Endometrial carcinoma treatment regimens cancer therapy advisor. Mesnex injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage ww at the time of ifosfamide administration. May also be given as a continuous iv infusion concurrently with ifosfamide. This includes testicular cancer, soft tissue sarcoma, osteosarcoma, bladder cancer, small cell lung cancer, cervical cancer, and ovarian cancer. Ifosfamide is a chemotherapeutic agent chemically related to the nitrogen mustards and a synthetic analog of cyclophosphamide. It is administered by injection into a vein common side effects include hair loss, vomiting, blood in the urine. Ifex ifosfamide for injection, usp singledose vials for constitution and administration by. Total daily dose 60% to 160% of ifosfamide dose or 60% to 200% of cyclophosphamide dose. Case report open access acute liver toxicity with ifosfamide. Apr 30, 2012 vinp03 vinblastine sulfate for injection usp warning caution this preparation should be administered by individuals experienced in the administration of vinblastine sulfate.
Learn about simponi aria golimumab for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis. Studies of ifosfamide injection in patients with hepatic or renal impairment have not been conducted see use in specifi c populations 8. Ifosfamide induced encephalopathy overview ifosfamide induced encephalopathy is an acute neurological disturbance occurring during or shortly after ifosfamide infusion. For iv administration the drug can be diluted by adding the mesna injection. Ifosfamide for injection is a potent drug and should only be administered by a qualified healthcare professional. Ifosfamide, like cyclophosphamide, is an oxazophosphorine alkylating agent. Toronto, on m9w 0c8 april 18, 2017 submission control number. Firefighting measures for the full text of the rphrases mentioned in this section, see section 16 casno.
The molecular formula is c 7 h 15 cl 2 n 2 o 2 p and its molecular weight is 261. Mesnex fda prescribing information, side effects and uses. Cytoxan tablets cyclophosphamide tablets, usp are for oral use and contain 25 mg or 50 mg cyclophosphamide. As a single agent it has successfully produced objective remissions in a wide range of. Holoxan sterile ifosfamide is supplied as singledose vials of 500mg, mg, or 2000mg for reconstitution and administration by. Vdc cyclophosphamide, vincristine, doxorubicin or dactinomycin v. Ifosfamide ifos is given before autologous hcts in combination with carboplatin and vp16 ifosfamide, carboplatin, and etoposide regimen for relapsed or refractory lymphomas. This case report describes the use of ifosfamide in a patient with synovial sarcoma, a common type of soft tissue sarcoma. Benzyl alcohol contained in the mesna injection multidose vials can reduce the stability of cyclophosphamide and ifosfamide. Highlights of prescribing information these highlights do not. Accidental release measures contain spill and collect, as appropriate. Highlights of prescribing information these highlights do not include all the information needed to use yervoy safely and effectively. Cytoxan cyclophosphamide for injection, usp cytoxan tablets.
Pr ifosfamide for injection 1 gvial and 3 gvial usp antineoplastic agent fresenius kabi canada ltd. Oct 18, 2019 mesna should be used to reduce the incidence of hemorrhagic cystitis. Ifosfamide injection 1g summary of product characteristics smpc. Recommended intravenous and oral dosing schedule 0 hours 2 hours 6 hours ifosfamide 1. Patients should have loperamide readily available to begin treatment for late diarrhea generally occurring more than 24 hours. The total daily dose of mesnex is 100% of the ifosfamide dose. Injections are prepared for parenteral use by adding sterile. Oct 01, 2019 read accompanying package insert for detailed indications, dosage, and precautions. Cytoxan cyclophosphamide for injection, usp cytoxan. This indication is approved under accelerated approval. The nccn compendium is a derivative work of the nccn guidelines. In vivo, ifosfamide has induced mutagenic effects in mice and. Jul 30, 2018 ifosfamide is 32chloroethyl22chloroethylaminotetrahydro2h1,3,2oxazaphosphorine 2oxide. Potential adverse reactions from prescribed doses and overdoses are described in the package insert.
Dailymed ifex ifosfamide injection, powder, for solution. Westwards ifosfamide injection is indicated for use in combination with. In case of contact, immediately flush eyes with plenty of water for at least 15 minutes. Administration of ifosfamide may cause stomatitis oral mucositis. Atrial fibrillation has been attributed to ifosfamide after a dose of only 1800 mgm 2, with mesna, in a regimen for metastatic breast cancer 1 nervous system. Although it is usually reversible, it is a serious and potentially fatal complication and should always be discussed with the consultant on call. Mesnex is indicated as a prophylactic agent in reducing the. Ifosfamide ifo, sold under the brand name ifex among others, is a chemotherapy medication used to treat a number of types of cancer. Ifosfamide injection should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Padcev enfortumab vedotinejfv dosing in patients with muc. Mesnex may be given on a fractionated dosing schedule of three bolus intravenous injections as outlined below.
Ifosfamide is a white crystalline powder soluble in water. In some instances, hbv reactivation occurring in conjunction with tnfblocker therapy has been fatal. In meylers side effects of drugs sixteenth edition, 2016. Ifex ifosfamide for injection singledose vials for constitution and administration by intravenous infusion each contain 1 gram or 3 grams of sterile ifosfamide. Patients and caregivers should be informed of gastrointestinal complications, such as nausea, vomiting, abdominal cramping, and diarrhea.
