Consumer Information for: DEFEROXAMINE MESYLATE FOR INJECTION

Consumer Information

Information about the product including what the product is used for, dosage, warnings, proper use and side effects. This summary will not tell you everything about the product. Contact your healthcare professional if you have any questions about the product.


What the medication is used for

Deferoxamine Mesylate for Injection is used in the treatment of the following conditions:

  • acute iron poisoning as an adjunct to the standard treatments,
  • chronic iron overload due to frequent blood transfusion,
  • chronic aluminum overload in patients with end-stage kidney failure requiring dialysis.

Deferoxamine Mesylate for Injection is also used to test for aluminum overload.

What it does

Deferoxamine Mesylate for Injection contains the active substance deferoxamine, which is a so-called “chelator”. It works by binding to excess iron or aluminum in the blood and removing them from the body (through the urine and feces).

When it should not be used
  • If you are allergic (hypersensitive) to deferoxamine.
What the medicinal ingredient is

Deferoxamine mesylate.

What the non-medicinal ingredients are

None. Vials of Deferoxamine Mesylate for Injection contain the medicinal ingredient deferoxamine mesylate without non-medicinal ingredients.

What dosage form it comes in

Deferoxamine Mesylate for Injection is available as 500 mg and 2 g sterile lyophilized powder for injection in vials.

Warnings and precautions

The treatment with Deferoxamine Mesylate for Injection should be started and followed up by a doctor experienced in the treatment of chronic iron or aluminum overload.

BEFORE you use Deferoxamine Mesylate for Injection, talk to your doctor or pharmacist if you:

  • have any hearing or eyesight problems. Deferoxamine Mesylate for Injection may cause hearing problems and eyesight problems;
  • have high blood sugar (diabetes);
  • have blood clotting problems;
  • have any neurological problems (convulsion, dementia);
  • have a severe kidney problem that does not require dialysis;
  • have a lung disease or problem breathing;
  • are pregnant or planning to become pregnant. Deferoxamine Mesylate for Injection can harm the unborn child, especially if it is used during the first 3 months of pregnancy. If the treatment with Deferoxamine Mesylate for Injection is needed, female patients who can get pregnant should use an effective birth control method before starting, while taking, and for at least one month after the last treatment with Deferoxamine Mesylate for Injection
  • are breast-feeding.

Deferoxamine Mesylate for Injection may reduce growth rate. Patients under 16 years of age should be monitored for body weight and height every three months.

Increased risk of eye disorders have been reported in patients older than 65 years of age.

Effects on ability to drive or use machines:
Deferoxamine Mesylate for Injection may affect your sight or hearing, make you feel dizzy, or cause other disturbances of nervous function. If you experience such effects, you should not drive or use machines.

Interactions with this medication

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines in addition to Deferoxamine Mesylate for Injection, including medicines obtained without a prescription. You may need to change the dosage or stop taking one of the medicines.

Drugs that may interact with Deferoxamine Mesylate for Injection include:

  • medicines containing prochlorperazine, a neuroleptic drug used to treat neurological disorders
  • vitamin C
  • erythropoietin
  • gallium-67, a medicine given before imaging (scanning, which is used in diagnosis of certain diseases)

In patients without heart failure, their doctor may tell them to take vitamin C one month before and during regular treatment with Deferoxamine Mesylate for Injection. The maximum daily dose of vitamin C should not exceed 200 mg for adult patients, 100 mg in older children and 50 mg for children under 10 years of age. However, their doctor also needs to monitor their heart function.

Proper use of this medication

Your doctor has chosen the right dose and method of administration for your particular condition. Follow your doctor’s instructions carefully. Make sure you use the medication exactly as your doctor tells you.

Usual dose

Acute iron poisoning
Deferoxamine Mesylate for Injection can be used in cases of poisoning with iron preparations. This treatment is carried out in hospital.

Chronic iron overload
Daily doses of 20 to 60 mg per kilogram bodyweight. Deferoxamine Mesylate for Injection can be given by slow infusion under the skin (subcutaneously), by infusion into a vein (intravenously), or by injection into a muscle (intramuscularly).

Chronic aluminum overload in patients with severe kidney disease
Deferoxamine Mesylate for Injection is usually given once a week by slow infusion into a vein during the last 60 minutes of a dialysis session, or 5 hours before a dialysis session, depending on the aluminum concentration in your blood.

The dose of Deferoxamine Mesylate for Injection is 5 mg per kilogram of bodyweight.

