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Nilotinib

About Nilotinib

Nilotinib is a prescription medicine used to treat a specific type of blood cancer called Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). It is prescribed for adults and children who have been newly diagnosed or those who can no longer tolerate or respond to previous leukemia treatments.

For this medicine to work effectively, it must be taken consistently at the same times each day as directed by your doctor. It is vital to take Nilotinib on an empty stomach, meaning you should not eat any food for at least one hour before and two hours after your dose. Avoiding grapefruit products and limiting heavy, high-fat meals around your dosing times will also help keep the medicine at safe levels in your body.

Common side effects when taking this medicine include skin rash, itching, mild headaches, nausea, and muscle aches. However, you must contact your doctor immediately if you experience serious symptoms such as shortness of breath, a fluttering or rapid heartbeat, sudden swelling, or yellowing of your eyes.

Before starting treatment, tell your doctor if you have a history of heart rhythm problems, liver disease, pancreatitis, or low blood levels of potassium or magnesium. Do not take this if you have long QT syndrome, an inherited heart rhythm disorder, or if you have uncorrected low levels of potassium or magnesium in your blood.

Certain medicines, including strong antibiotics, anti-seizure drugs, and even over-the-counter stomach acid reducers, can alter the amount of Nilotinib in your bloodstream, potentially causing dangerous heart issues or reducing the treatment's effectiveness. You should also avoid smoking and alcohol because they can increase stress on your liver and aggravate side effects. Pregnant or breastfeeding women must not take this medicine, and elderly patients should be closely monitored by their healthcare team.

Uses of Nilotinib

Nilotinib is used in the treatment of Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). The detailed uses of Nilotinib are as follows: • Treats Ph+ CML: Nilotinib targets and slows the growth of cancerous white blood cells in patients with this specific type of leukemia. • Helps achieve remission: Nilotinib reduces the number of abnormal cells in the blood and bone marrow, helping control the disease. • Lowers the risk of disease progression: Nilotinib helps prevent the leukemia from advancing to more aggressive stages.

Medicinal Benefits

Using Nilotinib as prescribed helps control chronic myeloid leukaemia (CML) and supports long-term disease management. Here are the key benefits you can expect:

  • Targets the cause of CML: Nilotinib targets the specific abnormal proteins that drive leukaemia growth, helping to restore normal blood cell production.
  • Relieves CML symptoms: It may help reduce symptoms such as fatigue, night sweats, and a swollen spleen, allowing you to feel more energetic and comfortable.
  • Helps prevent disease progression: By keeping the cancer under control, it helps prevent CML from advancing to more aggressive phases.
  • Supports long-term outcomes: This targeted approach aims to help patients achieve very low or even undetectable levels of leukaemia cells in the blood, which can significantly improve long-term survival and overall quality of life.

Directions for Use

  • Nilotinib should be taken on an empty stomach, at least 2 hours before or 1 hour after eating food, or as advised by the doctor.
  • Follow your doctor’s instructions on the dosage and timing of this medication to ensure safety.
  • Swallow Nilotinib as a whole with a glass of water.
  • Do not chew, crush, or break it.

Storage

Store in a cool and dry place away from sunlight

Side Effects of Nilotinib

Common Side Effects (Usually mild):

  • Nausea, vomiting, or temporary loss of appetite
  • Mild skin rash, dry skin, or itching
  • Headaches or muscle and joint pain
  • Feeling unusually tired or weak
  • Mild diarrhoea or constipation


Serious Side Effects (Consult your doctor right away):

  • Chest pain, shortness of breath, dizziness, or a fast, pounding, or irregular heartbeat
  • Yellowing of your skin or eyes, dark-coloured urine, or severe pain in your upper stomach (signs of liver damage or pancreas inflammation)
  • Sudden numbness or weakness in your face, arm, or leg, or difficulty speaking (signs of blood vessel blockage)
  • Fever, chills, sore throat, or other signs of infection
  • Unusual bruising or bleeding, such as nosebleeds or blood in your stool

