Drugs Details

Drugs Info of Ifex
Drugs Details
  • Drugs Type  : Multum
  • Date : 9th Feb 2015 11:44 pm
  • Brand Name : Ifex
  • Generic Name :  ifosfamide (Pronunciation: eye FOS fah mide
Descriptions

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-2H1,3,2-oxazaphosphorine 2-oxide. The molecular formula is C7H15Cl2N2O2P and its molecular weight is 261.1. Its structural formula is: Ifosfamide is a white crystalline powder that is soluble in water.

 

IFEX (ifosfamide) Structural Formula Illustration

What are the possible side effects of ifosfamide (Ifex)?

If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (shortness of breath; closing of your throat; difficulty breathing; swelling of your lips, face, or tongue; or hives);
  • blood in the urine;
  • lower back or side pain;
  • frequent, painful or difficult urination;
  • black or tarry stools;
  • signs of infection such as fever; chills, or sore throat;
  • extreme sleepiness, confusion, hallucination or coma; or
  • unusual bleeding or...

Read All Potential Side Effects and See Pictures of Ifex »

What are the precautions when taking ifosfamide (Ifex)?

Before using ifosfamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (e.g., anemia, low blood cell counts), current infection, kidney disease, liver disease, radiation treatment.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.

To lower your risk of getting...

Read All Potential Precautions of Ifex »


This monograph has been modified to include the generic and brand name in many instances.

Indications

IFEX (ifosfamide) , used in combination with certain other approved antineoplastic agents, is indicated for third line chemotherapy of germ cell testicular cancer. It should be used in combination with a prophylactic agent for hemorrhagic cystitis, such as mesna.

Dosage Administration

IFEX (ifosfamide) should be administered intravenously at a dose of 1.2 g/m² per day for 5 consecutive days. Treatment is repeated every 3 weeks or after recovery from hematologic toxicity (Platelets ≥ 100,000/μL, WBC ≥ 4,000/μL).

In order to prevent bladder toxicity, IFEX (ifosfamide) should be given with extensive hydration consisting of at least 2 liters of oral or intravenous fluid per day. A protector, such as mesna, should also be used to reduce the incidence of hemorrhagic cystitis. IFEX (ifosfamide) should be administered as a slow intravenous infusion lasting a minimum of 30 minutes. Although IFEX (ifosfamide) has been administered to a small number of patients with compromised hepatic and/or renal function, studies to establish optimal dose schedules of IFEX (ifosfamide) in such patients have not been conducted.

Preparation for Intravenous Administration/Stability

Injections are prepared for parenteral 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. Use the quantity of diluent shown below to constitute the product:

 

Dosage Strength Quantity of Diluent Final Concentration
1 gram 20 mL 50 mg/mL
3 grams 60 mL 50 mg/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 Injection, 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 (eg, 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 (ifosfamide) should be refrigerated and used within 24 hours.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration.

How Supplied

IFEX (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).

Caution should be excersied when handling IFEX (ifosfamide) . Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1-4 Skin reactions associated with accidental exposure to IFEX (ifosfamide) may occur. To minimize the risk of dermal exposure, always wear impervious gloves when handling vials and solutions containing IFEX (ifosfamide) . If IFEX (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.

REFERENCES

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) Pulication 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. Am J Health-Syst Pharm. 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.

Manufactured by: Baxter Healthcare Corporation Deerfield, IL 60015 USA. For Product Inquiry 1800 ANA DRUG (1-800-262-3784).


This monograph has been modified to include the generic and brand name in many instances.

Side Effects

In patients receiving IFEX (ifosfamide) as a single agent, the dose-limiting toxicities are myelosuppression and urotoxicity. Dose fractionation, vigorous hydration, and a protector such as mesna can significantly reduce the incidence of hematuria, especially gross hematuria, associated with hemorrhagic cystitis. At a dose of 1.2 g/m² daily for 5 consecutive days, leukopenia, when it occurs, is usually mild to moderate. Other significant side effects include alopecia, nausea, vomiting, and central nervous system toxicities.

