Ifex
Ifosfamide · Injection, Powder, For Solution · Intravenous
• Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle [see Warnings and Precautions (5.1) ] .
• Encephalopathy can be severe and may result in death. Monitor for CNS toxicity and discontinue treatment for encephalopathy [see Warnings and Precautions (5.2) ] .
• Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe and can be reduced by the prophylactic use of mesna [see Warnings and Precautions (5.3) ] . WARNING: MYELOSUPPRESSION, ENCEPHALOPATHY, NEPHROTOXICITY and UROTOXICITY See full prescribing information for complete boxed warning .
• Myelosuppression can be severe and lead to fatal infections ( 5.1 )
• Encephalopathy can be severe and may result in death ( 5.2 )
• Nephrotoxicity can be…
Current shortage
IFEX, Injection, 1 g/20 mL (NDC 0338-3991-01) – Unavailable (Baxter Healthcare, updated Sep 17, 2026)
Estimated recovery: September 2026
IFEX, Injection, 3 g/60 mL (NDC 0338-3993-01) – Unavailable (Baxter Healthcare, updated Sep 17, 2026)
Estimated recovery: October 2026
Uses
1 INDICATIONS AND USAGE IFEX is indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. IFEX is an alkylating drug indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.
Dosage and administration
• Administer IFEX with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day to reduce the incidence or severity of bladder toxicity. ( 2.1 , 5.3 )
• Administer mesna with IFEX to reduce the incidence or severity of hemorrhagic cystitis. ( 2.1 , 5.3 )
• Administer IFEX as a slow intravenous infusion (at least 30 minutes) at a dose of 1.2 grams per m 2 per day for 5 consecutive days. Repeat every 3 weeks or after recovery from hematologic toxicity. ( 2.2 )
• Individualize the dose and dosing schedule of IFEX based on patient risk factors and adverse reactions. ( 2.2 )
• See Full Prescribing Information for instructions on preparation and administration. ( 2.3 ) 2.1 Important Administration Instructions Administer IFEX with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day to reduce the incidence or severity of bladder toxicity. Administer IFEX with mesna to reduce the incidence or severity of hemorrhagic cystitis [see Warnings and Precautions (5.3) ] . 2.2 Recommended Dosage The recommended dosage of IFEX is 1.2 grams per m 2 per day administered as a slow intravenous infusion (lasting at least 30 minutes) for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity. Individualize the dose and dosing schedule of IFEX based on patient risk factors and adverse reactions. 2.3 Preparation and Administration IFEX is a hazardous drug. Follow applicable special handling and disposal procedures. 1 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. Prepare IFEX for intravenous use by adding Sterile Water for Injection, USP or Bacteriostatic Water for Injection, USP (benzyl alcohol or parabens preserved) to the vial and shaking to dissolve. Before administration, the substance must be completely dissolved. Use the quantity of diluents shown in Table 1 below to reconstitute the product: Table 1: IFEX Quantities for Dilution and Final Concentrations Dosage Strength Quantity of Diluent Final Concentration 1 gram 20 mL 50 mg per mL 3 grams 60 mL 50 mg per mL 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 Ringer’s 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 Ringer’s 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. Refrigerate constituted or constituted and further diluted solutions of IFEX and use 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 forms and strengths
For injection: white, crystalline powder available in:
• 1 gram single-dose vial for reconstitution
• 3 gram single-dose vial for reconstitution
• For injection: Single dose vials: 1 gram, 3 grams ( 3 )
Contraindications
4 CONTRAINDICATIONS IFEX is contraindicated in patients with:
• Known hypersensitivity to administration of ifosfamide.
• Urinary outflow obstruction.
