Desferal

Package leaflet: Information for the patient

Warning! Keep this leaflet! The information on the immediate packaging is in a foreign language.
Desferal, 500 mg, powder for solution for injection
Deferoxamine mesylate
Please read carefully all the information in this leaflet before using this medicine, as it contains
important information for the patient

• Keep this leaflet, so that you can read it again if necessary.
• If you have any questions, please consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. This medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet:

1. What Desferal is and what it is used for
2. Important information before using Desferal
3. How to use Desferal
4. Possible side effects
5. How to store Desferal
6. Contents of the pack and other information

1. What Desferal is and what it is used for

What Desferal is
Desferal contains the active substance deferoxamine mesylate, known as a "chelating agent". This medicine removes excess iron or aluminium from the body.
What Desferal is used for
Desferal is used in the treatment of chronic iron overload, for example:

• in patients treated for various types of anaemia, such as thalassaemia, sideroblastic anaemia, autoimmune haemolytic anaemia, or other chronic forms of anaemia, who require multiple blood transfusions. Repeated transfusions may lead to excessive accumulation of iron in the body;
• in patients with idiopathic (primary) haemochromatosis;
• in patients with late-stage porphyria cutanea tarda.

Desferal can be used in adults, adolescents, and children.
It may also be used for:

• treatment of acute iron poisoning;
• treatment of chronic aluminium overload in patients with end-stage renal failure requiring regular dialysis. In certain situations, dialysis may lead to excessive accumulation of aluminium in the body;
• diagnosis of excessive accumulation of iron or aluminium in the body.

You must strictly follow your doctor's instructions. These may differ from the general information provided in this leaflet.

2. Important information before using Desferal

When not to use Desferal

• if the patient is allergic to deferoxamine mesylate – the active substance in Desferal, except in cases where a successful desensitization procedure has allowed administration of Desferal.

Warnings and precautions
Before starting treatment with Desferal, discuss this with your doctor or pharmacist.
Before using Desferal, inform your doctor if:

• the patient suspects they may be allergic to Desferal;
• allergic reactions (skin rash, shortness of breath, or breathing difficulties) occurred after previous use of Desferal;
• the patient has any kidney function disorders.

Tell your doctor immediately if, during treatment with Desferal, the patient experiences any of the following symptoms:

• high fever, sore throat, shortness of breath, abdominal pain, acute diarrhoea, or general feeling of discomfort (symptoms of fungal or bacterial infections);
• significantly reduced urine output (a sign of kidney function disorders);
• visual or hearing disturbances;
• dizziness, feeling of emptiness in the head (symptoms of low blood pressure), or shortness of breath, which may occur if Desferal is administered too rapidly by intravenous infusion. See also section 3, "Overdose of Desferal";
• cardiac function disorders, which may occur in patients taking Desferal together with high doses of vitamin C. If your doctor additionally recommends vitamin C supplementation, ensure that Desferal has been used regularly for at least one month before starting vitamin C. Strictly adhere to the recommended doses of vitamin C. Do not exceed a daily dose of 200 mg of vitamin C.

Monitoring the patient's health during treatment with Desferal

• Certain blood and urine tests may be required before and during treatment.
• In patients with iron overload, serum ferritin levels will be monitored to assess the effectiveness of Desferal treatment. Regular eye and hearing examinations will also be performed. In children and adolescents, growth and body weight will be monitored regularly. The doctor will consider the results of these tests when determining the appropriate Desferal dose for the patient.
• If the patient is taking vitamin C during treatment with Desferal, the doctor will also assess heart function.

During treatment with Desferal, urine may turn red-brown due to excretion of the iron complex. This is usually not a cause for concern, but if the change in urine colour causes concern, contact your doctor or nurse.
Contact your doctor if you have any questions about how Desferal works or why it was prescribed.

Children and adolescents
Inform your doctor if you notice that the child’s growth rate has slowed during treatment with Desferal.

