Desferal

Desferal is a prescription medication used to treat acute iron intoxication and chronic iron overload due to transfusion-dependent anemias. It removes excess iron in the body. If you have too much iron in the body, it can damage various organs and tissues.

Desferal belongs to a group of drugs called chelating agents. Desferal works by combining with iron in the blood. The combination of iron and Desferal is then removed from the body by the kidneys.

This medication is available in an injectable form to be given directly into a vein (IV) or a muscle (IM) or injected under the skin (subcutaneously) by a healthcare professional.

Common side effects of Desferal include redness or flushing of the skin, difficulty breathing, fast heartbeat, and injection site reactions.

Desferal can also cause blurred vision and dizziness. Do not drive or operate heavy machinery until you know how Desferal affects you.

Desferal is a prescription medication used to treat acute iron intoxication and chronic iron overload due to transfusion-dependent anemias by removing excess iron in the body.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

• Novartis Pharmaceuticals Corporation

Serious side effects have been reported with Desferal. See the “Desferal Precautions” section.

Common side effects of Deferal include the following:

• bluish fingernails, lips, or skin
• blurred vision or other problems with vision
• convulsions (seizures)
• difficulty with breathing or fast breathing
• fast heartbeat
• hearing problems
• redness or flushing of the skin

This is not a complete list of Desferal side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• vitamin C
• prochlorperazine (Compazine, Compro)
• gallium-67

This is not a complete list of drug interactions. Ask your doctor or pharmacist for more information.

Serious side effects have been reported with Desferal including the following:

Tell your healthcare provider right away if you have some or all of the following symptoms while receiving Desferal:

• bluish fingernails, lips, or skin
• blurred vision or other problems with vision
• convulsions (seizures)
• difficulty with breathing or fast breathing
• fast heartbeat
• hearing problems
• redness or flushing of the skin
• diarrhea
• difficult urination
• fever
• leg cramps
• nausea
• stomach and muscle cramps
• stomach discomfort
• unusual bleeding or bruising
• vomiting

Desferal can cause blurred vision and dizziness. Do not drive or operate heavy machinery until you know how Desferal affects you.

Do not take Desferal if you:

• are allergic to Desferal or to any of its ingredients
• have severe renal disease or are unable to pass urine

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Desferal, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Desferal, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• are allergic to Desferal or to any of its ingredients
• have aluminum overload
• are receiving dialysis treatment
• have aluminum-related encephalopathy (brain disease)
• have or have had anuria (the inability to form urine)
• have severe kidney disease or any kidney problems
• have hyperparathyroidism (overactive parathyroid)
• have or have had seizures
• have an infection of any type
• are pregnant or breastfeeding

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X - are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Desferal falls into category C. In animal studies, pregnant animals were given this medication and had some babies born with problems. No well-controlled studies have been done in humans. Therefore, this medication may be used if the potential benefits to the mother outweigh the potential risks to the unborn child.

Tell your doctor if you are breastfeeding or plan to breastfeed.

It is not known if Desferal crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Desferal.

Take Desferal exactly as prescribed.

This medication is available in an injectable form to be given directly into a vein (IV) or a muscle (IM) or injected under the skin (subcutaneously) by a healthcare professional.

Take this medication exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medications you are taking
• how you respond to this medication
• your weight

The recommended dosage of Desferal for the treatment of acute iron intoxication is a dose of 1000 mg administered intramuscularly. This may be followed by 500 mg every 4 hours for two doses. Depending upon the clinical response, subsequent doses of 500 mg may be administered every 4-12 hours. The total amount of Desferal administered should not exceed 6000 mg in 24 hours. Desferal should be administered intravenously for acute iron intoxication only in patients who are in cardiovascular collapse.

The recommended dosage of Desferal for the treatment of chronic iron overload is 1000-2000 mg (20-40 mg/kg/day) subcutaneously over 8-24 hours using a small portable infusion pump. For patients with intravenous access, Desferal may be administered intravenously for chronic iron overload. The standard dose is 20-40 mg/kg/day for children and 40-50 mg/kg/day over 8-12 hours 5-7 days per week. The infusion rate should not exceed 15 mg/kg/hr.

Alternatively, a daily dose of 500-1000 mg Desferal may be administered intramuscularly for chronic iron overload.

If you take too much Desferal, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Desferal is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if overdose is suspected, seek emergency medical attention.

• Store Desferal at room temperature.
• Keep this and all medicines out of the reach of children.
• Your urine may have a reddish discoloration while taking Desferal.