Ifex

It is used to treat cancer of the testicles as well as some other kinds of cancer. Another medicine, called mesna, is usually given along with ifosfamide to prevent bladder problems that can be caused by ifosfamide.

Ifosfamide interferes with the growth of cancer cells, which are eventually destroyed. Since the growth of normal body cells may also be affected by ifosfamide, other effects will also occur. Some of these may be serious and must be reported to your doctor . Other effects, like hair loss, may not be serious but may cause concern. Some effects may not occur until months or years after the medicine is used.

Before you begin treatment with ifosfamide, you and your doctor should talk about the good this medicine will do as well as the risks of using it.

Ifosfamide is to be administered only by or under the immediate supervision of your doctor .

Once a medicine has been approved for marketing for a certain use, experience may show that it is also useful for other medical problems . Although these uses are not included in product labeling, ifosfamide is used in certain patients with the following medical conditions:

• Acute lymphocytic leukemia (a type of cancer of the blood)


• Cancer of the bladder


• Cancer of the bone (including Ewing`s sarcoma)


• Cancer of the breast


• Cancer of the cervix


• Cancer of the endometrium


• Cancers of the head and neck


• Cancer of the lung


• Cancer of the ovaries


• Lymphomas


• Neuroblastoma (a certain type of brain cancer)


• Thymoma and other cancer of the thymus (a small organ beneath the breastbone)


• Tumors in the ovaries


• Wilms` tumor (a cancer of the kidneys occurring mainly in children)

This product is available in the following dosage forms:

• Powder for Solution

Before Using

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

Although there is no specific information comparing use of ifosfamide in children with use in other age groups, this medicine is not expected to cause different side effects or problems in children than it does in adults.

Geriatric

Many medicines have not been studied specifically in older people . Therefore, it may not be known whether they work exactly the same way they do in younger adults or if they cause different side effects or problems in older people . There is no specific information comparing use of ifosfamide in the elderly with use in other age groups.

Pregnancy

Breastfeeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Drug Interactions

Using this medicine with any of the following medicines is not recommended . Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

• Rotavirus Vaccine, Live

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Aprepitant


• Bacillus of Calmette and Guerin Vaccine, Live


• Fosaprepitant


• Influenza Virus Vaccine, Live


• Measles Virus Vaccine, Live


• Mumps Virus Vaccine, Live


• Poliovirus Vaccine, Live


• Rotavirus Vaccine, Live


• Rubella Virus Vaccine, Live


• Smallpox Vaccine


• Typhoid Vaccine


• Varicella Virus Vaccine


• Yellow Fever Vaccine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

• Warfarin

Other Interactions

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Chickenpox (including recent exposure) or


• Herpes zoster (shingles)a€”Risk of severe disease affecting other parts of the body

• Infectiona€”Ifosfamide can decrease your body`s ability to fight infection

• Kidney diseasea€”Effects may be increased because of slower removal of ifosfamide from the body

• Liver diseasea€”Effects may be increased or decreased because the liver both makes ifosfamide work and removes it from the body

Proper Use

Ifosfamide is sometimes given together with certain other medicines. If you are using a combination of medicines, make sure that you take each one at the proper time and do not mix them. Ask your health care professional to help you plan a way to remember to take your medicines at the right times.

While you are receiving ifosfamide, it is important that you drink extra fluids so that you will pass more urine . Also, empty your bladder frequently, including at least once during the night . This will help prevent kidney and bladder problems and keep your kidneys working well . Ifosfamide passes from the body in the urine . If too much of it appears in the urine or if the urine stays in the bladder too long, it can cause dangerous irritation. Follow your doctor`s instructions carefully about how much fluid to drink every day. Some patients may have to drink up to 7 to 12 cups (3 quarts) of fluid a day.

Ifosfamide often causes nausea and vomiting . However, it is very important that you continue to receive the medicine even if you begin to feel ill. Ask your health care professional for ways to lessen these effects.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor`s orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

Precautions

It is very important that your doctor check your progress at regular visits to make sure that this medicine is working properly and to check for unwanted effects.

While you are being treated with ifosfamide, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor`s approval. Ifosfamide may lower your body`s resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your house should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the past several months. Do not get close to them, and do not stay in the same room with them for very long . If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth .

Ifosfamide can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. It can also lower the number of platelets, which are necessary for proper blood clotting. If this occurs, there are certain precautions you can take to reduce the risk of infection or bleeding:

• If you can, avoid people with infections. Check with your doctor immediately if you think you are getting an infection or if you get a fever or chills, cough or hoarseness, lower back or side pain, or have painful or difficult urination .


• Check with your doctor immediately if you notice any unusual bleeding or bruising; black, tarry stools; blood in urine or stools; or pinpoint red spots on your skin .


• Be careful when using a regular toothbrush, dental floss, or toothpick. Your medical doctor, dentist, or nurse may recommend other ways to clean your teeth and gums. Check with your medical doctor before having any dental work done.


• Do not touch your eyes or the inside of your nose unless you have just washed your hands and have not touched anything else in the meantime.


• Be careful not to cut yourself when you are using sharp objects such as a safety razor or fingernail or toenail cutters.


• Avoid contact sports or other situations where bruising or injury could occur.

Side Effects

Along with their needed effects, medicines like ifosfamide can sometimes cause unwanted effects such as blood problems, loss of hair, and problems with the bladder . These and others are described below. Also, because of the way these medicines act on the body, there is a chance that they might cause other unwanted effects that may not occur until months or years after the medicine is used. These may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor .

Although not all of these side effects may occur, if they do occur they may need medical attention .

Check with your doctor immediately if any of the following side effects occur:

More common

• Blood in urine


• Frequent urination


• Painful urination

Less common

• Cough or hoarseness accompanied by fever or chills


• Fever or chills


• Lower back or side pain accompanied by fever or chills

Rare

• Black, tarry stools


• Blood in stools


• Pinpoint red spots on skin


• Unusual bleeding or bruising

Check with your doctor as soon as possible if any of the following side effects occur:

More common

• Agitation


• Confusion


• Hallucinations (seeing, hearing, or feeling things that are not there)


• Unusual tiredness

Less common

• Dizziness


• Redness, swelling, or pain at place of injection

Rare

• Convulsions (seizures)


• Cough or shortness of breath


• Sores in mouth and on lips

Some side effects may occur that usually do not need medical attention . These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common

• Nausea and vomiting

Ifosfamide often causes a temporary loss of hair. After treatment has ended, normal hair growth should return.

After you stop using this medicine, it may still produce some side effects that need attention . During this period of time, check with your doctor immediately if you notice the following side effects:

• Blood in urine

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional .

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