 

Adverse Reaction *Incidence (%)
Alopecia 83
Nausea-Vomiting 58
Hematuria 46
Gross Hematuria 12
CNS Toxicity 12
Infection 8
Renal Impairment 6
Liver Dysfunction 3
Phlebitis 2
Fever 1
Allergic Reaction < 1
Anorexia < 1
Cardiotoxicity < 1
Coagulopathy < 1
Constipation < 1
Dermatitis < 1
Diarrhea < 1
Fatigue < 1
Hypertension < 1
Hypotension < 1
Malaise < 1
Polyneuropathy < 1
Pulmonary Symptoms < 1
Salivation < 1
Stomatitis < 1
*Based upon 2,070 patients from the published literature in 30 single agent studies.

Hematologic Toxicity

Myelosuppression was dose related and dose limiting. It consisted mainly of leukopenia and, to a lesser extent, thrombocytopenia. A WBC count < 3000/μL is expected in 50% of the patients treated with IFEX (ifosfamide) single agent at doses of 1.2 g/m² per day for 5 consecutive days. At this dose level, thrombocytopenia (platelets < 100,000/μL) occurred in about 20% of the patients. At higher dosages, leukopenia was almost universal, and at total dosages of 10 to 12 g/m²/cycle, one half of the patients had a WBC count below 1000/μL and 8% of patients had platelet counts less than 50,000/μL. Myelosuppression was usually reversible and treatment can be given every 3 to 4 weeks. When IFEX (ifosfamide) is used in combination with other myelosuppressive agents, adjustments in dosing may be necessary. Patients who experience severe myelosuppression are potentially at increased risk for infection. Anemia has been reported as part of postmarketing surveillance.

Digestive System

Nausea and vomiting occurred in 58% of the patients who received IFEX (ifosfamide) . They were usually controlled by standard antiemetic therapy. Other gastrointestinal side effects include anorexia, diarrhea, and in some cases, constipation.

Urinary System

Urotoxicity consisted of hemorrhagic cystitis, dysuria, urinary frequency and other symptoms of bladder irritation. Hematuria occurred in 6% to 92% of patients treated with IFEX (ifosfamide) . The incidence and severity of hematuria can be significantly reduced by using vigorous hydration, a fractionated dose schedule and a protector such as mesna. At daily doses of 1.2 g/m² for 5 consecutive days without a protector, microscopic hematuria is expected in about one half of the patients and gross hematuria in about 8% of patients.

Renal toxicity occurred in 6% of the patients treated with ifosfamide as a single agent. Clinical signs, such as elevation in BUN or serum creatinine or decrease in creatinine clearance, were usually transient. They were most likely to be related to tubular damage. One episode of renal tubular acidosis which progressed into chronic renal failure was reported. Proteinuria and acidosis also occurred in rare instances. Metabolic acidosis was reported in 31% of patients in one study when IFEX (ifosfamide) was administered at doses of 2.0 to 2.5 g/m²/day for 4 days. Renal tubular acidosis, Fanconi syndrome, renal rickets and acute renal failure have been reported.

Close clinical monitoring of serum and urine chemistries including phosphorus, potassium, alkaline phosphatase and other appropriate laboratory studies is recommended. Appropriate replacement therapy should be administered as indicated.

Central Nervous System

CNS side effects were observed in 12% of patients treated with IFEX (ifosfamide) . Those most commonly seen were somnolence, confusion, depressive psychosis, and hallucinations. Other less frequent symptoms include dizziness, disorientation, and cranial nerve dysfunction. Seizures and coma with death were occasionally reported. The incidence of CNS toxicity may be higher in patients with altered renal function.

Other

Alopecia occurred in approximately 83% of the patients treated with IFEX (ifosfamide) as a single agent. In combination, this incidence may be as high as 100%, depending on the other agents included in the chemotherapy regimen. Increases in liver enzymes and/or bilirubin were noted in 3% of the patients. Other less frequent side effects included phlebitis, pulmonary symptoms, fever of unknown origin, allergic reactions, stomatitis, cardiotoxicity, and polyneuropathy.

