Ixabepilone package insert pdf

Floxuridine should be used with extreme caution in poor risk patients with impaired hepatic or renal function or a history of highdose pelvic irradiation or previous use of alkylating. Istodax is supplied as a kit which includes a sterile, lyophilized powder in a 10 mg singledose vial containing 11 mg of romid epsin and 22 mg of the bulking agent, povidone, usp. Each vial contains 200 mg of dacarbazine the active ingredient, citric acid monohydrate and mannitol. The final solution must be used within 6 hours of preparation 2. Ixabepilone plus capecitabine for metastatic breast. This article focuses on considerations for ixabepilone. Cytoxan cyclophosphamide for injection, usp cytoxan. Priftin is only recommended for the treatment of active pulmonary tuberculosis caused by drugsusceptible organisms as part of regimens consisting of a 2month initial phase followed by a 4month. Ixabepilone ixempra is a member of a new class of cytotoxic agents, the epothilones. Only supplied diluent must be used for constituting ixempra ixabepilone for injection. Arava is contraindicated for use in pregnant women because of the potential for fetal harm. Ixempra ixabepilone prior auth criteria proprietary information.

Abraxane is 125 mgm2 intravenously over 3040 minutes on days 1, 8 and 15 of each 28day cycle. For at least 48 hours after you receive a dose, avoid allowing your body fluids to come into contact with your hands or other surfaces. Full prescribing information 1 indications and usage nuedexta is indicated for the treatment of pseudobulbar affect pba. Epothilones promote tubulin polymerization in vitro and demonstrate antitumor activity. This medicine may cause harm to the unborn baby if you take it while you are pregnant.

Dailymed protamine sulfate protamine sulfate injection. Constituted solution must be diluted with one of the specified fluids, to a final ixabepilone. Dailymed floxuridine floxuridine injection, powder. For information on 5fluorouracil and leucovorin, see the respective package inserts. The ixabepilone concentration in constituted solution is 2 mgml. Dacarbazine for injection is a colorless to an ivory colored solid which is light sensitive.

Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention 1 indications and usage. If you are pregnant or you get pregnant while taking ixabepilone. Use birth control that you can trust to prevent pregnancy while taking ixabepilone. Bristolmyers squibb is a novel microtubule stabilizing agent recently approved for the treatment of metastatic breast cancer mbc. Manifestations may include generalized signs and symptoms such as fever. Learn about ixempra ixabepilone, including safety information and boxed warning, side. Medication management please refer to the fda label package insert for details regarding these topics. Protamine sulfate injection, usp is a sterile, isotonic solution of protamine sulfate. It may occur as early as the first week after start of therapy.

Full prescribing information 1 indications and usage zaltrap, in combination with. Constituted solution must be diluted with one of the specified fluids, to a final ixabepilone concentration of 0. The 15mg ixempra kit is supplied with a vial providing 8 ml of the diluent and the 45mg ixempra kit is supplied with a vial providing 23. Pba occurs secondary to a variety of otherwise unrelated. Ixempra can be used alone or with another cancer medicine called xeloda capecitabine. The recommended dosage of ixempra is 40 mgm2 administered intravenously over 3 hours every 3 weeks 2doses for patients with body surface area greater than 2. Ixempra ixabepilone dosing and administration guide. Grade 2 neuropathy moderate lasting 7 days or more. Sterile fudr brand of floxuridine for intraarterial infusion only description sterile fudr floxuridine, an antineoplastic antimetabolite, is available as a sterile, nonpyrogenic, lyophilized.

The 15mg ixempra kit is supplied with a vial providing 8 ml of the diluent and the 45mg ixempra kit. Insert needle and inject all the liquid subcutaneously. To view the most recent and complete version of the compendium, go online to. Ixempra kit pronounced as ixabepilone for injection, for intravenous infusion only read the patient information that comes with ixempra before you start receiving it and before each injection. Ixabepilone is a semisynthetic analog of epothilone b that binds to betatubulin subunits on microtubules, leading. Restricted access do not disseminate or copy without approval. Aetna considers ixabepilone ixempra medically necessary for members with locally advanced, recurrent or metastatic invasive breast cancer. Society of clinical oncology annual meetings, and the manufacturers prescribing information. Ixempra kit ixabepilone for injection, for intravenous infusion only. Aortitis has been reported in patients receiving filgrastim products. In addition to references for these three key clinical trials, sections on adverse events drew from the us prescribing information for ixabepilone. Ixempra ixabepilone is a prescription medicine used to treat locally advanced or metastatic breast cancer when certain other medicines have not worked or no longer work.

Ixempra ixabepilone for injection must be constituted with supplied diluent. Highlights of prescribing information take with food. Vinblastine sulfate is the salt of an alkaloid extracted from vinca rosea linn. This is a multidose vial which contains a total of 22. This label reflects clinical trials for lupron depot in prostate cancer. Leucovorin calcium for injection rx only description leucovorin is one of several active, chemically reduced derivatives of folic acid. Lupron depot leuprolide acetate for depot suspension. Managing ixabepilone adverse events with dose reduction.

Ixabepilone ixempra, a therapeutic option for locally. In study 1, grade 3 peripheral neuropathy occurred in 8% 40503 of patients, and grade 4 in 0. Dailymed vinblastine sulfate vinblastine sulfate injection. Teratogenicity and embryolethality occurred in animals administered leflunomide at doses. Ixempra kit must be stored in a refrigerator at 2 c 8 c 36 f 46 f in the original package to protect from light. Lysodren and after discontinuation of treatment for as long as mitotane plasma levels are detectable see use in specific populations 8. Ovarian macrocysts, often bilateral and multiple, have been reportedin premenopausal patie nts.

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