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Tasigna
Generic Name: nilotinib (nye LOE ti nib)
What is Tasigna?
Tasigna interferes with the growth of some cancer cells.
It is used to treat a type of blood cancer called Philadelphia chromosome positive chronic myeloid leukemia (CML).
Tasigna is usually given to people who cannot take certain other leukemia medications, or who have tried other medications without successful treatment.
Tasigna may also be used for other purposes not listed in this medication guide.
Important information about Tasigna
Do not use Tasigna without telling your doctor if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment. Do not use Tasigna while you are breast-feeding a baby. You should not use this medication if you are allergic to nilotinib, or if you have low blood levels of potassium or magnesium or a history of “Long QT syndrome.”
Before using Tasigna, tell your doctor if you have heart disease or a heart rhythm disorder, liver disease, a personal history of pancreatitis, or a family history of “Long QT syndrome”.
Take Tasigna on an empty stomach, at least 1 hour before or 2 hours after a meal.
Call your doctor at once if you have any serious side effects, such as dizziness, fainting, fast or pounding heartbeat, feeling short of breath, swelling, seizure, warmth, redness, or tingly feeling under your skin, jaundice (yellowing of the skin or eyes), or severe pain in your upper stomach spreading to your back, with nausea and vomiting.
There are many other medicines that can cause interact with Tasigna. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor. Keep a list with you of all the medicines you use and show this list to any doctor or other healthcare provider who treats you.
To be sure Tasigna is not causing harmful effects, your blood and bone marrow will need to be tested on a regular basis. Your heart rate may also be checked using electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart. Do not miss any scheduled appointments.
Before taking Tasigna
You should not use Tasigna if you are allergic to nilotinib, or if you have:
low blood levels of potassium or magnesium; or
a history of “Long QT syndrome.”
Before using Tasigna, tell your doctor if you are allergic to any drugs, or if you have:
heart disease or heart rhythm disorder;
liver disease;
a personal history of pancreatitis; or
a family history of “Long QT syndrome”;
If you have any of these conditions, you may need a dose adjustment or special tests to safely take Tasigna.
FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use Tasigna without your doctor’s consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. It is not known whether Tasigna passes into breast milk or if it could harm a nursing baby. Do not use this medication while you are breast-feeding a baby. Do not give Tasigna to anyone younger than 18 years old.
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).
How should I take Tasigna?
Take Tasigna exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
Take Tasigna on an empty stomach, at least 1 hour before or 2 hours after a meal. Take this medicine with a large glass of water. Do not break or open a Tasigna capsule. Swallow the pill whole.
Tasigna is usually taken every 12 hours.
To be sure this medication is not causing harmful effects, your blood and bone marrow will need to be tested on a regular basis. Your heart rate may also be checked using electrocardiograph or ECG (sometimes called an EKG). This machine measures electrical activity of the heart. Do not miss any scheduled appointments.
Do not stop using Tasigna or change your dose without talking to your doctor. If you stop taking the medication too soon, your condition may get worse. Store Tasigna at room temperature away from moisture and heat.
What happens if I miss a dose?
Skip the missed dose and take your next dose at the regularly scheduled time. Do not take extra medicine to make up the missed dose.
What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.
Symptoms of an Tasigna overdose may include severe muscle cramps.
What should I avoid while taking Tasigna?
Avoid eating for at least 1 hour after you take Tasigna. Food can increase your blood levels of Tasigna and may increase your risk of harmful side effects.
Grapefruit and grapefruit juice may interact with Tasigna and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor. Do not increase or decrease the amount of grapefruit products in your diet without first talking to your doctor.
Tasigna side effects
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. Call your doctor at once if you have any of these serious side effects:
dizziness and a fast or pounding heartbeat;
shortness of breath;
swelling in your hands or feet;
seizure (convulsions);
warmth, redness, or tingly feeling under your skin;
nausea, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
severe pain in your upper stomach spreading to your back; or
dry mouth, increased thirst, drowsiness, restless feeling, confusion, increased urination, muscle pain or weakness, uneven heart rate, or feeling like you might pass out.
Less serious side effects may be more likely to occur, such as:
skin rash or itching;
diarrhea, constipation;
headache, spinning sensation;
tired feeling;
numbness or tingling;
sleep problems (insomnia);
joint or muscle pain; or
runny or stuffy nose, cough, sore throat, hoarseness.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect Tasigna?
Before taking Tasigna, tell your doctor if you are using any of the following drugs:
arsenic trioxide (Trisenox);
chloroquine (Arelan) or halofantrine (Halfan);
droperidol (Inapsine);
midazolam (Versed);
a blood thinner such as warfarin;
HIV/AIDS medicine such as nelfinavir (Viracept) or ritonavir (Norvir);
narcotic medication such as levomethadyl (Orlaam), or methadone (Dolophine, Methadose);
an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., E-Mycin, Ery-Tab, Erythrocin), pentamidine (NebuPent, Pentam), rifampin (Rifadin, Rifamate, Rimactane), or troleandomycin (Tao);
an antifungal medication such as itraconazole (Sporanox) or ketoconazole (Nizoral);
an antidepressant such as amitriptyline (Elavil, Etrafon), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Janimine, Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), and others;
medicines to treat psychiatric disorders, such as chlorpromazine (Thorazine), haloperidol (Haldol), mesoridazine (Serentil), or thioridazine (Mellaril); or
heart rhythm medicine such as amiodarone (Cordarone, Pacerone), dofetilide (Tikosyn), disopyramide (Norpace), ibutilide (Corvert), procainamide (Procan, Pronestyl), quinidine (Quinidex, Quin-Release Quin-G), or sotalol (Betapace).
This list is not complete and there may be other drugs that can interact with Tasigna. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.
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