Paclitaxel package insert pdf

The name of your medicine is paclitaxel 6 mgml, concentrate for solution for infusion but in the rest of the leaflet it will be called paclitaxel injection. Cytoxan cyclophosphamide for injection, usp cytoxan. Paclitaxel injection, usp is available in 30 mg 5 ml, 100 mg 16. Nexavar is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of nexavar. Patients with combined abnormalities of transaminase and alkaline phosphatase should, in general, not be treated with taxotere. Although some reports indicate a crossreactivity rate of 90% between docetaxel and paclitaxel, others suggest it does not occur consistently. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Paclitaxel is a natural product with antitumor activity. Paclitaxel should be administered at 175 mgm2 on day 1 as a 3hour intravenous infusion before gemcitabine for injection. Following intravenous administration, paclitaxel exhibits a biphasic decline in plasma concentrations. Highlights of prescribing information these highlights. Taxol is the first of a new class of anticancer agents known as taxanes.

Dosing was determined according to baseline bilirubin levels as described in the package insert for taxolr paclitaxel, and patients received, 200 or 260 mgm2 nabpaclitaxel every 3 weeks. The pharmacokinetic data of 260 mgm2 abraxane administered over a 30minute infusion was compared to the pharmacokinetics of 175 mgm2 paclitaxel injection over a 3hour infusion. Paclitaxel proteinbound monograph 1 paclitaxel proteinbound nabpaclitaxel abraxane national drug monograph october 2015 va pharmacy benefits management services, medical advisory panel, and visn pharmacist executives. Taxol paclitaxel injection rx only patient information included warning taxol paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. Vectibix is not indicated for the treatment of patients with colorectal cancer that harbor somatic ras mutations in exon 2 codons 12 and, exon 3 codons 59 and 61, and exon 4 codons 117 and 146 of either kras or nras and hereafter is referred to as.

Paclitaxel injection, usp is a clear colorless to slightly yellow viscous solution. In vitro studies in human hepatocytes indicated that. Paclitaxel fda prescribing information, side effects and. Package insert template for carboplatin solution for injection brand or product name product name solution for injection 10mgml name and strength of active substances carboplatin 10mgml product description visual description of the appearance of the product eg colour etc eg clear colourless liquid pharmacodynamics. Paclitaxel injection, usp is contraindicated in patients who have a history of hypersensitivity reactions to paclitaxel or other drugs formulated in polyoxyl 35 castor oil, nf paclitaxel injection, usp should not be used in patients with solid tumors who have baseline neutrophil counts of paclitaxel injection patient information included rx only warning taxol paclitaxel should be administered under the supervision of a physician experienced in the use of cancer chemotherapeutic agents. What should i tell my healthcare provider before receiving paclitaxel. Highlights of prescribing information these highlights do not include all the information needed to use vemlidy safely and effectively. Highlights of prescribing information initial dose of. Taxol contains paclitaxel, a natural product with antitumour activity. Do not administer abraxane therapy to patients with baseline neutrophil counts of less than 1,500 cellsmm3. Mvasi, in combination with carboplatin and paclitaxel, is indicated for the firstline treatment of patients with unresectable, locally advanced, recurrent or metastatic. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are. Learn more about dosing, efficacy, safety and patient financial info for abraxane paclitaxel proteinbound particles for injectable suspension albuminbound. In vitro studies indicated that axitinib does not inhibit cyp2a6, cyp2c9, cyp2c19, cyp2d6, cyp2e1, cyp3a45, or ugt1a1 at therapeutic plasma concentrations.

Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available. Cytoxan tablets cyclophosphamide tablets, usp are for oral use and contain 25 mg or 50 mg cyclophosphamide. Dose modifications for other adverse drug reactions in patients with pancreatic. In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which. Each vial contains 100 mg of paclitaxel formulated as albumin bound nanoparticles. The disposition and toxicity of paclitaxel 3 hour infusion were evaluated in 35 patients with varying degrees of hepatic. Abraxane for injectable suspension paclitaxel proteinbound particles for injectable suspension. Nexavar in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer see warnings and precautions 5. Paclitaxel is a white to offwhite crystalline powder with the empirical formula. Clearance was larger 43% and the volume of distribution was higher 53% for abraxane than for paclitaxel injection. Initial dose of 4 mgkg as an intravenous infusion over 90 minutes then at 2 mgkg as an intravenous infusion over 30 minutes weekly during chemotherapy for the first 12 weeks paclitaxel or docetaxel or 18 weeks docetaxelcarboplatin. Paclitaxel binds to tubulin, the protein component of microtubules, simultaneously promoting their assembly and disassembly to form stable, nonfunctional microtubules.

See full prescribing information for complete boxed warning. Nonpvc containing administration sets, such as those which are polyethylenelined, should be used. Abraxane for injectable suspension paclitaxel protein. Contains sodium, see package leaflet for further information. Highlights of prescribing information these highlights do not include all the information needed to use gemcitabine for injection safely and effectively. Each vial contains 100 mg of paclitaxel formulated as albumin bound. Pfizer rxpathways connects eligible patients to a range of assistance programs to help them access their pfizer prescriptions. Paclitaxelpack insertusab2 windows kpvinodp vinodp d. Xeloda monotherapy is also indicated for the treatment of patients with metastatic breast cancer resistant to both paclitaxel and an anthracyclinecontaining chemotherapy regimen or resistant to paclitaxel and for whom further anthracycline therapy is not indicated e. For the 403 patients who received singleagent paclitaxel injection in the phase. Paclitaxel paclitaxel this product information is intended only for residents of the united states. Paclitaxel solutions should be prepared and stored in glass, polypropylene, or polyolefin containers. If respiratory symptoms develop, move victim away from source of exposure and into fresh air.

Paclitaxel injection, usp is a clear, colorless to slightly yellow viscous solution. Mvasi, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. Only select registry of toxic effects of chemical substances rtecs data is presented here. Neutropenia do not administer abraxane therapy to patients who have baseline neutrophil counts of less than 1,500 cellsmm3. Exposure and toxicity of paclitaxel can be increased in patients with. Abraxane is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. This leaflet is part iii of a threepart product monograph. See actual entry in rtecs for complete information.

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