• Known hypersensitivity to administration of ifosfamide. ( 4 )
• Urinary outflow obstruction. ( 4 )
Warnings and precautions
• Myelosuppression: Monitor blood counts prior to treatment, during treatment, and as clinically indicated. ( 5.1 )
• Encephalopathy: Monitor for signs and symptoms of CNS toxicity during and after IFEX treatment. Dose interruption or permanent discontinuation may be required based on individual safety and tolerability. ( 5.2 )
• Nephrotoxicity and Urotoxicity: Monitor signs and symptoms. Monitor serum and urine chemistries. ( 2.1 , 5.3 )
• Cardiotoxicity: Arrhythmias, other ECG changes, and cardiomyopathy can occur and result in death. Cardiotoxicity is dose dependent and the risk is increased in patients with preexisting cardiac, treatment with other cardiotoxic agents, radiation, and renal impairment. ( 5.4 )
• Pulmonary toxicity: Interstitial pneumonitis, pulmonary fibrosis, and pulmonary toxicity with fatal outcomes can occur. Monitor for signs and symptoms of pulmonary toxicity and treat as clinically indicated. ( 5.5 )
• Secondary malignancies can occur. ( 5.6 )
• Veno-occlusive Liver Disease can occur. ( 5.7 )
• Embryo-Fetal Toxicity: Can cause fetal harm. Advise of potential risk to a fetus and use of effective contraception. ( 5.8 , 8.1 , 8.3 )
• Infertility: Can impair male and female reproductive function. ( 5.9 )
• Anaphylactic/anaphylactoid reactions have been reported. ( 5.10 ) 5.1 Myelosuppression IFEX can cause myelosuppression that results in severe or fatal infections including sepsis or septic shock. Ifosfamide‑induced myelosuppression includes leukopenia, neutropenia, thrombocytopenia (with bleeding events), and anemia. The nadir of the leukocyte count usually occurs during the second week after administration of IFEX. The risk of myelosuppression is dose‑dependent and increased in patients with reduced renal function, bone marrow metastases, prior radiation, and concomitant or prior therapy with other cytotoxic agents. Monitor complete blood counts, including leukocytes, neutrophils, platelets, and hemoglobin prior to each administration of IFEX, at appropriate intervals during treatment, and as clinically indicated. Myelosuppression may require dosage delays. Avoid administration of IFEX to patients with a WBC count below 2000/µL, a platelet count below 50,000/µL, or when signs or symptoms of active infection or severe immunosuppression are present. 5.2 Encephalopathy IFEX can cause encephalopathy which may be fatal. Signs and symptoms may include confusion, somnolence, coma, hallucination, blurred vision, psychotic behavior, extrapyramidal symptoms, urinary incontinence, and seizures. Risk factors include high ifosfamide dosage, hypoalbuminemia, impaired renal function, poor performance status, bulky abdominal-pelvic disease, nephrotoxic treatments including cisplatin, CNS active drugs, or alcohol use. Signs and symptoms may occur or recur within hours to days after administration of IFEX. Continue supportive care until complete resolution of CNS signs and symptoms. Monitor for signs and symptoms of encephalopathy during and after IFEX treatment. Dose interruption or permanent discontinuation may be required based on individual safety and tolerability. Consider methylene blue for treatment of encephalopathy. 5.3 Nephrotoxicity and Urotoxicity IFEX can cause severe or fatal nephrotoxicity and urotoxicity including glomerular or tubular dysfunction, tubular necrosis, renal parenchymal necrosis, acute renal failure, chronic renal failure, and hemorrhagic cystitis (requiring blood transfusion). Tubular damage may occur up to years after cessation of IFEX treatment. The risk of nephrotoxicity is increased in patients with renal impairment or reduced nephron reserve. Hemorrhagic cystitis is dose‑dependent and the risk is increased with past or concomitant radiation of the bladder or busulfan treatment. Evaluate glomerular and tubular kidney function before treatment with IFEX, during IFEX treatment, and as clinically indicated. Monitor serum and urine chemistries (including phosphorus and potassium) and urinary sediment for the presence of erythrocytes or other signs of nephrotoxicity. Signs and symptoms may include a decrease in glomerular filtration rate, increased serum creatinine, proteinuria, enzymuria, cylindruria, aminoaciduria, phosphaturia, glycosuria, osteomalacia, tubular acidosis, Fanconi syndrome, and syndrome of inappropriate antidiuretic hormone secretion (SIADH). Before starting treatment, exclude or correct any urinary tract obstructions [see Contraindications (4) ] . During or immediately after administration, provide oral or intravenous fluid to force dieresis to reduce the risk of urinary tract toxicity. Administer mesna with IFEX to reduce the incidence and severity of urotoxicity [see Dosage and Administration (2.1) ] . Obtain a urinalysis prior to each dose of IFEX. Avoid administration of IFEX in patients with active urinary tract infections. If microscopic hematuria (greater than 10 RBCs per high power field) is present, then withhold administration of IFEX until complete resolution. Further administration of IFEX should be given with vigorous oral or parenteral hydration. Dosage interruption or permanent discontinuation may be required based on individual safety and tolerability. 5.4 Cardiotoxicity IFEX can cause severe or fatal cardiotoxicity including any of the following:
• Supraventricular or ventricular arrhythmias, including atrial/supraventricular tachycardia, atrial fibrillation, pulseless ventricular tachycardia
• Decreased QRS voltage and ST-segment or T-wave changes
• Toxic cardiomyopathy leading to heart failure with congestion and hypotension
• Pericardial effusion, fibrinous pericarditis, and epicardial fibrosis Cardiotoxic effects are dose‑dependent and the risk is increased in patients with cardiac disease, prior or concomitant treatment with other cardiotoxic agents, radiation of the cardiac region, and renal impairment.
