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Nilotinib Safety Information and Warnings

Nilotinib, also known by its brand name Tasigna, is a medication that requires careful consideration due to its potential risks and necessary precautions. Below are important safety details to keep in mind:

• Heart Rhythm Concerns: Nilotinib can cause QT prolongation, a serious heart rhythm condition that may lead to fainting, seizures, or, in severe cases, death. Healthcare providers will conduct an electrocardiogram (EKG) prior to and during treatment to monitor heart activity. Blood tests will also be performed to check electrolyte levels, such as potassium and magnesium, which can affect heart rhythm. If you experience symptoms like lightheadedness, fainting, or a rapid heartbeat, seek medical attention immediately.

• Blood Flow Issues: There is a risk of blood clots, heart attacks, or strokes associated with nilotinib. Inform your healthcare provider of any history of heart conditions, as this may require closer monitoring. Symptoms like leg pain, swelling, chest pain, or signs of a stroke should be reported to your healthcare provider immediately.

• Blood Cell Count Changes: Nilotinib can reduce red and white blood cells and platelets, increasing the risk of fatigue, infections, and bleeding. Regular blood tests will be conducted to monitor these levels. Contact your provider if you experience persistent fevers, chills, or unexplained bruising or bleeding.

• Pancreatitis Risk: There is a potential for pancreatitis, especially in individuals with a history of this condition. Monitoring of lipase levels will be done, and any sudden abdominal pain with nausea or vomiting should be reported promptly.

• Liver Health: Liver problems can occur with nilotinib, particularly in children. Regular monitoring of liver function is advised. Symptoms like fatigue, appetite loss, dark urine, or jaundice should be communicated to your healthcare provider.

• Fluid Retention: Some patients may experience swelling or fluid buildup, especially in the limbs, heart, or lungs. Symptoms such as rapid weight gain or shortness of breath should be reported for further evaluation.

• Bleeding Episodes: Although rare, bleeding events can be serious. Any unusual bleeding, changes in vision, or sudden headaches should be promptly discussed with your healthcare provider.

• Tumor Lysis Syndrome: This condition can occur when cancer cells break down rapidly, potentially leading to kidney damage and abnormal heart rhythms. Report symptoms such as decreased urination or muscle cramps immediately.

• Growth Concerns in Children: Prolonged use of nilotinib in children may affect growth rates, especially in those under 12. Regular growth monitoring is recommended.

• Pregnancy Risks: Nilotinib can harm an unborn baby. A pregnancy test is advised before starting treatment, and effective birth control should be used during treatment and for two weeks after the last dose. Inform your provider if pregnancy occurs.

Contraindications:

• Individuals with low levels of potassium or magnesium, or those with long QT syndrome should not use nilotinib without consulting a healthcare provider due to increased health risks.

Drug Interactions and Usage:

• Do not consume food within 2 hours before or 1 hour after taking nilotinib, as this can increase the risk of heart rhythm issues. Keep a comprehensive list of all medications and supplements you are taking and share it with your healthcare provider to avoid harmful interactions.
• Nilotinib is available in various forms, such as tablets and capsules. Do not switch between forms without consulting your healthcare provider.

When taking this medication, some common side effects include nausea, headache, tiredness, and vomiting, which are generally mild. Other frequent issues may involve rash, itchy skin, diarrhea, fever, and cold-like symptoms. While these are typically not severe, you should consult a healthcare provider if they persist or worsen.

More serious side effects can occur and may include irregular heartbeat, severe bleeding, and heart-related issues such as chest pain or shortness of breath. Stroke symptoms like weakness on one side of the body, severe headache, and confusion also require immediate medical attention. Kidney problems might present as muscle cramps, numbness, or changes in urine output.

This medication can affect bone marrow function, leading to a decrease in blood cells and potentially causing anemia, increased infection risk, or easy bruising. If you experience unusual tiredness, pale skin, or signs of infection, seek medical advice promptly. Additionally, tumor lysis syndrome could develop, marked by symptoms such as flank pain and kidney issues. Ensure you stay hydrated and follow medical guidance.

Rare but serious allergic reactions could occur, indicated by rash, swelling, severe dizziness, or trouble breathing, necessitating urgent medical care. Always report new or worsening symptoms to your healthcare provider for guidance.

Nilotinib, marketed as Tasigna, can have interactions with various medications and supplements. It is crucial to inform your healthcare provider about all the medications and supplements you are currently taking, including prescription, over-the-counter, vitamins, and herbal products.

Certain medications are not recommended to be taken with nilotinib. These include Bepridil, Colchicine, Dronedarone, Eliglustat, Fluconazole, Nelfinavir, Piperaquine, Posaconazole, Saquinavir, Sparfloxacin, Terfenadine, Thioridazine, Ziprasidone, and several live vaccines such as Measles, Mumps, Rotavirus, Rubella, Varicella, and Zoster.

In some cases, using nilotinib with particular medications may not be advisable, but if deemed necessary, your healthcare provider might adjust the dosage or frequency. These include a wide range of drugs such as Amiodarone, Clarithromycin, Carbamazepine, and others that can affect how nilotinib is processed in the body, potentially impacting its efficacy.

Additionally, medications like Pioglitazone and Suvorexant might increase the risk of side effects when taken with nilotinib, but they might still be prescribed if the benefits outweigh the risks. In such instances, dosage adjustments and close monitoring by your doctor will be necessary.

Overall, nilotinib may interact with medications that affect the heart rhythm, such as those that cause QT prolongation, and drugs like azole antifungals, macrolide antibiotics, and certain seizure medications. Always consult your healthcare provider for advice tailored to your specific situation.