Nilotinib

Nilotinib is used to treat certain types of blood cancer called Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML).

Nilotinib comes as capsules (including Tasigna), tablets (including Danziten), and orally disintegrating tablets (including Cavhanza). Different nilotinib products may have different instructions and doses. Do not switch to another nilotinib product unless your doctor tells you to.

Nilotinib capsules are used in adults. Some nilotinib capsules may also be used in children who are at least 1 year old.

Nilotinib tablets and orally disintegrating tablets are used only in adults.

Nilotinib may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may change your dose from time to time. Use the medicine exactly as directed.

Your dose may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using it exactly as directed on the label or as prescribed by your doctor.

Nilotinib is usually taken twice a day (about 12 hours apart). Follow your doctor's instructions.

Take nilotinib capsules on an empty stomach, at least 2 hours before or 1 hour after a meal. You may take nilotinib tablets and orally disintegrating tablets with or without food.

For children taking nilotinib capsules, doses are based on body surface area (height and weight). Your child's dose may change if the child gains or loses weight or is still growing.

Swallow nilotinib capsules whole with water. Some nilotinib capsules may be opened if you cannot swallow them, but others must not be opened. Follow the instructions that come with your medicine. If your capsule may be opened, mix the contents with 1 teaspoon of applesauce and swallow the mixture right away, within 15 minutes.

Swallow nilotinib tablets whole with water. Do not cut, crush, or chew them. If you cannot swallow the tablets whole, read and carefully follow the instructions that come with your medicine about how to mix and take your dose. Ask your doctor or pharmacist if you do not understand the instructions.

Use dry hands to handle nilotinib orally disintegrating tablets. Place the tablet on your tongue and let it dissolve, then swallow. You may also chew the tablet or swallow it whole with water. Do not crush the tablet before taking it.

Some medicines should not be used with nilotinib. Do not change your dose or start or stop any medicine without your doctor's advice.

Your doctor will check your heart with an electrocardiogram (ECG) before treatment, 7 days after you start nilotinib, periodically during treatment, and after any dose change.

You may need frequent medical tests before and during your treatment with this medicine. Your cancer treatments may change, be delayed, or stopped based on the results.

Store at room temperature away from moisture and heat.

Keep nilotinib orally disintegrating tablets in their original bottle with the cap tightly closed. Do not throw away the desiccant that keeps the tablets dry.

Nilotinib can lead to a serious heart issue, especially if you are taking certain other medicines at the same time. Inform your doctor about all your other medicines. Your heart function may need to be monitored before and during treatment with nilotinib.

Contact your doctor immediately if you experience fast or pounding heartbeats, shortness of breath, or sudden dizziness.

You should not take nilotinib if you have long QT syndrome or low levels of potassium or magnesium in your blood.

You should not use nilotinib if you are allergic to it, or if you have:

• low blood levels of potassium or magnesium; or
• a heart rhythm disorder called long QT syndrome.

Tell your doctor if you have or have ever had:

• heart problems such as irregular heartbeats, or long QT syndrome;
• a stroke;
• blood circulation problems in your legs;
• bleeding problems;
• an electrolyte imbalance (such as low blood levels of potassium or magnesium);
• severe problems with lactose (milk sugar);
• pancreatitis;
• surgical removal of your stomach (total gastrectomy); or
• liver disease.

May harm an unborn baby. You may need a pregnancy test to make sure you are not pregnant. Use effective birth control while taking nilotinib and for at least 14 days after your last dose. Tell your doctor if you are pregnant or plan to become pregnant.

Do not breastfeed while taking nilotinib, and for at least 14 days after your last dose.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

You may feel faint while taking nilotinib. Call your doctor right away if you have fast or pounding heartbeats, shortness of breath, and sudden dizziness.

Nilotinib may cause serious side effects. Call your doctor at once if you have:

• fluid retention--shortness of breath (even while lying down), swelling, rapid weight gain (especially in your face and midsection);
• bleeding problems--bleeding that will not stop, sudden vision changes, feeling faint, sudden headache, or sudden confusion;
• signs of liver or pancreas problems--loss of appetite, upper stomach pain (that may spread to your back), nausea or vomiting, dark urine, jaundice (yellowing of the skin or eyes);
• low blood cell counts--fever, chills or other signs of infection, unexplained bleeding or bruising, unexplained weakness, or shortness of breath;
• signs of an electrolyte imbalance--increased thirst or urination, constipation, muscle weakness, leg cramps, feeling jittery, fluttering in your chest;
• signs of decreased blood flow--leg pain or cold feeling, chest pain, numbness or weakness, trouble walking or speaking, skin discoloration in your legs; or
• signs of tumor cell breakdown--muscle cramps, diarrhea, fast or slow heart rate, decreased urination, tingling in your hands and feet or around your mouth.

Nilotinib can affect growth in children. Tell your doctor if your child is not growing at a normal rate while taking nilotinib.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects of nilotinib may include:

• fever, nausea, vomiting, diarrhea, constipation;
• muscle, bone, arm, leg, spine, or joint pain that may increase after stopping nilotinib for treatment-free remission;
• rash, itching;
• night sweats;
• headache, feeling tired; or
• runny or stuffy nose, sneezing, cough, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

If you take nilotinib capsules or tablets: skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

If you take nilotinib orally disintegrating tablets: skip the missed dose and take your next dose at the usual time the next day. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Grapefruit may interact with nilotinib and cause side effects. Avoid consuming grapefruit products.

If you take nilotinib capsules or tablets, follow these instructions for medicines that reduce stomach acid:

• Avoid taking a stomach acid reducer (such as Pepcid, Tagamet, or Zantac) within 10 hours before or 2 hours after you take nilotinib.
• Do not take proton pump inhibitor medicines (Prilosec, Nexium, Prevacid) with nilotinib capsules or tablets.
• Avoid taking an antacid that contains aluminum, magnesium, or simethicone (such as Di-Gel, Gaviscon, Maalox, Milk of Magnesia, Mylanta, or Rolaids) within 2 hours before or 2 hours after you take nilotinib.

Sometimes it is not safe to use certain medicines together. Some drugs can change the levels of other drugs in your blood, which may increase side effects or make the medicines less effective.

Nilotinib can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Tell your doctor about all your other medicines, especially:

• proton pump inhibitor medicines such as omeprazole (Prilosec), lansoprazole (Prevacid), esomeprazole (Nexium), or pantoprazole (Protonix), if you take nilotinib capsules or tablets.

Many drugs can affect nilotinib. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.