There is a black box warning for this drug as shown here. Ixempra ixabepilone dosing and administration guide. Using ifosfamide may increase your risk of developing other cancers, such as leukemia. To the best of our knowledge, this is the first case of ifosfamideinduced encephalopathy presented 16 days after ifosfamide exposure. Pdf acute liver toxicity with ifosfamide in the treatment. If symptoms of serotonin syndrome occur, discontinue aloxi and initiate supportive treatment. To the best of our knowledge, this is the first case of ifosfamide induced encephalopathy presented 16 days after ifosfamide exposure. Medlineplus information on ifosfamide a lay language summary of important information about this drug that may include the following. Supportive therapy should be maintained until their complete resolution. Mesnex injection is given as intravenous bolus injections in a dosage equal to 20% of the ifosfamide dosage. Medscape prescription drug monographs are based on fdaapproved.
Ifex ifosfamide dosing, indications, interactions, adverse effects. Ifex ifosfamide side effects, images, uses, dosage. Ifosfamide can cause birth defects if a woman is exposed to it during pregnancy. You may be able to overcome this with stronger flavored herbs such as basil, sage, or thyme. Warnings patients being treated with toposar must be frequently observed for myelosuppression both during and after therapy. Ifosfamide is an alkylating agent that is fda approved for the treatment of germ cell testicular cancer. Refer to the ifosfamide prescribing information for more information on use during lactation. There are no data on the presence of mesna in human or animal milk, the effect on the breastfed child, or the effect on milk production. Ifosfamide therapy is associated with minor transient serum enzyme elevations and has been linked to cases of acute. Ifosfamide has also been assessed in combination with other drugs such as doxorubicin and dacarbazine dtic. Known hypersensitivity to administration of ifosfamide. Myelosuppression, neurotoxicity, and urotoxicity see full prescribing information for complete boxed warning.
Ifex ifosfamide for injection, usp singledose vials for constitution and administration by intravenous infusion each contain 1 gram or 3 grams of sterile ifosfamide. Use effective birth control to prevent pregnancy, whether you are a man or a woman. Ifosfamide ifo, sold under the brand name ifex among others, is a chemotherapy medication. Ifosfamide use by either parent may cause birth defects. Fda label information for this drug is available at dailymed. Ifosfamide has a broad spectrum of antineoplastic activity. Only your doctor can recommend a course of treatment after checking your health condition. Mesnex injection contains the preservative benzyl alcohol. Clinical pharmacology of ifosfamide and metabolites. Patients are calculated based on an estimated annual cumulative dose.
Ifosfamide is a prodrug which is converted by p450 enzymes into the inactive decholoroethyl ifosfamide and 4hydroxy ifosfamide, which exists in equilibrium with its tautomeric form aldoifosfamide. Aug, 2018 ifex ifosfamide for injection, usp singledose vials for constitution and administration by intravenous infusion each contain 1 gram or 3 grams of sterile ifosfamide. Ifosfamidebased combination chemotherapy in advanced soft. A adriamycin doxorubicin i ifosfamide ifex m mesna mesnex goals of therapy. Ifosfamide fda prescribing information, side effects and uses. Ifosfamide therapy is associated with minor transient serum enzyme. For treating sarcomas, testicular cancer lymphoma or other types of cancers. Official consumer website for remicade infliximab remicade. Patients should be informed of the increased risk of serotonin syndrome, especially if aloxi is used concomitantly with other serotonergic drugs see drug interactions 7, patient counseling information 17. Highlights of prescribing information when administering. It is used in patients who have already been treated with two other types of chemotherapy ifosfamide is also being studied in the treatment of other types of cancer. If you become pregnant, talk to your doctor right away about. Information from its description page there is shown below. Women using this drug should ask about reliable forms of birth control while using this medication.
Ifosfamide is 32chloroethyl22chloroethylaminotetrahydro2h1,3,2. Ifosfamide is a chemotherapeutic agent chemically related to the nitrogen mustards and a synthetic analog of cyclophosphamide. The recommended dose of yervoy ipilimumab is 3 mgkg administered intravenously iv over 90 minutes every 3 weeks for a maximum of 4 doses. Risk factors for ifosfamide nephrotoxicity include. The release liner is removed prior to application to. Aim is given to shrink tumors and alleviate symptoms of sarcoma. It is very soluble in methanol and chloroform, slightly. Jul 26, 2018 ifosfamide is a chemotherapeutic agent chemically related to the nitrogen mustards and a synthetic analog of cyclophosphamide. Ifosfamide can also cause hypophosphatemic rickets. Aim may be given with the goal of cure, and while not always curative, it may still relieve symptoms and prolong life. These highlights do not include all the information needed to use advate safely and effectively.
