Deferasirox Abdi

Patient Information Leaflet: Information for the User

Deferasirox Abdi 90 mg film-coated tablets, 180 mg film-coated tablets, 360 mg film-coated tablets

Deferasirox
Generic medicine
Please read all of this leaflet carefully before you or your child take this medicine as it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you or your child only. Do not pass it on to others. It may be harmful to others even if their symptoms are the same as yours.
• If you or your child experience any side effects, including any not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

1. What Deferasirox Abdi is and what it is used for
2. What you need to know before taking Deferasirox Abdi
3. How to take Deferasirox Abdi
4. Possible side effects
5. How to store Deferasirox Abdi
6. Contents of the pack and other information

1. What Deferasirox Abdi is and what it is used for

What Deferasirox Abdi is
Deferasirox Abdi contains an active substance called deferasirox. It is an iron chelator, that is, a
medicinal product used to remove excess iron from the body (also known as iron overload). Deferasirox
binds to excess iron and removes it, primarily eliminating it through the faeces.

What Deferasirox Abdi is used for
In patients with various forms of anaemia (for example, thalassaemia, sickle cell anaemia, or myelodysplastic syndromes (MDS)), repeated blood transfusions may be necessary. However, these can lead to an excess of iron in the body. This occurs because blood contains iron, and the body lacks a natural way to remove the excess iron introduced through blood transfusions. In patients with thalassaemia syndromes who are not receiving blood transfusions, iron overload may also develop over time, primarily due to increased dietary iron absorption in response to a low number of blood cells.
Over time, excess iron can damage vital organs such as the liver and heart. Medicinal products called iron chelators are used to eliminate excess iron and reduce the risk of organ damage.

Deferasirox Abdi is used to treat iron overload due to frequent blood transfusions in patients with beta-thalassaemia major aged 6 years and older.

Deferasirox Abdi is also used to treat iron overload when therapy with deferoxamine is contraindicated or inadequate in patients with beta-thalassaemia major with iron overload due to infrequent blood transfusions, in patients with other forms of anaemia, and in children aged between 2 and 5 years.

Deferasirox Abdi is also used when therapy with deferoxamine is contraindicated or inadequate for the treatment of patients aged 10 years and older who have iron overload associated with thalassaemia syndromes but who do not require blood transfusions.

2. What you need to know before taking Deferasirox Abdi

Do not take Deferasirox Abdi

• if you are allergic to deferasirox or to any of the other ingredients of this medicine (listed in section 6). If this applies to you, inform your doctor before taking Deferasirox Abdi. If you think you may be allergic, consult your doctor.
• if you have moderate or severe kidney disease.
• if you are currently taking any other iron-chelating medicine.

Deferasirox Abdi is not recommended

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

Warnings and precautions
Talk to your doctor or pharmacist before taking Deferasirox Abdi:

• if you have kidney or liver problems.
• if you have heart problems due to iron overload.
• if you notice a marked decrease in urine output (a sign of kidney problems).
• if you develop a severe skin rash, or have difficulty breathing, dizziness, or swelling, particularly of the face and throat (signs of a severe allergic reaction; see also section 4 “Possible side effects”).
• if you experience a combination of any of the following symptoms: skin rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, or swollen lymph nodes (signs of a severe skin reaction; see also section 4 “Possible side effects”).
• if you experience a combination of drowsiness, pain in the upper right part of the abdomen, yellowing or increased yellowing of the skin or eyes, and dark urine (signs of liver problems).
• if you experience difficulty thinking, remembering information, or solving problems, if you feel less alert or aware, or feel very drowsy and lack energy (signs of high blood ammonium levels, which may be associated with liver or kidney problems; see also section 4 “Possible side effects”).
• if you vomit blood and/or have black stools.
• if you experience frequent abdominal pain, especially after eating or taking Deferasirox Abdi.
• if you frequently suffer from heartburn.
• if you have low platelet or white blood cell counts in blood tests.
• if you experience blurred vision.
• if you have diarrhoea or vomiting. If any of these situations apply to you, inform your doctor immediately.

Monitoring of treatment with Deferasirox Abdi
During treatment, you will undergo regular blood and urine tests.
These will measure the amount of iron in your body (blood ferritin levels) to assess how well Deferasirox Abdi is working. The tests will also monitor kidney function (blood creatinine levels, presence of protein in urine) and liver function (blood transaminase levels). Your doctor may request a kidney biopsy if significant kidney damage is suspected. To determine the amount of iron in your liver, you may also undergo magnetic resonance imaging (MRI) scans. Your doctor will use these tests to determine the most appropriate dose of Deferasirox Abdi for you and to decide when you should stop taking it.
As a precautionary measure, your vision and hearing will be examined annually during treatment.

