DEFERASIROX ZENTIVA 90 MG FILM-COATED TABLETS - patient leaflet, side effects, dosage

Patient leaflet - DEFERASIROX ZENTIVA 90 MG FILM-COATED TABLETS

1.what deferasirox is and what it is used forwhat deferasirox isdeferasirox contains an active substance called deferasirox. it is an iron chelator which is a medicine used to remove the excess iron from the body (also called iron overload). it traps and removes excess iron which is then excreted mainly in the stools.

What Deferasirox is used for

Repeated blood transfusions may be necessary in patients with various types of anaemia (for example thalassaemia, sickle cell disease or myelodysplastic syndromes (MDS)). However, repeated blood transfusions can cause a build-up of excess iron. This is because blood contains iron and your body does not have a natural way to remove the excess iron you get with your blood transfusions. In patients with non-transfusion-dependent thalassaemia syndromes, iron overload may also develop over time, mainly due to increased absorption of dietary iron in response to low blood cell counts. Over time, the excess iron can damage important organs such as the liver and heart. Medicines called iron chelators are used to remove the excess iron and reduce the risk of it causing organ damage.

Deferasirox is used to treat chronic iron overload caused by frequent blood transfusions in patients with beta-thalassaemia major aged 6 years and older. Deferasirox is also used to treat chronic iron overload when deferoxamine therapy is contraindicated or inadequate in patients with beta-thalassaemia major with iron overload caused by infrequent blood transfusions, in patients with other types of anaemias, and in children aged 2 to 5 years.

Deferasirox is also used when deferoxamine therapy is contraindicated or inadequate to treat patients aged 10 years or older who have iron overload associated with their thalassaemia syndromes, but who are not transfusion dependent.

2.what you need to know before you take deferasirox

Do not take Deferasirox if you

are allergic to deferasirox or any of the other ingredients of this medicine (listed in section 6). If this applies to you, tell your doctor before taking Deferasirox. If you think you may be allergic, ask your doctor for advice.
have moderate or severe kidney disease.
are currently taking any other iron chelator medicines.

Deferasirox is not recommended if you

are at an advanced stage of myelodysplastic syndrome (MDS; decreased production of blood cells by the bone marrow) or have advanced cancer.

Warnings and precautions

Talk to your doctor or pharmacist before taking Deferasirox if you

have a kidney or liver problem.
have a cardiac problem due to iron overload.
notice a marked decrease in your urine output (sign of kidney problem).
develop a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and throat (signs of severe allergic reaction, see also section 4 “Possible side effects”).
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, enlarged lymph nodes (signs of severe skin reaction, see also section 4 “Possible side effects”).
experience a combination of drowsiness, upper right abdominal pain, yellowing or increased yellowing of your skin or eyes and dark urine (signs of liver problems).
experience difficulty thinking, remembering information, or solving problems, being less alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in _____ your blood, which may be associated with liver or renal problems, see also section 4 “Possible side effects”).
vomit blood and/or have black stools.
experience frequent abdominal pain, particularly after eating or taking Deferasirox.
experience frequent heartburn.
have a low level of platelets or white blood cells in your blood test.
have blurred vision.
have diarrhoea or vomiting.

If any of these apply to you, tell your doctor straight away.

Monitoring your Deferasirox treatment You will have regular blood and urine tests during treatment. These will monitor the amount of iron in your body (blood level of ferritin) to see how well Deferasirox is working. The tests will also monitor your kidney function (blood level of creatinine, presence of protein in the urine) and liver function (blood level of transaminases). Your doctor may require you to undergo a kidney biopsy, if he/she suspects significant kidney damage. You may also have MRI (magnetic resonance imaging) tests to determine the amount of iron in your liver. Your doctor will take these tests into consideration when deciding on the dose of Deferasirox most suitable for you and will also use these tests to decide when you should stop taking Deferasirox.

Your eyesight and hearing will be tested each year during treatment as a precautionary measure.

