PATIENT INFORMATION LEAFLET

Desferin 500 mg powder for injection or infusion

Deferoxamine mesylate

Storage of the container and additional information

Desferin belongs to the group of iron chelating preparations. It is used to eliminate excess iron and aluminum from the blood. This may be necessary in patients with certain types of anemia who frequently require blood transfusions (which can lead to iron overload) and in patients with severe kidney failure undergoing maintenance dialysis (which can lead to aluminum overload).

Desferin is indicated for the treatment of:

• chronic iron overload, for example due to frequent blood transfusions in cases of beta-thalassemia major

• acute iron poisoning

• chronic aluminum overload in patients with kidney failure undergoing maintenance dialysis

Desferin can be used to detect iron or aluminum overload.

Desferin is indicated for some patients, but not for all.

Do not use Desferin

• If you are allergic (you have had skin rash or shortness of breath) after using Desferin in the past, inform your doctor.

Warnings and precautions

• Desferin should only be administered by intramuscular or subcutaneous slow injection or by slow intravenous infusion. DO NOT USE a rapid intravenous infusion as it may lead to shock.
• If you have severe kidney disease.
• Never use a dose or concentration of Desferin greater than that indicated by your doctor, as this may cause adverse effects at the injection site, or even affect your vision, hearing, lungs, nervous system, or growth rate.
• If your doctor prescribes vitamin C supplements, ensure that you have been taking Desferin regularly for at least 1 month and take only the doses of vitamin C prescribed by your doctor. High doses of vitamin C (above 500 mg daily) administered during Desferin treatment for chronic iron overload may harm your heart.
• Desferin may favor the development of certain severe infections. If you experience fever, sore throat, shortness of breath, abdominal pain, or general discomfort during Desferin treatment, these may be symptoms of a severe infection. In these cases, suspend Desferin treatment and inform your doctor immediately.
• During treatment, it is possible that your urine may turn brownish-red due to increased iron levels. This is usually harmless, but if you are concerned, speak with your doctor or nurse.

Your doctor may perform blood or urine tests, conduct vision and hearing tests before using this medication and at regular intervals. In children, growth and weight will be monitored periodically.

Use of other medications

Inform your doctor or pharmacist if you are using or have recently used other medications, including those obtained without a prescription,particularly if you are taking a tranquilizer called proclorperazine. You may need to adjust the dose or discontinue one of the medications.

Also, do not take vitamin C in doses above 200 mg daily during Desferin treatment.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

In general, Desferin should not be taken during pregnancy or breastfeeding, unless your doctor advises treatment. Desferin may harm the child. Your doctor will advise.

Driving and operating machines

Do not drive or operate tools or machines as Desferin may affect your vision or hearing, make you feel dizzy, or cause other nervous system symptoms.

Use in children

Desferin can be administered to children. In children under 3 years, growth should be monitored.

Use in the elderly

Desferin can be administered to the elderly. The minimum effective dose will be used.

Follow exactly the administration instructions for Desferin as indicated by your doctor. Consult your doctor if you have any doubts.

Your doctor will choose the appropriate dose and method of administration for your specific situation and will inform you of the duration of your treatment with Desferin.

Make sure to take the medication regularly and exactly as your doctor has instructed. This will help you achieve the best results and reduce the risk of adverse effects. If you have any doubts about your treatment, consult your doctor.

Desferin must be reconstituted with water for injectable preparations. At a concentration of 10%, the reconstituted solution is colorless to yellowish. The solution must be clear. Do not use cloudy or turbid solutions.

The reconstituted Desferin solution can be further diluted with commonly used infusion solutions (NaCl 0.9%, glucose 5%, Ringer's solution, Ringer-Lactate solution, peritoneal dialysis solution such as Dianeal 137 Glucose 2.27%, Dianeal PD4 Glucose 2.27%, and CAPD/DPCA 2 Glucose 1.5%).

Chronic iron overload treatment

Your doctor will adjust the dose according to your specific situation. In most patients, a daily dose of 20-60 mg per kilogram of body weight is adequate.

Desferin can be administered by slow subcutaneous infusion with a pump, by intravenous infusion, or by intramuscular injection.

In long-term treatments in patients with iron overload, it is advisable to administer Desferin slowly subcutaneously using a portable, lightweight pump for a period of 8-12 hours (e.g., during the night). The pump must be installed carefully under aseptic conditions. Follow the instructions below to prepare the infusion solution and inject it subcutaneously:

1. Aspirate the necessary water for injectables in a syringe:

• for subcutaneous (pump) or intravenous use: 5 ml of water for injectable preparations (concentration after reconstitution: 95 mg/ml)
• for intramuscular use: 2 ml of water for injectable preparations (concentration after reconstitution: 213 mg/ml)

1. After cleaning the rubber stopper of the Desferin vial with alcohol, inject the contents of the syringe into the vial.

