Ifosfamide Injection

IMPORTANT WARNING:

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 material that resembles coffee grounds.

Ifosfamide may cause encephalopathy (a serious and potentially fatal nervous system disorder). If you experience any of the following symptoms, call your doctor immediately: confusion; drowsiness; blurred vision; difficulty moving or keeping your balance; difficulty understanding or speaking; seeing things or hearing voices that do not exist (hallucinating); 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. 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.

WHY is this medicine prescribed?

Ifosfamide is used to treat certain types of cancer of the testicles. Ifosfamide is in a class of medications called alkylating agents. It works by slowing or stopping the growth of cancer cells in your body.

Are there OTHER USES for this medicine?

Ifosfamide is also sometimes used to treat certain types of bladder cancer, lung cancer, cancer of the ovaries (cancer that begins in the female reproductive organs where eggs are formed), cancer of the cervix (cancer that begins in the opening of the uterus [womb]), and soft tissue or bone cancer (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.

HOW should this medicine be used?

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. Your doctor will tell you how often you will receive ifosfamide injection. The schedule depends on the condition you have and on how your body responds to the medication.

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 injection.

What SPECIAL PRECAUTIONS should I follow?

Before receiving ifosfamide injection,

• tell your doctor or pharmacist if you are allergic to this drug, any part of this drug, or any other drugs, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.

• 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, or liver disease.

• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving ifosfamide injection. Ifosfamide may slow the healing of wounds.

• Tell your doctor if you are pregnant or planning to become pregnant. You or your partnershould not become pregnant while you are receiving ifosfamide injection.Ifosfamide may interfere with the normal menstrual cycle (period) in women and maystop sperm production in men. However, you should not assume that you cannot get pregnantor that you cannot get someone else pregnant. If you can become pregnant, your doctor mayorder a pregnancy test before you start treatment. If you can become pregnant, you should use effectivebirth control during therapy and for 1 year after the last dose. If your partner can become pregnant, you should use effective birth control during therapy and for 6 months after the last dose. Talk to your doctor about birthcontrol methods that will work best for you. If you or your partnerbecome pregnant while receiving isfosfamide injection, call your doctor immediately. Ifosfamide may harm the fetus.

• Tell your doctor if you are breastfeeding. You should not breastfeed during therapy and for 1week after receiving the last dose.

• ask your doctor about the safe use of alcoholic beverages while you are receiving ifosfamide injection. Alcohol can make the side effects from ifosfamide worse.

• you should know that ifosfamide may make you drowsy or dizzy or cause vision problems. Do not drive a car or operate machiniery until you know how this medication affects you.

• You should know that this medication may cause permanent infertility in men and women. Talkto your doctor about the risks of receiving ifosfamide injection.

What SPECIAL DIETARY instructions should I follow?

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

What SIDE EFFECTS can this medicine cause?

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; hives; difficulty breathing or swallowing; hoarseness; or swelling of the face, eyelids, tongue, or throat
• poor or slow wound healing
• new or worsening cough, wheezing, or shortness of breath
• chest pain; fast, irregular, or pounding heartbeat
• swelling of legs, ankles, or feet; shortness of breath; or unusual weight gain
• yellowing of the skin or eyes, extreme tiredness, nausea or vomiting, right sided stomachpain, dark colored urine, or decreased appetite

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).

What should I do in case of OVERDOSE?

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 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)

What OTHER INFORMATION should I know?

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.