Description
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 then destroyed by the body. Since the growth of normal body cells may also be affected by temozolomide injection, other side effects may occur. Some of these may be serious and must be reported to your doctor. Some side effects may not occur for 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 given only by or under the direct supervision of a doctor.
This product is available in the following dosage forms:
- Powder for Solution
- 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
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. Children receiving this medicine are more likely to have kidney problems and slowed growth.
This medicine may cause infertility (unable to have children) in females and may increase the risk of early menopause. This medicine may also cause sterility and testicular atrophy in teenage males.
Geriatric
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.
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
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.
- Bacillus of Calmette and Guerin Vaccine, Live
- Dengue Tetravalent Vaccine, Live
- Measles Virus Vaccine, Live
- Mumps Virus Vaccine, Live
- Rubella Virus Vaccine, Live
- Smallpox Monkeypox Vaccine
- Typhoid Vaccine
- Varicella Virus Vaccine
- Yellow Fever Vaccine
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
- Abiraterone Acetate, Micronized
- Adenovirus Vaccine Type 4, Live
- Adenovirus Vaccine Type 7, Live
- Amprenavir
- Aprepitant
- Atazanavir
- Avacopan
- Boceprevir
- Bupropion
- Carbamazepine
- Ceritinib
- Cholera Vaccine
- Ciprofloxacin
- Clarithromycin
- Cobicistat
- Conivaptan
- Crizotinib
- Darunavir
- Delavirdine
- Diltiazem
- Dronedarone
- Ebola Zaire Vaccine, Live
- Efavirenz
- Erythromycin
- Etravirine
- Fedratinib
- Fexinidazole
- Fluconazole
- Fosamprenavir
- Fosaprepitant
- Fosphenytoin
- Hydroxychloroquine
- Idelalisib
- Imatinib
- Indinavir
- Influenza Virus Vaccine, Live
- Itraconazole
- Ketoconazole
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.
- Mavacamten
- 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 (eg, granulocytopenia, leukopenia, neutropenia, thrombocytopenia) or
- Bone problems (eg, osteomalacia) or
- Brain disease (eg, encephalopathy) or
- Heart disease or
- Kidney disease or
- Liver disease or
- Lung disease (eg, interstitial pneumonitis, pulmonary fibrosis) or
- Sepsis (severe infection in the blood) or
- Urinary tract infection—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
Medicines used to treat cancer are very strong and can have many side effects. Before receiving this medicine, make sure you understand all the risks and benefits. It is important for you to work closely with your doctor during your treatment.
A nurse or other trained health professional will give you this medicine in a hospital or cancer treatment center. This medicine is given through an IV catheter that is placed in one of your veins. The medicine must be injected slowly, so your IV 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
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.
Receiving this medicine while you are pregnant can harm your unborn baby. If you are a woman who can get pregnant, your doctor may do tests to make sure you are not pregnant. Female patients should use an effective form of birth control during treatment and for at least 12 months after the last dose. Male patients who have female partners should use effective birth control during treatment and for at least 6 months after the last dose. If you think a pregnancy has occurred while receiving this medicine, tell your doctor right away.
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 condition called encephalopathy. Tell your doctor right away if you have 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.
Check with your doctor right away if you have blood in the urine, change in frequency of urination or amount of urine, drowsiness, increased thirst, loss of appetite, nausea or vomiting, swelling of the feet or lower legs, trouble breathing, or weakness. These maybe symptoms of serious kidney problems.
This medicine may cause heart problems (eg, arrhythmias, heart failure). Check with your doctor right away if you have chest pain or discomfort, fainting, fast, pounding, or irregular heartbeat or pulse, palpitations, or trouble breathing.
Check with your doctor right away if you have blue lips, fingernails, or skin, cough, fever, or trouble breathing. These maybe symptoms of lung or breathing problems (eg, interstitial pneumonitis, pulmonary fibrosis, respiratory failure).
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 (eg, leukemia, sarcoma, thyroid cancer). Talk to your doctor if you have concerns about this risk.
Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.
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 allergic reaction, including anaphylaxis, which 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 take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.
Side Effects
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
- sore throat
- sores, ulcers, or white spots on the lips or in the mouth
- swollen glands
- trouble breathing
- unusual bleeding or bruising
- unusual tiredness or weakness
Less common
- 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
- stomach pain or tenderness
- swelling of the feet or lower legs
- yellow eyes or skin
Rare
- Blurred vision
- burning, numbness, tingling, or painful sensations
- confusion
- dizziness, faintness, or lightheadedness when getting up suddenly from a lying or sitting position
- fast or irregular heartbeat
- seizures
- sweating
- 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.
DRG-20064266
