Desferal (Deferoxamine)

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

BEFORE you use DESFERAL talk to your doctor or pharmacist if you:

• have any hearing or eye sight problems. DESFERAL 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. DESFERAL can harm the unborn child, especially if it is used during the first 3 months of pregnancy. If the treatment with DESFERAL 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 DESFERAL;
• are breastfeeding.

DESFERAL 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:

DESFERAL 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.

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 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

Tell your doctor or pharmacist if you are taking or have recently taken any other medicines in addition to DESFERAL, 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 DESFERAL 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 DESFERAL. 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.

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:

DESFERAL 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. DESFERAL 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:

DESFERAL 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 DESFERAL is 5 mg per kilogram of bodyweight.

The duration of treatment and any change in your individual dose of DESFERAL 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 DESFERAL 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 DESFERAL, tell your doctor at once.