Exferana

Leaflet attached to the packaging: patient information

Exferana 90 mg coated tablets

Exferana 180 mg coated tablets

Exferana 360 mg coated tablets

Deferasirox

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

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including any not listed in this leaflet, please inform your doctor or pharmacist. See section 4.

Table of contents of the leaflet

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

1. What is Exferana and what is it used for

What is Exferana

Exferana contains the active substance deferasirox. It is an iron chelator, i.e. a medicine used to remove excess iron (also known as iron overload) from the body. Exferana captures and removes excess iron, which is then mainly excreted in the stool.

What is Exferana used for

Repeated blood transfusions may be necessary for patients with various types of anemia (e.g. thalassemia, sickle cell anemia, or myelodysplastic syndromes). However, repeated blood transfusions can cause iron to accumulate. This happens because blood contains iron, and the body does not have natural methods to remove excess iron received during transfusions. In patients with thalassemia who are not dependent on blood transfusions, iron overload may also develop over time, mainly due to increased iron absorption from food, as a reaction to a low number of red blood cells. Over time, excessive iron can cause damage to important organs, such as the liver and heart. To remove excess iron and reduce the risk of organ damage, iron chelators are used. Exferana is used to treat chronic iron overload due to frequent blood transfusions in patients with severe beta thalassemia aged 6 years and older. Exferana is also used to treat chronic iron overload when treatment with deferoxamine is contraindicated or inappropriate, in patients with severe beta thalassemia with iron overload due to infrequent blood transfusions, in patients with other types of anemia, and in patients aged 2 to 5 years. Exferana is also used when deferoxamine therapy is contraindicated or insufficient, in the treatment of patients aged 10 years and older with iron overload in the course of thalassemia syndromes, independent of blood transfusions.

2. Important information before taking Exferana

When not to take Exferana

• if you are allergic to deferasirox or any of the other ingredients of this medicine (listed in section 6). If you have such an allergy, you must inform your doctor before taking Exferana. If you suspect that you may be allergic, consult your doctor;
• if you have moderate or severe kidney impairment;
• if you are currently taking any other iron chelators.

Exferana is not recommended

• if you have advanced myelodysplastic syndrome (reduced production of blood cells by the bone marrow) or advanced cancer.

Warnings and precautions

Before starting treatment with Exferana, you should discuss it with your doctor or pharmacist:

• if you have kidney or liver disease;
• if you have heart problems caused by iron overload;
• if you notice a significant decrease in the amount of urine you pass (a sign of kidney disease);
• if you experience a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and throat (symptoms of a severe allergic reaction, see also section 4. "Possible side effects");
• if you experience any of the following symptoms: rash, red skin, blisters on the lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, swollen lymph nodes (symptoms of a severe skin reaction, see also section 4. "Possible side effects");
• if you experience drowsiness, pain in the upper right part of the abdomen, yellowing or darkening of the skin or eyes, and dark urine (symptoms of liver disease);
• if you experience difficulty thinking, remembering information, or solving problems, you become less alert or aware, or you feel drowsy with a lack of energy (symptoms of high ammonia levels in the blood, which may be related to liver or kidney disorders, see also section 4. "Possible side effects");
• if you vomit blood and/or pass black stools;
• if you frequently experience abdominal pain, especially after eating or taking Exferana;
• if you frequently experience heartburn;
• if you have a low platelet count or white blood cell count;
• if you experience blurred vision;
• if you experience diarrhea or vomiting.

If any of the above applies to you, you should immediately inform your doctor.

Monitoring Exferana treatment

During treatment, you will undergo regular blood and urine tests. Their purpose is to monitor the amount of iron in your body (ferritin levels in the blood) to check how Exferana works. Blood tests also allow monitoring of kidney function (creatinine levels in the blood, protein in the urine) and liver function (increased aminotransferase activity in the blood). Your doctor may order a kidney biopsy if they suspect significant kidney damage. You may also undergo an MRI (magnetic resonance imaging) to determine the amount of iron in the liver. Your doctor will take into account the results of these tests when determining the optimal dose of Exferana for you and when deciding whether to stop taking Exferana. As a precaution, annual vision and hearing tests will be performed during treatment.

Exferana and other medicines

Tell your doctor or pharmacist about all medicines you are taking, have recently taken, or plan to take, including:

• other iron chelators, which should not be taken with Exferana;
• antacids (medicines used to treat heartburn) containing aluminum, which should not be taken at the same time of day as Exferana;
• cyclosporine (used to prevent rejection of a transplanted organ or to treat other diseases, such as rheumatoid arthritis or atopic dermatitis);
• simvastatin (used to lower cholesterol levels);
• painkillers or anti-inflammatory drugs (e.g. aspirin, ibuprofen, corticosteroids);
• oral bisphosphonates (used to treat osteoporosis);
• anticoagulant medicines (used to prevent or treat excessive blood clotting);
• hormonal contraceptives (birth control pills);
• bepridil, ergotamine (used to treat heart diseases or migraines);
• repaglinide (used to treat diabetes);
• rifampicin (used to treat tuberculosis);
• phenytoin, phenobarbital, carbamazepine (used to treat epilepsy);
• ritonavir (used to treat HIV infection);
• paclitaxel (used to treat cancer);
• theophylline (used to treat respiratory diseases, such as asthma);
• clozapine (used to treat mental disorders, such as schizophrenia),
• tizanidine (used as a muscle relaxant);
• colestyramine (used to lower cholesterol levels in the blood);
• busulfan (used to treat cancer before receiving a transplant to destroy the existing bone marrow before receiving the transplant).

