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

1. what deferasirox is and what it is used forwhat deferasirox isthis product 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 tlialassaemia, 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 tlialassaemia 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 tlialassaemia 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 tlialassaemia 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 tlialassaemia 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.

• – if you have moderate or severe kidney disease.

• – if you 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.

• – if you have a cardiac problem due to iron overload.

• – if you notice a marked decrease in your urine output (sign of kidney problem).

• – if you 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”).

• – 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, enlarged lymph nodes (signs of severe skin reaction, see also section 4 “Possible side effects”).

• – if you 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).

• – if you 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”).

• – if you vomit blood and/or have black stools.

• – if you experience frequent abdominal pain, particularly after eating or taking Deferasirox.

• – if you experience frequent heartburn.

• – if you have a low level of platelets or white blood cells in your blood test.

• – if you have blurred vision.

• – if you 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, it 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.

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 fihn-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,
• 7 mg per kilogram body weight for children and adolescents not receiving regular blood transfusions.

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Deferasirox also comes as “dispersible” tablets. If you are switching from the dispersible tablets to these fihn-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 fihn-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 fihn-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 tliat 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 tlie pack of tablets. Urgent medical treatment may be necessary. You may experience effects such as abdominal pain, diarrhoea, nausea, vomiting and kidney or liver problems tliat 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).

• If you get a severe rash, or difficulty breathing and dizziness or swelling mainly of the face and throat (signs of 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, enlarged lymph nodes, (signs of severe skin reactions),
• If you notice a marked decrease in your urine output (sign of kidney problem),
• If you 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),
• If you 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)
• If you vomit blood and/or have black stools,
• If you experience frequent abdominal pain, particularly after eating or taking this medicine,
• If you experience frequent heartburn,
• If you experience partial loss of vision,
• If you experience severe upper stomach pain (pancreatitis),

stop taking this medicine and tell your doctor straight away.

Some side effects could become serious.

These side effects are uncommon.

• If you get blurred or cloudy eyesight,
• If you get reduced hearing, tell your doctor straight away

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 anus 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 tliat can be painful and cause nausea
• Severe upper stomach pain (pancreatitis)
• Abnormal level of acid in blood

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

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 wwwmhra. gov.uk/yellowcard or search for ‘MHRA Yellow Card’ in tlie Google Play or Apple App Store.

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

5. how to store deferasirox

• Keep this medicine out of tlie 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 tlie last day of tliat month.
• This medicine does not require any special storage conditions.
• Do not use any pack tliat 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 fihn-coated tablet of Deferasirox 90 mg contains 90 mg deferasirox.
• Each fihn-coated tablet of Deferasirox 180 mg contains 180 mg deferasirox.
• Each fihn-coated tablet of Deferasirox 360 mg contains 360 mg deferasirox.

The other ingredients are:

- Tablet core: crospovidone (E1202); povidone (E1201); cellulose microcrystalline (1:460): magnesium stearate (4 :470b ); poloxamer and silica,colloidal anhydrous (E551).

- Tablet coating: hypromellose (4 :464 ); titanium dioxide (E171); macrogol (E1521); talc (E553b); Indigo carmine aluminium lake (El32).

What Deferasirox looks like and contents of the pack

Deferasirox is supplied as fihn-coated tablets. The fihn-coated tablets are ovaloid and biconvex.

• Deferasirox 90 mg fihn-coated tablets are light blue, ovaloid, biconvex, fihn-coated tablets with bevelled edges, embossed with ‘90’ on one side and plain on tlie other side. The dimensions of the tablet are approximately 10.3 nun x 4.1 nun ± 5%.
• Deferasirox 180 mg fihn-coated tablets are medium blue, ovaloid, biconvex, fihn-coated tablets with bevelled edges, embossed with ‘180’ on one side and plain on tlie other side. The dimensions of the tablet are approximately 13.4 nun x 5.4 nun ± 5%.
• Deferasirox 360 mg fihn-coated tablets are dark blue, ovaloid, biconvex, fihn-coated tablets with bevelled edges, embossed with ‘360’ on one side and plain on tlie other side. The dimensions of the tablet are approximately 16.6 nun x 6.6 nun ± 5%.

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