nilotinib

What is the most important information I should know about nilotinib?

You should not use nilotinib if you are allergic to it, or if you have low blood levels of potassium or magnesium, or a history of Long QT syndrome.

Do not use nilotinib if you are pregnant. It could harm the unborn baby.

You should not breast-feed while you are taking nilotinib.

Before using nilotinib, tell your doctor if you have heart disease or a heart rhythm disorder, liver disease, a personal history of pancreatitis, a family history of Long QT syndrome, or if your stomach has been surgically removed (total gastrectomy).

There are many other drugs that can cause serious or life-threatening medical problems if you take them together with nilotinib. Tell your doctor about all medications you use.

You will need regular medical tests to be sure this medication is not causing harmful effects. Your cancer treatments may be delayed based on the results of these tests. Visit your doctor regularly.

Call your doctor at once if you have a serious side effect such as feeling light-headed with a fast or pounding heartbeat, pale skin, easy bruising or bleeding, fever, flu symptoms, cough with stabbing chest pain, mouth sores, feeling light-headed or short of breath, swelling, sudden headache or vision problems, upper stomach pain, dark urine, or jaundice (yellowing of the skin or eyes).

What is nilotinib?

Nilotinib interferes with the growth of some cancer cells.

Nilotinib is used to treat a type of blood cancer called Philadelphia chromosome positive chronic myeloid leukemia (CML).

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

What should I discuss with my healthcare provider before taking nilotinib?

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

• low blood levels of potassium or magnesium; or
• a history of Long QT syndrome.

To make sure you can safely take nilotinib, tell your doctor if you have any of these other conditions:

• heart disease or heart rhythm disorder;
• liver disease;
• a personal history of pancreatitis;
• a family history of Long QT syndrome; or
• if your stomach has been surgically removed (total gastrectomy).

FDA pregnancy category D. Do not use nilotinib if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

It is not known whether nilotinib passes into breast milk or if it could harm a nursing baby. You should not breast-feed while you are taking nilotinib.

Nilotinib capsules may contain lactose. Talk to your doctor before using this medication if you have galactose intolerance, or severe problems with lactose (milk sugar).

How should I take nilotinib?

Take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Nilotinib is usually taken every 12 hours. Follow your doctor's instructions.

Take nilotinib on an empty stomach, at least 1 hour before or 2 hours after eating. Do not take nilotinib with food.

Take this medicine with a full glass of water.

Do not break or open a nilotinib capsule. Swallow the pill whole.

You may open the nilotinib capsule and sprinkle the medicine into a spoonful of applesauce to make swallowing easier. Swallow right away without chewing. Do not save the mixture for later use. Discard the empty capsule.

To be sure this medication is helping your condition and not causing harmful effects, your blood and bone marrow will need to be tested often. Your heart function will also need to be checked using an electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart. Your cancer treatments may be delayed based on the results of these tests. Visit your doctor regularly.

Do not stop using nilotinib or change your dose without talking to your doctor. If you stop taking the medication too soon, your condition may get worse.

Store nilotinib at room temperature away from moisture and heat.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

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

Overdose may cause drowsiness or vomiting.

What should I avoid while taking nilotinib?

Do not take with food. Food can increase your blood levels of nilotinib and may increase your risk of harmful side effects.

Grapefruit and grapefruit juice may interact with nilotinib and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

What are the possible side effects of nilotinib?

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

Stop using nilotinib and call your doctor at once if you have a serious side effect such as:

• lower back pain, blood in your urine, urinating less than usual or not at all;
• numbness or tingly feeling around your mouth, fast or slow heart rate, weak pulse, feeling short of breath, confusion, fainting;
• muscle weakness, tightness, or contraction, overactive reflexes;
• feeling like you might pass out, fast or pounding heartbeat, seizure (convulsions);
• pale skin, weakness, rapid heart rate, trouble concentrating;
• easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
• fever, chills, body aches, flu symptoms, sores in your mouth and throat;
• feeling short of breath, even with mild exertion;
• swelling, rapid weight gain;
• redness or crusting around your hair follicles;
• sudden severe headache, confusion, or problems with vision;
• cold feeling, blue-colored appearance, and severe pain or numbness in your arms or legs;
• nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• severe pain in your upper stomach spreading to your back; or
• cough with yellow or green mucus, stabbing chest pain, wheezing, feeling short of breath.

Less serious side effects may be more likely to occur, such as:

• mild skin rash or itching;
• diarrhea, constipation;
• headache, neck or back pain;
• weight changes;
• tired feeling; or
• cold symptoms such as stuffy nose, sneezing, 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.

What other drugs will affect nilotinib?

Many drugs can interact with nilotinib. Below is just a partial list. Tell your doctor if you are using:

• arsenic trioxide (Trisenox);
• conivaptan (Vaprisol);
• droperidol (Inapsine);
• imatinib (Gleevec);
• isoniazid (for treating tuberculosis);
• midazolam (Versed);
• pimozide (Orap);
• St. John's wort;
• a blood thinner such as warfarin (Coumadin, Jantoven);
• an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin, Pediazole), moxifloxacin (Avelox), telithromycin (Ketek), and others;
• antifungal medication such as itraconazole (Sporanox), ketoconazole (Nizoral), miconazole (Oravig), or voriconazole (Vfend);
• an antidepressant such as amitriptyline (Elavil, Vanatrip, Limbitrol), clomipramine (Anafranil), desipramine (Norpramin), or nefazodone;
• anti-malaria medications such as chloroquine (Aralen), halofantrine (Halfan), or mefloquine (Lariam);
• heart or blood pressure medication such as amiodarone (Cordarone, Pacerone), diltiazem (Cartia, Cardizem), dofetilide (Tikosyn), disopyramide (Norpace), dronedarone (Multaq), felodipine (Plendil), ibutilide (Corvert), nicardipine (Cardene), procainamide (Procan, Pronestyl), propafenone (Rythmol), quinidine (Quin-G), or sotalol (Betapace);
• HIV/AIDS medicine such as delavirdine (Rescriptor), fosamprenavir (Lexiva), indinavir (Crixivan), ritonavir (Kaletra, Norvir), and others;
• medicines used to prevent organ transplant rejection, such as cyclosporine (Gengraf, Neoral, Sandimmune), sirolimus (Rapamune), or tacrolimus (Prograf);
• medicine to prevent or treat nausea and vomiting such as dolasetron (Anzemet), droperidol (Inapsine), or ondansetron (Zofran);
• medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), clozapine (FazaClo, Clozaril), haloperidol (Haldol), pimozide (Orap), thioridazine (Mellaril), or ziprasidone (Geodon);
• migraine headache medicine such as sumatriptan (Imitrex, Treximet) or zolmitriptan (Zomig);
• narcotic medication such as methadone (Methadose, Diskets, Dolophine); or
• stomach acid reducers such as dexlansoprazole (Dexilant), esomeprazole (Nexium), lansoprazole (Prevacid), omeprazole (Prilosec), pantoprazole (Protonix), or rabeprazole (Aciphex).

This list is not complete and there are many other drugs that can cause serious or life-threatening medical problems if you take them together with nilotinib. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor. Keep a list of all your medicines and show it to any healthcare provider who treats you.

Where can I get more information?

Your pharmacist can provide more information about nilotinib.