Desferal

Leaflet attached to the packaging: patient information

DESFERAL, 500 mg, powder for solution for injection

Deferoxamine mesilate

Read the leaflet carefully before using the medicine, as it contains important information for the patient

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet:

• 1. What is Desferal and what is it used for
• 2. Important information before using Desferal
• 3. How to use Desferal
• 4. Possible side effects
• 5. How to store Desferal
• 6. Package contents and other information

1. What is Desferal and what is it used for

What is Desferal

Desferal contains the active substance deferoxamine mesilate, also known as a "chelator". The medicine removes excess iron or aluminum from the body.

What is Desferal used for

Desferal is used to treat chronic iron overload in the body, for example:

• in patients being treated for various types of anemia, such as thalassemia, sideroblastic anemia, autoimmune hemolytic anemia, or other chronic forms of anemia, where frequent blood transfusions are necessary. Frequent transfusions can lead to excessive iron accumulation in the body;
• in patients with primary (hereditary) hemochromatosis;
• in patients with late-stage porphyria cutanea tarda.

Desferal can be used in adults, adolescents, and children.

It can also be used for:

• treatment of acute iron poisoning;
• treatment of chronic aluminum overload in patients with end-stage renal failure requiring regular dialysis. In some cases, dialysis can lead to excessive aluminum accumulation in the body;
• diagnosis of iron or aluminum overload in the body.

Follow the doctor's instructions carefully. They may differ from the general information contained in this leaflet.

2. Important information before using Desferal

When not to use Desferal

• if the patient is allergic to deferoxamine mesilate, the active substance of Desferal, unless a successful desensitization procedure allows the use of Desferal.

Warnings and precautions

Before starting treatment with Desferal, discuss it with your doctor or pharmacist. Before using Desferal, tell your doctor if:

• the patient suspects they may be allergic to Desferal;
• in the past, after using Desferal, allergic reactions (skin rash, shortness of breath, or difficulty breathing) have occurred;
• the patient has any kidney function disorders.

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

• high fever, sore throat, shortness of breath, abdominal pain, severe diarrhea, or general feeling of discomfort (symptoms of fungal or bacterial infections);
• significantly reduced urine output (symptom of kidney function disorders);
• vision and hearing disturbances;
• dizziness, feeling of emptiness in the head (symptoms of low blood pressure), shortness of breath, which may occur if Desferal is administered too quickly by intravenous infusion. See also section 3 "Using a higher dose of Desferal than recommended";
• heart function disorders, possible symptoms that may occur in patients taking Desferal and also taking high doses of vitamin C. If the doctor also recommends taking vitamin C supplements, make sure that Desferal has been used regularly for at least one month before starting vitamin C. Follow the recommended vitamin C doses strictly. Do not exceed the daily dose of 200 mg of vitamin C.

Monitoring the patient's health during Desferal treatment

• It may be necessary to perform certain blood and urine tests on the patient before starting and during treatment.
• In patients with iron overload, the iron concentration (ferritin) will be monitored to assess the effectiveness of Desferal. It will also be necessary to perform vision and hearing tests. In children and adolescents, growth and body weight will be regularly monitored. The doctor will take into account the results of these tests when selecting the appropriate dose of Desferal for the patient.
• If the patient is taking vitamin C while using Desferal, the doctor will also assess heart function.

During Desferal treatment, urine may turn reddish-brown due to iron complex excretion. This is usually not a cause for concern, but if the change in urine color causes concern, consult a doctor or nurse. If you have any questions about Desferal or why it has been prescribed, consult your doctor or pharmacist.

Children and adolescents

Tell your doctor if you notice that the growth rate of the child being treated with Desferal has slowed down.

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 is especially important for the following medicines:

• medicines containing prochlorperazine (a neuroleptic used to treat neurological disorders);
• vitamin C. Do not take more than 200 mg of vitamin C per day (see "Warnings and precautions" above);
• gallium isotope (Ga), administered before imaging tests (scans) to diagnose certain diseases. It may be necessary to adjust the dosage or even discontinue one of the medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, or thinks they may be pregnant or plans to have a child, they should consult their doctor before using this medicine.

Pregnancy

Desferal should not be used during pregnancy unless the doctor decides that 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 stop breastfeeding or discontinue Desferal, taking into account the importance of the medicine for the mother.

Fertility

There is no data on the effect of deferoxamine on fertility, but animal studies have shown that Desferal may harm the fetus. Sexually active women of childbearing age are advised to use effective contraception during Desferal treatment and for 1 month after stopping treatment.