Other medicines and Deferasirox

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. This includes in particular: Other iron chelators, which must not be taken with Deferasirox.
Antacids (medicines used to treat heartburn) containing aluminium, which should not be taken at the same time of day as Deferasirox.
Ciclosporin (used to prevent the body rejecting a transplanted organ or for other conditions, such as rheumatoid arthritis or atopic dermatitis).
Simvastatin (used to lower cholesterol).
Certain painkillers or anti-inflammatory medicines (e.g. aspirin, ibuprofen, corticosteroids).
Oral bisphosphonates (used to treat osteoporosis).
Anticoagulant medicines (used to prevent or treat blood clotting).
Hormonal contraceptive agents (birth control medicines).
Bepridil, ergotamine (used for heart problems and migraines).
Repaglinide (used to treat diabetes).
Rifampicin (used to treat tuberculosis).
Phenytoin, phenobarbital, carbamazepine (used to treat epilepsy).
Ritonavir (used in the treatment of 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).
Cholestyramine (used to lower cholesterol levels in the blood).
Busulfan (used as a treatment prior to transplantation in order to destroy the original bone marrow before the transplant).

Additional tests may be required to monitor the blood levels of some of these medicines.

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

Children and adolescents

Deferasirox can be used in children and adolescents receiving regular blood transfusions aged 2 years and over and in children and adolescents not receiving regular blood transfusions aged 10 years and over. As the patient grows the doctor will adjust the dose. Deferasirox is not recommended for children aged under 2 years.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

Deferasirox is not recommended during pregnancy unless clearly necessary.

If you are currently using an oral contraceptive or using a patch contraceptive to prevent pregnancy, you should use an additional or different type of contraception (e.g. condom), as Deferasirox may reduce the effectiveness of oral and patch contraceptives. Breast-feeding is not recommended during treatment with Deferasirox.

Driving and using machines

If you feel dizzy after taking Deferasirox, do not drive or operate any tools or machines until you are feeling normal again.

Deferasirox contains lactose

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicine.

3.How to take Deferasirox

Treatment with Deferasirox will be overseen by a doctor who is experienced in the treatment of iron overload caused by blood transfusions. Always take this medicine exactly as your doctor has told you. Check with your doctor or pharmacist if you are not sure.

How much Deferasirox to take

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

The usual daily dose for Deferasirox film-coated tablets at the start of the treatment for patients receiving regular blood transfusions is 14 mg per kilogram body weight. A higher or lower starting dose may be recommended by your doctor based on your individual treatment needs.
The usual daily dose for Deferasirox film-coated tablets at the start of the treatment for patients not receiving regular blood transfusions is 7 mg per kilogram body weight.
Depending on how you respond to treatment, your doctor may later adjust your treatment to a higher or lower dose.
The maximum recommended daily dose for Deferasirox film-coated tablets is 28 mg per kilogram body weight for patients receiving regular blood transfusions, 14 mg per kilogram body weight for adult patients not receiving regular blood transfusions and 7 mg per kilogram body weight for children and adolescents not receiving regular blood transfusions.

Deferasirox also comes as “dispersible” tablets. If you are switching from the dispersible tablets to these film-coated tablets, you will need an adjustment of the dose.

When to take Deferasirox

Take Deferasirox once a day, every day, at about the same time each day with some water.
Take Deferasirox film-coated tablets either on an empty stomach or with a light meal.

Taking Deferasirox at the same time each day will also help you remember when to take your tablets.

For patients who are unable to swallow whole tablets, Deferasirox film-coated tablets may be crushed and taken by sprinkling the full dose onto soft food such as yogurt or apple sauce (pureed apple). The food should be immediately and completely consumed. Do not store it for future use.

How long to take Deferasirox

Continue taking Deferasirox every day for as long as your doctor tells you. This is a long-term treatment, possibly lasting for months or years. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect (see also section 2: “Monitoring your Deferasirox treatment”).

If you have questions about how long to take Deferasirox, talk to your doctor.

If you take more Deferasirox than you should If you have taken too much Deferasirox, or if someone else accidentally takes your tablets, contact your doctor or hospital for advice straight away. Show the doctor the pack of tablets.

Urgent medical treatment may be necessary. You may experience effects such as abdominal pain, diarrhoea, nausea and vomiting and kidney or liver problems that can be serious.

