Pronunciation:

eye-FOS-fa-mide

Brand Names:

• Ifex

Dosage Forms:

• Powder for Solution
• Solution

Warnings:

Myelosuppression can be severe and lead to fatal infections. Monitor blood counts prior to and at intervals after each treatment cycle. CNS toxicities can be severe and result in encephalopathy and death. Monitor for CNS toxicity and discontinue treatment for encephalopathy. Nephrotoxicity can be severe and result in renal failure. Hemorrhagic cystitis can be severe and can be reduced by the prophylactic use of mesna .

Classifications:

Therapeutic—

Antineoplastic Agent

Pharmacologic—

Alkylating Agent

Chemical—

Nitrogen Mustard

Uses of This Medicine:

Ifosfamide belongs to the group of medicines called alkylating agents. Ifosfamide injection is used in combination with other medicines to treat cancer of the testicles.

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 benefits this medicine will do as well as the risks of using it.

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

Before Using This Medicine:

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.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of ifosfamide injection in the pediatric population. Safety and efficacy have not been established.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of ifosfamide injection in the elderly. However, elderly patients are more likely to have age-related kidney problems, which may require caution and an adjustment in the dose for patients receiving ifosfamide injection.

Breast-feeding—

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.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. When you are receiving this medicine, it is especially important that your healthcare professional know if you are taking any of the medicines listed below. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

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.

• Measles Virus Vaccine, Live
• Mumps Virus Vaccine, Live
• Rotavirus Vaccine, Live
• Rubella Virus Vaccine, Live
• Varicella Virus Vaccine, Live
• Zoster 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.

• Abametapir
• Abiraterone Acetate
• Adenovirus Vaccine, Live
• Amprenavir
• Aprepitant
• Atazanavir
• Bacillus of Calmette and Guerin Vaccine, Live
• Boceprevir
• Bupropion
• Carbamazepine
• Ceritinib
• Cholera Vaccine, Live
• Ciprofloxacin
• Clarithromycin
• Cobicistat
• Conivaptan
• Crizotinib
• Darunavir
• Delavirdine
• Dengue Tetravalent Vaccine, Live
• Diltiazem
• Dronedarone
• Ebola Zaire Vaccine, Live
• Efavirenz
• Erythromycin
• Etravirine
• Fedratinib
• Fexinidazole
• Fluconazole
• Fosamprenavir
• Fosaprepitant
• Fosphenytoin
• Idelalisib
• Imatinib
• Indinavir
• Influenza Virus Vaccine, Live
• Itraconazole
• Ketoconazole
• Lemborexant
• Lopinavir
• Lorlatinib
• Mavacamten
• Miconazole
• Mifepristone
• Modafinil
• Nefazodone
• Nelfinavir
• Nevirapine
• Omaveloxolone
• Oxcarbazepine
• Phenobarbital
• Phenytoin
• Pioglitazone
• Poliovirus Vaccine, Live
• Posaconazole
• Primidone
• Rifabutin
• Rifampin
• Ritonavir
• Saquinavir
• Smallpox Monkeypox Vaccine, Live Non-Replicating
• Smallpox Vaccine
• Sorafenib
• Sparsentan
• St John's Wort
• Telaprevir
• Telithromycin
• Ticagrelor
• Tipranavir
• Typhoid Vaccine, Live
• Verapamil
• Voriconazole
• 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. The following interactions have been selected on the basis of their potential significance and are not necessarily all-inclusive.

Using this medicine with any of the following is usually not recommended, but may be unavoidable in some cases. If used together, your doctor may change the dose or how often you use this medicine, or give you special instructions about the use of food, alcohol, or tobacco.

• Grapefruit Juice

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:

• Anemia or
• Bone marrow problems (e.g., granulocytopenia, leukopenia, neutropenia, thrombocytopenia) or
• Bone problems (e.g., osteomalacia) or
• Brain disease (e.g., encephalopathy) or
• Fanconi syndrome (kidney disease) or
• Heart disease or
• Lung disease (e.g., interstitial pneumonitis, pulmonary fibrosis) or
• Sepsis (severe infection in the blood) or
• Urinary tract infection or
• Veno-occlusive liver disease—Use with caution. May make these conditions worse.

