Desferal

Leaflet attached to the packaging: patient information

Warning! Keep the leaflet, information on the immediate packaging in a foreign language!

DESFERAL, 500 mg (0.5 g), powder for solution for injection

Deferoxamine mesylate

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient

• You should keep this leaflet, so that you can read it again if necessary.
• In case of any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed to a specific person. It should not be given to others. The medicine may harm another person, even if the symptoms of their illness are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor. 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. Contents of the packaging and other information

1. What is Desferal and what is it used for

What is Desferal

Desferal contains the active substance - deferoxamine mesylate, 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 excessive iron accumulation 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, in whom repeated blood transfusions are necessary. Repeated transfusions can lead to excessive iron accumulation in the body;
• in patients with primary (idiopathic) hemochromatosis;
• in patients with late-stage porphyria cutanea tarda.

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

It may also be used for:

• treatment of acute iron poisoning;
• treatment of chronic excessive aluminum accumulation 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 excessive iron or aluminum accumulation in the body.

You should strictly follow the doctor's recommendations. They may differ from the general information contained in this leaflet.

2. Important information before using Desferal

When not to use Desferal

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• if the patient is allergic to deferoxamine mesylate - the active substance of Desferal, unless a successfully completed desensitization procedure allows the administration of Desferal.

Warnings and precautions

Before starting Desferal, you should discuss it with your doctor or pharmacist.
Before using Desferal, you should inform your doctor if:

• the patient suspects that 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.

You should immediately tell your doctorif, during treatment with Desferal, the patient experiences any of the following symptoms:

• high body temperature, sore throat, shortness of breath, abdominal pain, severe diarrhea, or general feeling of discomfort (symptoms of fungal or bacterial infections);
• significant decrease in 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 rhythm disturbances, 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, you should make sure that Desferal has been used regularly for at least one month before starting vitamin C. You should strictly follow the recommended doses of vitamin C. 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 in the patient before and during treatment.
• In patients with excessive iron accumulation in the body, 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 the excretion of the iron complex. This is usually not a cause for concern, but if the change in urine color causes concern, you should contact your doctor or nurse.
You should consult your doctor if you have any questions about the action of Desferal or the reasons why it was prescribed.

Children and adolescents

You should inform your doctor if you notice that the growth rate of a child being treated with Desferal has slowed down.

Desferal and other medicines

You should tell your doctor or pharmacist about all medicines that the patient is currently taking or has recently taken, as well as any medicines that the patient plans to take. This is especially true for the following medicines:
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• medicines containing prochlorperazine (a neuroleptic medicine used to treat neurological disorders);
• vitamin C. You should not take more than 200 mg of vitamin C per day (see "Warnings and precautions" above);
• gallium isotope (Ga), administered before performing imaging tests (X-rays) in the diagnosis of certain diseases. It may be necessary to change the dosage or even discontinue one of the medicines.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, 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 to use this medicine. 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. You should not drive a vehicle or operate machines until these symptoms have resolved.

3. How to use Desferal

This medicine should always be used according to the doctor's recommendations. If you have any doubts, you should consult your doctor.
Dosage and method of 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 decrease or increase the dose of Desferal.
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 clear solutions should be used. 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 excessive iron accumulation

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.
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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 inform the patient how to prepare the solution themselves. In long-term treatment of patients with excessive iron accumulation in the body, it is very practical and convenient to administer Desferal by slow subcutaneous infusion, lasting from 8 to 12 hours (e.g., at night). For this purpose, a lightweight, portable infusion pump is used. With the help of the pump, Desferal is usually administered 5-7 times a week. The pump should be used carefully, in aseptic conditions.
Below is the method of 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 a 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 thoroughly clean the skin 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. The end of the needle should move freely under the skin. If the end of the needle 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.

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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 preparation poisoning.

