Ifosfamide Injection

Ifosfamide can cause a severe decrease in the number of blood cells in your bone marrow. This may cause certain symptoms and may increase the risk that you will develop a serious or life-threatening infection or bleeding. If you experience any of the following symptoms, call your doctor immediately: fever, chills, sore throat, ongoing cough and congestion, or other signs of infection; unusual bleeding or bruising; bloody or black, tarry stools; bloody vomit; or vomiting blood or brown material that resembles coffee grounds.

Ifosfamide may cause severe or life-threatening damage to the nervous system. If you experience any of the following symptoms, call your doctor immediately: confusion; drowsiness; blurred vision; seeing things or hearing voices that do not exist (hallucinating); or pain, burning, numbness, tingling in the hands or feet; seizures; or coma (loss of consciousness for a period of time).

Ifosfamide may cause severe or life-threatening kidney problems. Kidney problems may occur during therapy or months or years after you stop receiving treatment. Tell your doctor if you have or have ever had kidney disease. If you experience any of the following symptoms, call your doctor immediately: decreased urination; swelling of the face, arms, hands, feet, ankles, or lower legs; or unusual tiredness or weakness.

Ifosfamide may cause severe urinary side effects. Tell your doctor if you have problems urinating. Your doctor may tell you not to receive ifosfamide or wait to start treatment until you are able to urinate regularly. Also tell your doctor if you have a urinary tract infection or if you have or have ever had radiation (x-ray) therapy to the bladder. Tell your doctor and pharmacist if you are taking or have ever received busulfan (Busulfex). If you experience any of the following symptoms, call your doctor immediately: blood in the urine or frequent, urgent, or painful urination. Your doctor will give you another medication to help prevent severe urinary side effects during your treatment with ifosfamide. You should also drink plenty of fluids and urinate frequently during your treatment to help reduce urinary side effects.

Keep all appointments with your doctor and the laboratory. Your doctor will order laboratory tests regularly before and during your treatment to check your body's response to ifsofamide and to treat side effects before they become severe.

Ifosfamide is used in combination with other medications to treat cancer of the testicles that has not improved or that has worsened after treatment with other medications or radiation therapy. Ifosfamide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in your body.

Ifosfamide comes as powder to be mixed with liquid to be injected over at least 30 minutes intravenously (into a vein) by a doctor or nurse in a medical facility. It may be injected once a day for 5 days in a row. This treatment may be repeated every 3 weeks. The length of treatment depends on how well your body responds to treatment with ifosfamide.

Your doctor may need to delay your treatment if you experience certain side effects. It is important for you to tell your doctor how you are feeling during your treatment with ifosfamide.

Ifosfamide is also sometimes used to treat bladder cancer, lung cancer, cancer of the ovaries (cancer that begins in the female reproductive organs where eggs are formed), cancer of the cervix, and certain types of soft tissue or bone sarcomas (cancer that forms in muscles and bones). Talk to your doctor about the risks of using this medication for your condition.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before receiving ifosfamide,

• tell your doctor and pharmacist if you are allergic to ifosfamide, cyclophosphamide (Cytoxan), any other medications, or any of the ingredients in ifosfamide injection. Ask your pharmacist for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins and nutritional supplements you are receiving or plan to take while receiving ifosfamide. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• the following herbal product may interact with ifosfamide: St. John's wort. Be sure to let your doctor and pharmacist know that you are taking this medication before you start receiving ifosfamide. Do not start this medication while receiving ifosfamide without discussing with your healthcare provider.
• tell your doctor if you have previously received treatment with other chemotherapy medications or if you have previously received radiation therapy. Also tell your doctor if you have or have ever had heart, kidney, or liver disease.
• you should know that ifosfamide may slow the healing of wounds.
• you should know that ifosfamide may interfere with the normal menstrual cycle (period) in women and may stop sperm production in men. Ifosfamide may cause permanent infertility (difficulty becoming pregnant); however, you should not assume that you cannot get pregnant or that you cannot get someone else pregnant. Women who are pregnant or breast-feeding should tell their doctors before they begin receiving this drug. You should not become pregnant or breast-feed while you are receiving ifosfamide. Use a reliable method of birth control to prevent pregnancy while you are receiving ifosfamide and for 6 months after treatments. If you are male, you and your female partner should continue to use birth control for 6 months after you stop receiving ifosfamide injection. If you become pregnant while receiving ifsofamide, call your doctor immediately. Ifosfamide may harm the fetus.

Do not eat large amounts of grapefruit or drink grapefruit juice while receiving this medication.

ifosfamide may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• vomiting
• loss of appetite
• diarrhea
• sores in the mouth and throat
• hair loss
• general feeling of pain and tiredness

Some side effects can be serious. If you experience any of these symptoms or those listed in the IMPORTANT WARNING section, call your doctor immediately:

• swelling, redness, and pain in the place where the medication was injected
• rash
• itching
• difficulty breathing or swallowing
• shortness of breath
• wheezing
• irregular heartbeat
• chest pain
• hoarseness
• yellowing of the skin or eyes

Ifosfamide may increase the risk that you will develop other cancers. Talk to your doctor about the risks of receiving ifosfamide injection.

Ifosfamide may cause other side effects. Call your doctor if you have any unusual problems while receiving this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• blurred vision
• seeing things or hearing voices that do not exist (hallucinating)
• fever, sore throat, chills, or other signs of infection
• unusual bleeding or bruising
• black and tarry stools
• red blood in stools
• bloody vomit
• vomited material that looks like coffee grounds
• decreased urination
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• sores in the mouth and throat
• seizures
• confusion
• coma (loss of consciousness for a period of time)

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Ifex^®

• Isophosphamide