Drug Warnings

  • Inspect Before Use: Check the capsules before taking them. Do not use any capsule that is cracked, broken, or leaking powder.
  • Attend ECG Monitoring: Keep all scheduled electrocardiogram (ECG) appointments so your doctor can monitor your heart's electrical rhythm.
  • Have Regular Blood Tests: Attend all recommended blood tests to monitor your potassium, magnesium, and blood cell counts during treatment.
  • Avoid Taking Acid-Reducing Medicines Together: Do not take antacids, H2 blockers, or proton pump inhibitors at the same time as Nilotinib, as they can reduce the absorption of the medicine.
  • Space Out Antacid Use: If you need to take an antacid, take it at least 2 hours before or 2 hours after your dose of Nilotinib.

Drug Interactions

  • Strong CYP3A4 inhibitors (like ketoconazole, clarithromycin): May dangerously increase the levels of Nilotinib in your blood, raising the risk of severe side effects.
  • Strong CYP3A4 inducers (like rifampin, phenytoin): May lower the levels of Nilotinib in your blood, making the treatment less effective.
  • Stomach acid reducers (like omeprazole or ranitidine): Can reduce the absorption of Nilotinib, lowering its effectiveness.
  • Medicines that prolong the QT interval (like certain heart rhythm drugs or antipsychotics): May increase the risk of life-threatening irregular heartbeats.

Drug-Drug Interactions Checker List:

  • DISOPYRAMIDE
  • QUINIDINE
  • AMIODARONE
  • SOTALOL
  • PROCAINAMIDE
  • CLARITHROMYCIN
  • MOXIFLOXACIN
  • CHLOROQUINE
  • HALOPERIDOL
  • PIMOZIDE
  • METHADONE
  • FENTANYL
  • ALFENTANIL
  • PHENYTOIN
  • CARBAMAZEPINE
  • PHENOBARBITAL
  • WARFARIN
  • RIFAMPICIN
  • ITRACONAZOLE
  • KETOCONAZOLE
  • VORICONAZOLE
  • CYCLOSPORINE
  • TACROLIMUS
  • SIROLIMUS
  • Safety Advice

    • Safety Warning

      Alcohol

      consult your doctor

      The interaction of Nilotinib with alcohol is unknown. Please discuss with your doctor if you have any concerns regarding this.

    • Safety Warning

      Pregnancy

      unsafe

      Nilotinib is not recommended for use during pregnancy as it may harm the unborn baby. Therefore, inform your doctor if you are pregnant or planning for pregnancy before taking Nilotinib. Also, you are advised to use effective birth control measures during treatment with Nilotinib and for up to 2 weeks after the last dose of Nilotinib.

    • Safety Warning

      Breast Feeding

      unsafe

      You are recommended to avoid breastfeeding during treatment with Nilotinib and for two weeks after the final dose. Inform your doctor if you are breastfeeding.

    • Safety Warning

      Driving

      caution

      If you experience side effects such as dizziness or visual disorders, avoid driving or operating machinery until you are alert.

    • Safety Warning

      Liver

      caution

      Inform your doctor if you have liver problems before taking Nilotinib. Your doctor may adjust the dose if necessary based on your condition.

    • Safety Warning

      Kidney

      consult your doctor

      Limited information is available on the use of Nilotinib in patients with impaired kidney function. Therefore, if you have kidney problems, inform your doctor before taking Nilotinib.

    • Safety Warning

      Children

      caution

      Nilotinib is not recommended for children below 1 year of age as the safety and effectiveness were not established.

    Habit Forming

    No

    Diet & Lifestyle Advise

    • Stick to the fasting window: Always schedule your meals strictly around your medication. Eating food close to your dose can dangerously increase the absorption of Nilotinib and lead to severe heart complications.
    • Avoid grapefruit entirely: Do not consume grapefruit, grapefruit juice, or Seville oranges, as they interfere with how your body breaks down the medicine.
    • Protect your skin: This medicine can make your skin highly sensitive to sunlight. Wear broad-spectrum sunscreen, protective clothing, and a hat when outdoors.
    • Stay well-hydrated: Drink plenty of water throughout the day to support your kidneys and liver as your body processes the medication and clears away cellular waste.