Driving and using machines

Using Desferal may cause vision and hearing disturbances, as well as dizziness or other nervous system disorders. Do not drive or operate machinery until these symptoms have resolved.

3. How to use Desferal

Always use this medicine exactly as your doctor has told you. If you are not sure, check with your doctor. Dosage and administration The doctor will determine the appropriate dose and method 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 in the form of an aqueous solution. The powder should be dissolved in water for injection. The resulting solution with a recommended concentration of 95 mg/ml (for subcutaneous and intravenous administration) should be clear, colorless to slightly yellow. Only use clear solutions. Do not use opaque or cloudy solutions. The Desferal solution with a concentration of 95 mg/ml can be diluted with fluids commonly used for infusion (0.9% NaCl solution, 5% glucose solution, Ringer's solution, lactated Ringer's 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 dosage is determined by the doctor, depending on the patient's condition. For most patients, a dose of 20-60 mg per kilogram of body weight per day is sufficient. Desferal can be administered by slow subcutaneous infusion (subcutaneous injection using an infusion pump), intravenous infusion, or intramuscular injection. The doctor or nurse can prepare a ready-to-use solution for the patient or instruct the patient on how to prepare the solution themselves. In long-term treatment of patients with iron overload, it is very practical and convenient to administer Desferal by slow subcutaneous infusion, lasting from 8 to 12 hours (e.g., at night). A lightweight, portable infusion pump is used for this purpose. The pump is usually used 5-7 times a week. The pump should be used carefully, in sterile conditions. The following is the method for preparing the solution for subcutaneous infusion:

• 1. Draw water for injection into a syringe.
• 2. After rubbing the rubber stopper of the Desferal vial with alcohol, inject the contents of the syringe into the vial.
• 3. Shake the vial thoroughly until the powder is dissolved.
• 4. Draw the resulting solution into the syringe.
• 5. Attach the tube tip to the syringe, connect the tip to a special butterfly needle, and inject the medicine into an empty tube.
• 6. Place the syringe in the pump.
• 7. The butterfly needle can be inserted under the skin of the abdomen, arm, or upper leg (thigh). Remember to clean the skin thoroughly with alcohol before inserting the needle. Then, with one hand, create a skin fold, and with the other hand, insert the needle until the "wings" are felt. If the needle tip does not move freely, it may be inserted too superficially under the skin. In this case, try to insert the needle in a new location, after cleaning the skin with alcohol.
• 8. Secure the needle with a plaster.
• 9. The pump is usually worn on the body on a belt or in a special case attached to the arm. Many patients find it most convenient to use it at night.

Elderly patients

Desferal can be used in elderly patients. For an elderly patient, the doctor will select the appropriate dose, usually starting with the lowest value in the dose range, due to the higher frequency of impaired liver, kidney, or heart function, as well as concomitant diseases and the use of other medicines.

Concomitant use of vitamin C

After at least one month of regular Desferal treatment, the doctor may recommend concurrent 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 dose of 50 mg of vitamin C per day is usually appropriate, while for older children, a dose of 100 mg is used.

Treatment of acute iron poisoning

• Desferal can be used in cases of iron poisoning.

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

• Depending on the patient's blood aluminum concentration, Desferal is usually administered once a week 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 fluid exchange of the day.
• The dose of Desferal is 5 mg per kilogram of body weight.
• The duration of treatment depends on the test results recommended by the doctor.

Iron and aluminum overload test

• In the case of a test for iron overload, Desferal is administered intramuscularly in a dose of 500 mg. Urine is collected for 6 hours, and then the iron content is determined.
• In the case of patients requiring aluminum overload assessment, Desferal is administered by slow intravenous infusion during dialysis, in a dose of 5 mg/kg body weight. Aluminum content is determined in blood samples taken immediately before and after dialysis.

How long to use Desferal

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

Using a higher dose of Desferal than recommended

Do not use a higher dose or concentration of the medicine than recommended by the doctor, as this may cause local side effects at the injection site and other general side effects, such as dizziness, feeling of emptiness in the head (symptoms of low blood pressure), rapid heartbeat, or shock (occurring when the medicine is administered too quickly), bleeding, fever, sore throat, or mouth ulcers, rash, itching, hives, difficulty breathing or swallowing, feeling of pressure in the chest with wheezing or coughing, swelling, mainly of the face, tongue, and throat, nervous system disorders, significantly reduced urine output, seizures. If a higher dose of Desferal than recommended is used, consult a doctor or hospital staff immediately. Appropriate treatment may be necessary.

