Ifosfamide (Ifosfamide)

Trade Name : Ifosfamide

Hikma Pharmaceuticals USA Inc.

INJECTION

Strength 50 mg/mL

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

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GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Ifosfamide (Ifosfamide) which is also known as Ifosfamide and Manufactured by Hikma Pharmaceuticals USA Inc.. It is available in strength of 50 mg/mL per ml. Read more

Ifosfamide (Ifosfamide) 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
  • WARNING: MYELOSUPPRESSION, NEUROTOXICITY, and UROTOXICITY
  • See full prescribing information for complete boxed warning
  • u2022 Myelosuppression can be severe and lead to fatal infections u00a0
  • u2022 CNS toxicities can be severe and result in encephalopathy and death u00a0
  • u2022 Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe. u00a0
  • Ifosfamide Injection is indicated for use in combination with certain other approved antineoplastic agentsfor third-line chemotherapy of germ cell testicular cancer. It should be used in combination with mesna for prophylaxis of hemorrhagic cystitis.
  • Ifosfamide Injection 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. u00a0
  • Ifosfamide Injection 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, ifosfamide injection 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. Ifosfamide injection should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Studies of ifosfamide injection in patients with hepatic or renal impairment have not been conducted .
  • Preparation for Intravenous Administration/Stability
  • Solutions of ifosfamide injection may be diluted further to achieve concentrations of 0.6 to 20 mg/mL in the following fluids:
  • 5% Dextrose Injection
  • 0.9% Sodium Chloride Injection
  • Lactated Ringeru2019s Injections
  • Sterile Water for Injection
  • 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 PABu2122 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.
  • Further diluted solutions of ifosfamide injection should be refrigerated and used within 24 hours. Benzyl alcohol-containing solutions can reduce the stability of ifosfamide injection.
  • 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. u00a0
  • u2022 Ifosfamide injection should be administered as a slow intravenous infusion lasting a minimum of 30 minutes at a dose of 1.2 grams per m2 per day for 5 consecutive days.u00a0u00a0u00a0
  • u2022 Treatment is repeated every 3 weeks or after recovery from hematologic toxicity. u00a0
  • u2022 To prevent bladder toxicity, ifosfamide injection should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fl uid per day.u00a0u00a0 u00a0)
  • u2022 Mesna should be used to reduce the incidence of hemorrhagic cystitis. u00a0
  • 1 g/20 mL single-dose vial
  • 3 g/60 mL single-dose vial
  • u2022 Single dose vials: 1 g/20 mL, 3 g/60 mL (3)
  • Ifosfamide is contraindicated in patients with:
  • u2022 Known hypersensitivity to administration of ifosfamide.
  • u2022 Urinary outflow obstruction.
  • u2022 Known hypersensitivity to administration of ifosfamide. u00a0
  • u2022 Urinary outflow obstruction. u00a0
  • u2022 Myelosuppression: Can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after treatment. u00a0
  • u2022 Neurotoxicity: Severe and fatal neurotoxicity can occur. Carefully monitor the patient for CNS toxicity and other neurotoxic effects. Discontinue therapy should encephalopathy develop. u00a0
  • u2022 Urotoxicity: Severe nephrotoxicity with renal failure and death can occur. Monitor for nephrotoxicity with serum and urine chemistries. Mesna should be used to reduce hemorrhagic cystitis. u00a0
  • u2022 Cardiotoxicity: Arrhythmias, other ECG changes, and cardiomyopathy can occur and result in death. Use with caution in patients with cardiac risk factors and in patients with preexisting cardiac disease. The risk of cardiotoxicity is dose dependent. u00a0
  • u2022 Pulmonary toxicity: Interstitial pneumonitis, pulmonary fi brosis, and other forms of pulmonary toxicity with fatal outcomes can occur. Monitor for signs and symptoms of pulmonary toxicity and treat as clinically indicated u00a0
  • u2022 Secondary malignancies as late sequelae have occurred. u00a0
  • u2022 Pregnancy: Can cause fetal harm. Women should not become pregnant and men should not father a child during therapy. (5.8)
