ifosfamide (Rx)

Brand and Other Names:Ifex
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

kit: powder with mesna solution

  • 1g/vial
  • 3g/vial

solution

  • 1g/20mL
  • 3g/60mL

Germ Cell Testicular Cancer

Indicated in combination with other antineoplastic agents for third-line germ cell testicular cancer

1.2 g/m²/day IV infusion over 30 minutes on days 1-5 q3-4wk or after recovering from hematologic toxicity (>100,000 cells/mm³ plateletes or ≥4,000 cells/mm³ WBC)  

Off-label: 2 g/m²/day IV infusion on days 1-3 (MAID regimen, for total dose of 6 g/m²); doses as high as 5 g/m² over 24hr via continuous IV infusion in combination with other antineoplastic agents used

Administration

Use concomitant mesna (240 mg/m² IV at 0, 4, 8 hr) to prevent hemorrhagic cystitis

Maintain oral or IV hydration >2 L fluid/day

Monitor: CBCs

Bone Sarcomas (Orphan)

Orphan indication sponsor

  • Bristol-Myers Squibb Company; P.O. Box 4000, Mail Stop D12-02; Princeton, NJ 08543-4000

Soft Tissue Sarcomas (Orphan)

Orphan indication sponsor

  • Bristol-Myers Squibb Company; P.O. Box 4000, Mail Stop D12-02; Princeton, NJ 08543-4000

Renal Impairment

Dose adjustments not described in package insert; some clinicians have used the following guidelines

CrCl >60 mL/min: 100% of regular dose

CrCl 30-60 mL/min: 75% of regular dose

CrCl 10-30 mL/min: 50% of regular dose

CrCl <10 mL/min: Not recommended

Hepatic Impairment

Dose adjustments not described in package insert; some clinicians have used the following guidelines

Bilirubin >3 mg/dL: 25% of regular dose

Other Indications & Uses

Off-label: Cancer of lung, breast, ovary, cervix, pancreas, bladder, and stomach; NHL; sarcomas

Safety and efficacy not established

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Interactions

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            Adverse Effects

            >10%

            Alopecia (83%)

            Nausea (58%)

            Vomiting (58%)

            Leukopenia (50%)

            Hematuria (46%)

            Metabolic acidosis (31%)

            Thrombocytopenia (20%)

            CNS toxicity (12%)

            Neurotoxicity (10-20%)

            1-10%

            Infection (8%)

            Nephrotoxicity (6%)

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            Warnings

            Black Box Warnings

            The drug should be administered under the supervision of an experienced cancer chemotherapy physician

            Bone marrow suppression may occur

            Hemorrhagic cystitis reported

            Confusion and coma due to CNS toxicity have been associated with therapy. Discontinue therapy if it occurs.

            Dose-related severe myelosuppression reported

            Contraindications

            Hypersensitivity

            Severe myelosuppression

            Cautions

            Avoid pregnancy

            May interfere with wound healing

            Use caution in renal impairment

            Heart Failure risk

            • Acute heart failure, often occurring within 1 to 10 days of treatment, has been reported with induction therapy at doses greater than 12.5 mg/m2
            • The onset of HF can be reversible, usually resolving over 3 to 4 weeks
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            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: excreted in breast milk, do not nurse

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Synthetic analog of cyclophosphamide; cross-links DNA strands; inhibits DNA synthesis and protein synthesis

            Absorption

            Bioavailability: 90-100%

            Peak plasma time: 20-30 minutes

            Distribution

            Vd: 33 L

            Metabolism

            Extensively metabolized

            Metabolites: 3-dechloroethylifosfamide, 2-dechloroethylifosfamide, and carboxyifosfamide

            Elimination

            Half-life elimination: 15 hr (high dose of 3800-5000 mg/m²); 7 hr (low dose of 1800-2400 mg/m²)

            Excretion: Urine 70-86% (high dose of 5000 mg/m²); 12-16% (low dose of 1600-2400)

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            Administration

            IV Incompatibilities

            Syringe: mesna with epirubicin

            Y-site: cefepime, methotrexate

            IV Compatibilities

            Solution: D5/Ringer's, D5/NS, D5W, LR, ½NS, NS, Na-Lactate (1/6 M)

            Additive: carboplatin, carboplatin w/ etoposide, cisplatin, cisplatin w/etoposide, epirubicin, etoposide, fluorouracil, mesna

            Syringe: epirubicin, mesna

            Y-site (partial list): allopurinal, amphotericin B cholesteryl sulfate, etoposide phosphate, filgrastim, fludarabine, gemcitabine, granisetron, linezolid, melphalan, ondansetron, paclitaxel, propofol, NaHCO3, teniposide, thiotepa