Desferal and other medicines
Tell your doctor or pharmacist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take. This especially includes the following:

• medicines containing prochlorperazine (a neuroleptic used in the treatment of neurological disorders);
• vitamin C. Do not take vitamin C in doses exceeding 200 mg per day (see section "Warnings and precautions" above);
• gallium isotope (Ga), administered before imaging procedures (scans) used in diagnosing certain diseases. A dose adjustment or even discontinuation of one of the medicines may be necessary.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant, breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult her doctor before using this medicine.

Pregnancy
Desferal should not be used during pregnancy unless the doctor decides it is necessary. The doctor will inform the patient about the risks of using Desferal during pregnancy.

Breastfeeding
Desferal should not be used during breastfeeding. The doctor will decide whether to discontinue breastfeeding or stop treatment with Desferal, taking into account the importance of the medicine for the mother.

Fertility
There is no data on the effect of deferoxamine on fertility; however, animal studies have shown that Desferal may harm the unborn child. Sexually active women of childbearing potential are advised to use effective contraception during treatment with Desferal and for 1 month after stopping treatment.

Driving and operating machinery
Desferal may cause visual or hearing disturbances, dizziness, or other nervous system disorders. Do not drive or operate machinery until these symptoms have resolved.

3. How to use Desferal

This medicine should always be used as directed by your doctor. If in doubt, consult your doctor.

Dosage and method of administration

Your doctor will determine the appropriate dose and route of administration individually for each patient. Depending on how the patient responds to treatment, the doctor may reduce or increase the dose of the medicine.

Desferal is intended for injection as an aqueous solution. The powder must be dissolved in water for injections. The resulting solution at the recommended concentration of 95 mg/ml (for subcutaneous and intravenous administration) should be clear, colourless to slightly yellow. Only clear solutions should be used. Do not use opalescent or cloudy solutions.

The Desferal solution at a concentration of 95 mg/ml may be diluted with fluids routinely used for infusion (0.9% NaCl solution, 5% glucose solution, Ringer's solution, Ringer's lactate solution, peritoneal dialysis fluids such as: Dianeal 137 Glucose 2.27%, Dianeal PD4 Glucose 2.27%, and CAPD/DPCA 2 Glucose 1.5%).

Treatment of chronic iron overload

The dose is determined by the doctor depending on the individual patient's condition. For most patients, a dose of 20 to 60 mg per kilogram of body weight per day is sufficient.

Desferal may be administered by slow subcutaneous infusion (subcutaneous injection using an infusion pump), intravenous infusion, or by intramuscular injections.

The doctor or nurse may prepare the ready-to-use solution for the patient or instruct the patient how to prepare the solution independently. In long-term treatment of patients with iron overload, administration of Desferal by slow subcutaneous infusion lasting from 8 to 12 hours (e.g., overnight) is very practical and convenient. For this purpose, a small, portable infusion pump is used. Using the pump, Desferal is usually administered 5 to 7 times per week. The pump should be used carefully under sterile conditions.

Below is the method for preparing the solution for subcutaneous infusion:

1. Draw up water for injections into a syringe.
2. After wiping the rubber stopper of the Desferal vial with alcohol, inject the syringe contents into the vial.
3. Shake the vial thoroughly until the powder is completely dissolved.
4. Draw the resulting solution into the syringe.
5. Attach the tubing connector to the syringe, connect the end to a special butterfly needle, and inject the medicine into the empty tubing.
6. Place the syringe into the pump.
7. The butterfly needle can be inserted subcutaneously into the abdomen, arm, or upper leg (thigh). Remember to clean the skin thoroughly with alcohol before inserting the needle. Then, with one hand, pinch a skin fold and with the other hand insert the needle up to the "wings." The tip of the needle should move freely under the skin. If the tip does not move freely, this may indicate that it is placed too superficially under the skin. In such a case, try inserting the needle at a new site after cleaning the skin with alcohol.
8. Secure the needle with adhesive tape.
9. The pump is usually worn on the body with a belt or in a special holder attached to the arm. Many patients find overnight administration most convenient.

