Patient Medication Information: uses, side effects, how to take - Ifex
What is IFEX used for?
IFEX (ifosfamide) is used to treat:
- soft tissue cancers
- cancer of the pancreas in patients who have had prior cancer treatments
- Advanced or recurrent cancer of the cervix alone or in combination with cisplatin or bleomycin
How does IFEX work?
Ifosfamide interferes with the growth of cancer cells and slows their growth and spread in the body. Ifosfamide may also affect the growth of normal body cells, leading to undesirable side effects.
What are the ingredients in IFEX?
Medicinal ingredients: Ifosfamide
Non-medicinal ingredients: There are no nonmedicinal ingredients in IFEX.
Serious Warnings and Precautions
IFEX should be used under the supervision of a doctor experienced with drugs used to treat cancer. Serious side effects with IFEX include:
Certain medications can affect the blood level of IFEX, and may increase the risk of having serious side effects. |
IFEX comes in the following dosage forms:
IFEX is available as a sterile powder supplied in 1 g and 3 g vials. It is reconstituted and further diluted for intravenous infusion.
Do not use IFEX if:
- you have urinary tract disease (obstructions to the urine flow (difficulty with urination); bladder inflammation)
- you have severe suppression of bone marrow function
- you have severe kidney problems
- you have severe liver problems
- you have active infection/suppressed immune system
- you have hardening of the artery walls in the brain
- you are allergic to ifosfamide
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take IFEX. Talk about any health conditions or problems you may have, including if you:
have the following risk factors for conditions that cause brain dysfunction (encephalopathy)
- when your body doesn't produce enough of the albumin protein, or when you lose too much albumin in your urine or stool (Hypoalbuminemia),
- impaired kidney function,
- patient's level of functioning in terms of their ability to care for themself (poor performance status),
- presence of tumour in lower abdomen, bulky abdominal disease (pelvic disease), and
- previous or related nephrotoxic treatments including cisplatin.
- have pre-existing cardiac disease
- have previously received radiation treatment, or any cancer treatment that destroys or damages body cells (cytotoxicity);
- have cancer that has spread to the brain;
- have low white blood cell count, or cancer that has spread to the bone marrow;
- have liver problems;
- have kidney problems;
- have heart problems;
- have lung problems;
- have infections, or bladder infection (cystitis);
- have disorder of the nervous system;
- have surgery or had one in the previous 2 weeks. IFEX may prevent normal wound healing;
are pregnant or planning to become pregnant;
- are breast feeding.
Other warnings you should know about:
Cancer: IFEX may cause other types of cancer.
Birth control, Pregnancy and breast-feeding:
Female patients:
- Should use an effective birth control method while using IFEX.
- Keep taking birth control and not become pregnant for up to 12 months, after the last dose of IFEX.
- Do not breastfeed while using IFEX, the drug can get into the breast milk, and therefore, into the baby.
Male patients:
- Should not father a child while using IFEX and for up to 6 months after the last dose of IFEX.
Driving and using machines: IFEX may impair your ability to operate an automobile or other heavy machinery. Even if you have not felt these effects, you must still be cautious.
Heart problems: Cardiotoxic effects (heart damage arising from cancer treatment) is increased in patients with treatment with:
- Other substances that negatively affect the heart (cardiotoxic agents) or
- radiation of the heart region and,
- possibly, kidney problems
Monitoring and Laboratory Tests:
- You will be monitored for condition that cause brain dysfuctions (encephalopathies)
- You will be monitored for kidney function.
- You will be monitored for signs of toxicity.
- Your healthcare professional will do regular blood tests.
Tell your healthcare professional about all the medicines you take, including any drugs, vitamins, minerals, natural supplements or alternative medicines.
The following may interact with IFEX:
Alcohol;
- Antibiotics (aminoglycosides);
- Anticoagulant such as Warfarin;
- Antidepressants including St. John’s Wort;
- Antihistamines;
- Anti-epileptics (phenytoin, carbamazepine);
- Anti-fungal medications (ketoconazole, fluconazole);
- Anti-viral medications;
- Medications for high blood pressure (ACE inhibitors);
- Medications to treat heart problems (amiodarone);
- Corticosteroids;
- Medications to prevent vomiting (aprepitant);
- Medication to stimulate the bone marrow;
- Medications to treat cancers (docetaxel, cisplatin);
- Sedatives;
- Natalizumab (or Tysabri for multiple sclerosis);
- Vaccines, especially live-vaccines;
- Previous irradiation of the cardiac region and urinary bladder area
How to take IFEX:
IFEX will be given to you by a healthcare professional in a healthcare setting.
Usual dose:
Your doctor will determine what dose of IFEX is right for you and how often you should receive it.
Usual dose: 2000 – 2400 mg/m2 body surface area per day given as an intravenous (into the vein) infusion over a period of a minimum of 30 minutes, on 5 consecutive days. This 5-day treatment is called a treatment cycle.
The administration of high single dose infusions is feasible up to 5000-8000 mg/m2/24 h under protection of continuous mesna infusion to reduce the risk of urotoxicity.
