Before you take Neonib

Do not take Neonib

If you are allergic to nilotinib or any of the other ingredients of Neonib (listed in section 6).

 

Warnings and precautions

Talk to your doctor or pharmacist before taking Neonib:

• If you have suffered prior cardiovascular events such as a heart attack, chest pain (angina), problems with the blood supply to your brain (stroke) or problems with the blood flow to your leg (claudication) or you have risk factors for cardiovascular disease such as high blood pressure (hypertension), diabetes or problems with the level of fats in your blood (lipid disorders).
• If you have a heart disorder, such as an abnormal electrical signal called “prolongation of the QT interval”.
• If you are being treated with medicines that affect the heart beat (anti-arrhythmics) or the liver (see other medicines and Neonib).
• If you suffer from lack of potassium or magnesium.
• If you have a liver or pancreas disorder.
• If you have symptoms such as easy bruising, feeling tired, short of breath or have experienced repeated infections.
• If you have had a surgical procedure involving the removal of the entire stomach (total gastrectomy).
• If you have ever had or might now have a hepatitis B infection. This is because Neonib 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 Neonib:

• If you faint (loss of consciousness) or have an irregular heart beat 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 heart beat may lead to sudden death. Uncommon cases of sudden death have been reported in patients taking Neonib.
• 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 tumor lysis syndrome. Rare cases of tumor lysis syndrome have been reported in patients treated with Neonib.
• If you develop chest pain or discomfort, numbness or weakness, problems with walking or with speech, pain, discoloration 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 the blood flow to the leg (peripheral arterial occlusive disease), ischemic heart disease and problems with the blood supply to the brain (ischemic cerebrovascular disease) have been reported in patients taking Neonib. Your doctor should assess the level of fats (lipids) and sugar in your blood before initiating treatment with Neonib and during treatment.
• If you develop swelling of the hands or feet, generalized swelling or rapid weight gain tell your doctor as these may be sign of severe fluid retention. Uncommon cases of severe fluid retention have been reported in patients treated with Neonib.

 

If you are the parent of a child who is being treated with Neonib, tell the doctor if any of the above conditions apply to your child.

Children and adolescents

Neonib 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 Neonib 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 Neonib for long periods of time are not known.

Some children and adolescents taking Neonib may have slower than normal growth. The doctor will monitor growth at regular visits.

 

Other medicines and Neonib

Neonib may interfere with some other medicines. Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines including:

• Anti-arrhythmics (used to treat irregular heart beat)
• Chloroquine, Halofantrine, Clarithromycin, Haloperidol, Methadone, Moxifloxacin (medicines that may have an unwanted effect on the function of the heart)
• Ketoconazole, Itraconazole, Voriconazole, Clarithromycin, Telithromycin (used to treat infections)
• Ritonavir (used to treat HIV)
• Carbamazepine, Phenobarbital, Phenytoin (used to treat epilepsy)
• Rifampin (used to treat tuberculosis)
• St. John’s wort (a herbal product used to treat depression and other conditions)
• Midazolam (used to relieve anxiety before surgery)
• Alfentanil and Fentanyl (used to treat pain and as a sedative before or during surgery or medical procedures)
• Cyclosporine, Sirolimus and Tacrolimus (medicines that suppress the “self-defense” ability of the body and fight infections and are commonly used to prevent the rejection of transplanted organs such as the liver, heart and kidney)
• Dihydroergotamine and Ergotamine (used to treat dementia)
• Lovastatin, Simvastatin (used to treat high level of fats in blood)
• Warfarin (used to treat blood coagulation disorders)
• Astemizole, Terfenadine, Cisapride, Pimozide, Quinidine, Bepridil

 

These medicines should be avoided during your treatment with Neonib. If you are taking any of these, your doctor might prescribe other alternative medicines.

 

In addition, tell your doctor or pharmacist before taking Neonib if you are taking any antacids, which are medicines against heartburn. These medicines need to be taken separately from Neonib:

• H2 blockers (should be taken approximately 10 hours before and approximately 2 hours after you take Neonib)
• Antacids (should be taken approximately 2 hours before or approximately 2 hours after you take Neonib)

 

You should also tell your doctor if you are already taking Neonib and you are prescribed a new medicine that you have not taken previously during Neonib treatment.

 

Neonib with food and drink

Do not take Neonib with food. Food may enhance the absorption of Neonib and therefore increase the amount of Neonib in the blood, possibly to a harmful level. Do not drink grapefruit juice or eat grapefruit. It may increase the amount of Neonib in the blood, possibly to a harmful level.

 

Pregnancy and breast-feeding

Neonib must NOT be administered if you are pregnant unless clearly indicated by your doctor.

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

If you might get pregnant, you should use a reliable method of contraception during treatment and for up to two weeks after ending treatment with Neonib.

If you are breast-feeding, tell your doctor. You should not breast-feed during treatment with Neonib.

 

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 Neonib, you should refrain from these activities until the effect has disappeared.