Tap along the timeline to move to different parts of the audio file. Ifosfamide ifo, sold under the brand name ifex among others, is a chemotherapy medication used to treat a number of types of cancer. List of drug master files dmf of ifosfamide active pharmaceutical ingredient api submitted to the u. Toronto, on m9w 0c8 april 18, 2017 submission control number. This file is licensed under the creative commons attributionshare alike 4.
Dailymed ifex ifosfamide injection, powder, for solution. Ifosfamide has been included in various salvage regimens after relapse following bep therapy. It is 4demethylepipodophyllotoxin 94,60rethylidene. Dosage and duration of treatment andor treatment intervals depend on the scheme of combination. Due to its urotoxic effect, ifex should not be administered without the use of a uroprotective agent such as mesna. Ifosfamide has a similar spectrum of antitumor activity but has different pharmacokinetics that could provide advantages. By continuing to browse this site you are agreeing to our use of cookies. Common adverse reactions include alopecia, nausea and vomiting, leukopenia, anemia, cns toxicity.
Following activation in the liver, ifosfamide interferes with dna through formation of phosphotriesters and dnadna crosslinks, thereby inhibiting protein synthesis and dna synthesis. Toposar etoposide injection, usp also commonly known as vp16 is a semisynthetic derivative of podophyllotoxin used in the treatment of certain neoplastic diseases. This includes testicular cancer, soft tissue sarcoma, osteosarcoma, bladder cancer, small cell lung cancer, cervical cancer, and ovarian cancer. Ifex ifosfamide for injection singledose vials for constitution and administration by intravenous infusion each contain 1 gram or 3 grams of sterile ifosfamide. Venofer iron sucrose injection, usp is an established and effective treatment for chronic kidney disease ckd patients experiencing iron deficiency anemia. Ifex ifosfamide dose, indications, adverse effects. Ifosfamide is chemically related to the nitrogen mustards and is similar in chemical structure to cyclophosphamide. Some patients, especially those 65 years and older, have had serious infections caused by viruses, fungi or bacteria that have spread throughout the body, including tuberculosis tb and histoplasmosis. Pr ifosfamide for injection 1 gvial and 3 gvial usp antineoplastic agent fresenius kabi canada ltd. Ifosfamide is 32chloroethyl22chloroethylaminotetrahydro2h1,3,2oxazaphosphorine 2oxide. Highlights of prescribing information advanced renal cell. Two of s the rct 10, 12 reported that the addition of ifosfamide to an anthracycline regimen either doxorubicin, or doxorubicin and dtic significantly.
In order to reduce the risk for this condition, ifosfamide is given in combination with a medication known as mesna mesnex. Store intact vials at room temp or under refrigeration. Dec 17, 2018 mesnex mesna is a detoxifying agent to inhibit the hemorrhagic cystitis induced by ifosfamide. Gleevec imatinib mesylate tablets, for oral use initial u. Ifosfamide investigated as a drug, mutagen, reproductive effector, and tumorigen.
Alkylating agents are most active in the resting phase of the cell. Ifosfamide is a parenterally administered alkylating agent similar to cyclophosphamide that is used in the treatment of several forms of cancer including lymphomas, sarcoma and advanced forms of solid organ cancer such as breast, testicular, ovarian, gastric and lung cancer. Although ifosfamide has several significant toxic effects, the doselimiting toxicity is hemorrhagic cystitis. Lidoderm lidocaine patch 5% is comprised of an adhesive material containing 5% lidocaine, which is applied to a nonwoven polyester felt backing and covered with a polyethylene terephthalate pet film release liner. Highlights of prescribing information these highlights do not include all the information needed to use gleevec safely and effectively. Ifosfamide can be toxic to the bladder, and may cause hemorrhagic cystitis, a condition associated with bladder irritation and blood in the urine. Ifosfamide is approved to be used with other drugs to treat.
