic cells, which present tumor ags to t cells programming them to destroy cancer cells throughout the body. If marrow suppression is detected, gemzar dosage should be modified according to guidelines in table 1. Aug 30, 2019 gemcitabine is used to treat cancers of the pancreas, lung, ovary, and breast. Visually inspect reconstituted product for particulate matter and discoloration.
Gemcitabine is a commonly used chemotherapeutic agent. Discard if particulate matter or discoloration is observed. The cancer medication gemzar is now available in both brandname and generic form. Food and drug administration considers them equivalent to. Withdraw the calculated dose from the vialand discard any unused portion. Information for the patient gemcitabine 200 mg, powder for solution for infusion gemcitabine mg, powder for solution for infusion gemcitabine read all of this leaflet carefully before you start taking this medicine because it contains important information for you. This program will include a discussion of offlabel treatment and investigational agents not approved by the fda for use in the united states, and data that were presented in abstract form.
Gemcitabine gemzar gemcitabine gemzar is a chemotherapy regimen for pancreatic cancer. It is administered intravenously and is usually given at your healthcare providers office, a hospital, or an infusion center. Find patient medical information for gemcitabine intravenous on webmd including its uses, side effects and safety, interactions, pictures, warnings and user ratings. Discard if not used within 24 hours after dilution. Chemotherapy was held with resolution of most mri and clinical findings within 2. Aug 14, 2014 gemcitabine injection should be used with extreme caution in patients whose bone marrow reserve may have been compromised by prior irradiation or chemotherapy, or whose marrow function is recovering from previous chemotherapy. To define the performance guidelines surrounding the instillation of intravesical cytotoxic, immunotherapeutic andor therapeutic drugs via sterile technique catheterization for patients with. Gemcitabine is given by infusion through a vein intravenously, by iv. Preclinical evidence shows that fixed dose rate fdr infusion of gemcitabine could optimize plasma concentration of gemcitabine, while the clinical efficacy and toxicity of fdr infusion of gemcitabine in advanced pancreatic carcinoma has not been systematically investigated. See full prescribing information for gemcitabine for injection, usp.
Features gemcitabine has been used for pancreatic cancer as the most effective anticancer drug. This information does not take the place of talking with your doctor about. Jan 01, 2020 gemcitabine injection is available in sterile singledose vials individually packaged in a carton as follows. 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. Abraxane is 125 mgm2 intravenously over 3040 minutes on days 1, 8 and 15 of each 28day cycle. When gemcitabine is used to treat ovarian or breast cancer, it is usually given on certain days every 3 weeks. 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. The empirical formula for gemcitabine hcl is c9h11f2n3o4 hcl. Find documents on drug safety and administration for healthcare providers, including calculations. Gemzar gemcitabine for injection usp is a white to offwhite lyophilized powder available in sterile singleuse vials containing 200 mg or 1 g gemcitabine. Cutaneous side effects of all grades are common and require discontinuation in less than 1% of cases. Many people living with cancer experience nausea, diarrhea and other symptoms from their treatment or disease. Cvs caremark administers the prescription benefit plan for the patient identified. Every 4week schedule the recommended dose of gemzar is mgm.
Food and drug administration considers them equivalent to brandname gemzar. Intravesical administration of therapeutic medication standard operating procedure approved by the aua board of directors july 2015 i. This information does not take the place of talking with your doctor about your medical condition or your treatment. Mar 16, 20 i think its fairly common to have pain in the veins during infusions of gemcitabine which is causing some problems for my mum. 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 cancer. Refer to carboplatin prescribing information for additional information. Pain during gemcitabine gemzar infusion lung cancer. Our cases add to the literature on gemcitabine induced scle. Reconstituted gemzar is a clear, colorless to light strawcolored solution. 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. Gemcitabine investigated as a drug, mutagen, natural product, and tumorigen. Gemzar vials contain no antimicrobial preservatives and are intended for single use only. Patient information abraxane ahbraksane paclitaxel. Gemcitabine is used to treat cancers of the pancreas, lung, ovary, and breast.
Administer gemcitabine immediately after abraxane on days 1, 8 and 15 of each 28day cycle see clinical studies 14. If you have any further questions, ask your doctor, pharmacist or nurse. I think its fairly common to have pain in the veins during infusions of gemcitabine which is causing some problems for my mum. The amount of gemcitabine you will receive depends on many factors, including your height and weight, your general health or other health problems, and the type of cancer you have. I f marrow suppression is detected, gemcitabine for injection dosage should be modified according to guidelines in table 1.
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