• Infection (bacteria, virus, fungus)—May decrease your body's ability to fight infection.

• Kidney disease or
• Liver disease—Use with caution. The effects may be increased because of slower removal of the medicine from the body.

• Urinary blockage—Should not be used in patients with this condition.

Proper Use of This Medicine:

A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through a needle placed in one of your veins. The medicine must be injected slowly, so your IV tube will need to stay in place for 30 minutes.

This medicine is usually given for 5 consecutive days. This 5-day treatment is given again every 3 weeks or when your body can tolerate it.

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 doctor 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.

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 doctor for ways to lessen these effects.

Precautions While Using This Medicine:

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

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant. Women should not become pregnant during therapy and men should not father a child while receiving this medicine and for 6 months after stopping it. If you think you have become pregnant while using the medicine, tell your doctor right away.

While you are being treated with ifosfamide, and after you stop treatment with it, do not have any immunizations (vaccines) 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. This may also cause delay in wound healing. 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 the 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.

This medicine may cause a brain disease called encephalopathy. Tell your doctor right away if you have the following symptoms while taking this medicine: agitation, back pain, blurred vision, coma, confusion, dizziness, drowsiness, fever, hallucinations, headache, irritability, mood or mental changes, seizures, stiff neck, or unusual tiredness or weakness.

This medicine may cause drowsiness, trouble in thinking, trouble in controlling movements, or trouble in seeing clearly. Make sure you know how you react to this medicine before you drive, use machines, or do other jobs that require you to be alert, well-coordinated, or able to think or see well.

This medicine will add to the effects of alcohol and other CNS depressants (medicines that make you drowsy or less alert). Some examples of CNS depressants are antihistamines or medicine for hay fever, other allergies, or colds; sedatives, tranquilizers, or sleeping medicine; prescription pain medicine or narcotics; medicine for seizures or barbiturates; muscle relaxants; or anesthetics, including some dental anesthetics. Check with your medical doctor or dentist before taking any of the above while you are using this medicine.

This medicine may cause children to grow more slowly than usual. Talk to your child's doctor if you have any concerns.

Using this medicine may increase your risk of getting lymphoma (cancer of the lymph nodes) and other types of cancers (such as leukemia, sarcoma, thyroid cancer). Talk to your doctor if you have concerns about this risk.

If you plan to have children, talk with your doctor before using this medicine. Some men and women using this medicine have become infertile (unable to have children).

This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, hoarseness, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while you are using this medicine.

Do not eat grapefruit or drink grapefruit juice while you are using this medicine without asking your doctor first.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal (e.g., St. John's wort) or vitamin supplements.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

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

More common

Agitation

black, tarry stools

blood in the urine

chest pain

confusion

cough or hoarseness

fever or chills

frequent urination

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

lower back or side pain

painful or difficult urination

pale skin

shortness of breath

sore throat

sores, ulcers, or white spots on the lips or in the mouth

swollen glands

troubled breathing with exertion

unusual bleeding or bruising

unusual tiredness or weakness

Less common

Abdominal or stomach pain or tenderness

bleeding gums

bluish color

changes in skin color

clay colored stools

dark urine

decreased appetite

dizziness

headache

itching

loss of appetite

nausea and vomiting

pain

pinpoint red spots on the skin

skin rash

swelling of the feet or lower legs

yellow eyes or skin

Rare

Blurred vision

burning, numbness, tingling, or painful sensations

confusion

convulsions (seizures)

dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position

fast or irregular heartbeat

sweating

troubled breathing

unsteadiness or awkwardness

weakness in the arms, hands, legs, or feet

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

Diarrhea

hair loss or thinning of the hair

swelling or inflammation of the mouth

Less common

Redness, swelling, or pain at place of injection

weight loss

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.