Your doctor may order additional tests to monitor the levels of some of these medicines in your blood.

Elderly patients (65 years and older)

Exferana can be used in patients aged 65 years and older at the same doses as in other adult patients. In elderly patients, more side effects may occur (especially diarrhea) than in younger patients. Patients in this age group should be closely monitored by their doctor to detect possible side effects that may require dose adjustment.

Children and adolescents

Exferana can be used in children and adolescents aged 2 years and older who receive regular blood transfusions and in children and adolescents aged 10 years and older who do not receive regular blood transfusions. As the patient grows, the doctor will adjust the dose of the medicine. Exferana is not recommended for children under 2 years of age.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to have a child, consult your doctor before taking this medicine. Exferana is not recommended during pregnancy unless there is a clear need for treatment. If you are currently taking oral contraceptives or using contraceptive patches to prevent pregnancy, you should use an additional method of contraception, or a different type of contraception (e.g. condoms), as deferasirox may reduce the effectiveness of oral and patch contraceptives. During treatment with Exferana, breastfeeding is not recommended.

Driving and using machines

If you experience dizziness while taking Exferana, do not drive or operate machinery until you feel normal again.

Exferana contains lactose

If you have been diagnosed with an intolerance to some sugars, consult your doctor before taking the medicine.

Exferana contains sodium

The medicine contains less than 1 mmol (23 mg) of sodium per dose, which means it is considered "sodium-free".

3. How to take Exferana

Treatment with Exferana will be supervised by a doctor with experience in treating patients with iron overload due to blood transfusions. This medicine should always be taken exactly as prescribed by your doctor. If you are unsure, consult your doctor or pharmacist.

How much Exferana to take

In all patients, the dose of Exferana is based on body weight. Your doctor will calculate the required dose and tell you how many tablets to take per day.

• Usually, the initial daily dose of deferasirox is 14 mg per kilogram of body weight in patients receiving regular blood transfusions. Depending on individual needs, your doctor may recommend a higher or lower initial dose.
• In patients not receiving regular blood transfusions, the initial daily dose of deferasirox is usually 7 mg per kilogram of body weight.
• Depending on the response to treatment, your doctor may adjust the dose later, increasing or decreasing it.
• The maximum recommended daily dose of deferasirox is: 28 mg per kilogram of body weight in patients receiving regular blood transfusions, 14 mg per kilogram of body weight in adult patients not receiving regular blood transfusions, 7 mg per kilogram of body weight in children and adolescents not receiving regular blood transfusions.

Deferasirox is also available in a formulation for the preparation of an oral suspension. If you switch from tablets to an oral suspension, your dose may need to be adjusted.

When to take Exferana

• Take Exferana once a day, every day, at approximately the same time each day, with a small amount of water.
• Exferana tablets should be taken on an empty stomach or with a light meal.

Taking Exferana at the same time every day will also help you remember to take your medicine. If you are unable to swallow the tablets whole, Exferana tablets can be crushed and sprinkled on a soft, non-acidic food such as yogurt or applesauce. You should consume the dose immediately with the food and not store it for later use.

How long to take Exferana

You should continue to take Exferana every day for as long as your doctor recommends. This is a long-term treatment that may last several months or years. Your doctor will regularly check your health to see if the treatment is working (see also section 2: "Monitoring Exferana treatment"). If you have questions about the duration of treatment with Exferana, consult your doctor.

Taking more Exferana than recommended

If you take more Exferana than recommended or if someone else accidentally takes the tablets, you should immediately consult your doctor or go to the nearest hospital. You should show the doctor the packaging of the medicine. Immediate treatment may be necessary. You may experience symptoms such as abdominal pain, diarrhea, nausea, and vomiting, as well as kidney or liver problems, which can be serious.

Missing a dose of Exferana

If you miss a dose, take it as soon as possible on the same day. Take the next dose at the usual time. Do not take a double dose the next day to make up for the missed tablet (tablets).

Stopping Exferana treatment

Do not stop taking Exferana unless your doctor tells you to. If you stop treatment, excess iron will no longer be removed from your body (see also "How long to take Exferana").

4. Possible side effects

Like all medicines, Exferana can cause side effects, although not everybody gets them. Most side effects are mild to moderate and usually go away after a few days or weeks of treatment.