Side effects
The most common (≥ 10%) adverse reactions were alopecia, nausea/vomiting, hematuria, leukopenia, anemia, CNS toxicity, infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at phone: 1 866 888 2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted from widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The adverse reactions in Table 2 below are based on 30 publications describing clinical experience with fractionated administration of ifosfamide as a single agent with a total dose of 4 to 12 g/m 2 per course. Table 2: Adverse Reactions in Patients Treated with Single Agent IFEX Adverse Reaction Single Agent IFEX % (number of patients) Skin and Subcutaneous Tissue Disorders Alopecia 90% (540/603) Dermatitis 0.08% (1/1317) Papular rash 0.08% (1/1317) Gastrointestinal Disorders Nausea/Vomiting 47% (443/964) Diarrhea 0.7% (9/1317) Stomatitis 0.3% (4/1317) Renal and Urinary Disorders Hemorrhagic cystitis Includes dysuria and pollakiuria Hematuria - without mesna 44% (282/640) - with mesna 21% (33/155) Macrohematuria - without mesna 11% (66/594) - with mesna 5% (5/97) Renal dysfunction Includes acute renal failure, irreversible renal failure (fatal outcomes) serum creatinine increased, BUN increased, creatinine clearance decreased, metabolic acidosis, anuria, oliguria, glycosuria, hyponatremia, uremia, creatinine clearance increased -- Renal structural damage Includes acute tubular necrosis, renal parenchymal damage, enzymuria, cylindruria, proteinuria -- Blood and Lymphatic System Disorders Leukopenia Includes neutropenia, granulocytopenia, lymphopenia, and pancytopenia (any) -- Leukopenia <1 x 10 3 /µL 44% (267/614) Anemia Includes anemia and decrease in hemoglobin/hematocrit 38% (202/533) Thrombocytopenia Includes severe or fatal bleeding (any) -- Thrombocytopenia, 50 x 10 3 /µL 4.8% (35/729) Nervous System Disorders Central nervous system toxicity Includes coma and death Includes abnormal behavior, affect lability aggression, agitation, anxiety, aphasia, asthenia, ataxia, cerebellar syndrome, cerebral function deficiency, cognitive disorder, coma, confusional state, convulsions, cranial nerve dysfunction, depressed state of consciousness, depression, disorientation, dizziness, electroencephalogram abnormal, encephalopathy, flat affect, hallucinations, headache, ideation, lethargy, memory impairment, mood change, motor dysfunction, muscle spasms, myoclonus, progressive loss of brainstem reflexes, psychotic reaction, restlessness, somnolence, tremor, urinary incontinence 15% (154/1001) Peripheral neuropathy 0.4% (5/1317) Infections and Infestations Infection 10% (112/1128) General Disorders and Administration Site Conditions Phlebitis Includes phlebitis and irritation of the venous walls 2.8% (37/1317) Neutropenic fever Includes granulocytopenic fever 1% (13/1317) Fatigue 0.3% (4/1317) Malaise Unable to calculate Hepatobiliary Disorders Hepatotoxicity Includes increased serum alanine aminotransferase (ALT), serum aspartate aminotransferase (AST), alkaline phosphatase, gamma-glutamyltransferase (GGT) and lactate dehydrogenase (LDH) 1.8% (22/1190) Metabolism and Nutrition Disorders Anorexia 1.1% (15/1317) Cardiac Disorders Cardiotoxicity Includes severe or fatal congestive heart failure, tachycardia, pulmonary edema 0.5% (7/1317) Vascular Disorders Hypotension Includes shock and death 0.3% (4/1317) 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of IFEX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Drug interactions
• CYP3A4 Inducers: Monitor for increased toxicity when used in combination with CYP3A4 inducers. ( 7.1 )
• CYP3A4 Inhibitors: Use in combination with CYP3A4 inhibitors could decrease the effectiveness of ifosfamide. ( 7.2 ) 7.1 Inducers of CYP3A4 CYP3A4 inducers may increase the metabolism of ifosfamide to its active alkylating metabolites. CYP3A4 inducers may increase the formation of the neurotoxic/nephrotoxic ifosfamide metabolite, chloroacetaldehyde. Closely monitor patients taking ifosfamide with CYP3A4 inducers for toxicities and consider dose adjustment. 7.2 Inhibitors of CYP3A4 CYP3A4 inhibitors may decrease the metabolism of ifosfamide to its active alkylating metabolites, perhaps decreasing the effectiveness of ifosfamide treatment.