            IV Preparation

            Reconstitute with SWI or NS to a concentration of 50 mg/mL

            Standard dilution

            • IV push: dose/syringe (concentration: 50 mg/mL)
            • IVPB: dose/100-1000 mL D5W or NS

            IV Administration

            Slow IV infusion over 30 min, or continuous infusion over 5 d

            Mesna should be administered concomitantly (20% of the ifosfamide dose 15 min before, 4 hr after, & 8 hr after ifosfamide administration)

            Adequate hydration (at least 2 L/day) before & for 72 hr after therapy is recommended to minimize risk of hemorrhagic cystitis

            Storage

            Store intact vials at room temp or under refrigeration

            Syringe & IVPB are stable for 7 days at room temp& 6 wk under refrigeration

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Ifex intravenous
            -
            1 gram vial
            Ifex intravenous
            -
            3 gram vial
            ifosfamide intravenous
            -
            1 gram/20 mL vial
            ifosfamide intravenous
            -
            3 gram/60 mL vial
            ifosfamide intravenous
            -
            3 gram/60 mL vial
            ifosfamide intravenous
            -
            1 gram/20 mL vial
            ifosfamide intravenous
            -
            1 gram vial
            ifosfamide intravenous
            -
            3 gram/60 mL vial
            ifosfamide intravenous
            -
            1 gram vial
            ifosfamide intravenous
            -
            1 gram vial
            ifosfamide intravenous
            -
            3 gram vial
            ifosfamide intravenous
            -
            3 gram vial

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            ifosfamide intravenous

            IFOSFAMIDE - INJECTION

            (eye-FOSS-fuh-mide)

            COMMON BRAND NAME(S): Ifex

            WARNING: Ifosfamide may cause serious (even fatal) side effects (including urinary problems such as hemorrhagic cystitis, mental/mood changes, blood/bone marrow disorders), which may require your treatment with this medication to be stopped. Tell your doctor right away if you develop symptoms such as pink/bloody urine, frequent/painful urination, severe drowsiness, confusion, unusual changes in behavior, or hallucinations. Blood/bone marrow disorders can affect your body's ability to stop bleeding, or fight infection. Tell your doctor right away if you develop easy bruising/bleeding or signs of infection (such as sore throat that doesn't go away, fever, chills).

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

            HOW TO USE: This medication is given by injection into a vein by a health care professional. The 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 get medical help right away.To help prevent urinary problems, drink plenty of fluids and urinate often unless otherwise directed by your doctor. Your doctor may also prescribe other medication (such as mesna, intravenous fluids) to decrease the risk.

            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, avoiding alcoholic beverages, or limiting activity may help lessen some of these effects. If these effects last or get worse, tell your doctor or pharmacist promptly.Severe nausea, vomiting, and diarrhea may rarely cause 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.Pain or sores in the mouth and throat may occur. Brush your teeth gently/carefully, avoid using mouthwash that contains alcohol, and rinse your mouth frequently with cool water mixed with baking soda or salt. It may also be best to eat soft, moist foods.Temporary hair loss may occur. Normal hair growth should return after treatment has ended.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor 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: numbness/tingling in the hands/feet, signs of heart problems (such as fast/slow/irregular heartbeat, shortness of breath, swelling ankles/feet, unusual tiredness, unusual/sudden weight gain), change in the amount of urine, vision changes (such as decreased/blurred vision), irregular/stopped menstrual periods (women).Get medical help right away if you have any very serious side effects, including: 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 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            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 problems (such as anemia, low blood cell counts), current infection, heart problems (such as fast/irregular heartbeat, heart failure), kidney disease, liver disease, radiation treatment, problems with urination (such as blockage).This drug may make you drowsy. Alcohol or marijuana (cannabis) can make you more drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).Ifosfamide can make you more likely to get infections or may worsen any current infections. Avoid contact with people who have infections that may spread to others (such as chickenpox, measles, flu). Consult your doctor if you have been exposed to an infection or for more details.Tell your health care professional that you are using ifosfamide before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).This medication may make a wound heal more slowly than usual. 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.Rarely, people who are treated with this medication have developed other cancers (such as leukemia). Talk with your doctor for more details.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using ifosfamide. Ifosfamide may harm an unborn baby. Women using this drug should ask about reliable forms of birth control while using this medication. If you become pregnant, talk to your doctor right away about the risks and benefits of this medication. This medication may affect the production of sperm, increasing the risk of fathering a child with birth defects. Men with female partners of childbearing age should ask about reliable forms of birth control (such as condoms) while using this drug and for up to 6 months after stopping treatment.This medication passes into breast milk and may have undesirable effects on a nursing infant. Breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

            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.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Lab and/or medical tests (such as complete blood counts, blood salt/mineral levels, kidney function) should be done while you are using this medication. Keep all medical and lab appointments.

            MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for 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 December 2021. Copyright(c) 2022 First Databank, Inc.

            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.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

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            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.