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Ifosfamide (Ifex)

Trade Name : IFEX

Baxter Healthcare Corporation

INJECTION, POWDER, FOR SOLUTION

Strength 1 g/20mL

IFOSFAMIDE Alkylating Activity [MoA],Alkylating Drug [EPC]

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ifosfamide (Ifex) which is also known as IFEX and Manufactured by Baxter Healthcare Corporation. It is available in strength of 1 g/20mL per ml. Read more

Ifosfamide (Ifex) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle. CNS toxicities can be severe and result in encephalopathy and death. Monitor for CNS toxicity and discontinue treatment for encephalopathy. Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe and can be reduced by the prophylactic use of mesna. n
  • WARNING: MYELOSUPPRESSION, NEUROTOXICITY, and UROTOXICITY
  • See full prescribing information for complete boxed warning
  • IFEX is indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis.
  • IFEX (ifosfamide) is an alkylating drug indicated for use in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis. n
  • IFEX should be administered intravenously at a dose of 1.2 grams per m per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity.
  • In order to prevent bladder toxicity, IFEX should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day. Mesna should be used to reduce the incidence of hemorrhagic cystitis. IFEX should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Studies of IFEX in patients with hepatic or renal impairment have not been conducted [see Use in Specific Populations (, )]n
  • Injections are prepared for parenteral use by adding or (benzyl alcohol or parabens preserved), to the vial and shaking to dissolve. Before parenteral administration, the substance must be completely dissolved. Use the quantity of diluents shown below to constitute the product:
  • Solutions of ifosfamide may be diluted further to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:
  • 5% Dextrose Injection, USP
  • 0.9% Sodium Chloride Injection, USP
  • Lactated Ringeru2019s Injections, USP
  • Sterile Water for Injection, USP
  • Because essentially identical stability results were obtained for Sterile Water admixtures as for the other admixtures (5% Dextrose Injection, 0.9% Sodium Chloride Injection, and Lactated Ringeru2019s Injection), the use of large volume parenteral glass bottles, VIAFLEX bags or PAB bags that contain intermediate concentrations or mixtures of excipients (e.g., 2.5% Dextrose Injection, 0.45% Sodium Chloride Injection, or 5% Dextrose and 0.9% Sodium Chloride Injection) is also acceptable.
  • Constituted or constituted and further diluted solutions of IFEX should be refrigerated and used within 24 hours. Benzyl-alcohol-containing solutions can reduce the stability of ifosfamide.
  • Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
  • Dosage and duration of treatment and/or treatment intervals depend on the scheme of combination therapy, the patientu2019s general state of health and organ function, and the results of laboratory monitoring. ()
  • 2n- 5.3
  • 1 gram single-dose vial
  • 3 gram single-dose vial
  • Single dose vials: 1 gram, 3 grams ()
  • IFEX is contraindicated in patients with:
  • No data
  • In clinical trials of ifosfamide monotherapy, the most common (u2265 10%) adverse reactions were alopecia, nausea/vomiting, leukopenia, anemia, CNS toxicity, hematuria, and infection. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at phone: 1 866 888 2472 or FDA at 1-800-FDA-1088 or .
  • Ifosfamide is a substrate for both CYP3A4 and CYP2B6.
  • No data
  • No specific antidote for IFEX is known.
  • Patients who receive an overdose should be closely monitored for the development of toxicities. Serious consequences of overdosage include manifestations of dose-dependent toxicities such as CNS toxicity, nephrotoxicity, myelosuppression, and mucositis n
  • Management of overdosage would include general supportive measures to sustain the patient through any period of toxicity that might occur, including appropriate state-of-the-art treatment for any concurrent infection, myelosuppression, or other toxicity. Ifosfamide as well as ifosfamide metabolites are dialyzable.
  • Cystitis prophylaxis with mesna may be helpful in preventing or limiting urotoxic effects with overdose.
  • IFEX (ifosfamide for injection, USP) single-dose vials for constitution and administration by intravenous infusion each contain 1 gram or 3 grams of sterile ifosfamide. Ifosfamide is a chemotherapeutic agent chemically related to the nitrogen mustards and a synthetic analog of cyclophosphamide. Ifosfamide is 3-(2-chloroethyl)-2-[(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide. The molecular formula is CHClNOP and its molecular weight is 261.1. Ifosfamide is a white crystalline powder soluble in water. There are no excipients in the formulation. Each vial contains 1 gram or 3 grams of sterile ifosfamide alone.
  • Its structural formula is:
  • No data
  • Ifosfamide has been shown to be carcinogenic in rats when administered by intraperitoneal injection at 6 mg/kg (37 mg/m, or about 3% of the daily human dose on a mg/m basis) 3 times a week for 52 weeks. Female rats had a significantly higher incidence of uterine leiomyosarcomas and mammary fibroadenomas than vehicle controls.
  • The mutagenic potential of ifosfamide has been documented in bacterial systems and mammalian cells . , ifosfamide has induced mutagenic effects in mice and germ cells, and has induced a significant increase in dominant lethal mutations in male mice as well as recessive sex-linked lethal mutations in Drosophila.
  • Ifosfamide was administered to male and female beagle dogs at doses of 1.00 or 4.64 mg/kg/day (20 or 93 mg/m) orally 6 days a week for 26 weeks. Male dogs at 4.64 mg/kg (about 7.7% of the daily clinical dose on a mg/m basis) had testicular atrophy with degeneration of the seminiferous tubular epithelium. In a second study, male and female rats were given 0, 25, 50, or 100 mg/kg (0, 150, 300, or 600 mg/m) ifosfamide intraperitoneally once every 3 weeks for 6 months. Decreased spermatogenesis was observed in most male rats given 100 mg/kg (about half the daily clinical dose on a mg/m basis).
  • Patients with refractory testicular cancer (n=59) received a combination of ifosfamide, cisplatin, and either etoposide (VePesid) or vinblastine (VIP) as third-line therapy or later. The selection of etoposide or vinblastine (u201cVu201d in the VIP regimen) was guided by the therapeutic effect achieved with prior regimens. The contribution of ifosfamide to the VIP combination was determined in patients treated with cisplatin-etoposide prior to ifosfamide- cisplatin-etoposide or those who received cisplatin-vinblastine prior to ifosfamide-cisplatin-vinblastine.
  • A total of 59 patients received a third-line salvage regimen which consisted of ifosfamide 1.2 g/m/day intravenously on days 1 to 5, cisplatin 20 mg/m/day intravenously on days 1 to 5, and either etoposide 75 mg/m/day intravenously on days 1 to 5 or vinblastine 0.22 mg/kg intravenously on day 1. Efficacy results with the VIP regimen were compared to data pooled from six single agent phase II trials conducted between August 1980 and October 1985 including a total of 90 patients of whom 65 were eligible as controls of this study. Twenty-three patients in the VIP regimen became free of disease with VIP alone or VIP plus surgery, whereas a single patient in the historical control group achieved complete response. The median survival time exceeded two years in the VIP group versus less than one year in the control group. Performance status u2265 80, embryonal carcinoma and minimal disease were favorable prognostic factors for survival. In all prognostic categories, the difference between VIP and historical controls remained highly significant.
  • In a study, 50 fully evaluable patients with germ cell testicular cancer were treated with IFEX in combination with cisplatin and either vinblastine or etoposide after failing (47 of 50 patients) at least two prior chemotherapy regimens consisting of cisplatin/vinblastine/bleomycin, (PVB), cisplatin/vinblastine/actinomycinu00a0D/bleomycin/cyclophosphamide, (VAB6), or the combination of cisplatin and etoposide. Patients were selected for remaining cisplatin sensitivity because they had previously responded to a cisplatin containing regimen and had not progressed while on the cisplatin containing regimen or within 3 weeks of stopping it. Patients served as their own control based on the premise that long term complete responses could not be achieved by retreatment with a regimen to which they had previously responded and subsequently relapsed.
  • Ten of 50 fully evaluable patients were still alive 2 to 5 years after treatment. Four of the 10 long term survivors were rendered free of cancer by surgical resection after treatment with the ifosfamide regimen; median survival for the entire group of 50 fully evaluable patients was 53 weeks.
  • No data
  • IFEX (ifosfamide for injection, USP) is available in single-dose vials as follows:
  • Store at controlled room temperature 20u00b0C to 25u00b0C (68u00b0F to 77u00b0F).
  • Protect from temperatures above 30u00b0C (86u00b0F).
