Gemcitabine 2 0,2 difluorodeoxycytidine dfdc is a deoxycytidine analogue with a broad spectrum of antitumouractivity. Gemcitabine is then deactivated by deamination into 2 0,2. The nccn recommends cancer patient participation in clinical trials as the gold standard. Gemcitabine ebewe containing 10 mgml gemcitabine hydrochloride in vial containing 200 mg, 500 mg or mg of gemcitabine. Monitor for myelosuppression, which can be doselimiting. Store diluted product in accordance with package insert instructions gemzar.
Bar codes included on the vial and carton for ease of scanning. Administer gemcitabine immediately after abraxane on days 1, 8 and 15 of each 28day cycle see clinical studies 14. For dose adjustment guidelines, see dosage adjustment, dose. Patients should be monitored prior to each dose with a complete. Afinitor is a prescription medicine used to treat adults with a type of cancer known as neuroendocrine tumor net of the stomach and intestine gastrointestinal or lung that has progressed and cannot be treated with surgery. Gemcitabine for injection, usp is a sterile white to offwhite lyophilized powder and available as 200 mg and 1 gram singledose vials for intravenous use only. Gemzar vials contain no antimicrobial preservatives and are intended for single use only. Camptosar should be diluted in 5% dextrose injection, usp, preferred or 0.
Gemcitabine concentration lower than cited in package insert. A phase i, openlabel, doseescalation study to evaluate the safety, tolerability and recommended phase ii dose rp2d of copanlisib with gemcitabine or with. Camptosar injection must be diluted prior to infusion. Highlights of prescribing information these highlights do not include all of the information needed to use onivyde safely and effectively. Uterine sarcoma treatment regimens cancer therapy advisor. Gemcitabine hcl for injection description gemzar gemcitabine hcl is a nucleoside analogue that exhibits antitumor activity. Each vial contains 200 mg, mg or 2000 mg of gemcitabine. The empirical formula for gemcitabine hcl is c9h11f2n3o4 hcl. These highlights do not include all the information needed to use halaven safely and effectively. Intermittent courses of carboplatin injection in combination with cyclophosphamide should not be repeated until the neutrophil count is at least 2,000 and the platelet count is at least 100,000. Gemcitabine hydrochloride is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. Patients with a known hypersensitivity to gemcitabine 4 warnings and precautions infusion time and dose frequency.
Cisplatin fda prescribing information, side effects and uses. Gemzar gemcitabine dose, indications, adverse effects. Gemcitabine fda prescribing information, side effects. Highlights of prescribing information these highlights do not include all the information needed to use tarceva safely and effectively. These medicines kill dividing cells, including cancer cells. See cisplatin prescribing information for administration and hydration guidelines. Onivyde is not indicated as a single agent for the treatment of patients with.
Do not refrigerate reconstituted product may be stored at controlled room temperature 68 to 77 degrees f store unreconstituted product at 68 to 77 degrees f use within 24 hours from time of preparation. Gemzar reference guide for safe and effective use from the american society of healthsystem. Severe hypersensitivity reactions with fatal outcome have been reported. Some of these precautions include the safety of taking the drug when pregnant or breastfeeding, the risk of the drug causing kidney damage or liver problems in some people, and potential drug interactions. Cisplatin injection is a clear, lightyellow, sterile aqueous solution available in amber vials containing 1 mgml of cisplatin. Gemcitabine for injection, usp sagent pharmaceuticals. Highlights of prescribing information neulasta safely and. Jun 01, 2015 cisplatin injection is a clear, lightyellow, sterile aqueous solution available in amber vials containing 1 mgml of cisplatin. Elderly population 65 years gemcitabine has been well tolerated in patients over the age of 65. The incidence of fatal vtes was similar between arms 0. Gemzar gemcitabine for injection, for intravenous use. Follow applicable special handling and disposal procedures. Sections or subsections omitted from the full prescribing information are not listed full prescribing information warning. Before prescribing keytruda, please read the selected safety information on pages 8 to 10 and the accompanying prescribing information.
In study 1, the incidence of vte was 9% in patients receiving portrazza plus gemcitabine and cisplatin versus 5% in patients receiving gemcitabine and cisplatin alone and the incidence of grade 3 or higher vte was 5% versus 3%, respectively. Xeloda tablets should be swallowed whole with water within 30 minutes after a meal. Gemcitabine injection is available in sterile singledose vials individually packaged in a carton as follows. What gemcitabine powder for solution for infusion looks like and contents of the pack gemcitabine powder for solution for infusion is a white to offwhite powder, for solution for infusion in a vial.
