Nilotinib 150mg

1. Dosage:

- 150 mg

2. What Nilotinib IPI is and what is it used for:

Nilotinib IPI is used to treat a type of leukaemia called Philadelphia chromosome-positive chronic myeloid leukaemia (Ph-positive CML). CML is a cancer of the blood which makes the body produce too many abnormal white blood cells. Nilotinib IPI is used in adult and pediatric patients with newly diagnosed CML. It is also used in pediatric patients with CML who are no longer benefiting from previous treatment, including imatinib, or who experienced serious side effects with previous treatment and are not able to continue taking it.

3. What you need to know before you take Nilotinib IPI:

- Follow all the doctor's instructions carefully. They may differ from the general information contained in this leaflet.

- Do not take Nilotinib IPI if you are allergic to nilotinib or any of the other ingredients of this medicine.

4. Warnings and Precautions:

Talk to your doctor or pharmacist before taking Nilotinib IPI:

- If you have suffered prior cardiovascular events such as a heart attack, chest pain, problems with the blood supply to your brain (stroke), or problems with the blood flow to your leg, or if you have risk factors for cardiovascular disease such as high blood pressure, diabetes or problems with the level of fats in your blood.

- If you have a heart disorder.

- If you are being treated with medicines that affect the heartbeat or the liver.

- If you suffer from a lack of potassium or magnesium.

- If you have a liver or pancreas disorder.

- If you have symptoms such as easy bruising, feeling tired or short of breath or have experienced repeated infections.

- If you have had a surgical procedure involving the removal of the entire stomach.

- If you have ever had or might now have a hepatitis B infection. This is because Nilotinib IPI could cause hepatitis B to become active again, which can be fatal in some cases. Patients will be carefully checked by their doctor for signs of this infection before treatment is started.

During treatment with Nilotinib IPI:

- If you faint or have an irregular heartbeat while taking this medicine, tell your doctor immediately as this may be a sign of a serious heart condition. Prolongation of the QT interval or an irregular heartbeat may lead to sudden death. Uncommon cases of sudden death have been reported in patients taking Nilotinib.

- If you have sudden heart palpitations, severe muscle weakness or paralysis, seizures or sudden changes in your thinking or level of alertness, tell your doctor immediately as this may be a sign of a fast breakdown of cancer cells called tumour lysis syndrome. Rare cases of tumour lysis syndrome have been reported in patients treated with Nilotinib.

- If you develop chest pain or discomfort, numbness or weakness, problems with walking or with your speech, pain, discolouration, or a cool feeling in a limb tell your doctor immediately, as this may be a sign of a cardiovascular event. Serious cardiovascular events, including problems with blood flow of the leg, ischaemic heart disease and problems with the blood supply to the brain have been reported in patients taking Nilotinib. Your doctor should assess the level of fats and sugar in your blood before initiating treatment with Nilotinib and during treatment.

- If you develop swelling of the feet or hands, generalized swelling or rapid weight gain tell your doctor as these may be signs of severe fluid retention.

Uncommon cases of severe fluid retention have been reported in patients treated with Nilotinib. If you are the parent of a child who is being treated with Nilotinib, tell the doctor if any of the above conditions apply to your child.

Children and adolescents:

- Nilotinib is a treatment for children and adolescents with CML. There is no experience with the use of this medicine in children below 2 years of age.

- There is no experience with the use of Nilotinib in newly diagnosed children below 10 years of age and limited experience in patients below 6 years of age who are no longer benefiting from previous treatment for CML. The long-term effects of treating children with Nilotinib for long periods are not known. Some children and adolescents taking Nilotinib may have slower than normal growth. The doctor will monitor growth at regular visits.

Other medicines and Nilotinib:

- Nilotinib may interfere with some other medicines.

- Tell your doctor if you are taking, have recently taken, or might take any other medicines.

Nilotinib with food and drink:

- Do not take Nilotinib with food. Food may enhance the absorption of Nilotinib and, therefore, increase the amount of Nilotinib in the blood, possibly to a harmful level.

- Do not drink grapefruit juice or eat grapefruit. It may increase the amount of Nilotinib in the blood, possibly to a harmful level.

Pregnancy and breast-feeding:

- Nilotinib is not recommended during pregnancy unless clearly necessary. If you are pregnant or think that you may be, tell your doctor, who will discuss with you whether you can take this medicine during your pregnancy.

- Women who might get pregnant are advised to use highly effective contraception during treatment and for up to two weeks after ending treatment.

- Breastfeeding is not recommended during treatment with Nilotinib and for two weeks after the last dose. Tell your doctor if you are breastfeeding. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines:

If you experience side effects such as dizziness or visual disorders with a potential impact on the ability to safely drive or use any tools or machines after taking this medicine, you should refrain from these activities until the effects have disappeared.

Nilotinib contains lactose.

5. How much Nilotinib to take:

Always take this medicine exactly as your doctor has told you.

How much Nilotinib IPI to take:

- Use in adults: The recommended dose is 600 mg per day. This dose is achieved by taking two hard capsules of 150 mg twice a day.

- Use in children and adolescents: The dose given to your child will depend on your child's body weight and height. The doctor will calculate the correct dose usage and tell you which and how many capsules of Nilotinib IPI to give to your child. The total daily dose given to your child must not exceed 800 mg. Your doctor may prescribe a lower dose depending on how you respond to treatment.

Older people (Age 65 years and over):

Nilotinib IPI can be used by people aged 65 years and over at the same dose as other adults.

6. How and When to Take Nilotinib:

When to take Nilotinib:

- Twice a day (approximately every 12 hours).

- At least 2 hours after any food,

- Then wait 1 hour before eating again.

How to take Nilotinib:

- Swallow the hard capsules whole with water.

