Paclitaxel fda prescribing information, side effects and uses. Click on the paclitaxel taxol package insert below for all manufacturer reported side effects and possible drug interactions. A complete guide to combination chemotherapy regimens, 8th ed. Severe local tissue necrosis will occur if there is extravasation during administration. After reconstitution, it should be administered by intramuscular im or intravenous iv routes see dosage and administration. Pentamidine isethionate is a white crystalline powder soluble in water and glycerin, slightly soluble in alcohol and insoluble in ether. Highlights of prescribing information these highlights do not.
Gemzar vials contain no antimicrobial preservatives and are intended for single use only. Paclitaxel injection, usp safety data sheet sds effective date. For example, the drug may cause side effects or serious complications, such as an irregular heart rhythm, slow heart rate, nerve problems, or lifethreatening allergic reactions. Patients who experience severe hypersensitivity reactions to paclitaxel should not be rechallenged with the drug. Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively. Carboplatin fda prescribing information, side effects and uses. Dose increase or reduction is recommended based on individual safety and tolerability. For directions regarding the use and administration of cyclophosphamide please refer to its package insert. Survival median ncic swog carboplatin 110 weeks 86 weeks cisplatin 99 weeks 79 weeks 2year survival carboplatin 51. Information for the user paclitaxel 6 mgml, concentrate for solution for infusion paclitaxel read all of this leaflet carefully before you start using this medicine because it contains important information for you keep this leaflet. 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.
Paclitaxel is a natural product with antitumor activity. Abraxane is a cytotoxic drug and, as with other potentially toxic paclitaxel compounds, caution. Side effect videos diarrhea hair loss fatigue bleeding constipation pain anemia neutropenic fever see dailymed package insert. What should i tell my healthcare provider before receiving paclitaxel. Oct 01, 2019 carboplatin injection 300 mgm 2 iv on day 1 every 4 weeks for 6 cycles alternatively see formula dosing. Dailymed pentam 300 pentamidine isethionate injection. Read all of this leaflet carefully before you start using. Highlights of prescribing information initial dose of. Package insert fluorouracil injection, usp for intravenous use only description fluorouracil injection, an antineoplastic antimetabolite, is a sterile, nonpyrogenic injectable solution for intravenous administration. The clinical formulation is supplied in a sterile form for intravenous use only. In cases of severe neutropenia taxol 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. Paclitaxel 6 mgml concentrate for solution for infusion.
It is freely soluble in water, soluble in methanol, and slightly soluble in ethanol. Abraxane is 125 mgm2 intravenously over 3040 minutes on days 1, 8 and 15 of each 28day cycle. Cyramza as a single agent, or in combination with paclitaxel, is indicated for the treatment of patients with advanced or metastatic gastric or gastroesophageal junction gej adenocarcinoma with disease progression on or after prior fluoropyrimidine or platinumcontaining chemotherapy. Following intravenous administration, paclitaxel exhibits a biphasic decline in plasma concentrations. Serious irreversible myocardial toxicity with delayed congestive. 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. Gleevec imatinib mesylate tablets, for oral use initial u. Firstline treatment of advanced nonsmall cell lung cancer. Prescribing information as of april 2003 r only taxotere docetaxel injection concentrate warning taxotere docetaxel injection concentrate should be administered. Avastin, in combination with paclitaxel and cisplatin or paclitaxel and topotecan, is indicated for the treatment of patients with persistent, recurrent, or metastatic cervical cancer. Adriamycin must not be given by the intramuscular or subcutaneous route. 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. Learn more about dosing, efficacy, safety and patient financial info for abraxane paclitaxel proteinbound particles for injectable suspension albuminbound. Our products paclitaxel paclitaxel paclitaxel this product information is intended only for residents of the united states.
Contraindications warnings fluorouracil warnings see boxed. As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel. Dosing was determined according to baseline bilirubin levels as described in the package insert for taxol r paclitaxel, and patients received, 200 or 260 mgm2 nabpaclitaxel every 3 weeks. Taxol paclitaxel dosing, indications, interactions. Our products carboplatin carboplatin carboplatin this product information is intended only for residents of the united states. Highlights of prescribing information platinumresistant. Taxol paclitaxel injection is a clear, colorless to slightly yellow viscous solution. Taxol paclitaxel injection, solution bristolmyers squibb company princeton, nj 08543 usa. It is supplied as a nonaqueous solution intended for dilution with a suitable parenteral fluid prior to intravenous infusion. Appropriate management of complications is possible only when adequate diagnostic and treatment facilities are readily available.