Alcohol consumption may increase the severity of chemotherapyinduced nausea and vomiting. Dailymed ifosfamide injection, powder, for solution. Ifex ifosfamide dosing, indications, interactions, adverse. Ifosfamide has been shown to be carcinogenic in rats, with female rats showing a significant incidence of leiomyosarcomas and mammary fibroadenomas. Injections are prepared for parenteral use by adding sterile water for. The total daily dose of mesna is 100% of the ifosfamide dose. Vai vincristine, doxorubicin or dactinomycin, ifosfamide ii. Animal studies indicate that the drug is capable of causing gene mutations. Highlights of prescribing information microsatellite. Mesnex is indicated as a prophylactic agent in reducing. Antiemetics for prevention and amelioration of nausea and vomiting should be used.
Cytoxan cyclophosphamide for injection, usp cytoxan tablets cyclophosphamide tablets, usp description cytoxan cyclophosphamide for injection, usp is a sterile white powder containing cyclophosphamide mono. These highlights do not include all the information needed to use etopophos safely and effectively. Bladder cancer treatment regimens cancer therapy advisor. Mesna 240mgm 2 iv over 15 minutes before ifosfamide, then at 4 and 8 hours from the start of each ifosfamide dose. Ifosfamide fda prescribing information, side effects and. Department of health and human services silver spring md 20993. The recommended dosing schedule is outlined in table 2. Ifosfamide neurotoxicity may become manifest within a few hours to a few days after first administration and in most cases resolves within 48 to 72 hours of ifosfamide discontinuation. Sep 06, 2017 ifex ifosfamide for injection, usp singledose vials for constitution and administration by intravenous infusion each contain 1 gram or 3 grams of sterile ifosfamide. Constituted solutions should be refrigerated and used within 24 hours. Ifosfamide is 32chloroethyl22chloroethylaminotetrahydro2h1,3,2oxazaphosphorine 2oxide.
Vdcie vincristine, doxorubicin or dactinomycin, and cyclophosphamide alternating with ifosfamide and etoposide iii. Mesna fda prescribing information, side effects and uses. Description dacarbazine for injection is a colorless to an ivory colored solid which is light sensitive. Keep the ampule in the original package to protect from light. Press release hikma launches ifosfamide injection london, 18. May give 20% ww 15min prior, and then q3hrs x 36 doses. Table 1 shows a list of adverse drug reactions listed on the product package insert. For additional information, please refer to the package insert for full. Share your location or enter your city or zip code to find studies near you. Ifosfamide very commonly causes nausea and vomiting. Following activation in the liver, ifosfamide interferes with dna through formation of phosphotriesters and dnadna crosslinks, thereby inhibiting protein synthesis and dna synthesis. Please see full prescribing information for simponi aria, including boxed warning. Page 3 of 44 full prescribing information 1 indications and usage 1. Patients undergoing treatment with mesna may experience syncope, lightheadedness, lethargydrowsiness, dizziness, and blurred vision which could affect the ability to drive or use machines see druglifestyle interactions.
Each vial contains 200 mg of dacarbazine the active ingredient, citric acid monohydrate and mannitol. Ifosfamide is contraindicated in patients with known hypersensitivity to the drug, with severe myelosuppression, severe renal andor hepatic impairment, cystitis. The mutagenic potential of ifosfamide has been documented in bacterial systems. Oct 30, 2019 ifosfamide is a chemotherapeutic agent chemically related to the nitrogen mustards and a synthetic analog of cyclophosphamide. Convulsions, severe facial spasms, and trismus occurred 7 hours after an infusion of ifosfamide in a dose of 7 gm 2, having not. Diarrhea and myelosuppression see full prescribing information for complete boxed warning early and late forms of diarrhea can occur. See patient package insert in shipping carton for complete information. Ifosfamide injection, powder, lyophilized, for solution dailymed. Endometrial carcinoma treatment regimens cancer therapy. Apf530 granisetron injection extendedrelease in a threedrug regimen for delayed cinv in highly emetogenic chemotherapy. Labelingcontainercarton labels, labeling package insert. Fever and infection in patients with neutropenia, nausea, vomiting, transient hypotension drop in blood pressure, anaphylacticlike reactions chills, fever, tachycardia, bronchospasm, and dyspnea. This replacement approval letter is a correction of that error, and the enclosure now contains the agreed upon package inserts for both ifex trade name and ifosamide distributors labeling. Highlights of prescribing information these highlights do not include all the information needed to use sutent safely and effectively.
Ifosfamide is a cytotoxic drug for the treatment of malignant disease. Ifosfamide induced encephalopathy is an acute neurological disturbance occurring during or shortly after ifosfamide infusion. Only your doctor can recommend a course of treatment after checking your health condition. Mesnex injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage weight by weight ww at the time of ifosfamide administration and 4 and 8 hours after each dose of ifosfamide. The majority of these reports have occurred in patients who received concomitant immunosuppressants. Some patients, especially those 65 years and older, have had serious infections which include tuberculosis tb and infections caused by viruses, fungi, or bacteria that have spread throughout the. Ifosfamide fda prescribing information, side effects and uses. Each vial contains 1 gram or 3 grams of sterile ifosfamide alone. Search for clinical trials by condition, keyword or trial number. Mesnex tablets are given orally in a dosage equal to 40% of the ifosfamide dose 2 and 6 hours after each dose of ifosfamide. Carcinogenesis and mutagenesis see toxicology mutagenicity and carcinogenicity sections.
Ha3001425 ifex ifosfamide for injection, usp package insert. Supportive therapy should be maintained until their complete resolution. In pregnant mice, resorptions increased and anomalies were present at day 19 after a 30 mgm. Padcev enfortumab vedotinejfv is indicated for the treatment of adult patients with locally advanced or metastatic urothelial cancer muc who have previously received a programmed death receptor1 pd1 or programmed deathligand 1 pdl1 inhibitor, and a platinumcontaining chemotherapy in the neoadjuvantadjuvant, locally advanced or metastatic setting.
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