The treatment cycle should be repeated every 3-4 weeks.
IFEX should always be given with mesna to prevent bladder problems. It is also important to drink extra fluids to help prevent kidney and bladder problems.
Overdose:
| If you think you, or a person you are caring for, have taken too much IFEX, contact a healthcare professional, hospital emergency department, or regional poison control centre or Health Canada’s toll-free number, 1-844 POISON-X (1-844-764-7669) immediately, even if there are no symptoms. |
|---|
Missed Dose:
If you miss your scheduled treatment, contact your healthcare professional as soon as possible to schedule your next treatment.
What are possible side effects from using IFEX?
These are not all the possible side effects you may have when taking IFEX. If you experience any side effects not listed here, tell your healthcare professional.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| VERY COMMON | |||
| Anemia (reduction in red blood cells): Tiredness, fatigue, loss of energy, being short of breath, looking pale, bruising or bleeding for longer than usual if you hurt yourself. | √ | ||
| Gastrointestinal disorders: stomach pain, decreased appetite, diarrhea, injection, nausea, vomiting, and constipation. | √ | ||
| Kidney or urinary problems: Blood in urine, difficulty and pain when passing urine, exaggerated sense of needing to urinate, nausea, vomiting, fever, swelling of extremities, fatigue, thirst, dry skin, irritability, dark urine, increased or decreased urine output, blood in the urine, rash, weight gain (from retaining fluid), loss of appetite, abnormal blood test results, mental status changes (drowsiness, confusion, coma). | √ | ||
| Leukopenia (decreased white blood cells): infections, fatigue, breathlessness, fever, aches, pains, flu-like symptoms and bruising and bleeding more easily. | √ | ||
| Nervous System problems: Harmful effects to the brain such as cognitive disorder, behaving in an abnormal manner, being aggressive, being agitated or anxious, being confused or disoriented, coma, convulsions, depression, dizziness, forming of mental images, hallucinations, headache, impaired thinking, loss of balance, loss of understanding, memory impairment, mood change, muscle spasms, | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| restlessness, somnolence/ sleepiness, tremor, weakness, or paralysis of limbs or face, difficulty speaking, severe headache, seeing, feeling or hearing things that are not there, loss of consciousness, confusion, disorientation, trembling. | |||
| Skin and Tissue disorders: Hair Loss. | √ | ||
| COMMON | |||
| Hypotension (low blood pressure): dizziness, fainting, light-headedness, blurred vision, nausea, vomiting, fatigue (may occur when you go from lying or sitting to standing up). | √ | ||
| Liver problems: yellow skin and whites of eyes, nausea, tiredness, loss of appetite, fever, skin rash, joint pain and inflammation, pain in the upper right abdomen, pale stools and dark-coloured urine. | √ | ||
| Neutropenia (decreased white blood cells): infections, fatigue, fever, aches, pains and flu-like symptoms (see Leukopenia). | √ | ||
| Peripheral neuropathy: Damaged nerves that cause weakness, numbness and pain, usually in the hands and feet. | √ | ||
| Phlebitis (swelling of a vein): pain, tenderness, redness or swelling, feeling of discomfort (malaise). | √ | ||
| Skin reactions: Papular rash Raised area of the skin that causes redness, skin inflammation. | √ | ||
| Stomatitis (mouth sores): redness and swelling of the lining of the mouth. | √ | ||
| Thrombocytopenia (low blood platelets): bruising or bleeding for | √ | ||
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help | |
|---|---|---|---|
| Only if severe | In all cases | ||
| longer than usual if you hurt yourself, fatigue and weakness. | |||
| UNCOMMON | |||
| Stomach problems: Diarrhea (frequent bowel movement). | √ | ||
| Cardiovascular problems (heart problems): Heart troubles, heart failure, fast heart beat, low blood pressure, heart damage arising from cancer treatment (cardiotoxicity), death. | √ | ||
| General feeling of discomfort, illness, or lack of well-being, fatigue. | √ | ||
| Stomatitis: Mouth inflammation. | √ | ||
| Skin reactions: Raised area of the skin that causes redness, skin inflammation. | √ | ||
| Peripheral neuropathy: Damaged nerves that cause weakness, numbness and pain, usually in the hands and feet. | √ | ||
| UNKNOWN | |||
| Leukemia (Cancer of the blood): Fatigue, breathlessness, infections, and bruising or bleeding more easily. | √ | ||
If you have a troublesome symptom or side effect that is not listed here or becomes bad enough to interfere with your daily activities, tell your healthcare professional.
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
Storage:
Store at controlled room temperature (20° to 25° C). Protect from temperatures above 30 °C.
Reconstituted and further diluted solutions should be used within 24 hours from the time of the initial constitution or within 72 hours when refrigerated when stored in glass bottles, viaflex bag or PAB bags.Keep out of reach and sight of children.
If you want more information about IFEX:
- Talk to your healthcare professional
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website: (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html; the manufacturer’s website www.baxter.ca, or by calling 1-800-387-8399.