Use in specific populations
• Lactation: Advise not to breastfeed. ( 8.2 )
• Renal impairment: Closely monitor for adverse reactions and consider dosage modifications. ( 8.6 ) 8.1 Pregnancy Risk Summary Based on mechanism of action [see Clinical Pharmacology (12.1) ] , and human and animal data (see Data) , IFEX can cause fetal harm when administered to a pregnant woman. Fetal growth retardation and neonatal anemia have been reported following exposure to ifosfamide‑containing chemotherapy regimens during pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Animal studies indicate that ifosfamide is capable of causing gene mutations and chromosomal damage in vivo . In pregnant mice, resorptions increased and anomalies were present at day 19 after a 30 mg/m 2 dose of ifosfamide was administered on day 11 of gestation. Embryo-lethal effects were observed in rats following the administration of 54 mg/m 2 doses of ifosfamide from the 6th through the 15th day of gestation and embryotoxic effects were apparent after dams received 18 mg/m 2 doses over the same dosing period. Ifosfamide is embryotoxic to rabbits receiving 88 mg/m 2 /day doses from the 6th through the 18th day after mating. The number of anomalies was also significantly increased over the control group. 8.2 Lactation Risk Summary Ifosfamide is excreted in breast milk. Because of the potential for serious adverse events, and the tumorigenicity shown for ifosfamide in animal studies, advise women not to breastfeed during treatment with IFEX and for one week after the last dose. 8.3 Females and Males of Reproductive Potential IFEX can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Verify pregnancy status in females of reproductive potential prior to initiating IFEX [see Use in Specific Populations (8.1) ] . Contraception Females Advise female patients of reproductive potential to use effective contraception during treatment with IFEX and for 12 months after the last dose. Males Advise males with female sexual partners of reproductive potential to use effective contraception during treatment with IFEX and for 6 months after the last dose [see Nonclinical Toxicology (13.1) ] . Infertility Females Amenorrhea has been reported in patients treated with ifosfamide. The risk of permanent chemotherapy induced amenorrhea increases with age. Males Men treated with ifosfamide may develop oligospermia or azoospermia. Azoospermia may be reversible in some patients, though the reversibility may not occur for several years after cessation of therapy. Sexual function and libido are generally unimpaired in these patients. Some degree of testicular atrophy may occur. Patients treated with ifosfamide have subsequently fathered children. Females and Males Based on animal studies, IFEX may impair fertility in females and males of reproductive potential. The reversibility of these effects is unknown [see Nonclinical Toxicology (13.1) ] . 8.4 Pediatric Use Safety and effectiveness have not been established in pediatric patients. Renal rickets and growth retardation in pediatric patients treated with ifosfamide have been reported. IFEX may cause temporary or permanent infertility in prepubertal girls or in females of child-bearing potential and may have an increased risk of developing premature menopause. IFEX may cause abnormal secondary sexual characteristic development in prepubertal males. Sterility, azoospermia, and testicular atrophy have been reported in male patients. Azoospermia may be reversible in some patients, but may not occur for several years after cessation of IFEX therapy. 8.5 Geriatric Use Clinical studies of IFEX did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. A study of patients 40 to 71 years of age indicated that elimination half-life appears to increase with advancing age [see Pharmacokinetics (12.3) ]. This apparent increase in half-life appeared to be related to increases in volume of distribution of ifosfamide with age. No significant changes in total plasma clearance or renal or non-renal clearance with age were reported. Ifosfamide and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, closely monitor for adverse reactions and monitor renal function as clinically indicated. 8.6 Use in Patients with Renal Impairment Ifosfamide and its metabolites are known to be excreted by the kidneys and may accumulate in plasma with decreased renal function. Closely monitor patients with renal impairment for adverse reactions and consider dosage modifications. Ifosfamide and its metabolites are dialyzable . 8.7 Use in Patients with Hepatic Impairment Ifosfamide is extensively metabolized in the liver and forms both efficacious and toxic metabolites. Closely monitor patients with impaired hepatic function for adverse reactions during treatment with IFEX.
