What Ifex is used for and how to use it
Россия
  • Россия
  • Украина

Ifex - Consumer Medicine Information

Manufacture: Baxter
Country: Canada
Condition: Cancer, Cervical Cancer, Testicular Cancer
Class: Alkylating agents
Form: Intravenous (IV), Powder
Ingredients: Ifosfamide

IFEX

(Ifosfamide for Injection)

About this Medication

What the medication is 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

What it does

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.

When it should not be used

IFEX should not be used if you have:

  • urinary tract disease (obstructions to the urine flow (difficulty with urination); bladder inflammation)
  • severe suppression of bone marrow function
  • severe kidney problems
  • severe liver problems
  • active infection/suppressed immune system
  • hardening of the artery walls in the brain
  • allergy to ifosfamide

What the medicinal ingredient is

Ifosfamide

What the important nonmedicinal ingredients are

There are no nonmedicinal ingredients in IFEX.

What dosage forms it comes in

IFEX is available as a sterile powder supplied in 1 g and 3 g vials. It is reconstituted and further diluted for intravenous infusion.

Warnings and Precautions

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:

  • Urotoxic side effects (on the kidneys and urinary bladder), especially hemorrhagic cystitis (inflammation and bleeding inside the bladder). IFEX should always be used with a drug called mesna that helps to prevent hemorrhagic cystitis.
  • A severe decrease in the production of blood cells (myelosuppression)
  • Neurotoxicity such as confusion and coma
  • Rarely, serious lung diseases such as interstitial pneumonitis, pulmonary fibrosis

Certain medications can affect the blood level of IFEX, and may increase the risk of having serious side effects.

BEFORE you use IFEX talk to your doctor or pharmacist if you have any of the following conditions:

  • Previously received radiation treatment, or any cancer treatment that destroys or damages body cells (cytotoxicity);
  • Cancer that has spread to the brain;
  • Low white blood cell count, or cancer that has spread to the bone marrow;
  • Liver problems;
  • Kidney problems;
  • Heart problems;
  • Lung problems;
  • Infections, or bladder infection (cystitis);
  • Disorder of the nervous system;
  • Surgery or had one in the previous 2 weeks. IFEX may prevent normal wound healing;
  • Pregnant or planning to become pregnant;
  • Breast feeding.

IFEX may cause other types of cancer.IFEX may cause harm to an unborn baby. Female patients should use an effective birth control method while using IFEX. Male patients should not father a child while using IFEX and for up to 6 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.

Interactions with this Medication

Before and while taking IFEX, you should always tell your doctor or pharmacist about other medications, including those you can buy without a prescription. The following drugs or procedures 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.

Proper Use of this Medication

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 have been given more IFEX than you should, contact a health care practitioner, or a hospital emergency department or a local Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you miss your scheduled treatment, contact your doctor or nurse as soon as possible to schedule your next treatment.

Side Effects and what to do about them

Ifosfamide can sometimes cause unwanted effects such as blood problems, loss of hair, and problems with the bladder. Also, because of the way the drug acts on the body, there is a chance that it might cause other unwanted effects that may not occur until months or years later. These may include certain types of cancer, such as leukemia. Discuss these possible effects with your doctor.

Serious side effects and what to do about them

Symptom / effectTalk with
your doctor or
pharmacist
Stop taking
drug and
call your
doctor or
pharmacist
Only
if
severe
In all
cases
Very
Common
Anemia
Kidney problems
Blood in Urine
Central Nervous
System Troubles*
Loss of hair
Low platelet count
Low white cell
count
Nausea/Vomiting
Urinary Problems
CommonFever or fever with
low white cell count
Infection
Liver problems
Loss of Appetite
Vein inflammation
UncommonDiarrhea
Fatigue
Heart troubles
Low blood pressure
Malaise
Mouth inflammation
Papular rash
Peripheral
neuropathy**
Skin inflammation

* For example, Abnormal behavior, Aggression, Agitation, Anxiety, Cognitive disorder, Coma, Confusion, Convulsions, Depression, Disorientation, Dizziness, Hallucinations, Headache, Ideation, Loss of balance, Loss of understanding, Memory impairment, Mood change, Muscle spasms, Restlessness, Somnolence, Tremor, Weakness.

** For example, numbness of the hands and feet.

This is not a complete list of side effects. For any unexpected effects while taking IFEX, contact your doctor or pharmacist.

How to Store it

Store at controlled room temperature (20° to 25° C). Protect from temperatures above 30 °C.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701D
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect Canada Web site at www.healthcanada.gc.ca/medeffect.

NOTE: Should you require information related to the management of side effects, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can obtained by contacting the sponsor at:
Baxter Corporation, at:
1-888-719-9955