Read the Ifex (ifosfamide) Side Effects Center for a complete guide to possible side effects

Interactions

The physician should be alert for possible combined drug actions, desirable or undesirable, involving ifosfamide even though ifosfamide has been used successfully concurrently with other drugs, including other cytotoxic drugs.

Wound Healing

Ifosfamide may interfere with normal wound healing.

Read the Ifex Drug Interactions Center for a complete guide to possible interactions

Learn More »


This monograph has been modified to include the generic and brand name in many instances.

Warnings

Urinary System

Urotoxic side effects, especially hemorrhagic cystitis, have been frequently associated with the use of IFEX (ifosfamide) .

It is recommended that a urinalysis should be obtained prior to each dose of IFEX (ifosfamide) . If microscopic hematuria (greater than 10 RBCs per high power field), is present, then subsequent administration should be withheld until complete resolution.

Further administration of IFEX (ifosfamide) should be given with vigorous oral or parenteral hydration.

Hematopoietic System

When IFEX (ifosfamide) is given in combination with other chemotherapeutic agents, severe myelosuppression is frequently observed. Close hematologic monitoring is recommended. White blood cell (WBC) count, platelet count and hemoglobin should be obtained prior to each administration and at appropriate intervals. Unless clinically essential, IFEX (ifosfamide) should not be given to patients with a WBC count below 2000/μL and/or a platelet count below 50,000/μL.

Central Nervous System

Neurologic manifestations consisting of somnolence, confusion, hallucinations and in some instances, coma, have been reported following IFEX (ifosfamide) therapy. The occurrence of these symptoms requires discontinuing IFEX (ifosfamide) therapy. The symptoms have usually been reversible and supportive therapy should be maintained until their complete resolution.

Pregnancy

Animal studies indicate that the drug is capable of causing gene mutations and chromosomal damage in vivo. Embryotoxic and teratogenic effects have been observed in mice, rats and rabbits at doses 0.05 to 0.075 times the human dose. Ifosfamide can cause fetal damage when administered to a pregnant woman. If IFEX (ifosfamide) is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus.

Precautions

General

IFEX (ifosfamide) should be given cautiously to patients with impaired renal function as well as to those with compromised bone marrow reserve, as indicated by: leukopenia, granulocytopenia, extensive bone marrow metastases, prior radiation therapy, or prior therapy with other cytotoxic agents.

Laboratory Tests

During treatment, the patient's hematologic profile (particularly neutrophils and platelets) should be monitored regularly to determine the degree of hematopoietic suppression. Urine should also be examined regularly for red cells which may precede hemorrhagic cystitis.

Pregnancy

Pregnancy Category D. See WARNINGS section.

Nursing Mothers

Ifosfamide is excreted in breast milk. Because of the potential for serious adverse events and the tumorigenicity shown for ifosfamide in animal studies, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Carcinogenesis, Mutagenesis, Impairment of Fertility

Ifosfamide has been shown to be carcinogenic in rats, with female rats showing a significant incidence of leiomyosarcomas and mammary fibroadenomas.

The mutagenic potential of ifosfamide has been documented in bacterial systems in vitro and mammalian cells in vivo. In vivo, ifosfamide has induced mutagenic effects in mice and Drosophila melanogaster 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.

In pregnant mice, resorptions increased and anomalies were present at day 19 after a 30 mg/m² dose of ifosfamide was administered on day 11 of gestation. Embryolethal effects were observed in rats following the administration of 54 mg/m² doses of ifosfamide from the 6th through the 15th day of gestation and embryotoxic effects were apparent after dams received 18 mg/m² doses over the same dosing period. Ifosfamide is embryotoxic to rabbits receiving 88 mg/m²/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

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

In general, dose selection for an elderly patient should be cautious, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

A study of patients 40 to 71 years of age indicated that elimination half-life appears to increase with advancing age (see CLINICAL PHARMACOLOGY section). 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, care should be taken in dose selection, and it may be useful to monitor renal function.


This monograph has been modified to include the generic and brand name in many instances.

OverDose

No specific antidote for IFEX (ifosfamide) is known. Management of overdosage would include general supportive measures to sustain the patient through any period of toxicity that might occur.

