WARNING

Nilotinib is a medication that is primarily used to treat a type of blood cancer called chronic myeloid leukemia (CML). Like any medication, Nilotinib carries certain risks and potential side effects. Here are some important risks associated with taking Nilotinib:

• Cardiovascular risks: Nilotinib may increase the risk of cardiovascular problems such as heart attack, stroke, and heart rhythm abnormalities. It is important to monitor heart function regularly while taking this medication.
• Liver toxicity: Nilotinib can cause liver damage or abnormalities in liver function. Regular liver function tests are necessary to monitor for any signs of liver problems.
• Pancreatic inflammation: There have been rare cases of pancreatitis (inflammation of the pancreas) associated with Nilotinib use. Symptoms may include severe abdominal pain, nausea, and vomiting.
• Hematologic toxicities: Nilotinib can affect the production of blood cells, leading to low levels of white blood cells, red blood cells, and platelets. Regular blood tests are required to monitor blood cell counts.
• Fluid retention: Nilotinib may cause fluid retention, leading to swelling in the arms, legs, or other parts of the body. It is important to report any sudden or significant swelling to a healthcare professional.
• QT interval prolongation: Nilotinib may prolong the QT interval, which is a measure of electrical activity in the heart. This can increase the risk of developing an irregular heart rhythm.
• Other side effects: Common side effects of Nilotinib include nausea, diarrhea, fatigue, muscle and joint pain, headache, and rash.

It is essential to discuss the risks and benefits of Nilotinib treatment with a healthcare professional before starting the medication. They can provide personalized guidance based on the individual’s medical history and help manage any potential risks or side effects.

Why is this medication prescribed?

Nilotinib is a prescription medication that belongs to a class of drugs called tyrosine kinase inhibitors. It is primarily prescribed for the treatment of chronic myeloid leukemia (CML), a type of blood cancer that affects the bone marrow and white blood cells.

Specifically, Nilotinib is used to treat newly diagnosed CML in adults, as well as CML that has progressed or is resistant to other treatments, including another tyrosine kinase inhibitor called imatinib. Nilotinib works by blocking the activity of an abnormal protein called BCR-ABL, which is produced by cancer cells in people with CML. By inhibiting the activity of this protein, Nilotinib helps to slow down the growth and division of cancer cells, thereby reducing the progression of the disease.

How should this medicine be used?

Nilotinib should be used exactly as prescribed by a healthcare professional. It is typically available in the form of capsules, which should be swallowed whole with water. Nilotinib can be taken with or without food, but it’s generally recommended to take it on an empty stomach, at least 1 hour before or 2 hours after a meal.

Here are some general guidelines for using Nilotinib:

• Follow the prescribed dosage: Take the medication exactly as instructed by your doctor. Do not take more or less of it, and do not alter the dosing schedule without consulting your healthcare provider.
• Timing of doses: Take Nilotinib at the same time each day to maintain consistent levels of the medication in your body.
• Avoid grapefruit products: Grapefruit and grapefruit juice can interact with Nilotinib and affect its absorption. It’s best to avoid consuming grapefruit or grapefruit products while taking this medication.
• Do not open or crush capsules: Swallow the capsules whole. Do not open, crush, or chew them, as it may affect the way the medication is released in your body.
• Adhere to additional instructions: Your doctor may provide specific instructions based on your individual circumstances. It’s important to follow any additional recommendations they provide.
• Regular check-ups: Regularly visit your doctor for check-ups and monitoring of your condition. They may order blood tests and other assessments to evaluate the effectiveness and safety of the treatment.

It’s crucial to communicate with your healthcare provider regarding any concerns or side effects you experience while taking Nilotinib. They can provide personalized guidance and address any questions you may have throughout the course of treatment.

Other uses for this medicine

While Nilotinib is primarily used for the treatment of chronic myeloid leukemia (CML), it is important to note that it may have off-label uses or be under investigation for potential use in other conditions. However, it is crucial to consult with a healthcare professional to determine the appropriate use of Nilotinib beyond its approved indications.

What special precautions should I follow?