Other medicines and Deferasirox Abdi
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This is particularly important for:

• other iron chelators, which must not be taken with Deferasirox Abdi,
• antacids (medicines used to treat heartburn) containing aluminium, which must not be taken at the same time of day as Deferasirox Abdi,
• cyclosporine (used to prevent rejection of a transplanted organ or for other conditions such as rheumatoid arthritis or atopic dermatitis),
• simvastatin (used to lower cholesterol),
• certain painkillers or anti-inflammatory drugs (e.g. aspirin, ibuprofen, corticosteroids),
• oral bisphosphonates (used to treat osteoporosis),
• anticoagulant medicines (used to prevent or treat blood clotting),
• hormonal contraceptives (birth control medicines),
• bepridil, ergotamine (used for heart conditions and 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 in cancer treatment),
• theophylline (used to treat respiratory diseases such as asthma),
• clozapine (used to treat psychiatric disorders such as schizophrenia),
• tizanidine (used as a muscle relaxant),
• colestyramine (used to reduce blood cholesterol levels),
• busulfan (used as pre-transplant treatment to destroy the original bone marrow before transplantation),
• midazolam (used to relieve anxiety and/or sleep disorders).

Additional monitoring may be required to check blood levels of some of these medicines.

Elderly (age 65 years or older)
Deferasirox Abdi can be used in people aged 65 years or older at the same dose as in adults. Elderly patients may experience more side effects (particularly diarrhoea) than younger patients. They should be closely monitored by their doctor for side effects that may require dose adjustment.

Children and adolescents
Deferasirox Abdi 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. Your doctor will adjust the dose according to the patient's growth.
Deferasirox Abdi is not recommended for children under 2 years of age.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before taking this medicine.
Deferasirox Abdi is not recommended during pregnancy unless strictly necessary.
If you are currently using a hormonal contraceptive to prevent pregnancy, you must use an additional or different type of contraception (e.g. a condom), as Deferasirox Abdi may reduce the effectiveness of hormonal contraceptives.
Breastfeeding is not recommended during treatment with Deferasirox Abdi.

Driving and using machines
If you feel dizzy after taking Deferasirox Abdi, do not drive or operate tools or machinery until you feel normal again.

Deferasirox Abdi contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per dose, i.e. essentially 'sodium-free'.

3. How to take Deferasirox Abdi

Treatment with Deferasirox Abdi will be monitored by a doctor experienced in managing iron overload due to blood transfusions.
Take this medicine exactly as your doctor has told you. If you are unsure, consult your doctor or pharmacist.

How much Deferasirox Abdi to take
The dose of Deferasirox Abdi is based on body weight for all patients. Your doctor will calculate the dose you need and will tell you how many tablets to take each day.

• The usual starting daily dose of Deferasirox Abdi film-coated tablets for patients receiving regular blood transfusions is 14 mg per kilogram of body weight. Your doctor may recommend a higher or lower starting dose depending on your individual treatment needs.
• The usual starting daily dose of Deferasirox Abdi film-coated tablets for patients not receiving regular blood transfusions is 7 mg per kilogram of body weight.
• Depending on your response to treatment, your doctor may later adjust your dose by increasing or decreasing it.
• The maximum recommended daily dose of Deferasirox Abdi film-coated tablets is:
  • 28 mg per kilogram of body weight for patients receiving regular blood transfusions,
  • 14 mg per kilogram of body weight for adults not receiving regular blood transfusions,
  • 7 mg per kilogram of body weight for children and adolescents not receiving regular blood transfusions.

Deferasirox is also available as dispersible tablets. If switching from dispersible tablets to these film-coated tablets, a dose adjustment will be required.

When to take Deferasirox Abdi

• Take Deferasirox Abdi once daily, every day, at approximately the same time each day, with a glass of water.
• Take the film-coated deferasirox tablets on an empty stomach or with a light meal.
• Taking Deferasirox Abdi at the same time every day will help you remember to take your tablets.

For patients unable to swallow the tablets whole, Deferasirox Abdi film-coated tablets may be crushed and administered by sprinkling the full dose onto soft food such as yoghurt or applesauce (apple puree). The food must be consumed immediately and entirely. Do not store for later use.

How long to take Deferasirox Abdi
Continue taking Deferasirox Abdi every day for the duration prescribed by your doctor. This is a long-term treatment, which may last for months or years. Your condition will be regularly monitored by your doctor to ensure the treatment is effective (see also section 2: "Monitoring of treatment with Deferasirox Abdi").
If you have any questions about how long to take Deferasirox Abdi, speak with your doctor.

If you take more Deferasirox Abdi than you should
If you have taken too much Deferasirox Abdi, or if someone else has accidentally taken your tablets, contact your doctor or hospital immediately for advice. Show them the tablet packaging. Medical treatment may be necessary. Symptoms may include abdominal pain, diarrhoea, nausea and vomiting, and kidney or liver problems, which can be serious.

If you forget to take Deferasirox Abdi
If you forget to take a dose, take it as soon as you remember, during the same day. Take your next dose at the usual time. Do not take a double dose the next day to make up for the missed tablet(s).

If you stop taking Deferasirox Abdi
Do not stop taking Deferasirox Abdi unless instructed by your doctor. If you stop taking it, excess iron will no longer be removed from your body (see also above section "How long to take Deferasirox Abdi").