Some side effects can be serious and require immediate medical attention.

These side effects occur uncommonly(may affect up to 1 in 100 people) or rarely(may affect up to 1 in 1,000 people).

• If you experience a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and throat (symptoms of a severe allergic reaction);
• if you experience any of the following symptoms: rash, red skin, blisters on the lips, eyes, or mouth, skin peeling, high fever, flu-like symptoms, swollen lymph nodes (symptoms of severe skin reactions);
• if you notice a significant decrease in the amount of urine you pass (a sign of kidney disease);
• if you experience drowsiness, pain in the upper right part of the abdomen, yellowing or darkening of the skin or eyes, and dark urine (symptoms of liver disease);
• if you experience difficulty thinking, remembering information, or solving problems, you become less alert or aware, or you feel drowsy with a lack of energy (symptoms of high ammonia levels in the blood, which may be related to liver or kidney disorders and may lead to changes in brain function);
• if you vomit blood and/or pass black stools;
• if you frequently experience abdominal pain, especially after eating or taking Exferana;
• if you frequently experience heartburn;
• if you experience partial loss of vision;
• if you experience severe abdominal pain (pancreatitis); you should stop taking the medicine and immediately inform your doctor.

Some side effects can become serious.

These side effects occur uncommonly.

• If you experience blurred or cloudy vision;
• if you experience hearing loss; you should inform your doctor as soon as possible.

Other side effects

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

• Abnormal kidney function test results.

Common(may affect up to 1 in 10 people)

• Gastrointestinal disorders, such as nausea, vomiting, diarrhea, abdominal pain, bloating, constipation, indigestion
• Rash
• Headache
• Abnormal liver function test results
• Itching
• Abnormal urine test results (protein in the urine) If any of these symptoms are severe, you should inform your doctor.

Uncommon(may affect up to 1 in 100 people)

• Dizziness
• Fever
• Sore throat
• Swelling of the arms and legs
• Changes in skin color
• Restlessness
• Sleep disorders
• Fatigue If any of these symptoms are severe, you should inform your doctor.

Frequency not known(cannot be estimated from the available data)

• Decreased number of platelets, red blood cells, white blood cells, or all types of blood cells
• Hair loss
• Kidney stones
• Low urine output
• Rupture of the stomach or intestine, which can cause pain and nausea
• Severe abdominal pain (pancreatitis)
• Abnormal blood acidity

Reporting side effects

If you experience any side effects, including any not listed in this leaflet, you should inform your doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring 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. 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 Exferana

• The medicine should be stored out of sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister pack and carton after EXP and Expiry Date (EXP). The expiry date refers to the last day of the month stated.
• Do not use this medicine if you notice signs of damage or deterioration of the packaging.
• 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 pack and other information

What Exferana contains

The active substance of Exferana is deferasirox. Each Exferana 90 mg coated tablet contains 90 mg of deferasirox. Each Exferana 180 mg coated tablet contains 180 mg of deferasirox. Each Exferana 360 mg coated tablet contains 360 mg of deferasirox. The other ingredients are: Tablet core: microcrystalline cellulose (type 101 and 102), povidone K-30, crospovidone (type A and B), poloxamer 188, colloidal silicon dioxide, magnesium stearate Coating: hypromellose (E 464), lactose monohydrate, titanium dioxide (E 171), triacetin, aluminum lake of indigo carmine (E 132)

What Exferana looks like and contents of the pack

Exferana is available in the form of coated tablets. The tablets are oval and biconvex.

• Exferana 90 mg coated tablets Light blue, oval, biconvex coated tablets, approximately 10 mm x 6 mm in size, with "D7FX" embossed on one side and "90" on the other.
• Exferana 180 mg coated tablets Blue, oval, biconvex coated tablets, approximately 13 mm x 7 mm in size, with "D7FX" embossed on one side and "180" on the other.
• Exferana 360 mg coated tablets Dark blue, oval, biconvex coated tablets, approximately 15 mm x 9 mm in size, with "D7FX" embossed on one side and "360" on the other.

Single packs containing 30 or 90 coated tablets. The blister pack may be perforated or non-perforated. Not all pack sizes or strengths may be marketed.

Marketing authorization holder

VIPHARM S.A. ul. A. i F. Radziwiłłów 9 05-850 Ożarów Mazowiecki Poland

Manufacturers

Synthon Hispania S.L. Calle Castello 1 08830 Sant Boi de Llobregat Barcelona Spain Synthon BV Microweg 22 6545 CM Nijmegen Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Netherlands Exferana 90 mg, filmomhulde tabletten Exferana 180 mg filmomhutten tabletten Exferana 360 mg filmomhutten tabletten Czech Republic Exferana Hungary Exferana 90 mg filmtabletta Exferana 180 mg filmtabletta Exferana 360 mg filmtabletta Poland Exferana Slovakia Exferana 90 mg Exferana 180 mg Exferana 360 mg

Date of last revision of the leaflet: 01.10.2021