ContrainDications

Continued use of IFEX (ifosfamide) is contraindicated in patients with severely depressed bone marrow function (see WARNINGS AND PRECAUTIONS sections). IFEX (ifosfamide) is also contraindicated in patients who have demonstrated a previous hypersensitivity to it.


This monograph has been modified to include the generic and brand name in many instances.

Clinical Pharamacology

Ifosfamide has been shown to require metabolic activation by microsomal liver enzymes to produce biologically active metabolites. Activation occurs by hydroxylation at the ring carbon atom 4 to form the unstable intermediate 4-hydroxyifosfamide. This metabolite rapidly degrades to the stable urinary metabolite 4-ketoifosfamide. Opening of the ring results in formation of the stable urinary metabolite, 4-carboxyifosfamide. These urinary metabolites have not been found to be cytotoxic. N, N-bis (2-chloroethyl)-phosphoric acid diamide (ifosphoramide) and acrolein are also found. Enzymatic oxidation of the chloroethyl side chains and subsequent dealkylation produces the major urinary metabolites, dechloroethyl ifosfamide and dechloroethyl cyclophosphamide. The alkylated metabolites of ifosfamide have been shown to interact with DNA.

In vitro incubation of DNA with activated ifosfamide has produced phosphotriesters. The treatment of intact cell nuclei may also result in the formation of DNA-DNA cross-links. DNA repair most likely occurs in G-1 and G-2 stage cells.

Pharmacokinetics

Ifosfamide exhibits dose-dependent pharmacokinetics in humans. At single doses of 3.8 to 5.0 g/m², the plasma concentrations decay biphasically and the mean terminal elimination half-life is about 15 hours. At doses of 1.6 to 2.4 g/m²/day, the plasma decay is monoexponential and the terminal elimination half-life is about 7 hours.

Ifosfamide is extensively metabolized in humans and the metabolic pathways appear to be saturated at high doses.

After administration of doses of 5 g/m² of 14C-labeled ifosfamide, from 70% to 86% of the dosed radioactivity was recovered in the urine, with about 61% of the dose excreted as parent compound. At doses of 1.6 to 2.4 g/m² only 12% to 18% of the dose was excreted in the urine as unchanged drug within 72 hours.

Two different dechloroethylated derivatives of ifosfamide, 4-carboxyifosfamide, thiodiacetic acid and cysteine conjugates of chloroacetic acid have been identified as the major urinary metabolites of ifosfamide in humans and only small amounts of 4-hydroxyifosfamide and acrolein are present. Small quantities (nmole/mL) of ifosfamide mustard and 4hydroxyifosfamide are detectable in human plasma. Metabolism of ifosfamide is required for the generation of the biologically active species and while metabolism is extensive, it is also quite variable among patients.

A study of 20 patients between 40 to 71 years of age receiving 1.5 g/m² of ifosfamide daily for 3 or 5 days indicated that elimination half-life appears to increase with age. The elimination half-life increase appeared to be related to the increase in ifosfamide volume of distribution with age. No significant changes in total plasma clearance or renal clearance with age were reported.

In a study at Indiana University, 50 fully evaluable patients with germ cell testicular cancer were treated with IFEX (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.


This monograph has been modified to include the generic and brand name in many instances.

Patient Information

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.


This monograph has been modified to include the generic and brand name in many instances.

Consumer Overview Uses

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

 

IFOSFAMIDE - INJECTION

 

(eye-FOSS-fuh-mide)

 

COMMON BRAND NAME(S): Ifex

 

WARNING: Ifosfamide may cause serious side effects (e.g., urinary problems such as hemorrhagic cystitis, mental/mood changes, and blood/bone marrow disorders), which may require your treatment with this medication to be stopped. Tell your doctor immediately if you develop symptoms such as pink/bloody urine, frequent/painful urination, severe drowsiness, confusion, or hallucinations. Blood/bone marrow disorders can affect your body's ability to stop bleeding or fight infection. Tell your doctor immediately if you develop easy bruising/bleeding or signs of infection (e.g., fever, chills, persistent sore throat).

 

USES: Ifosfamide is used to treat various cancers (such as testicular cancer). It works by slowing or stopping the growth of cancer cells.

