Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2diaminocyclohexanedach and with an oxalate ligand as a leaving group. Highlights of prescribing information adjuvant setting. Often it is used together with fluorouracil and folinic acid leucovorin in advanced cancer. Each of the medications in folfirinox are designed to kill cancer cells or slow their growth and ability to multiply. Oxaliplatin eloxatin fda approved for injection in combination with infusional. Thalidomide is a known human teratogen that causes severe lifethreatening birth defects 4, 5. Eloxatin oxaliplatin powder, for solution for intravenous use. Toposar is contraindicated in patients who have demonstrated a previous hypersensitivity to it. The main side effect of oxaliplatin is a sensory neuropathy exacerbated by cold exposure. With the vial sitting on a flat surface, insert the tip of the syringe into the adapter opening. Our products oxaliplatin oxaliplatin oxaliplatin this product information is intended only for residents of the united states. Highlights of prescribing information reduce the dose of. Mitomycin for injection is a sterile dry mixture of mitomycin and mannitol, which, when reconstituted with sterile water for injection, provides a solution for intravenous administration. Dotarem product information page 1 of 9 product information dotarem.
Things that may occur during or within hours after each treatment. Lift the package cover away from the vial adapter and discard the cover. Kaletra oral solution should not be used in preterm neonates in the immediate postnatal period because of possible toxicities. Eloxatin oxaliplatin powder, for solution for intravenous use eloxatin oxaliplatin concentrate, for solution for intravenous use initial u. Each 1 ml of precedex contains 118 mcg of dexmedetomidine hcl equivalent to 100 mcg dexmedetomidine base and 9.
Eloxatin oxaliplatin injection should be administered under the supervision of a quali. Alprolix is available as a lyophilized powder in singleuse vials containing nominally 250, 500, 2000, 3000, or 4000 international units iu. The purpose of this report is to summarize information on oxaliplatin, a drug recently approved by the u. For treatment of colon cancer, rectal cancer, and other cancers. Interrupt and then reduce or discontinue stivarga for hepatotoxicity as manifested by elevated liver.
While holding the adapter in the package, place the vial adapter over the vial and press down firmly on the package until. Dotarem gadoteric acid paramagnetic contrast medium for magnetic resonance imaging mri. Highlights of prescribing information major surgery. Chantix should be used cautiously in patients with a history of seizures or other factors that can lower the seizure threshold. Etopophos solutions may be administered at infusion rates up to 3. Warnings patients being treated with toposar must be frequently observed for myelosuppression both during and after therapy. Anal cancer treatment regimens cancer therapy advisor. Valproate increases lamotrigine concentrations more than 2fold. Hepatotoxicity severe and sometimes fatal hepatotoxicity has occurred in clinical trials see warnings and precautions 5. Oxaliplatin eloxatin ox al i pla tin how drug is given.
This daily dose is approximately onesixth of the recommended human dose. Neuropathy was graded using a studyspecific neurotoxicity scale see package insert for warnings and precautions 5. While holding onto the diluent vial, carefully remove the outer package from the mix2vial, being careful to leave the mix2vial attached firmly to. The teratogenic potential of eloxatin was manifested by the embryonic mortality, decreased fetal weight and delayed ossifications in rats at doses up to 12 mgm2day. See full prescribing information for complete boxed warning. Monitor hepatic function prior to and during treatment see warnings and precautions 5. For reoccurrence of grade 2 hfsr at the 120 mg dose after recovery of any grade 3 or 4 adverse reaction at the 120 mg dose except hepatotoxicity or infection. To prepare reduced doses for patients with baseline crcl less than or equal to 60 mlmin, withdraw the. Eloxatin was shown to be mutagenic and clastogenic in mammalian test systems in vitro and in vivo. Peel back the cover from the clear plastic vial adapter package. If you have any further questions, ask your doctor, pharmacist or nurse. This solution is readytouse and may be administered directly to the patient without further preparation.
Etopophos is a topoisomerase inhibitor indicated for the treatmentof patients with. Toposar etoposide injection, usp also commonly known as vp16 is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. In patients with severe renal impairment, the initial recommended eloxatin dose should be reduced to 65 mgm 2 see use in specific populations 8. Eloxatin oxaliplatin injection should be administered under the supervision of a qualified physician experienced in the use of cancer chemotherapeutic agents. Leucovorin calcium for injection rx only description leucovorin is one of several active, chemically reduced derivatives of folic acid.
Other toxicities were graded by the nci ctc, version 2. Thymoglobulin antithymocyte globulin rabbit is a purified, pasteurized, gamma immune globulin obtained by immunization of rabbits with human thymocytes. The name of your medicine is oxaliplatin 5 mgml concentrate for solution for infusion but in the rest of the leaflet it will be called oxaliplatin concentrate for. The detection of antibody formation is highly dependent on sensitivity and specificity of the assay. Common and rare side effects for eloxatin intravenous. Restricted access do not disseminate or copy without approval. Read the patient information leaflet if available from your health care professional before you receive oxaliplatin this medication is.
Highlights of prescribing information adjuvant setting or. It is 4demethylepipodophyllotoxin 94,60rethylidene. Eloxatin is supplied in singleuse vials containing 50 mg, 100 mg or 200 mg of. Preclinical studies have demonstrated that oxaliplatin is synergistic with fu and sn38, the active metabolite of irinotecan. Pomalyst pomalidomide capsules, for oral use initial u. When possible, interrupt therapy with brilinta for fivedays prior to surgery that has a major risk of bleeding.