1. Shake the vial vigorously to dissolve the powder.

1. The dissolved medication is aspirated with the syringe.

1. The luer lock is attached to the syringe, connected to the luer lock with a hub, and then the empty space in the luer lock is filled with the injectable solution.

1. The syringe is then placed in the pump.

1. To administer the infusion, the hub can be inserted under the skin of the abdomen, arm, upper leg, or thigh. It is essential to clean the skin well with alcohol first. Then, insert the needle firmly, until the wings, into a skin fold, formed by the free hand. The tip of the needle should move freely when the needle is moved. If it does not move freely, the tip of the needle is too close to the skin. Try a new site after cleaning with alcohol.

1. The needle is securely attached with adhesive tape.

1. Generally, the pump is worn on the body, secured with a belt or straps. Nighttime use is the most suitable for the patient.

Your doctor may decide that you should take vitamin C in addition to Desferin, starting at least after a month of regular treatment with Desferin. The maximum daily dose of vitamin C for adults is 200 mg divided into several doses. For children under 10 years, 50 mg of vitamin C per day is sufficient, and for children over 10 years, 100 mg per day is sufficient.

Acute iron poisoning treatment

Desferin can be used in cases of iron poisoning. This treatment will be performed in a hospital. In this case, they will administer the medication by continuous intravenous infusion.

Chronic aluminum overload treatment

Desferin is usually administered once a week by slow intravenous infusion for the last 60 minutes of a dialysis session or 5 hours before the dialysis session, depending on the aluminum concentration in the blood.

If you receive continuous ambulatory peritoneal dialysis (CAPD) or continuous cyclic peritoneal dialysis (CCPD), you will need to use the Desferin dose before the final exchange of the day.

The dose of Desferin is 5 mg per kilogram of body weight.

The duration of treatment and any changes to the individual dose of Desferin will depend on the results of the tests performed by your doctor.

Desferin test

If your doctor wants to check if you have iron overload, they will administer 500 mg of Desferin intramuscularly. The iron content will be determined in the urine collected over 6 hours.

If you are receiving dialysis, your doctor will want to check if you have aluminum overload. They will administer 5 mg of Desferin per kilogram of body weight by slow intravenous infusion for the last 60 minutes of the dialysis session. The aluminum content will be determined in the blood samples taken just before this dialysis session and the next one.

Use in children

If treatment is started before the age of 3, growth should be closely monitored, and the daily dose should not exceed 40 mg/kg. Delayed growth may be a consequence of iron overload or excessive Desferin doses.

Patients over 65 years old

In general, the determination of the dose in elderly patients should be done with caution, usually starting with the lower dose range, because in elderly patients, the liver, kidneys, or heart may not function correctly, other diseases may be associated, and other medications may be taken.

If you take more Desferin than you should

Inform your doctor immediately.

In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicology Information Service. Phone 915 620 420, indicating the medication and the amount used.

If you forget to take Desferin

Inform your doctor immediately.

Like all medicines, Desferin can cause side effects, although not everyone will experience them.

A Desferin intravenous infusion that is too rapid can cause unpleasant side effects and may lead to a collapse.

Very common (may affect more than 1 in 10 patients/people)

Common (may affect between 1 in 100 patients/people)

Uncommon (may affect between 1 and 10 in 1,000 patients/people)

Rare (may affect between 1 and 10 in 10,000 patients/people)

Very rare (may affect fewer than 1 in 10,000 patients/people)

Frequency not known (cannot be estimated from available data)

If you consider that any of the side effects you are experiencing are severe or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist.

Reporting of side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for the Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep out of reach and sight of children.

Do not use Desferin after the expiration date shown on the packaging (the expiration date is the last day of the month indicated).

Do not use Desferin if you observea cloudy or turbid solution.

Do not store at a temperature above 30°C.

The vials are for single use. Once the solution has been reconstituted, the product must be used immediately afterwards (within 3 hours). If the solution has been reconstituted under sterile conditions, it is possible to store it for a maximum period of 24 hours at room temperature before starting treatment.

Medicines should not be disposed of through drains or in the trash.Deposit the containers and medicines that you no longer need at your local SIGRE collection point at your usual pharmacy.Ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will be helping to protect the environment.

Composition of Desferin

The active ingredient of Desferin is deferoxamine mesylate.

Appearance of the product and contents of the package

Desferin is presented in vials containing 500 mg of white powder for injectable solution and perfusion.

Only clear, colorless to yellowish solutions should be used.

Marketing Authorization Holder

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona / Spain

Responsible for Manufacturing

Novartis Farmacéutica, S.A.

Gran Via de les Corts Catalanes, 764

08013 Barcelona - Spain

or

Novartis Pharma GmbH

Roonstrasse 25

90429 Nürnberg - Germany

This leaflet was approved in June 2018

The detailed and updated information on this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/