The duration of treatment and any change in your individual dose of Deferoxamine Mesylate for Injection will depend on the results of the tests carried out by your doctor.

Diagnosis of aluminum overload
If you are receiving dialysis, your doctor will want to test whether you have aluminum overload. You will be given 5 mg of deferoxamine mesylate per kilogram of bodyweight by slow infusion into a vein during the last 60 minutes of a dialysis session. The aluminum content of blood samples taken just before this dialysis session and the next one will be determined.

Overdose

In case of drug overdose, contact a health care practitioner, hospital emergency department or regional Poison Control Centre immediately, even if there are no symptoms.

Missed Dose

If you have missed a dose of Deferoxamine Mesylate for Injection, tell your doctor at once.

Side effects and what to do about them

As with all medicines, Deferoxamine Mesylate for Injection can cause side effects. The following are the possible side effects of Deferoxamine Mesylate for Injection:

Very common side effects: (affecting more than 10 in 100 patients)

  • injection site reaction such as pain, swelling, reddening, itching of the skin, eschar (dead tissue that sheds from health skin), crust formation, small blisters, burning
  • joint or muscle pain

Common side effects: (affecting more than 1 and less than 10 in 100 patients)

  • nausea
  • headache
  • itchy rash
  • fever
  • reduced growth rate, bone disorders

Uncommon side effects: (affecting between 1 and 10 in 1000 patients)

  • vomiting
  • abdominal pain

Very rare side effects: (affecting less than 1 in 10 000 patients)

  • diarrhea
  • skin rash
  • sensation of numbness or tingling in fingers and toes

Unknown frequency:

  • muscle spasms
  • abnormal liver or kidney function test results
  • a low blood level of calcium, and worsening hyperparathyroidism in patients treated for aluminum overload
  • reddish-brown urine
  • low blood pressure, increased heart rate and shock

If any of the side effects gets serious or you experience any other side effects not listed in this leaflet, please tell your doctor or pharmacist.

Serious side effects, how often they happen and what to do about them
Symptom / effect Talk with your doctor or pharmacist Only if severe Talk with your doctor or pharmacist In all cases Stop taking drug and call your doctor or pharmacist
Uncommon
Disturbances of hearing such as ringing or noise in the ears, hearing loss   ✔  
Rare
Disturbances of vision such as blurred eyesight, abnormal colour vision, night blindness, black spots in the vision, loss of vision, clouding of the lens of the eye, visual field defects or decreased sharpness of vision   ✔  
Fungal or bacterial infections leading to high fever, shortness of breath, acute diarrhea, abdominal pain, general discomfort or sore throat.   ✔  
Dizziness, light-headedness (signs of low blood pressure that can occur when the drug is given too rapidly)   ✔  
Very rare
Breathlessness due to lung disorders   ✔  
Unusual bleeding/bruising (a sign that levels of blood platelets are low) ✔    
Fever, sore throat or mouth ulcers due to infections ( a sign that levels of white blood cells are low) ✔    
Rash itching, hives, difficulty breathing or swallowing, feeling of tightness in the chest with wheezing or coughing, dizziness, swelling mainly of the face and throat (signs of a severe allergic reaction or asthma)   ✔  
Disturbances of the nervous systems   ✔  
Unknown
Severely decreased output of urine (sign of a kidney problem)   ✔  
Convulsions (mainly in patients on dialysis)   ✔  

This is not a complete list of side effects. For any unexpected effects while taking Deferoxamine Mesylate for Injection, contact your doctor or pharmacist.
How to store
  • Keep out of reach and sight of children and pets.
  • Do not use Deferoxamine Mesylate for Injection after the expiry date shown on the pack.
  • Store Deferoxamine Mesylate for Injection vials containing the dry active substance between 15 and 25°C. Protect from light.
  • One vial is for single-use only. The product should be used immediately after the solution has been made up (reconstituted), i.e. treatment should start within 3 hours. When the solution has been prepared under recognized sterile conditions, it may be stored for a maximum period of 24 hours at room temperature before the start of treatment. Opaque or cloudy solutions should be discarded.
  • Remember to return any unused vials to your pharmacist
Reporting 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 1908C
                    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 be obtained by contacting the sponsor, Pfizer Canada Inc., at 1-800-463-6001.

This leaflet was prepared by:
Pfizer Canada Inc., Kirkland, Québec H9J 2M5

Last revised: July 12, 2017

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