Exferana

Leaflet accompanying the packaging: patient information

Exferana 180 mg coated tablets

Exferana 360 mg coated tablets

Deferasirox

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

• Keep this leaflet, so you can read it again if you need to.
• If you have any doubts, consult your 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 not listed in this leaflet, they should tell their 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 packaging 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-chelating substance, 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 syndromes independent of 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, excess 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-chelating medicines 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 deferoxamine treatment is contraindicated or inadequate 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

they should inform their doctor before taking Exferana. If the patient suspects they may be allergic, they should consult their doctor;

Exferana is not recommended

Warnings and precautions

Before starting Exferana, the patient should discuss the following with their doctor or pharmacist:

If any of the above applies to the patient, they should immediately inform their doctor.

Monitoring Exferana treatment

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

Exferana and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take. These include:

• other iron-chelating medicines, 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 organ rejection or treat other diseases, such as rheumatoid arthritis or atopic dermatitis);
• simvastatin (used to lower cholesterol levels);
• pain or anti-inflammatory medicines (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 medicines);
• 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);
• cholestyramine (used to lower cholesterol levels in the blood);
• busulfan (used before receiving a transplant to destroy the existing bone marrow before the transplant),
• midazolam (used to relieve anxiety and/or sleep problems).

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

Elderly patients (aged 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 (especially diarrhea) may occur 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 the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor before taking this medicine. Exferana is not recommended during pregnancy unless there is a clear need for treatment. If the patient is currently using hormonal contraception to prevent pregnancy, they should use additional or alternative contraception (e.g., a condom), as Exferana may reduce the effectiveness of hormonal contraceptives. Breastfeeding is not recommended during Exferana treatment.

Driving and using machines

If the patient experiences dizziness while taking Exferana, they should not drive or operate machines until they feel normal again.

Exferana contains lactose

If the patient has previously been diagnosed with intolerance to some sugars, they should contact their 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 according to the doctor's instructions. If the patient has any doubts, they should consult their doctor or pharmacist.

How much Exferana to take

In all patients, the dose of Exferana is based on body weight. The doctor will calculate the required dose and tell the patient 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, the 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, the 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.

In some countries, deferasirox may also be available in the form of tablets for oral suspension, manufactured by other companies. If the patient switches from such tablets for oral suspension to Exferana coated tablets, the dose will change. The doctor will calculate the required dose and tell the patient how many coated tablets to take daily.

When to take Exferana

• Exferana should be taken once a day, every day, at approximately the same time each day, with a small amount of water.
• Exferana coated tablets should be taken on an empty stomach or with a light meal. Taking Exferana at the same time every day will also help the patient remember to take the medicine.

In the case of patients who cannot swallow the tablets whole, Exferana coated tablets can be crushed and the entire dose can be sprinkled on a semi-liquid food, such as yogurt or applesauce. The patient should consume the entire dose immediately with the food and not store it for later use.

How long to take Exferana

The patient should continue to take Exferana every day for as long as their doctor recommends. This is a long-term treatment that may last several months or years. The doctor will regularly monitor the patient's health to check if the treatment is working (see also section 2: "Monitoring Exferana treatment"). If the patient has any questions about the duration of Exferana treatment, they should consult their doctor.

Taking more Exferana than recommended

If the patient takes more Exferana than recommended or if someone else accidentally takes the tablets, they should immediately consult their doctor or go to the nearest hospital. They should show the doctor the packaging of the medicine. Immediate treatment may be necessary. The patient 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 the patient misses a dose, they should take it as soon as possible on the same day. The next dose should be taken at the usual time. On the next day, the patient should not take a double dose to make up for the missed tablet (tablets).

Stopping Exferana treatment

The patient should not stop taking Exferana unless their doctor decides to. If treatment is stopped, excess iron will no longer be removed from the body (see also the section "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 the patient experiences a severe rash, or difficulty breathing and dizziness or swelling, mainly of the face and throat (symptoms of a severe allergic reaction);
they should stop taking the medicine and immediately tell their doctor.

Some side effects can become serious.

These side effects occur uncommonly.

• If the patient experiences blurred or cloudy vision;
they should tell their 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, the patient should tell their doctor.

Uncommon(may affect up to 1 in 100 people)

• Dizziness
• Fever
• Sore throat
• Swelling of the arms and legs
• Skin discoloration
• Anxiety
• Sleep disorders
• Fatigue If any of these symptoms are severe, the patient should tell their doctor.

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

• Decreased number of platelets, red blood cells (worsening anemia), white blood cells (neutropenia), or all types of blood cells (pancytopenia)
• Hair loss
• Kidney stones
• Low urine output
• Perforation of the stomach or intestine, which can cause pain and nausea
• Sudden severe abdominal pain (pancreatitis)
• Abnormal blood acidity

Reporting side effects

If the patient experiences any side effects, including any not listed in this leaflet, they should tell their doctor or pharmacist, or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, more information can be collected on the safety of the 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 signs of damage or deterioration of the packaging are visible.
• Medicines should not be disposed of via wastewater or household waste. The patient should ask their 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 Exferana contains

The active substance of Exferana is 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 silica anhydrous, 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 coated tablets are oval and biconvex. Exferana 180 mg coated tablets Blue, oval, biconvex coated tablets with dimensions of approximately 13 mm x 7 mm, with the imprint "D7FX" on one side and "180" on the other. Exferana 360 mg coated tablets Dark blue, oval, biconvex coated tablets with dimensions of approximately 15 mm x 9 mm, with the imprint "D7FX" on one side and "360" on the other. Single-dose packaging 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 180 mg film-coated tablets Exferana 360 mg film-coated tablets Czech Republic Exferana Hungary Exferana 180 mg film tablet Exferana 360 mg film tablet Poland Exferana Slovakia Exferana 180 mg Exferana 360 mg

Date of last revision of the leaflet: 29.03.2024