    Special Advise

    • Nilotinib can cause a possibly life-threatening heart problem called QTc prolongation (causes irregular heartbeat, which may lead to sudden death). Therefore, if you faint, feel lightheaded or have an irregular heartbeat while taking Nilotinib, please contact your doctor immediately, as these might be symptoms of QTc prolongation.

    Regular tests are recommended during treatment with Nilotinib:

    • To monitor the number of blood cells (red blood cells, white blood cells and platelets), liver and pancreas function in the body to see how Nilotinib is tolerated.
    • To monitor electrolytes (magnesium, potassium) in the body that are essential in the functioning of the heart.
    • To check the level of fats and sugar in the blood.
    • Also, ECG is recommended to check the heart rate.

    Patients Concern

    Disease/Condition Glossary

    Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML): It is a common form of chronic myeloid leukemia (CML) that occurs when specific chromosomes swap positions, causing an abnormality in the chromosomes, creating the Philadelphia chromosome. The abnormal chromosomes produce an abnormal protein called Bcr-Abl tyrosine kinase, which then triggers a signal to produce abnormal white blood cells in the bone marrow. CML is a type of blood cancer which makes the body produce too many abnormal white blood cells. Many people with Ph+ CML will not experience symptoms before their diagnosis. However, if symptoms do occur, they include weight loss, weakness, night sweats, extreme tiredness, feeling full after only small meals, bone pain, and easy bleeding.  

    FAQs

    Nilotinib is used to treat Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).

    Nilotinib contains Nilotinib, an anticancer drug. In chronic myeloid leukemia (CML) patients, a change in genetic material (DNA) triggers a signal that tells the body to produce more abnormal white blood cells (cancerous cells). Nilotinib works by blocking this signal and thus stops the production of cancerous cells.

    You are not recommended to take antacids and Nilotinib at the same time. You are advised to take antacids containing magnesium hydroxide, aluminium hydroxide, and simethicone about two hours before or two hours after taking Nilotinib. However, please consult a doctor before taking other medicines with Nilotinib.

    You are recommended to avoid grapefruit juice, grapefruit and any supplement containing grapefruit extract while taking Nilotinib as it may increase the amount of Nilotinib in the body and cause serious side effects.

    No, you must take Nilotinib on an empty stomach. Do not eat for at least 1 hour before and 2 hours after your dose, as food can cause your body to absorb too much medicine, leading to severe side effects. Talk to your doctor if you have trouble timing your meals.

    If you throw up after taking your capsules, do not take an extra dose to make up for it. Simply wait and take your next dose at the regular scheduled time. Talk to your doctor if vomiting becomes a frequent issue.

    This medicine can affect the electrical rhythm of your heart, a condition called QT prolongation (a change in the heart's electrical activity that can lead to serious irregular heart rhythms). Regular ECGs allow your doctor to monitor your heart safety and adjust your treatment if needed. Talk to your doctor if you feel dizzy or faint.

    Many acid reducers, especially proton pump inhibitors, can prevent Nilotinib from being absorbed properly. If you need an antacid, take it at least 2 hours before or 2 hours after your dose. Talk to your doctor or pharmacist before taking any new medicine for reflux.

    You should avoid or strictly limit alcohol while taking this medicine. Both alcohol and Nilotinib are processed by your liver, and combining them can increase your risk of liver damage and worsen side effects like dizziness. Talk to your doctor for advice.

    No, Nilotinib can cause serious harm to an unborn baby. Women who can become pregnant must use highly effective birth control during treatment and for at least several weeks after stopping the medication. Talk to your doctor immediately if you suspect you are pregnant.

    No, you should not breastfeed while taking Nilotinib and for at least 2 weeks after your final dose, as the medicine may pass into breast milk and harm your baby. Talk to your doctor about safe ways to feed your infant.

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