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate and usually disappear after a few days or weeks of treatment.
Some side effects may be serious and require immediate medical attention.
These side effects are uncommon (may affect up to 1 in 100 people) or rare
(may affect up to 1 in 1,000 people).

• If you develop a severe rash, or have difficulty breathing and dizziness, or swelling mainly of the face and throat (signs of a severe allergic reaction),
• If you experience a combination of any of the following symptoms: rash, red skin, blistering of the lips, eyes or mouth, skin peeling, high fever, flu-like symptoms, swollen lymph nodes (signs of severe skin reactions),
• If you notice a marked reduction in urine output (sign of kidney problem),
• If you experience a combination of drowsiness, pain in the upper right part of the abdomen, yellowing or increased yellowing of the skin or eyes, and dark urine (signs of liver problems),
• If you experience difficulty thinking, remembering information, or solving problems, if you feel less alert or aware, or feel very drowsy with low energy (signs of high blood ammonium levels, which may be associated with liver or kidney problems and may lead to changes in brain function),
• If you vomit blood and/or have black stools,
• If you have frequent abdominal pain, particularly after eating or taking Deferasirox Abdi,
• If you have frequent heartburn,
• If you experience partial loss of vision,
• If you have severe pain in the upper part of the abdomen (pancreatitis), stop taking this medicine and contact your doctor immediately.

Some side effects may become serious.
These side effects are uncommon.

• If you experience blurred or cloudy vision,
• If you have a decrease in hearing, contact your doctor as soon as possible.

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

• Abnormal kidney function tests.

Common (may affect up to 1 in 10 people)

• Gastrointestinal disorders, such as nausea, vomiting, diarrhoea, abdominal pain, bloating, constipation, indigestion
• Rash
• Headache
• Abnormal liver function tests
• Itching
• Abnormal urine test (protein in urine). If any of these side effects becomes severe, inform your doctor.

Uncommon (may affect up to 1 in 100 people)

• Dizziness
• Fever
• Sore throat
• Swelling of the arms or legs
• Change in skin colour
• Anxiety
• Sleep disorders
• Fatigue. If any of these side effects becomes severe, inform your doctor.

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

• A reduction in the number of cells involved in blood clotting (thrombocytopenia), in the number of red blood cells (worsening of anaemia), in the number of white blood cells (neutropenia), or in the number of all types of blood cells (pancytopenia)
• Hair loss
• Kidney stones
• Low urine production
• Tear in the wall of the stomach or intestine, which may be painful and cause nausea
• Severe pain in the upper part of the abdomen (pancreatitis)
• Increased acidity of the blood.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Deferasirox Abdi

• Keep this medicine out of the sight and reach of children.
• Do not use this medicine after the expiry date stated on the blister and carton after Exp. The expiry date refers to the last day of that month.
• Do not use the pack if it is damaged or shows signs of tampering.
• This medicine does not require any special storage conditions.
• Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Deferasirox Abdi contains
The active substance is deferasirox.

• Each film-coated tablet of Deferasirox Abdi 90 mg contains 90 mg of deferasirox.
• Each film-coated tablet of Deferasirox Abdi 180 mg contains 180 mg of deferasirox.
• Each film-coated tablet of Deferasirox Abdi 360 mg contains 360 mg of deferasirox.
  The other ingredients are microcrystalline cellulose (Type 101), crospovidone (Type A), Poloxamer 188 (micronized), povidone (K30), microcrystalline cellulose (Type 102), silica (anhydrous colloidal), magnesium stearate.
  The tablet coating contains: HPMC/hypromellose, titanium dioxide (E171), macrogol/PEG, talc, indigo carmine aluminium lake (E132).

Description of the appearance of Deferasirox Abdi and contents of the pack
Deferasirox Abdi is supplied as film-coated tablets. The film-coated tablets are oval and biconvex.

• Deferasirox Abdi 90 mg film-coated tablets are light grey in colour, marked with "D1" on one side and plain on the other side.
• Deferasirox Abdi 180 mg film-coated tablets are blue in colour, marked with "D2" on one side and plain on the other side.
• Deferasirox Abdi 360 mg film-coated tablets are dark blue in colour, marked with "D3" on one side and plain on the other side.

Pack sizes:
For all strengths: unit packs containing 30 or 90 film-coated tablets.
Additionally, for Deferasirox Abdi 360 mg: multiple packs containing 300 film-coated tablets (10 packs of 30).
Not all pack sizes may be marketed.

Marketing Authorisation Holder
ABDI FARMA GmbH
Donnersbergstraβe 4
64646 Heppenheim
Germany

Manufacturer
Interpharma Services Ltd.
43A Cherni Vrach Blvd.,
1407 Sofia, Bulgaria
Interpharma Services Ltd.
11, Rusalijski prohod Str., fl. 3, ap. 8
1407 Sofia, Bulgaria
Flavine Pharma France
3 Voie d’Allermagne, Vitrolles,
13127 France

This medicinal product is authorised in the European Economic Area Member States with the following trade names:

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