Ifex Vial

GENERIC NAME(S): Ifosfamide

OTHER NAME(S): Ifex Solution, Reconstituted (Recon Soln)

WARNINGS:

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).

Who should not take Ifex Vial?

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Uses

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 Ifex Vial

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

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 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.

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, your doctor has prescribed this drug because he or she has judged that the benefit to you is greater than the risk ofside 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

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.

Do not have immunizations/vaccinations without the consent of your doctor. 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.

Interactions

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.

A product that may interact with this drug is: nalidixic acid.

Overdose

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

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.Information last revised October 2018. Copyright(c) 2018 First Databank, Inc.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.