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

• Depending on the aluminum concentration in the patient's blood, 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 ambulatory continuous peritoneal dialysis or continuous cyclic peritoneal dialysis, Desferal should be administered before the last exchange of dialysis fluid on a given 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.

Test for excessive iron and aluminum accumulation

• In the case of a test for excessive iron accumulation in the body, Desferal is administered intramuscularly in a dose of 500 mg. Urine is collected for 6 hours, and then the iron content is determined. Page 5 8
• In the case of patients requiring determination of aluminum excess, Desferal is administered by slow intravenous infusion during dialysis, in a dose of 5 mg/kg body weight. The 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 recommendations. This will bring the best results and reduce the risk of side effects. If you have any questions or doubts about treatment, you should contact your doctor.
If you have any questions about how long to use Desferal, you should consult your doctor.

Using a higher dose of Desferal than recommended

You should not use a higher dose or concentration of Desferal 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 or slow heart rate, gastrointestinal disorders (nausea), significantly decreased urine output (symptom of acute kidney failure), nervous system disorders (e.g., agitation, loss of speech, headaches), shortness of breath (symptom of respiratory function disorders), vision and hearing disturbances.
If a higher dose of Desferal than recommended is used, you should immediately contact your doctor or hospital staff. It may be necessary to use appropriate treatment.

Missing a dose of Desferal

If a dose is missed, you should immediately inform your doctor.

Stopping Desferal treatment

You should 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 help may be necessary. Some side effects can be serious.

You should immediately inform your doctor if the patient experiences 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 heart rate, 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 decreased urine output, seizures.
If any of the following side effects occur, you should 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, delayed growth, bone disorders (metaphyseal dysplasia), fever.
Uncommon(these side effects may affect less than 1 in 100 people):
neurosensory 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 (loss of visual field, retinal degeneration, optic neuritis, cataract, decreased visual acuity, blurred vision, night blindness, visual field disorders, color vision disturbance), hypotension, rapid heart rate (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), shortness of breath, lung infiltrates, diarrhea, generalized rash.
Frequency not known(frequency cannot be estimated from the available data):
seizures, muscle spasms, acute kidney failure (significantly decreased 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, local swelling, and burning are uncommon. 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).
There have been rare reports of increased aminotransferase activity in patients treated with Desferal. Using Desferal to treat excessive aluminum accumulation in the body may decrease serum calcium levels and exacerbate hyperparathyroidism.
Reporting side effects
If any side effects occur, including any side effects not listed in this leaflet, you should tell your doctor. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, 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
By reporting side effects, you can help gather more information on the safety of the medicine.

5. How to store Desferal

Do not use this medicine after the expiration date stated on the packaging. The expiration date refers to the last day of the specified month.
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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 aseptic conditions, it can be stored at room temperature for a maximum of 24 hours before administration. Do not use opaque or cloudy solutions.
The medicine should be stored out of 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. Contents of the packaging and other information

What Desferal contains

The active substance of Desferal is deferoxamine mesylate.
Each vial contains 500 mg (0.5 g) of deferoxamine mesylate.

What Desferal looks like and what the packaging contains

Desferal is available as a powder in vials, in a cardboard box.
Each package contains 10 vials.
For more detailed information, you should contact the marketing authorization holder or parallel importer.

Marketing authorization holder in Bulgaria, the country of export:

Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany

Manufacturer:

Novartis Pharma GmbH
Roonstrasse 25
90429 Nuremberg
Germany

Parallel importer:

Aga Kommerz spol. s r.o., Frydecka 2006, 737 01 Cesky Tesin, Czech Republic

Repackaged by:

Euceryna Laboratory Pharmaceutical Factory COEL S.J., E.Z.M. KONSTANTY,
ul. Wł. Żeleńskiego 45, 31-353 Krakow
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Lodz
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw

Marketing authorization number in Bulgaria, the country of export: 9800063

Parallel import authorization number:363/14

Date of leaflet approval: 25.10.2024

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