  • u2022 Anaphylactic/anaphylactoid reactions have been reported. u00a0
  • In clinical trials of ifosfamide monotherapy, the most common (u2265 10%) adverse reactions were alopecia, nausea/vomiting, leukopenia, anemia, CNS toxicity, hematuria, and infection. u00a0
  • To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceuticals Corp. at 1-877-845-0689, or FDA at 1-800-FDA-1088 or n
  • Ifosfamide is a substrate for both CYP3A4 and CYP2B6.
  • u2022 CYP3A4 Inducers: monitor for increased toxicity when used in combination with CYP3A4 inducers. u00a0
  • u2022 CYP3A4 Inhibitors: use in combination with CYP3A4 inhibitors could decrease the effectiveness of ifosfamide. u00a0
  • u2022 Pregnancy: fetal growth retardation and neonatal anemia. u00a0
  • u2022 Geriatric use: dose selection should be cautious. u00a0
  • u2022 Patients with renal impairment: monitor for toxicity and consider dose reduction as needed u00a0
  • No specific antidote for ifosfamide 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.
  • Ifosfamide injection is presented in sterile, single-dose vials for administration by intravenous infusion. Each mL contains ifosfamide, 50 mg, monobasic sodium phosphate monohydrate, 1.035 mg, dibasic sodium phosphate, 3.55 mg and water for injection, q.s.. Ifosfamide is a chemotherapeutic agent chemically related to the nitrogen mustards and a synthetic analog cyclophosphamide. Ifosfamide is 3-(2-ChloroethyI)-2-[(2-chloroethyl) amino]tetrahydro-2-1,3,2- oxazaphosphorine 2-oxide.
  • Its structural formula is:
  • CHCNOP
  • M. W. = 261.09
  • Ifosfamide is a white crystalline powder that is soluble in water.
  • 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 signifi cantly 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 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 (VePesidu00ae) 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/m2/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.
  • a: Gehan-Breslow and Mantel-Cox tests
  • In a study, 50 fully evaluable patients with germ cell testicular cancer were treated with ifosfamide 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/actinomycin D/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.
  • 1. NIOSH Alert: Preventing occupational exposures to antineoplastic and other hazardous drugs in healthcare settings. 2004. U.S. Department of Health and Human Services, Public Health Service, Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health, DHHS (NIOSH) Publication No. 2004-165.
  • 2. OSHA Technical Manual, TED 1-0.15A, Section VI: Chapter 2. Controlling occupational exposure to hazardous drugs. OSHA, 1999. http://www.osha.gov/dts/osta/otm/otm_vi/otm_vi_2.html
  • 3. American Society of Health-System Pharmacists. ASHP guidelines on handling hazardous drugs. n . 2006; 63:1172-1193.
  • 4. Polovich M, White JM, Kelleher LO, (eds.) 2005. Chemotherapy and biotherapy guidelines and recommendations for practice. (2nd ed.) Pittsburgh, PA: Oncology Nursing Society.
  • Ifosfamide Injection is available in single-dose vials as follows:
  • NDCu00a00143-9531-01
  • NDCu00a00143-9530-01
  • Store in a refrigerator 2u00b0C to 8u00b0C (36u00b0F to 46u00b0F). See USP.
  • Exercise caution when handling ifosfamide. 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 ifosfamide may occur. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and solutions containing ifosfamide. If ifosfamide 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
  • Arrayn- Renal and Urothelial Toxicity and Effects
  • Cardiotoxicity
  • Arrayn- Pulmonary Toxicity
  • Secondary Malignancies
  • Arrayn- Veno-occlusive Liver Disease
  • Arrayn- Pregnancy
  • Lactation
  • Arrayn- Reproductive System Disorders
  • Arrayn- Skin and Subcutaneous Tissue Disorders
  • Gastrointestinal Disorders
  • Eye Disorders
  • Ear and Labyrinth Disorders
  • u00a0
  • Manufactured by:
  • THYMOORGAN PHARMAZIE GmbH,
  • Schiffgraben 23, 38690 Goslar, Germany
  • u00a0
  • Distributed by:u00a0
  • West-Ward Pharmaceuticals
  • Eatontown, NJ 07724 USA
  • Revised: March 2019
  • 127.207.010/02
  • u00a0NDC 0143-9531-01
  • Rx only
  • IFOSFAMIDE INJECTION
  • 1 g/20 mL
  • (50 mg/mL)
  • FOR INTRAVENOUS USE
  • Cytotoxic Agent
  • u00a0NDC 0143-9530-01
  • Rx only
  • IFOSFAMIDE INJECTION
  • 3u00a0g/60 mL
  • (50 mg/mL)
  • FOR INTRAVENOUS USE
  • Cytotoxic Agent
  • No data

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