If you forget to take Deferasirox

If you miss a dose, take it as soon as you remember on that day. Take your next dose as scheduled. Do not take a double dose on the next day to make up for the forgotten tablet(s). If you stop taking Deferasirox

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

4.Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment.

Some side effects could be serious and need 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).

Stop taking this medicine and tell your doctor straight away, if you

get a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and throat (signs of severe allergic reaction).
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, enlarged lymph nodes, (signs of severe skin reactions).
notice a marked decrease in your urine output (sign of kidney problem).
experience a combination of drowsiness, upper right abdominal pain, yellowing or increased yellowing of your skin or eyes and dark urine (signs of liver problems).
experience difficulty thinking, remembering information, or solving problems, being less alert or aware or feeling very sleepy with low energy (signs of a high level of ammonia in your blood, which may be associated with liver or renal problems and lead to a change in your brain function).
vomit blood and/or have black stools.
experience frequent abdominal pain, particularly after eating or taking Deferasirox.
experience frequent heartburn.
experience partial loss of vision.
experience severe upper stomach pain (pancreatitis).

Some side effects could become serious.

These side effects are uncommon (may affect up to 1 in 100 people).

Tell your doctor as soon as possible if you

get blurred or cloudy eyesight.
get reduced hearing.

Other side effects

Very common (may affect more than 1 in

10 people)

Disturbance in kidney function tests.

Common (may affect up to 1 in 10 people)

Gastrointestinal disorders, such as nausea, vomiting, diarrhoea, pain in the abdomen, bloating, constipation, indigestion.
Rash.
Headache.
Disturbance in liver function tests.
Itching.
Disturbance in urine test (protein in the urine) If any of these affects you severely, tell your doctor.

Uncommon (may affect up to 1 in 100 people)

Dizziness.
Fever.
Sore throat.
Swelling of arms or legs.
Change in the colour of the skin.
Anxiety.
Sleep disorder.
Tiredness.

If any of these affects you severely, tell your doctor.

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

A decrease in the number of cells involved in blood clotting (thrombocytopenia), in the number of red blood cells (anaemia aggravated), in the number of white blood cells (neutropenia) or in the number of all kinds of blood cells (pancytopenia).
Hair loss.
Kidney stones.
Low urine output.
Tear in stomach or intestine wall that can be painful and cause nausea.
Severe upper stomach pain (pancreatitis).
Abnormal level of acid in blood.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: or search for MHRA Yellow Card in the Google Play or Apple App Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

5.how to store deferasirox

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the blister and the carton after EXP. The expiry date refers to the last day of that month.
Store below 30°C. Do not use any pack that is damaged or shows signs of tampering.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6.contents of the pack and other informationwhat deferasirox containsthe active substance is deferasirox.

Each film-coated tablet contains 90 mg deferasirox.
Each film-coated tablet contains 180 mg deferasirox.
Each film-coated tablet contains 360 mg deferasirox.

The other ingredients are lactose monohydrate; cellulose, microcrystalline (101, 200); crospovidone; povidone K 30; poloxamer 188; silica colloidal anhydrous; magnesium stearate; hypromellose 2910/5; macrogol 4,000; titanium dioxide (E171); talc. The 180 mg and 360 mg tablets also contain indigo carmine aluminium lake (E132).

What Deferasirox looks like and contents of the pack

Deferasirox 90 mg film-coated tablets White to off-white oblong film-coated tablet with dimensions 11.8×5.5 mm.

Deferasirox 180 mg film-coated tablets Light blue oblong film-coated tablet with “Z” embossed on one side with dimensions 14.8×6.85 mm.

Deferasirox 360 mg film-coated tablets Light blue to blue, oblong, film-coated tablets with dimensions 18.65×8.6 mm.

Deferasirox 90 mg, 180 mg and 360 mg film-coated tablets are available in unit packs containing 30, 90 and 300 (360 mg only) film-coated tablets.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

Zentiva Pharma UK Limited, 12 New Fetter Lane, London, EC4A 1JP, United Kingdom

Manufacturer:

Labormed-Pharma S.A, Theodor Pallady Blvd. 3rd district, 032266 Bucharest, Romania

Pharmadox Healthcare Limited,

KW20A Kordin Industrial Park, Paola PLA 3000, Malta

This leaflet was last revised in October 2021