Abraxane for injectable suspension paclitaxel proteinbound particles for injectable suspension. Oct 28, 2016 paclitaxel injection, usp is a clear, colorless to slightly yellow viscous solution. Cyramza, in combination with docetaxel, is indicated for. Sep 23, 2019 paclitaxel injection, usp is a clear, colorless to slightly yellow viscous solution. Dosage and administration 3 dosage forms and strengths 4 contraindications 5 warnings and precautions 5. Pentam 300 pentamidine isethionate for injection, an antiprotozoal agent, is a sterile, nonpyrogenic, lyophilized product. Paclitaxel injection, usp is available in 30 mg 5 ml, 100 mg 16. Paclitaxel promotes assembly of microtubules and stabilizes them against. Taxol contains paclitaxel, a natural product with antitumour activity. Information for the user paclitaxel 6 mgml concentrate for solution for infusion paclitaxel read all of this leaflet carefully before you start using this medicine because it contains important information for you. Reviewing taxol warnings and precautions before taking it can help ensure a safe treatment process. Patients who experience severe hypersensitivity reactions to taxol should not be rechallenged with the drug.
In order to monitor the occurrence of bone marrow suppression, primarily neutropenia, which. Two hundred and thirtysix patients with breast carcinoma received paclitaxel. Permanently discontinue cyramza in patients who experience severe bleeding see dosage and. Exjade is an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older. Cyclophosphamide 600 mgm 2 iv on day 1 every 4 weeks for 6 cycles. Effect of ethanol in paclitaxel injections on the ethanol. Abraxane for injectable suspension paclitaxel protein. That being said, a 2017 article on paclitaxel hypersensitivity by m. We use cookies to offer you a better experience, personalize content, tailor advertising, provide social media features, and better understand the use of our services. Vials of vinblastine sulfate for injection usp contain 10 mg. Neutropenia do not administer abraxane therapy to patients who have baseline neutrophil counts of less than 1,500 cellsmm3. Paclitaxel injection, usp is a clear, colorless to slightly yellow viscous solution. Taxol is the first of a new class of anticancer agents known as taxanes. Paclitaxel is an antineoplastic drug isolated from a bark extract of taxus brevifolia taxaceae the governments of the us and canada approved paclitaxel for sale in 1992, and a parenteral solution of paclitaxel subsequently became commercially available in japan in 1997.
Paclitaxel injection, usp is a clear colorless to slightly yellow viscous solution. Paclitaxel induces formation of excess disordered microtubules by promoting microtubule polymerization and. For directions regarding the use and administration of cyclophosphamide, please refer to its package insert. Follow applicable special handling and disposal procedures. Cyramza increased the risk of hemorrhage, including severe and sometimes fatal hemorrhagic events. Taxol warnings and precautions breast cancer home page. Highlights of prescribing information when administering with.
Product information adriamycin solution for injection warnings 1. Learn about avastin bevacizumab solution for iv infusion, including benefits, risks, possible side effects, patient support, and options for financial help. Its not mentioned in the package insert and i could not find anything substantial during a recent literature search. See full prescribing information for complete boxed warning. Highlights of prescribing information these highlights. Neutropenia do not administer abraxane therapy to patients who have baseline neutrophil counts of less than 1,500.
Taxol paclitaxel dosing, indications, interactions, adverse. Paclitaxel package insert request pdf researchgate. Herceptin is indicated for adjuvant treatment of her2overexpressing nodepositive or nodenegative erprnegative or with one highrisk feature breast cancer. Neupogen is indicated for the mobilization of autologous hematopoietic progenitor cells into the peripheral blood for collection by leukapheresissee clinical studies 14. Picard immunol allergy clin n am 37 2017 679693, an author who has published several articles on this topic, quotes a firstdose reaction rate of 110%. Since the volume of ethanol in these preparations is approximately half of the total injection volume, the potential inhibitory effects of ethanol on the central nervous system cannot be disregarded, especially considering that patients may drive immediately after administration. Over the course of treatment, patients who tolerate inlyta for at least two consecutive weeks with no adverse reactions grade 2 according to the common toxicity criteria for adverse events ctcae, are normotensive, and are not receiving antihypertension medication, may. Ethanol is included in certain injectable preparations of anticancer drugs to increase their solubility. Toxic deaths, hepatotoxicity, neutropenia, hypersensitivity reactions, and fluid retention 1 indications and usage 1. This leaflet is part iii of a threepart product monograph.
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