Afterbeingtransportedinto the cell, it is phosphorylated and incorporated into the dna and rna, which cause inhibition of cell growth and trigger apoptosis 12. Paclitaxel should be administered at 175 mgm2 on day 1 as a 3hour intravenous infusion before gemcitabine for injection administration. Jan 16, 2019 gemcitabine hydrochloride is soluble in water, slightly soluble in methanol, and practically insoluble in ethanol and polar organic solvents. In patients who develop an acute onset of new or progressive pulmonary symptoms, such as dyspnea, cough or fever, treatment wit h tarceva should be. Cisplatin is a heavy metal complex containing a central atom of platinum surrounded by two chloride atoms and two ammonia molecules in the cis position. Gemzar is used for the treatment of ovarian cancer, breast cancer, nonsmall cell lung cancer, and pancreatic cancer. Afinitor is not for use in people with carcinoid tumors that actively produce hormones. You should talk with your healthcare provider about gemzar warnings and precautions prior to starting treatment with the medication. Tarceva in combination with gemcitabine is indicated for the firstline treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer. Policy document for gemzar gemcitabine gemcitabine generic.
Highlights of prescribing information patients at risk of. Jan 01, 2020 gemcitabine injection is available in sterile singledose vials individually packaged in a carton as follows. Gemcitabine monotherapy associated with posterior reversible. Increased toxicity with infusion time 60 minutes or dosing more frequently than once weekly. Every 4week schedule the recommended dose of gemzar is mgm. Taxol paclitaxel injection is a clear, colorless to slightly yellow viscous solution. Alimta pemetrexed for injection healthcare provider site. Camptosar injection 20 mgml is intended for single use only and any unused portion should be discarded. Highlights of prescribing information patients at risk. To define the performance guidelines surrounding the instillation of intravesical cytotoxic, immunotherapeutic andor therapeutic drugs via sterile technique catheterization for patients with. Policy document for gemzar gemcitabine gemcitabine generic the overall objective of this policy is to support the appropriate and cost effective use of the.
Gemcitabine powder for solution for infusion belongs to a group of medicines called cytotoxics. Intravesical administration of therapeutic medication standard operating procedure approved by the aua board of directors july 2015 i. Posterior reversible encephalopathy syndrome is a clinicoradiologic entity that may present with headaches, altered mental status, seizures and visual loss as well as specific neuroimaging findings. For the recommended dosing schedule, gemcitabine elimination should be virtually.
For directions regarding the use and administration of cyclophosphamide please refer to its package insert. The phase iii keynote189 study included patients with all programmed deathligand 1 pdl1 expression levels. Gemcitabine gemcitabine this product information is intended only for residents of the united states. Gemcitabine for injection should be administered intravenously at a dose of 1250 mgm2 over 30 minutes on days 1 and 8 of each 21day cycle. Gemcitabine for injection may be administered on an outpatient basis. Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention treatmentrelated mortality associated with docetaxel therapy is increased in patients.
Easytoread drug name and dosage strength to aid in identifying the right product. Policy document for gemzar gemcitabine gemcitabine. Each pack of gemcitabine powder for solution for infusion contains 1 vial. Gemcitabine fda prescribing information, side effects and uses.
Abraxane is 125 mgm2 intravenously over 3040 minutes on days 1, 8 and 15 of each 28day cycle. Highlights of prescribing information embolism pe can occur. Each vial contains either mitomycin 5 mg and mannitol 10 mg, or mitomycin 20 mg and mannitol 40 mg, or mitomycin 40 mg and mannitol 80 mg. The analyses contained in the article may differ from those in the package insert for abraxane. Dailymed gemcitabine gemcitabine hydrochloride injection. Highlights of prescribing information urothelial carcinoma. Please see important safety information and prescribing information, including boxed warning. Cisplatin, the active ingredient in cisplatin for injection, usp, is a yellow to orange crystalline powder with the molecular formulacl 2 h 6 n 2 pt and a molecular weight of 300. We report a case of a 74yearold woman receiving adjuvant gemcitabine chemotherapy as monotherapy for a stage iia pancreatic adenocarcinoma, who. Carboplatin auc 4 should be administered intravenously on day 1 after gemcitabine for injection administration. Half life ranged from 42 to 94 minutes depending on age and gender. Treatment should continue until disease progression or unacceptable toxicity occurs. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion.
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