As for special precautions, there are several important considerations when using Nilotinib:

• Medical history: Inform your doctor about your complete medical history, including any previous or current medical conditions, especially heart problems, liver disease, pancreatitis, bleeding disorders, or low blood levels of potassium, magnesium, or calcium.
• Drug interactions: Nilotinib may interact with other medications, potentially leading to harmful effects or reduced effectiveness. Inform your doctor about all the medications, supplements, or herbal products you are taking to avoid potential interactions.
• QT prolongation: Nilotinib can cause a heart rhythm disorder called QT prolongation, which can be serious or life-threatening. Inform your doctor if you have a history of irregular heart rhythms or take any medications that may prolong the QT interval.
• Liver toxicity: Nilotinib can cause liver toxicity, including liver failure. Regular liver function tests will be conducted by your doctor to monitor the condition. Report any signs of liver problems, such as yellowing of the skin or eyes, dark urine, or persistent nausea.
• Pancreatitis: Cases of pancreatitis, including fatal cases, have been reported in patients taking Nilotinib. Inform your doctor if you have a history of pancreatitis or experience persistent abdominal pain.
• Bleeding problems: Nilotinib may increase the risk of bleeding. Inform your doctor if you have a bleeding disorder or are taking medications that can increase the risk of bleeding.
• Pregnancy and breastfeeding: Nilotinib may harm an unborn baby, so it is important to discuss the risks and benefits with your doctor if you are pregnant or planning to become pregnant. It is not recommended to breastfeed while taking Nilotinib.

These precautions are not exhaustive, and it is essential to follow the specific instructions provided by your healthcare professional. They will consider your individual circumstances and closely monitor your progress throughout the treatment to ensure your safety and well-being.

What special dietary instructions should I follow?

Special dietary instructions for Nilotinib include avoiding grapefruit or grapefruit products while taking the medication. Grapefruit can interfere with the metabolism of Nilotinib in the body and may lead to increased levels of the drug, potentially causing adverse effects.

What should I do if I forget a dose?

If you forget to take a dose of Nilotinib, it is generally recommended to take it as soon as you remember, unless it is close to the time for your next scheduled dose. In that case, you should skip the missed dose and continue with your regular dosing schedule. It’s important not to take a double dose to make up for a missed one.

What side effects can this medication cause?

Nilotinib can cause various side effects, and their severity and frequency can vary from person to person. It’s important to note that not all individuals will experience these side effects, and some may experience different or no side effects at all. Common side effects of Nilotinib include:

• Nausea and vomiting
• Diarrhea
• Fatigue or weakness
• Headache
• Rash or skin reactions
• Itching
• Muscle or joint pain
• Abdominal pain
• Constipation
• Changes in taste
• Fluid retention (swelling in the arms, legs, ankles, or feet)
• Fever
• Night sweats
• Difficulty sleeping (insomnia)
• Dizziness or lightheadedness
• Respiratory tract infections (such as cold or flu-like symptoms)
• Cough
• Elevated liver enzyme levels
• Low blood counts (white blood cells, red blood cells, or platelets)
• QT prolongation (an irregular heart rhythm)

It’s important to promptly report any side effects to your healthcare provider. They can provide guidance on managing side effects or adjust the treatment regimen if necessary. Additionally, some side effects may require immediate medical attention, such as severe rash, chest pain, difficulty breathing, or signs of an allergic reaction.

This list does not encompass all possible side effects. Consult with your doctor or pharmacist for a comprehensive understanding of the potential side effects associated with Nilotinib.

What should I know about storage and disposal of this medication?

• Storage: Store Nilotinib capsules at room temperature, away from moisture and heat. Do not freeze the medication. It’s advisable to keep it in its original container, tightly closed, and out of reach of children or pets.
• Disposal: Follow your local regulations or guidelines for the proper disposal of unused or expired Nilotinib. Do not dispose of it in household waste or flush it down the toilet unless instructed to do so. Your healthcare provider or pharmacist can provide information on safe disposal methods.

In case of emergency/overdose

In case of emergency or an overdose, you should immediately seek medical attention or contact your local poison control center at the emergency telephone number provided in your country. Overdosing on Nilotinib can lead to severe adverse effects, and it’s important to receive prompt medical care.

What other information should I know?

• Regular check-ups: Attend scheduled appointments with your doctor for monitoring and evaluation of your condition. This may involve blood tests, electrocardiograms (ECGs), or other assessments to ensure the medication is working effectively and to monitor for any potential side effects.
• Medication interactions: Inform your healthcare provider about all the medications, supplements, or herbal products you are taking before starting Nilotinib. Some medications may interact with Nilotinib, potentially affecting its effectiveness or increasing the risk of side effects.
• Compliance with dosage: Take Nilotinib exactly as prescribed by your doctor. Do not alter the dosage or dosing schedule without consulting your healthcare provider.
• Informing healthcare providers: Let all healthcare professionals involved in your care know that you are taking Nilotinib. This includes doctors, dentists, and pharmacists. It’s important to keep them informed about your treatment to prevent any potential interactions or complications.
• Supportive care: In addition to taking Nilotinib, follow your healthcare provider’s recommendations for overall supportive care, including a healthy lifestyle, proper nutrition, and regular exercise.

Remember, this information provides a general overview and should not replace specific instructions or advice given by your healthcare provider. Always consult with them for personalized guidance and to address any concerns you may have about Nilotinib.