Policy document for eloxatin oxaliplatin oxaliplatin. Information provided includes regulatory history, study. For patients who experience persistent grade 2 neurosensory events that do not resolve, a dose reduction of oxaliplatin injection to 65 mgm2 should be considered. In a phase 3 trial, elitek given prophylactically prior to anticancer therapy maintained normal uric acid levels. In patients with normal renal function or mild to moderate renal impairment, the recommended dose of eloxatin is 85 mgm 2. Premedication with antiemetics, including 5ht3 blockers with or without dexamethasone, is recommended. Ultrafilterable platinum consists of oxaliplatin and free oxaliplatin metabolites. Oxaliplatin medac 5 mgml concentrate for solution for infusion oxaliplatin. Highlights of prescribing information these highlights do not. Adjuvant treatment of patients with stage iii dukes c colon cancer after complete resection of primary tumor. Oxaliplatin fda prescribing information, side effects and uses. For information on 5fluorouracil and leucovorin, see the respective package inserts. It is very soluble in methanol and chloroform, slightly.
Abelcet consists of amphotericin b complexed with two phospholipids in a 1. Highlights of prescribing information initial dose of 4 mg. Follow applicable special handling and disposal procedures. The administration of oxaliplatin injection does not require prehydration. Highlights of prescribing information urothelial carcinoma. Policy document for eloxatin oxaliplatin oxaliplatin generic the overall objective of this policy is to support the appropriate and cost effective use of the medication. 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. Premedication with antiemetics, including 5ht 3 blockers with or without dexamethasone, is recommended. A safe and effective dose of kaletra oral solution in this. The indication is based on a demonstrated improvement in diseasefree survival. See full prescribing information for complete boxed warning embryofetal toxicity pomalyst is contraindicated in pregnancy.
Zaltrap zivaflibercept injection, for intravenous use. Embryofetal toxicity and venous and arterial thromboembolism. Eloxatin oxaliplatin for injection in combination with infusional 5fluorouracilleucovorin 5fulv is indicated for. The administration of eloxatin does not require prehydration. Xeloda tablets should be swallowed whole with water within 30 minutes after a meal. Oxaliplatin 5mgml concentrate for solution for infusion oxaliplatin read all of this leaflet carefully before you start using this medicine keep this leaflet. The nccn compendium is a derivative work of the nccn guidelines.
Xifaxan rifaximin tablet salix pharmaceuticals, inc. If you get any side effects talk to your doctor,pharmacist or nurse. Eloxatin 100 mg intravenous powder for solution side effects by likelihood and severity common side effects if experienced, these tend to have a severe expression. Highlights of prescribing information thrombocytopenia. Oxaliplatin oxaliplatin this product information is intended only for residents of the united states. Name of the medicinal product eloxatin 5mgml concentrate for solution for infusion. Gamma immune globulin or immunoglobulins are heavy plasma proteins, often with added sugar chains on nterminal.
Eloxatin oxaliplatin prior auth criteria proprietary information. Oxaliplatin eloxatin package insert pdf pages 1516 oxaliplatin eloxatin patient drug information chemocare. Eloxatin is supplied in singleuse vials containing 50 mg, 100 mg or 200 mg of oxaliplatin as a sterile, preservativefree. See full prescribing information for complete boxed. Dosage forms, composition and packaging section of the product. Nov 02, 2018 the administration of eloxatin does not require prehydration. Ask to speak with a patient assistance technician or financial counselor at the clinic or hospital administering this therapy. Inert ingredients for the capsule formulations are. To report suspected adverse reactions, contact teva. Precedex is supplied as a clear, colorless, isotonic solution with a ph of 4. This drug might make you more sensitive to the cold.
The results of intradermal skin tests with carboplatin have been shown to be fairly reliable predictors of hypersensitivity reactions to the drug 6. Xifaxan can be taken with or without food see clinical pharmacology 12. Oxaliplatin, sold under the brand name eloxatin, is a cancer medication used to treat colorectal cancer. Eloxatin oxaliplatin injection for intravenous use. Eloxatin is supplied in singleuse vials containing 50 mg or 100 mg of oxaliplatin as a sterile, preservativefree lyophilized powder for reconstitution. Easy to read fda package insert, drug facts, dosage and administration, and adverse effects for eloxatin oxaliplatin. Doselimiting bone marrow suppression is the most significant toxicity associated with etoposide therapy. Push the blue plastic cannula of the mix2vial firmly through the rubber stopper of the diluent vial fig. Interrupt empliciti elotuzumab for grade 2 or higher and permanently discontinue for severe infusion reaction. Instruct patients to discontinue chantix, and contact a healthcare provider immediately if they experience a seizure while on treatment. Extravasation of etopophos may result in swelling, pain, cellulitis, and necrosis including skin necrosis.
Highlights of prescribing information these highlights do not include all the information needed to use keytrudasafely and effectively. Abelcet amphotericin b lipid complex injection description abelcet is a sterile, pyrogenfree suspension for intravenous infusion. Monitor for fever and other signs of infection and treat promptly. Highlights of prescribing information these highlights do not include all the information needed to use pomalyst safely and effectively. Common side effects include numbness, feeling tired, nausea, diarrhea, and low blood cell counts.
Oxaliplatin 5mgml concentrate for solution for infusion. This document provides specific information to each section of the overall policy. How to use eloxatin 100 mg intravenous powder for solution. Zaltrap, a vascular endothelial growth factor inhibitor, in combination with fluorouracil, leucovorin, irinotecan folfiri, is indicated for the treatment of patients with metastatic colorectal cancer that is resistant to or has progressed following an oxaliplatincontaining regimen. Refractory testicular tumors, in combination with other chemotherapeutic drugs. Policy document for eloxatin oxaliplatin oxaliplatin generic.