Pregnancy
8.1 Pregnancy Risk Summary Based on mechanism of action [see Clinical Pharmacology (12.1) ] , and human and animal data (see Data) , IFEX can cause fetal harm when administered to a pregnant woman. Fetal growth retardation and neonatal anemia have been reported following exposure to ifosfamide‑containing chemotherapy regimens during pregnancy. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data Animal studies indicate that ifosfamide is capable of causing gene mutations and chromosomal damage in vivo . In pregnant mice, resorptions increased and anomalies were present at day 19 after a 30 mg/m 2 dose of ifosfamide was administered on day 11 of gestation. Embryo-lethal effects were observed in rats following the administration of 54 mg/m 2 doses of ifosfamide from the 6th through the 15th day of gestation and embryotoxic effects were apparent after dams received 18 mg/m 2 doses over the same dosing period. Ifosfamide is embryotoxic to rabbits receiving 88 mg/m 2 /day doses from the 6th through the 18th day after mating. The number of anomalies was also significantly increased over the control group.
Pediatric use
8.4 Pediatric Use Safety and effectiveness have not been established in pediatric patients. Renal rickets and growth retardation in pediatric patients treated with ifosfamide have been reported. IFEX may cause temporary or permanent infertility in prepubertal girls or in females of child-bearing potential and may have an increased risk of developing premature menopause. IFEX may cause abnormal secondary sexual characteristic development in prepubertal males. Sterility, azoospermia, and testicular atrophy have been reported in male patients. Azoospermia may be reversible in some patients, but may not occur for several years after cessation of IFEX therapy.
Geriatric use
8.5 Geriatric Use Clinical studies of IFEX did not include sufficient numbers of patients aged 65 and over to determine whether they respond differently from younger subjects. A study of patients 40 to 71 years of age indicated that elimination half-life appears to increase with advancing age [see Pharmacokinetics (12.3) ]. This apparent increase in half-life appeared to be related to increases in volume of distribution of ifosfamide with age. No significant changes in total plasma clearance or renal or non-renal clearance with age were reported. Ifosfamide and its metabolites are known to be substantially excreted by the kidney, and the risk of toxic reactions to this drug may be greater in patients with impaired renal function. Because elderly patients are more likely to have decreased renal function, closely monitor for adverse reactions and monitor renal function as clinically indicated.
Overdosage
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 [see Warnings and Precautions (5) ]. 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.
Description
(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 alkylating drug 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 C 7 H 15 Cl 2 N 2 O 2 P 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: IFEX Structural Formula
Mechanism of action
12.1 Mechanism of Action Ifosfamide is a prodrug that requires metabolic activation by hepatic cytochrome P450 isoenzymes to exert its cytotoxic activity. Activation occurs by hydroxylation at the ring carbon atom forming the unstable intermediate 4-hydroxyifosfamide and its ring-opened aldo tautomer, which decomposes to yield the cytotoxic and urotoxic compound acrolein and an alkylating isophosphoramide mustard. The exact mechanism of action of ifosfamide has not been determined, but its cytotoxic action is primarily through DNA crosslinks caused by alkylation by the isophosphoramide mustard at guanine N-7 positions. The formation of inter- and intra-strand cross-links in the DNA results in cell death.
How supplied
(ifosfamide for injection, USP) is available in single-dose vials as follows: IFEX (ifosfamide for injection) NDC 0338-3991-01 1-gram Single-Dose Vial NDC 0338-3993-01 3-gram Single-Dose Vial Store at controlled room temperature 20°C to 25°C (68°F to 77°F). Protect from temperatures above 30°C (86°F).
Patient information
Myelosuppression
• Advise patients that treatment with IFEX may cause myelosuppression which can be severe and lead to infections and fatal outcomes.
• Inform patients of the risks associated with the use of IFEX and plan for regular blood monitoring during therapy [see Boxed Warning, Warnings and Precautions (5.1 )].
• Inform patients to report fever or other symptoms of an infection [see Boxed Warning, Warnings and Precautions (5.1) , Adverse Reactions (6.2) ].