Missing a dose of Desferal

If a dose is missed, inform your doctor immediately.

Stopping Desferal treatment

Do not stop using Desferal unless the doctor decides to do so. If the patient stops treatment, the ability to remove excess iron from the body will be lost (see "How long to use Desferal").

4. Possible side effects

Like all medicines, Desferal can cause side effects, although not everybody gets them. Too rapid intravenous administration of Desferal may cause side effects, and even shock. If side effects occur, medical attention may be necessary. Some side effects can be serious.

Tell your doctor immediately if you experience any of the following side effects:

hearing disturbances, vision disturbances, severe diarrhea, abdominal pain, dizziness, feeling of emptiness in the head (symptoms of low blood pressure), rapid heartbeat, shock (occurring when the medicine is administered too quickly), bleeding, fever, sore throat, or mouth ulcers, rash, itching, hives, difficulty breathing or swallowing, feeling of pressure in the chest with wheezing or coughing, swelling, mainly of the face, tongue, and throat, nervous system disorders, significantly reduced urine output, seizures. If you experience any of the following side effects, tell your doctor.Very common(these side effects may affect more than 1 in 10 people): joint pain, muscle pain, reactions at the injection site, including pain, swelling, redness, itching, and induration. Common(these side effects may affect less than 1 in 10 people): headache, nausea, hives, growth delay, bone disorders (metaphyseal dysplasia), fever. Uncommon(these side effects may affect less than 1 in 100 people): deafness (sensorineural deafness), tinnitus, asthma, vomiting, abdominal pain, reactions at the injection site, including blisters, swelling, burning. Rare(these side effects may affect less than 1 in 1000 people): fungal infections (mucormycosis/zygomycosis), vision loss, eye disorders (visual field loss, retinal degeneration, optic neuritis, cataract, reduced visual acuity, blurred vision, night blindness, visual field disorders, color vision disturbance), hypotension, rapid heartbeat (tachycardia) and shock (occurring when the medicine is administered too quickly). Very rare(these side effects may affect less than 1 in 10,000 people): gastrointestinal inflammation (caused by Yersinia bacteria), blood disorders (including low platelet count, low white blood cell count), severe allergic reactions, such as anaphylactic shock, anaphylactic reaction, angioedema (symptoms may include rash, itching, hives, difficulty breathing or swallowing; feeling of pressure in the chest with wheezing or coughing; dizziness; swelling, mainly of the face, tongue, and throat), neurological disorders (including dizziness, brain cell damage, peripheral neuropathy, paresthesia), difficulty breathing, lung infiltrates, diarrhea, generalized rash. Frequency not known(frequency cannot be estimated from the available data): seizures, muscle spasms, acute kidney failure (significantly reduced urine output), kidney function disorders, increased creatinine levels in the blood. At the injection site, very common side effects include pain, swelling, induration, redness, itching, and scabbing, while blisters, swelling, and burning are uncommon reactions. Local reactions may be associated with general reactions, such as joint pain or muscle pain (very common), headache (common), hives (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. Using Desferal to treat aluminum overload may decrease serum calcium levels and exacerbate hyperparathyroidism. Reporting side effects If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help 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 carton and vial after EXP. The expiry date refers to the last day of the month. Do not store above 25°C. Each vial is for single use only. The solution should be used immediately after preparation, i.e., administration should be started within 3 hours. If the solution is prepared in validated sterile conditions, it can be stored at room temperature for up to 24 hours before administration. Do not use opaque or cloudy solutions. Keep the medicine out of the sight and reach of children. Remember to return any unused vials to the pharmacy. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Package contents and other information

What Desferal contains

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

What Desferal looks like and contents of the pack

Desferal is available as a powder in vials, in a cardboard box. Each pack contains 10 vials.

Marketing authorization holder

Novartis Poland Sp. z o.o., ul. Marynarska 15, 02-674 Warsaw, Tel.: +48 22 375 48 88

Manufacturer/Importer

Novartis Poland Sp. z o.o., ul. Marynarska 15, 02-674 Warsaw, Novartis Pharma GmbH, Roonstrasse 25, 90429 Nürnberg, Germany, Novartis Farmaceutica S.A., Gran Via de les Corts Catalanes, 764, 08013 Barcelona, Spain

Date of last revision of the leaflet: