Patient Medication Information: uses, side effects, how to take - PMS-Deferoxamine
ABOUT THIS MEDICATION
What the medication is used for:
pms-DEFEROXAMINE is used in the treatment of 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 required dialysis.
pms-DEFEROXAMINE is also used to test for aluminum overload.
What it does:
pms-DEFEROXAMINE contains the active substance deferoxamine, which is a so-called “chelator”. It works by biding 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 nonmedicinal ingredients are:
Not applicable. The pms-DEFEROXAMINE vials contain the medicinal ingredient deferoxamine mesylate without non-medicinal ingredients.
What dosage forms it comes in:
pms-DEFEROXAMINE is available as 500 mg and 2 g lyophilized powder for injection in vials.
WARNINGS AND PRECAUTIONS
The treatment with pms-DEFEROXAMINE should be started and followed up by a doctor experienced in the treatment of chronic iron or aluminum overload.
BEFORE you use pms-DEFEROXAMINE talk to your doctor or pharmacist if you:
have any hearing or eye sight problems. pms-
DEFEROXAMINE may cause hearing problems and eye sight problems;
- have high blood sugar (diabetes);
- have blood clotting problems;
- have any neurological problems (convulsion, dementia);
- severe kidney problem that does not required dialysis;
- lung disease or problem breathing;
are pregnant or planning to become pregnant. pms-
DEFEROXAMINE can harm the unborn child, especially if it is used during the first 3 months of pregnancy. If the treatment with pms-
DEFEROXAMINE 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 pms-DEFEROXAMINE.
- are breastfeeding.
pms-DEFEROXAMINE 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:
pms-DEFEROXAMINE 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 pms-DEFEROXAMINE, 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 pms-DEFEROXAMINE 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 pms-DEFEROXAMINE. 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
pms-DEFEROXAMINE 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. pms-DEFEROXAMINE 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
pms-DEFEROXAMINE 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 pms-DEFEROXAMINE is 5 mg per kilogram of bodyweight.
The duration of treatment and any change in your individual dose of pms-DEFEROXAMINE 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 aluminium overload. You will be given 5 mg of pms-DEFEROXAMINE per kilogram of bodyweight by slow infusion into a vein during the last 60 minutes of a dialysis session. The aluminium 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 pms-DEFEROXAMINE, tell your doctor at once.
SIDE EFFECTS AND WHAT TO DO ABOUT THEM
As with all medicines, pms-DEFEROXAMINE can cause side effects. The following are the possible side effects of pms-DEFEROXAMINE:
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 healthy 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 1and 10 in 1000 patients)
- vomiting
- abdominal pain
Very rare side effects: (affecting less than 1 in 10,0000 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 | Stop taking drug and call your doctor or pharmacist | |
| Only if severe | In all cases | ||
| 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. | √ | ||
SERIOUS SIDE EFFECTS, HOW OFTEN THEY HAPPEN AND WHAT TO DO ABOUT THEM | |||
Talk with your doctor or pharmacist | |||
| 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 system | √ | ||
| 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 pms-DEFEROXAMINE, contact your doctor or pharmacist.
HOW TO STORE IT
- Keep out of reach and sight of children and pets.
Do not use pms-DEFEROXAMINE after the expiry date shown
on the pack.
- Store the vials containing the dry active substance below 25°C.
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 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:
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- 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 0701E 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 Pharmascience Inc. at1-888-550-6060.
Pharmascience Inc.
Montréal, Canada
H4P 2T4