tasigna

Tasigna (nilotinib) is a cancer medication that interferes with the growth and spread of cancer cells in the body.

Tasigna is used to treat a type of blood cancer called Philadelphia chromosome positive chronic myeloid leukemia (CML). It is usually given after other medications have been tried without success.

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

Important information

You should not use Tasigna if you have low blood levels of potassium or magnesium, or a heart rhythm disorder called Long QT syndrome.

Before and during your treatment with Tasigna, your heart function may be checked with an electrocardiograph or ECG (sometimes called an EKG), and you may need frequent blood tests.

Some medicines can cause unwanted or dangerous effects when used with Tasigna. Your doctor may need to change your treatment plan if you use any of the following drugs: chloroquine, methadone, nefazodone, an antibiotic--clarithromycin, moxifloxacin, telithromycin; antifungal medication--itraconazole, ketoconazole, voriconazole; heart rhythm medicine--amiodarone, disopyramide, dronedarone, procainamide, quinidine, sotalol; HIV or AIDS medicine--atazanavir, indinavir, nelfinavir, ritonavir, saquinavir; or medicine to treat a psychiatric disorder--haloperidol, pimozide, thioridazine, ziprasidone.

Take Tasigna on an empty stomach. Avoid eating anything for at least 2 hours before and 1 hour after you take Tasigna.

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).

Before taking this medicine

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

• low blood levels of potassium or magnesium; or

• a heart rhythm disorder called long QT syndrome.

Some medicines can cause unwanted or dangerous effects when used with Tasigna. Your doctor may need to change your treatment plan if you use any of the following drugs:

• chloroquine, methadone, nefazodone; or

• an antibiotic--clarithromycin, moxifloxacin, telithromycin; antifungal medication--itraconazole, ketoconazole, voriconazole; heart rhythm medicine--amiodarone, disopyramide, dronedarone, procainamide, quinidine, sotalol; HIV or AIDS medicine--atazanavir, indinavir, nelfinavir, ritonavir, saquinavir; or medicine to treat a psychiatric disorder--haloperidol, pimozide, thioridazine, ziprasidone.

To make sure Tasigna is safe for you, tell your doctor if you have any of these conditions:

• heart disease, heart rhythm problems;

• a personal or family history of Long QT syndrome;

• liver disease;

• a history of pancreatitis; or

• if your stomach has been surgically removed (total gastrectomy).

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

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

See also: Pregnancy and breastfeeding warnings (in more detail)

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 this medicine.

How should I take Tasigna?

Tasigna is usually taken every 12 hours. Follow the directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Take this medicine with a full glass of water. Swallow the capsule whole.

Take Tasigna on an empty stomach, at least 1 hour before or 2 hours after a meal. Do not take with food. Food can increase your blood levels of nilotinib and may increase your risk of harmful side effects.

To make swallowing easier, you may open the Tasigna capsule and sprinkle the medicine into no more than 1 teaspoon of applesauce. Swallow right away without chewing. Do not save the mixture for later use.

Avoid eating anything for at least 2 hours before and 1 hour after you take Tasigna.

Tasigna is to be taken long-term. You should not stop using this medicine suddenly. Stopping suddenly may make your condition worse.

Tasigna can lower blood cells that help your body fight infections and help your blood to clot. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results of these tests.

Your heart function may be checked with an electrocardiograph or ECG (sometimes called an EKG).

Store at room temperature away from moisture and heat.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

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 symptoms may include drowsiness and vomiting.

What should I avoid?

Avoid taking a stomach acid reducers (Axid, Pepcid, Tagamet, Zantac, and others) within 10 hours before or 2 hours after you take Tasigna.

Avoid taking an antacid (Di-Gel, Gaviscon, Maalox, Milk of Magnesia, Mylanta, Rolaids, and others) within 2 hours before or 2 hours after you take this medicine.

Grapefruit and grapefruit juice may interact with nilotinib and lead to unwanted side effects. Avoid the use of grapefruit products while taking this medicine.

This medicine can pass into body fluids (including urine, feces, vomit, semen, vaginal fluid). Patients and caregivers should wear rubber gloves while cleaning up body fluids, handling contaminated trash or laundry or changing diapers. Wash hands before and after removing gloves. Wash soiled clothing and linens separately from other laundry.

Body fluids should not be handled by a woman who is pregnant or who may become pregnant. Use condoms during sexual activity to avoid exposure to body fluids.

Tasigna side effects

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

Stop using Tasigna and call your doctor at once if you have:

• swelling, rapid weight gain, feeling short of breath;

• bone marrow suppression--fever, chills, painful mouth sores, pale skin, easy bruising or bleeding, red or pink urine, bloody or tarry stools, cough, trouble breathing, feeling light-headed, rapid heart rate;

• kidney problems--lower back pain, little or no urinating;

• pancreas problems--severe pain in your upper stomach spreading to your back, nausea and vomiting;

• high or low potassium---confusion, slow or uneven heart rate, weak pulse, extreme thirst, increased urination, leg discomfort, tingly feeling, muscle weakness or limp feeling;

• low calcium--numbness or tingly feeling around your mouth, fast or slow heart rate, muscle tightness or contraction, overactive reflexes;

• low sodium--headache, confusion, slurred speech, hallucinations, vomiting, severe weakness, muscle cramps, loss of coordination, feeling unsteady, seizure (convulsions), shallow breathing;

• liver problems--nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• bleeding in the brain--sudden headache, confusion, vision problems, and feeling like you might pass out.

Common Tasigna side effects may include:

• diarrhea, constipation, stomach discomfort;

• mild itching or rash, temporary hair loss;

• runny or stuffy nose, sneezing, sore throat;

• mild headache, back pain, joint or muscle pain; or

• tired feeling.

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.

See also: Side effects (in more detail)

Tasigna dosing information

Usual Adult Dose of Tasigna for Chronic Myelogenous Leukemia:

For use in patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase:
Initial dose: 300 mg orally twice daily, approximately 12 hours apart

For use in patients with chronic phase or accelerated phase Ph+ CML resistant to or intolerant to prior therapy that included imatinib:
Initial dose: 400 mg orally twice daily, approximately 12 hours apart

Treatment should continue as long as the patient does not show evidence of progression or unacceptable toxicity.

What other drugs will affect Tasigna?

Many drugs can interact with Tasigna, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all medicines you use, and those you start or stop using during your treatment. Not all possible interactions are listed in this medication guide.