Elderly patients

Desferal may be used in elderly patients. For elderly patients, the doctor will select the appropriate dose, usually starting at the lowest end of the recommended dose range, due to the higher frequency of impaired liver, kidney, or heart function, as well as coexisting diseases and concomitant medication use.

Concomitant use of vitamin C

After at least one month of regular Desferal treatment, the doctor may recommend concomitant administration of vitamin C. The maximum daily dose of vitamin C for adults is 200 mg, divided into smaller doses taken throughout the day. For children under 10 years of age, a daily dose of 50 mg of vitamin C is usually appropriate, while for older children, a dose of 100 mg is recommended.

Treatment of acute iron poisoning

• Desferal may be used in cases of poisoning with iron-containing preparations.

Treatment of chronic aluminium overload in patients with end-stage renal failure

• Depending on the patient's blood aluminium concentration, Desferal is usually administered once weekly by slow intravenous infusion during the last 60 minutes of dialysis or 5 hours before the start of dialysis.
• In patients undergoing continuous ambulatory peritoneal dialysis or continuous cyclic peritoneal dialysis, Desferal should be administered before the last dialysis fluid exchange of the day.
• The dose of Desferal is 5 mg per kilogram of body weight.
• The duration of treatment depends on test results as recommended by the doctor.

Iron and aluminium overload testing

• In the test for iron overload, Desferal is administered intramuscularly at a dose of 500 mg. Urine should be collected over 6 hours, and iron content in the urine is then measured.
• In patients requiring assessment of aluminium overload, Desferal is administered by slow intravenous infusion during dialysis at a dose of 5 mg/kg body weight. Aluminium content is measured in blood samples taken immediately before the dialysis session and before the next dialysis session.

How long to use Desferal

The medicine should be used regularly and strictly according to the doctor's instructions. This ensures the best results and reduces the risk of adverse effects. If you have any questions or doubts about the treatment, contact your doctor.
For questions about how long to use Desferal, consult your doctor.

Use of a higher than recommended dose of Desferal

Do not use a higher dose or concentration of Desferal than prescribed by your doctor, as this may cause local adverse reactions at the injection site and other systemic adverse effects such as dizziness, feeling of emptiness in the head (symptoms of low blood pressure), accelerated or slowed heart rate, gastrointestinal disturbances (nausea), markedly reduced urine output (sign of acute kidney failure), nervous system disturbances (e.g., restlessness, loss of speech ability, headaches), shortness of breath (sign of impaired lung function), and disturbances of vision and hearing.

If a higher dose of Desferal than recommended has been administered, contact your doctor or hospital staff immediately. Appropriate treatment may be necessary.

Missed dose of Desferal

If a dose is missed, inform your doctor immediately.

Stopping Desferal treatment

Do not stop using Desferal unless instructed by your doctor. If the patient discontinues treatment, the ability to remove excess iron from the body will be lost (see section "How long to use Desferal").