• Advise patients on the risks of bleeding and anemia [see Warnings and Precautions (5.1 , 5.8 ), Adverse Reactions (6.2) ], Use in Specific Populations (8.1 )]. Encephalopathy
• Advise patients on the risk of encephalopathy and other neurotoxic effects with fatal outcome [see Boxed Warning, Warnings and Precautions (5.2) ].
• Inform patients that IFEX may impair the ability to operate an automobile or other heavy machinery [see Boxed Warning, Warnings and Precautions (5.2) ]. Nephrotoxicity and Urotoxicity
• Advise patients on the risk of bladder and kidney toxicity.
• Advise patients of the need to increase fluid intake and frequent voiding to prevent accumulation in the bladder [see Warnings and Precautions (5.3) ]. Cardiotoxicity
• Advise patients on the risk of cardiotoxicity and fatal outcome.
• Advise patients to report preexisting cardiac disease and manifestations of cardiotoxicity [see Warnings and Precautions (5.4) , Adverse Reactions (6.2) ] . Pulmonary Toxicity
• Advise patients on the risk of pulmonary toxicity leading to respiratory failure with fatal outcome.
• Inform patients to report signs and symptoms of pulmonary toxicity [see Warnings and Precautions (5.5) ]. Secondary Malignancies
• Advise patients on the risk of secondary malignancies due to therapy [see Warnings and Precautions (5.6) ] . Veno-occlusive Liver Disease
• Advise patients on the risk of veno-occlusive liver disease [see Warnings and Precautions (5.7) ]. Embryo-Fetal Toxicity
• Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females to inform their healthcare provider of a known or suspected pregnancy [see Warnings and Precautions (5.8) and Use in Specific Populations (8.1) ] .
• Advise females of reproductive potential to use effective contraception during treatment with IFEX and for 12 months after the last dose [see Use in Specific Populations (8.3) ] .
• Advise male patients with female partners of reproductive potential to use effective contraception during treatment with IFEX and for 6 months after the last dose [see Use in Specific Populations (8.3) ] . Lactation
• Advise women not to breastfeed during treatment with IFEX and for 1 week after the last dose [see Use in Specific Populations (8.2) ] . Infertility
• Advise females and males of reproductive potential that IFEX may cause temporary or permanent infertility [see Use in Specific Populations (8.3) ] . Skin and Subcutaneous Tissue Disorders
• Advise patients on the risk of alopecia, wound healing, and other serious skin and subcutaneous tissue disorders [see Warnings and Precautions (5.11) , Adverse Reactions (6.2) ]. Gastrointestinal Disorders
• Advise patients that the therapy may cause gastrointestinal disorders and alcohol may increase nausea and vomiting [see Adverse Reactions (6.2) ].
• Advise patients on the risk of stomatitis and the importance of proper oral hygiene [see Adverse Reactions (6.2) ]. Eye Disorders
• Advise patients on the risk of eye disorders such as visual impairment, blurred vision, and eye irritation [see Adverse Reactions (6.2) ]. Ear and Labyrinth Disorders
• Advise patients on the risk of ear and labyrinth disorders such as deafness, vertigo, and tinnitus [see Adverse Reactions (6.2) ] . Manufactured by: Baxter Healthcare Corporation Deerfield, IL 60015 USA For Product Inquiry 1-800 ANA DRUG (1-800-262-3784) Made in Germany Baxter, Ifex and Viaflex are trademarks of Baxter International Inc. PAB is a trademark of B Braun HA-30-02-445
Label text from the FDA structured product label by Baxter Healthcare Corporation (revised Dec 2, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Ifosfamide in 2 products
Ifex NDC products (2)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 0338-3991 | Ifosfamide 1 g/20mL Injection, Powder, For Solution | Baxter Healthcare Corporation | NDA |
| 0338-3993 | Ifosfamide 3 g/60mL Injection, Powder, For Solution | Baxter Healthcare Corporation | NDA |
Frequently asked questions
What is Ifex used for?
1 INDICATIONS AND USAGE IFEX is indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer. IFEX is an alkylating drug indicated for use in adults in combination with certain other approved antineoplastic agents for third-line chemotherapy of germ cell testicular cancer.
What are the side effects of Ifex?
The most common (≥ 10%) adverse reactions were alopecia, nausea/vomiting, hematuria, leukopenia, anemia, CNS toxicity, infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare at phone: 1 866 888 2472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted from widely varying conditions, adverse reaction… See the full label for the complete list.
Who makes Ifex?
Ifex is listed by 1 labeler in the FDA NDC directory, including Baxter Healthcare Corporation.