 

OTHER USES: This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.

This drug may also be used to treat other types of cancer (such as sarcomas, lung cancer).

 

HOW TO USE: This medication is given by injection into a vein by a health care professional. Dosage is based on your medical condition, body size, and response to treatment.

If this medication touches your skin, immediately wash the area well with soap and water. If this medication gets in your eye, open the eyelid and flush with water for 15 minutes, then seek immediate medical attention.

To help prevent urinary problems, drink plenty of fluids and urinate frequently while using this medication unless otherwise directed by your doctor. Your doctor may also prescribe other medication (e.g., mesna, IV fluids) to decrease the risk.

Consumer Overview Side Effect

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, diarrhea, stomach/abdominal pain, loss of appetite, or redness/pain/swelling at the injection site may occur. Nausea and vomiting can be severe. In some cases, your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If these effects persist or worsen, tell your doctor or pharmacist promptly.

Severe nausea, vomiting, and diarrhea may infrequently result in a loss of too much body water (dehydration). Contact your doctor promptly if you notice any symptoms of dehydration such as unusual decreased urination, unusual dry mouth/increased thirst, lack of tears, dizziness/lightheadedness, or pale/wrinkled skin.

Temporary hair loss frequently occurs in patients using this drug. Normal hair growth should return after treatment has ended.

Many people using this medication have serious side effects. However, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.

Tell your doctor right away if you have any serious side effects, including: unusual weakness, seizure.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

 

Read the Ifex (ifosfamide) Side Effects Center for a complete guide to possible side effects

Learn More »

PRECAUTIONS: Before using ifosfamide, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bleeding disorders (e.g., anemia, low blood cell counts), current infection, kidney disease, liver disease, radiation treatment.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Before having surgery, tell your doctor or dentist that you are using this medication.

This drug may make you drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

This medication may affect the production of sperm, increasing the risk of fathering a child with birth defects. Therefore, men receiving treatment with this drug should use reliable forms of birth control (e.g., condoms). Consult your doctor for details and to discuss effective forms of birth control.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. If you become pregnant or think you may be pregnant, tell your doctor immediately. To avoid pregnancy, both males and females using this drug should use reliable form(s) of birth control (e.g., birth control pills, condoms) during treatment. Consult your doctor for details and to discuss effective forms of birth control.

This medication passes into breast milk and may have undesirable effects on a nursing infant. Therefore, breast-feeding is not recommended while using this drug. Consult your doctor before breast-feeding.

Consumer Overview Missed Dose

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: other anti-cancer drugs, aprepitant/fosaprepitant, nalidixic acid.

 

OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

 

NOTES: Laboratory and/or medical tests (e.g., complete blood counts, blood salt/mineral levels, kidney function tests) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

 

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor to establish a new dosing schedule.

 

STORAGE: Consult the product instructions and your pharmacist for storage details. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

 

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

 

Information last revised March 2013. Copyright(c) 2013 First Databank, Inc.

Patient Detailed Side Effect

Brand Names: Ifex

Generic Name: ifosfamide (Pronunciation: eye FOS fah mide)

  • What is ifosfamide (Ifex)?
  • What are the possible side effects of ifosfamide (Ifex)?
  • What is the most important information I should know about ifosfamide (Ifex)?
  • What should I discuss with my healthcare provider before taking ifosfamide (Ifex)?
  • How should I take ifosfamide (Ifex)?
  • What happens if I miss a dose (Ifex)?
  • What happens if I overdose (Ifex)?
  • What should I avoid while taking ifosfamide (Ifex)?
  • What other drugs will affect ifosfamide (Ifex)?
  • Where can I get more information?

What is ifosfamide (Ifex)?

Ifosfamide is a cancer (antineoplastic) medication. Ifosfamide interferes with the growth of cancer cells and slows their growth and spread in the body.

Ifosfamide is used to treat testicular cancer.

Ifosfamide may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of ifosfamide (Ifex)?

