Desferal
Poland
Table of Contents
Package leaflet: Information for the patient
Warning! Keep the package leaflet and the information on the immediate packaging in a foreign language!
DESFERAL, 500 mg (0.5 g), powder for solution for injection
Deferoxamine mesylate
Please read the following information carefully before using this medicine, as it contains
important information for the patient
- Please 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 other people, even if their symptoms are the same.
- If you experience any adverse reactions, including any not listed in this leaflet, inform your doctor. See section 4.
Table of contents:
- What Desferal is and what it is used for
- Important information before using Desferal
- How to use Desferal
- Possible side effects
- How to store Desferal
- 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". The medicine removes excess iron or aluminium from the body.
What Desferal is used for
Desferal is used to treat chronic iron overload in the body, 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 iron accumulation in the body;
- in patients with primary (hereditary) haemochromatosis;
- 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 aluminium overload in patients with end-stage renal failure requiring regular dialysis. In certain situations, dialysis may lead to excessive aluminium accumulation in the body;
- diagnosis of iron or aluminium overload in the body.
Always follow your doctor's instructions exactly. They may differ from the general information provided 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 in Desferal – except in cases where a desensitization procedure has been successfully completed, allowing Desferal to be administered.
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 occurred after previous use of Desferal (skin rash, shortness of breath, or difficulty breathing);
- the patient has any kidney function disorders.
Immediately inform the doctor if, during treatment with Desferal, the patient experiences any of the following symptoms:
- high fever, sore throat, shortness of breath, abdominal pain, severe diarrhoea, or general 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), shortness of breath – these may occur if Desferal is administered too rapidly by intravenous infusion. See also section 3, "Use of a higher than recommended dose of Desferal";
- heart function disorders – possible symptoms that may occur in patients taking Desferal together with high doses of vitamin C. If the doctor prescribes additional vitamin C supplementation, ensure that Desferal has been used regularly for at least one month prior to 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 Desferal treatment, the doctor will also assess heart function.
During treatment with Desferal, urine may turn red-brown in colour 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.
If you have any questions about how Desferal works or why it has been prescribed, consult your doctor.
Children and adolescents
Inform your doctor if you notice that the growth rate of a 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 particularly includes the following medicines:
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- 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 (Ga) isotope, administered before imaging procedures (scans) used in diagnosing certain diseases. A change in dosing or even discontinuation of one of the medicines may be necessary.
Pregnancy, breastfeeding, and fertility
If the patient is pregnant or 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 associated with using Desferal during pregnancy.
Breastfeeding
Desferal should not be used during breastfeeding. The doctor will decide whether to discontinue breastfeeding or stop Desferal treatment, 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 age 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 the physician. If in doubt, consult your doctor.
Dosage and method of administration
The appropriate dose and route of administration will be determined individually by the physician for each patient. Depending on the patient's response 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 physician according to the individual patient's condition. For most patients, a dose of 20 to 60 mg per kilogram of body weight per day is sufficient.
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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. during the night) is very practical and convenient. For this purpose, a small, portable infusion pump is used. The Desferal is usually administered via the pump 5 to 7 times per week. The pump should be used carefully under sterile conditions.
The following is the method for preparing the solution for subcutaneous infusion:
- Draw up Water for Injections into a syringe.
- After wiping the rubber stopper of the Desferal vial with alcohol, inject the contents of the syringe into the vial.
- Shake the vial thoroughly until the powder is completely dissolved.
- Draw the resulting solution into the syringe.
- Attach the infusion tubing end to the syringe, connect the end to a special butterfly needle, and inject the medicine into the empty tubing.
- Place the syringe into the pump.
- The butterfly needle may 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 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. In such a case, try inserting the needle at a new site after cleaning the skin with alcohol.
- Secure the needle with adhesive tape.
- The pump is usually worn on the body with a belt or in a special holder attached to the arm. Many patients find nighttime administration most convenient.
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Elderly patients
Desferal may be used in elderly patients.
