Ifosfamide for Injection: Uses, Side Effects and Dosage

ABOUT THIS MEDICATION

What the medication is used for:

Ifosfamide for Injection 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:

Ifosfamide for Injection 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 Ifosfamide for Injection.

What dosage forms it comes in:

Ifosfamide for Injection is available as a sterile lyophilized 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

BEFORE you use Ifosfamide for Injection 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. Ifosfamide for Injection may prevent normal wound healing;

• Pregnant or planning to become pregnant;

• Breast feeding.

Ifosfamide for Injection may cause other types of cancer. Ifosfamide for Injection may cause harm to an unborn baby. Female patients should use an effective birth control method while using ifosfamide. Male patients should not father a child while using ifosfamide and for up to 6 months after the last dose of ifosfamide.

Do not breastfeed while using Ifosfamide for Injection, the drug can get into the breast milk, and therefore, into the baby.

INTERACTIONS WITH THIS MEDICATION

Before and while taking Ifosfamide for Injection, you should always tell your doctor or pharmacist about other medications,

Ifosfamide for Injection – Product Monograph

including those you can buy without a prescription. The following drugs or procedures may interact with Ifosfamide for Injection:

• 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

Your doctor will determine what dose of Ifosfamide for Injection 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.

Ifosfamide for Injection 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:

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 for Injection 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.

Ifosfamide for Injection – Product Monograph

* 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 Ifosfamide for Injection, contact your doctor or pharmacist.

HOW TO STORE IT

Store Ifosfamide for Injection vials at room temperature between 15 °C and 25° C. Protect from temperatures above 30 °C.

Reporting Side Effects

MORE INFORMATION

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Fresenius Kabi Canada Ltd., at 1-877-821-7724.

Fresenius Kabi Canada Ltd.

165 Galaxy Blvd, Suite 100

Toronto, ON M9W 0C8

Last Revised: October 10, 2018