If you experience any of the following serious side effects, seek emergency medical attention or contact your doctor immediately:

  • an allergic reaction (shortness of breath; closing of your throat; difficulty breathing; swelling of your lips, face, or tongue; or hives);
  • blood in the urine;
  • lower back or side pain;
  • frequent, painful or difficult urination;
  • black or tarry stools;
  • signs of infection such as fever; chills, or sore throat;
  • extreme sleepiness, confusion, hallucination or coma; or
  • unusual bleeding or bruising.

Other less serious side effects may be more likely to occur. Talk to your doctor if you experience

  • nausea, vomiting, or decreased appetite;
  • mouth sores;
  • diarrhea; or
  • temporary hair loss.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

Read the Ifex (ifosfamide) Side Effects Center for a complete guide to possible side effects

Learn More »

What is the most important information I should know about ifosfamide (Ifex)?

Ifosfamide should only be administered under the supervision of a qualified healthcare provider experienced in the use of cancer chemotherapeutic agents.

Serious side effects have been reported with the use of ifosfamide including: allergic reactions (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives); decreased bone marrow function and blood problems (extreme fatigue; easy bruising or bleeding; black, bloody or tarry stools; fever or chills; or signs of infection such as fever; chills, or sore throat); urinary problems (blood in the urine, difficulty urinating, or increased frequency of urination); neurologic problems (drowsiness, confusion, hallucinations, and coma); and others. Talk to your doctor about the possible side effects from treatment with ifosfamide.

Side Effects Centers
  • Ifex

Patient Detailed How Take

What should I discuss with my healthcare provider before taking ifosfamide (Ifex)?

Before taking ifosfamide, tell your doctor if you have:

  • had recent vaccinations;
  • kidney disease;
  • bone marrow problems;
  • had radiation or x-ray therapy; or
  • been treated with other chemotherapy medicines.

You may not be able to take ifosfamide, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Ifosfamide is in the FDA pregnancy category D. This means that ifosfamide is known to cause birth defects in an unborn baby. Do not take ifosfamide without first talking to your doctor if you are pregnant or could become pregnant during treatment.

Ifosfamide passes into breast milk and may harm a nursing infant. Do not take ifosfamide without first talking to your doctor if you are breast feeding a baby.

How should I take ifosfamide (Ifex)?

Your doctor will determine the correct amount and frequency of treatment with ifosfamide depending upon the type of cancer being treated and other factors. Talk to your doctor if you have any questions or concerns regarding the treatment schedule.

Your doctor may suggest taking increased fluid by mouth or intravenously (IV) and may prescribe another drug, such as mesna, to prevent bleeding in the bladder.

Your doctor will probably want you to have regularly scheduled blood tests and other medical evaluations during treatment with ifosfamide to monitor progress and side effects.

Skin accidentally exposed to ifosfamide should be rinsed thoroughly with soap and warm water.

Your healthcare provider will store ifosfamide injection as directed by the manufacturer. If you are storing ifosfamide injection at home, follow the directions provided by your healthcare provider.

Side Effects Centers
  • Ifex

Patient Detailed Avoid Taking

What happens if I miss a dose (Ifex)?

Contact your doctor if you miss a dose of ifosfamide.

What happens if I overdose (Ifex)?

If for any reason an overdose of ifosfamide is suspected, seek emergency medical attention or contact your healthcare provider immediately.

Symptoms of a ifosfamide overdose tend to be similar to side effects caused by the medication, although often more severe.

What should I avoid while taking ifosfamide (Ifex)?

Ifosfamide can lower the activity of your immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive vaccines that contain live strains of a virus (e.g., live oral polio vaccine) during treatment with ifosfamide. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you.

Skin accidentally exposed to ifosfamide injection should be rinsed thoroughly with soap and warm water.

What other drugs will affect ifosfamide (Ifex)?

Do not receive "live" vaccines during treatment with ifosfamide. Administration of a live vaccine may be dangerous during treatment with ifosfamide.

Other medications may interact with ifosfamide. Talk to your doctor and pharmacist before taking any other prescription or over-the-counter medicines, including vitamins, minerals, and herbal products, during treatment with ifosfamide.

Where can I get more information?

Your pharmacist has additional information about ifosfamide written for health professionals that you may read.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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