  • Exercise caution when handling IFEX. The handling and preparation of ifosfamide should always be in accordance with current guidelines on safe handling of cytotoxic agents. Several guidelines on this subject have been published. Skin reactions associated with accidental exposure to IFEX may occur. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and solutions containing IFEX. If IFEX solution contacts the skin or mucosa, immediately wash the skin thoroughly with soap and water or rinse the mucosa with copious amounts of water.
  • Myelosuppression, Immunosuppression, and Infections
  • Central Nervous System Toxicity, Neurotoxicity
  • Renal and Urothelial Toxicity and Effects
  • Cardiotoxicity
  • Pulmonary Toxicity
  • Secondary Malignancies
  • Veno-occlusive Liver Disease
  • Pregnancy
  • Lactation
  • Reproductive System Disorders
  • Skin and Subcutaneous Tissue Disorders
  • Gastrointestinal Disorders
  • Eye Disorders
  • Ear and Labyrinth Disorders
  • Manufactured by:
  • Baxter Healthcare Corporation
  • Deerfield, IL 60015 USA
  • Made in Germany
  • Baxter, Ifex and Viaflex are trademarks of Baxter International Inc.
  • PAB is a trademark of B Braun
  • HA-30-01-800
  • NDC 0338-3991-01
  • IFEX n- IFOSFAMIDE FOR INJECTION, USP
  • 1 g/vial
  • Rx only
  • SINGLE-DOSE VIAL
  • This vial contains 1g ifosfamide.Add 20 mL Sterile Water for Injection, USP, or Sterile Bacteriostatic Water for Injection, USP, (benzyl alcohol or parabens preserved), shaking to dissolve, for a reconstituted concentration of 50 mg per mL.
  • Store at controlled room n- temperature 20u00b0 C to 25u00b0 C n- (68u00b0 F to 77u00b0 F)Protect from temperatures n- above 30u00b0 C (86u00b0 F).
  • FOR IV USEREAD ACCOMPANYING n- PACKAGE INSERT for detailed n- indications, dosage, and n- precautions.
  • Manufactured by: n n Deerfield, IL 60015 USA
  • USA HA-65-01-561
  • C130
  • Bar CodeN(01)1 03 0338 3991 01 7
  • Lot:/Exp.:
  • JMXXXMMJJJJ
  • Arrayn- Array
  • 1 vial
  • NDC 0338-3991-01
  • IFEXn- (ifosfamide for injection, USP)
  • Single-Dose Vialn- FOR IV USE
  • Rx only
  • 1 g
  • Arrayn- Baxter Healthcare Corporation
  • See bottom panel for lotnumber and expiration date.
  • Bar CodeN3 0338399101 0
  • This vial contains 1 g ifosfamide. Add20 mL Sterile Water for Injection, USP, or Sterile Bacteriostatic Water for Injection, USP, (benzyl alcohol or parabens preserved), shaking to dissolve, for a reconstituted concentration of 50 mg per mL.
  • READ ACCOMPANYING PACKAGE n- INSERT for detailed indications, n- dosage, and precautions.
  • Store at controlled room n- temperature 20u00b0 C to 25u00b0 C n- (68u00b0 F to 77u00b0 F). Protect from n- temperatures above 30u00b0 C (86u00b0 F).
  • Constituted solutions should be refrigerated and used within 24 hours.
  • Manufactured by:n n Deerfield, IL 60015 USAMade in Germany
  • NDC 0338-3993-01
  • IFEX n- IFOSFAMIDE FOR INJECTION, USP
  • 3 g/vial
  • Rx only
  • SINGLE-DOSE VIAL
  • This vial contains 3g ifosfamide.Add 60 mL Sterile Water for Injection, USP, or Sterile Bacteriostatic Water for Injection, USP, (benzyl alcohol or parabens preserved), shaking to dissolve, for a reconstituted concentration of 50 mg per mL.
  • Store at controlled room n- temperature 20u00b0 C to 25u00b0 C n- (68u00b0 F to 77u00b0 F) Protect from temperatures n- above 30u00b0 C (86u00b0 F).
  • FOR IV USE n- READ ACCOMPANYING n- PACKAGE INSERT for detailed n- indications, dosage, and n- precautions.
  • Manufactured by: n n Deerfield, IL 60015 USA
  • USA
  • Bar CodeN(01)1 03 0338 3993 01 1
  • Lot:/Exp.:
  • JMXXX
  • MM.JJJJ
  • 1 vial
  • NDC 0338-3993-01
  • IFEXn- (ifosfamide for injection, USP)
  • Single-Dose Vialn- FOR IV USE
  • Rx only
  • 3 g /vial
  • Arrayn- Baxter Healthcare Corporation
  • HA-80-02-154USA
  • See bottom panel for lotnumber and expiration date.
  • Arrayn- Baxter Healthcare Corporation
  • C837
  • (01) 0030338993014(21) XXXXXXXXXXXX(17) JJMMTT(10)JMXXXA
  • 1 vial NDC 0338-3993-01
  • IFEX(Ifosfamide for injection, USP)
  • Single Dose VialRx onlyFOR IV USE
  • 3 g /vial
  • Arrayn- Baxter Healthcare Corporation
  • Lot/Exp.:
  • JMXXXAMMJJJJ
  • 2617B5079
  • Barcode
  • FOLDING BOXCAN BE RECYCLED n
  • This vial contains 3 g ifosfamide. Add 60 mL Sterile Water for Injection, USP, or Sterile Bacteriostatic Water for Injection, USP, (benzyl alcohol or parabens preserved), shaking to dissolve, for a reconstituted concentration of 50 mg per mL.
  • READ ACCOMPANYING PACKAGE n- INSERT for detailed indications, n- dosage, and precautions.
  • Store at controlled room n- temperature 20u00b0 C to 25u00b0 C n- (68u00b0 F to 77u00b0 F). Protect from n- temperatures above 30u00b0 C (86u00b0 F).
  • Constituted solutions should be refrigerated and used within 24 hours.
  • Manufactured by:n n Deerfield, IL 60015 USAMade in Germany

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