- Do not take any food together with the hard capsules.

- Do not open the hard capsules unless you are unable to swallow them. If so, you may sprinkle the content of each hard capsule in one teaspoon of apple sauce and take it immediately.

- Do not use more than one teaspoon of apple sauce for each hard capsule, and do not use any food other than apple sauce.

How long to take Nilotinib:

- Continue taking Nilotinib IPI every day for as long as your doctor tells you. This is a long-term treatment. Your doctor will regularly monitor your condition to check that the treatment is having the desired effect.

- Your doctor may consider discontinuing your treatment with Nilotinib IPI based on specific criteria.

If you have taken more Nilotinib IPI than you should have, or if someone else accidentally takes your hard capsules, contact a doctor or hospital for advice straight away. Show them the pack of hard capsules and this package leaflet. Medical treatment may be necessary.

If you miss a dose, take your next dose as scheduled. Do not take a double dose to make up for a forgotten hard capsule.

Do not stop taking this medicine unless your doctor tells you to do so. Stopping Nilotinib IPI without your doctor's recommendation places you at risk for worsening your disease which could have life-threatening consequences.

Your doctor will regularly evaluate your treatment and decide whether you should continue to take this medicine. If you are told to discontinue Nilotinib IPI, your doctor may tell you to re-start Nilotinib IPI if your condition indicates that this is necessary.

7. Possible Side Effects:

- 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 more serious:

- Rapid weight gain, swelling of hands, ankles, feet or face.

- Chest pain or discomfort, high blood pressure, irregular heart rhythm, palpitations, fainting, blue discolouration of the lips, tongue, or skin.

- Difficulty or painful breathing, cough, wheezing with or without fever, swelling of the feet or legs.

- Fever, easy bruising or unexplained bleeding, frequent infections, unexplained weakness.

- Weakness or paralysis of the limbs or face, difficulty speaking, severe headache, seeing, feeling or hearing things that are not there, loss of consciousness, confusion, disorientation, trembling, sensation of tingling, pain or numbness in fingers and toes.

- Difficulty and pain when passing urine, abnormal urine colour.

- Visual disturbances including blurred vision, perceived flashes of light, loss of vision, blood in the eye, eye pain, redness, itching or irritation, dry eye, swelling or itching of the eyelids.

- Abdominal pain, nausea, vomiting of blood, bloody stools, constipation, heartburn, stomach acid reflux, swollen abdomen.

- Severe upper (middle or left) abdominal pain.

- Yellow skin and eyes, nausea, loss of appetite, dark-coloured urine.

- Painful red lumps, skin pain, skin reddening, peeling or blisters.

- Pain in joints and muscles.

- Excessive thirst, high urine output, increased appetite with weight loss, tiredness.

- Severe headache often accompanied by nausea, vomiting and sensitivity to light.

- Dizziness or spinning sensation.

- Nausea, shortness of breath, irregular heartbeat, clouding of urine, tiredness and/or joint discomfort associated with abnormal results of blood tests.

- Pain, discomfort, weakness or cramping in the leg muscles, which may be due to decreased blood flow, ulcers on the legs or arms that heal slowly or not at all and noticeable changes in colour or temperature of the legs or arms, as these symptoms could be signs of artery blockage in the affected limb and digits.

- Recurrence of hepatitis B infection when you have had hepatitis B in the past.

Some side effects are very common (May affect more than 1 in 10 people):

- Headache, tiredness, muscle pain, itching, rash, nausea, hair loss, musculoskeletal pain, muscle pain, pain in extremities, pain in joints, bone pain and spinal pain upon discontinuing treatment with Nilotinib IPI, slowing of growth in children and adolescents.

Some side effects are common (May affect up to 1 in 10 people):

- Diarrhea, vomiting, abdominal pain, stomach discomfort after meals, flatulence, swelling or bloating of the abdomen, constipation.

- Bone pain, pain in joints, muscle spasms, muscle weakness, pain in extremities, back pain, pain or discomfort in the side of the body.

- Upper respiratory tract infections.

- Dry skin, acne, wart, decreased skin sensitivity.

- Loss of appetite, disturbed sense of taste, weight increase.

- Insomnia, anxiety, depression.

- Night sweats, excessive sweating.

Some side effects are uncommon (May affect up to 1 in 100 people):

- Generally feeling unwell, painful and swollen joints, inability to achieve or maintain an erection, feeling body temperature change, and sensitive teeth.

The following other side effects have been reported with frequency not known (Cannot be estimated from the available data):

- Allergy, memory loss, disturbed or depressed mood, lack of energy, oral thrush, a skin cyst, thinning or thickening of the skin, thickening of the outermost layer of the skin, skin discolouration, hives, fungal infection of the feet, thickened patches of red/silver skin. Increased skin sensitivity, bleeding, tender or enlarged gums, nose bleed, dry mouth, sore throat, mouth sores, frequent urine output, haemorrhoids, anal abscess, enterocolitis, herpes virus infection, feeling of hardening in the breasts, heavy periods, nipple swelling, appetite disorder. weight decreased, breast enlargement in men, symptoms of restless legs syndrome.

During Nilotinib treatment, you may also have some abnormal blood test results such as:

- Low levels of blood cells or haemoglobin.

- Increase in the number of platelets or white cells or specific types of white cells in the blood.

- High blood level of lipase or amylase.

- High blood level of bilirubin or liver enzymes.

- Low or high blood level of insulin.

- Low or high levels of sugar, or high levels of fats in the blood.

- High blood levels of parathyroid hormone.

- Change in blood proteins.

- High blood level of alkaline phosphatase.

- High blood level of potassium, calcium, phosphorus or uric acid.

- Low blood level of potassium or calcium.