For elderly patients, the physician will select the appropriate dose, usually starting at the lowest end of the dosing range, due to the higher frequency of impaired liver, kidney, or heart function, as well as concomitant diseases and use of other medications.
Concomitant use of vitamin C
After at least one month of regular Desferal treatment, the physician 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 iron compound poisoning.
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 dialysate exchange of the day.
- The dose of Desferal is 5 mg per kilogram of body weight.
- The duration of treatment depends on test results recommended by the physician.
Iron and aluminium overload testing
- In the test for excessive iron accumulation in the body, Desferal is administered intramuscularly at a dose of 500 mg. Urine must be collected over 6 hours, and iron content in the urine is then measured. Page 5 of 8
- In patients requiring assessment of aluminium excess, Desferal is administered by slow intravenous infusion during dialysis at a dose of 5 mg/kg body weight. Aluminium levels are measured in blood samples taken immediately before the dialysis session and immediately before the next dialysis session.
How long should Desferal be used
The medicine should be used regularly and strictly according to the physician's instructions. This approach will provide the best results and reduce 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 the physician, as this may cause local adverse reactions at the injection site and other systemic symptoms such as dizziness, sensation 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 the doctor immediately.
Stopping Desferal treatment
Do not stop using Desferal unless instructed by the physician. If the patient stops treatment, the ability to remove excess iron from the body will be lost (see section "How long should Desferal be used").
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 lead to an adverse reaction and even shock. If adverse reactions occur, medical assistance may be required. Some adverse reactions may be severe.
Immediately inform the doctor if the patient experiences any of the following adverse symptoms:
hearing disturbances, visual disturbances, acute diarrhoea, abdominal pain, dizziness, feeling faint (symptoms of hypotension), rapid heartbeat, shock (occurring when the medicine is administered too quickly), bleeding, fever, sore throat or mouth ulcers, rash, itching, urticaria, difficulty breathing or swallowing, feeling of tightness in the chest with wheezing or coughing, 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 the doctor.
Very common (these adverse reactions may affect more than 1 in 10 people):
Joint pain, muscle pain, reactions at the injection site including pain, swelling, necrosis, erythema, itching, eschar.
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, reactions at the injection site including vesicles, swelling, burning sensation.
Rare (these adverse reactions may affect less than 1 in 1000 people):
Fungal infections (mucormycosis/zygomycosis), loss of vision, eye disorders (visual field defect, retinal degeneration, optic neuritis, cataract, reduced visual acuity, blurred vision, night blindness, visual field disturbances, visual disturbance characterized by seeing objects in colorless hues (chromatopsia), corneal clouding), hypotension, rapid heartbeat (tachycardia), and shock (occurring when the medicine is administered too quickly).
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 coughing; dizziness; swelling, mainly of the face, tongue and throat), neurological disorders (including dizziness, brain cell damage (encephalopathy), nerve damage (peripheral neuropathy), tingling and numbness (paresthesia)), dyspnoea, pulmonary infiltrates, diarrhoea, generalized rash.
Frequency not known (frequency cannot be estimated from available data):
Seizures, muscle cramps, acute renal failure (markedly reduced urine output), impaired kidney function, increased blood creatinine levels.
At the injection site, pain, swelling, induration, erythema, itching and eschar are very common, while vesicles, local swelling and burning sensation 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, tell your doctor. 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 the 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 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 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 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 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 (0.5 g) 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 Bulgaria, 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 Český Těšín, Czech Republic
Repackaged in:
Euceryn Pharmaceutical Laboratory COEL S.J., E.Z.M. KONSTANTY,
ul. Wł. Żeleńskiego 45, 31-353 Kraków
Medezin Sp. z o.o., ul. Zbąszyńska 3, 91-342 Łódź
CEFEA Sp. z o.o. Sp. komandytowa, ul. Działkowa 56, 02-234 Warsaw
Bulgaria Marketing Authorisation Number: 9800063
Parallel Import Authorisation Number: 363/14
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