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Too rapid intravenous administration of Desferal may cause adverse reactions and even collapse. If adverse reactions occur, medical assistance may be required. Some adverse reactions may be severe.
Immediately inform a doctor if the patient experiences any of the following adverse symptoms:
hearing disturbances, visual disturbances, acute diarrhoea, abdominal pain, dizziness, feeling of emptiness in the head (symptoms of hypotension), rapid heartbeat, shock (occurring when the medicine is administered too rapidly), bleeding, fever, sore throat or oral ulcers, rash, itching, urticaria, difficulty breathing or swallowing, feeling of tightness in the chest with wheezing or cough, swelling, mainly of the face, tongue and throat, nervous system disorders, significantly reduced urine output, seizures.
If any of the following adverse reactions occur, tell your doctor.
Very common (these adverse reactions may affect more than 1 in 10 people):
Joint pain, muscle pain, injection site reactions including pain, swelling, extravasation, erythema, itching, scab.
Common (these adverse reactions may affect less than 1 in 10 people):
Headache, nausea, urticaria, growth retardation, skeletal disorders (epiphyseal dysplasia), fever.
Uncommon (these adverse reactions may affect less than 1 in 100 people):
Deafness (sensorineural deafness), tinnitus, asthma, vomiting, abdominal pain, injection site reactions including blisters, swelling, burning.
Rare (these adverse reactions may affect less than 1 in 1,000 people):
Fungal infections (mucormycosis/zygomycosis), loss of vision, eye disorders (visual field defects, retinal degeneration, optic neuritis, cataract, decreased visual acuity, blurred vision, night blindness, visual field disturbances, chromatic vision disturbances such as seeing objects in pale colours (chromatopsia), corneal opacity), hypotension, rapid heartbeat (tachycardia) and shock (occurring when the medicine is administered too rapidly).
Very rare (these adverse reactions may affect less than 1 in 10,000 people):
Gastroenteritis (caused by Yersinia bacteria), blood disorders (including low platelet count (thrombocytopenia), low white blood cell count (leukopenia)), severe allergic reactions such as anaphylactic shock, anaphylactic reaction, angioedema (symptoms may include rash, itching, urticaria, difficulty breathing or swallowing; feeling of tightness in the chest with wheezing or cough; dizziness; swelling, mainly of the face, tongue and throat), neurological disorders (including dizziness, brain cell damage (encephalopathy), nerve damage (peripheral neuropathy), sensations of numbness and tingling (paresthesia)), dyspnoea, pulmonary infiltrates, diarrhoea, generalized rash.
Frequency unknown (frequency cannot be estimated from available data):
Seizures, muscle cramps, acute kidney failure (significantly reduced urine output), kidney function disorders, increased blood creatinine levels.
At the injection site, pain, swelling, infiltration, erythema, itching and scab are very common, while blisters, local oedema and burning are uncommon reactions. Local reactions may be associated with general reactions such as joint pain or muscle pain (very common), headache (common), urticaria (common), nausea (common), fever (common), vomiting (uncommon), abdominal pain (uncommon) or asthma (uncommon).
Rare cases of increased aminotransferase activity have been reported in patients treated with Desferal. The use of Desferal in the treatment of aluminium overload may reduce serum calcium levels and exacerbate hyperparathyroidism.
Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl.
Reporting adverse reactions helps to provide more information on the safety of this medicine.

5. How to store Desferal

Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the stated month.
Do not store above 25°C.
Each vial is intended for single use only. The solution should be used immediately after preparation, i.e. administration should be started within 3 hours. If the solution has been prepared under validated sterile conditions, it may be stored at room temperature for a maximum of 24 hours prior to administration. Do not use solutions that are opalescent or cloudy.
Keep the medicine out of sight and reach of children.
Remember to return any unused vials to the pharmacy.
Medicines must not be disposed of via the sewage system or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such measures help protect the environment.

6. Contents of the pack and other information

What Desferal contains
The active substance is deferoxamine mesylate.
Each vial contains 500 mg of deferoxamine mesylate.

What Desferal looks like and contents of the pack
Desferal is available as a powder in vials, packed in a cardboard box.
Each pack contains 10 vials.

For further information, please contact the responsible party or the parallel importer.

Marketing Authorisation Holder in Greece, the country of export:
Novartis (Hellas) A.E.B.E.
12 km Athens – Lamia National Road
144 51 Metamorfosi
Greece

Manufacturer:
Novartis (Hellas) A.E.B.E.
12 km Athens – Lamia National Road
144 51 Metamorfosi
Greece

Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany

Parallel Importer:
InPharm Sp. z o.o.
ul. Strumykowa 28/11
03-138 Warsaw
Poland

Repackaged in:
InPharm Sp. z o.o. Services sp. k.
ul. Chełmżyńska 249
04-458 Warsaw
Poland

Marketing Authorisation Number in Greece, the country of export: 44019/14-09-2009
Parallel Import Licence Number: 285/21