Myelosuppression can be severe and lead to fatal infections 5. Oct 24, 2016 ifosfamide interferes with oogenesis and spermatogenesis. Each of the medications in aim are designed to kill and slow growth of cancer cells. Doselimiting bone marrow suppression is the most significant toxicity associated with etoposide therapy. Ifosfamide is also sometimes used to treat bladder cancer, lung cancer, cancer of the ovaries cancer that begins in the female reproductive organs where eggs are formed, cancer of the cervix, and certain types of soft tissue or bone sarcomas cancer that forms in muscles and bones. Use the quantity of diluent shown below to constitute the product. Ifosfamide is also being studied in the treatment of other types of cancer. Ifex ifosfamide dosing, indications, interactions, adverse. Save money on your ifosfamide injection prescription by switching to tevas fdaapproved generic version. Ifosfamide api dmfs us drug master file dmf details.
Cyclophosphamide has been marketed for 32 years, and it remains a highly effective agent for a wide crosssection of malignancies. Ifosfamide is in the alkylating agent and nitrogen mustard family of medications. Ifosfamide is a newly available analog of cyclophosphamide in the oxazaphosphorine drug class. This file contains additional information such as exif metadata which may have been added by the digital camera, scanner, or software program used to create or digitize it. Ifosfamide injection 1g summary of product characteristics. See actual entry in rtecs for complete information. Medscape indicationspecific dosing for ifex ifosfamide, frequencybased. Unless clinically essential, ifosfamide should not be given to patients with a wbc count below 2000microliter andor a platelet count below 50,000microliter. Ifosfamide, carboplatin, and cisplatin can cause renal complications, including acute tubular dysfunction, although carboplatin is less nephrotoxic than cisplatin. Gamunex c immune globulin injection human, 10% caprylatechromatography purified is indicated for the treatment of primary humoral immunodeficiency disease pidd in patients 2 years of age and older, idiopathic thrombocytopenic purpura itp in adults and children, and chronic inflammatory demyelinating polyneuropathy cidp in adults. The high incidence of this toxicity requires uroprotection with aggressive hydration, frequent bladder emptying, and the concurrent use of mesna, a uroprotective agent. The acute tubular dysfunction can be manifested by increased excretion of potassium, phosphorus, and magnesium. Johns wort may decrease ixabepilone plasma concentrations unpredictably and should be avoided safety information.
Ifosfamide fda prescribing information, side effects and. The remaining seven phase studies ii, 29 34 used ifosfamide in combinations that did not include an anthracycline. Definition from the nci drug dictionary detailed scientific definition and other names for this drug. Dosage may be reduced, delayed or discontinued in patients with. Several payment sources exist for cancer drugs in ontario, depending on the drug, disease indication, and how and where it is delivered. Ifosfamide exhibits timedependent pharmacokinetics in humans. Mesna can be given as an intravenous iv injection or as a tablet. Voorma, ingevolge het besluit van het college voor promoties. Ifex ifosfamide for injection, intravenous use warning. In the event of toxicity, doses may be delayed, but all treatment must be administered within 16 weeks of the first dose see clinical studies 14. Ifosfamide has been designated an orphan drug by the fda for the treatment of testicular cancer. The molecular formula is c 7 h 15 cl 2 n 2 o 2 p and its molecular weight is 261.
If the file has been modified from its original state, some details such as the timestamp may not fully reflect those of the original file. White blood cell wbc count, platelet count and hemoglobin should be obtained prior to each administration and at appropriate intervals after administration. Toposar is contraindicated in patients who have demonstrated a previous hypersensitivity to it. Ifosfamide may cause transient or permanent amenorrhea in women and oligospermia or azoospermia in men. Development of sterility appears to depend on the dose of ifosfamide, duration of therapy, and state of gonadal function at the time of treatment. Ifosfamide is a prodrug which is converted by p450 enzymes into the inactive decholoroethylifosfamide and 4hydroxyifosfamide, which exists in equilibrium with its tautomeric form aldoifosfamide. Manufacturer advises adequate contraception during and for at least 6. Ifosfamide, like cyclophosphamide, is an oxazophosphorine alkylating agent. Use of ifosfamide is associated with an increased incidence of acute leukaemia. 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. Venofer is indicated for the treatment of iron deficiency anemia in patients. Remicade infliximab can cause serious side effects such as lowering your ability to fight infections. Jul 01, 2019 discontinue ifosfamide or reduce dosage in patients who develop hematuria 50 erythrocyteshpf while receiving usual dosages of ifosfamide in conjunction with mesna. This typically regresses after completing treatment.
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