Tasigna (nilotinib) is used to treat patients with a certain type of leukemia called Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) after Glivec. Ph+ CML is a cancer of the blood that makes the body produce too many abnormal white blood cells. Tasigna is used in adult patients with Ph+ chronic myeloid leukemia in chronic or accelerated phase who are no longer benefiting from previous CML treatment, including treatment with Glivec (imatinib mesylate). Tasigna is also used in adult Ph+ CML patients in chronic or accelerated phase who experienced serious side effects with previous CML treatment, including Glivec, and are not able to continue taking it despite management of side effects.

How does Tasigna work?

In adult patients with Ph+ CML in chronic or accelerated phase who are no longer benefiting from previous treatments such as Glivec, a change in DNA (genetic material) in white blood cells triggers a signal that causes the cells to multiply abnormally. Tasigna is designed to block this signal, and thus stop the overproduction of these cells.

How is Tasigna different from Glivec?

Tasigna is a next-generation treatment for Ph+ CML in adult patients in chronic or accelerated phase who are resistant or intolerant to Glivec. Glivec binds to the Bcr-Abl protein, blocking the signal that causes your body to produce too many damaged white blood cells. However, over time, the Bcr-Abl protein can change or mutate. This can lead to Glivec resistance, meaning that Glivec no longer stops the signal that leads to the production of leukemic cells. Tasigna works similarly to Glivec, but Tasigna was developed to bind to the protein with greater selectivity. In non-human studies, Tasigna was active against most common mutations that can cause Glivec resistance. Tasigna also has other characteristics that make it an effective treatment against chronic and accelerated phase Ph+ CML

Who should NOT take Tasigna?

Tasigna is not recommended during pregnancy. Patients who are pregnant or who think they may be, should discuss with their healthcare provider whether they can take Tasigna during pregnancy.
Women of child-bearing potential must use effective birth control while taking Tasigna.
Breast-feeding is not recommended during treatment with Tasigna.
Tasigna contains lactose (milk sugar). Patients with intolerance to lactose, or who should avoid products containing lactose due to another condition, should discuss this with their doctor before taking this medicine.

What should patients tell their doctor before taking Tasigna?

Before taking Tasigna patients should tell their healthcare provider if they: have a heart disorder; are taking medication for the heart; know that they suffer from low levels of electrolytes, such as potassium or magnesium; have a liver disorder; or have pancreatitis.

Can Tasigna be taken with other medicines?

Patients should tell their doctor or pharmacist before taking Tasigna if they are taking or have recently taken any other medicines, including over-the-counter medicines or herbal products. Tasigna and certain other medicines can interact with each other. Tasigna, as well as other drugs, are metabolized by enzymes in the liver. These enzymes may not work on several drugs at the same time. This can result in higher or lower than expected levels of Tasigna or other drugs in the bloodstream. Some medications should be avoided during your treatment with Tasigna including certain nonprescription medications and herbal products.

Examples of these drugs include, but are not limited to, the following list:

quinidine, amiodarone – antiarrhythmics – used to treat irregular heart beat
verapamil, diltiazem – used to treat high blood pressure
ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, erythromycin - used to treat infections
cyclosporine, tacrolimus – used as immunosuppressants
ritonavir - an anti-HIV medicine from the class “antiproteases”
carbamazepine, phenobarbital, phenytoin - used to treat seizure disorder (e.g. epilepsy)
rifampin - used to treat a type of infection called tuberculosis
St. John’s Wort - a herbal product used to treat depression and other conditions (also known as Hypericum Perforatum)
midazolam - used to relieve anxiety before surgery, which is usually administered by an anesthesiologist
warfarin - used to treat blood coagulation disorders (such as blood clots or thromboses)
phenytoin - used to treat seizure

If patients are taking any of these, their doctor might prescribe other alternative medicines. Patients should also tell their doctor if they are already taking Tasigna and are prescribed a new medicine or wish to take an over-the-counter medicine or herbal product they have not taken previously during Tasigna treatment.

How should Tasigna be taken?

Tasigna should always be taken exactly as instructed by the physician. Patients should check with their doctor or pharmacist if they have any questions.

Tasigna should NOT be taken with food.
No food should be consumed for at least 2 hours before the dose is taken and no food should be consumed for at least one hour after the dose is taken

The capsules should be swallowed whole with water. Patients should not open the capsules. Tasigna should be taken twice a day, with each dose taken approximately 12 hours apart. Patients should not drink grapefruit juice, eat grapefruit, or take supplements containing grapefruit extract. These may affect the levels of Tasigna in the blood.

What are the possible side effects of Tasigna?

Most side effects are mild to moderate and will generally disappear after a few days to a few weeks of treatment or can be managed with other medicines or treatments. However, in some cases side effects can be serious or even life threatening. In these cases Tasigna therapy will likely be temporarily stopped and/or the dose lowered. However, in rare cases, Tasigna therapy may be stopped permanently. The physician will monitor patients on a regular basis for signs or symptoms of serious side effects. The following information describes the most common side effects of Tasigna:

Low blood count
Nausea, vomiting, or abdominal pain
Swelling of hands, ankles, feet or face
Other common side effects include rash, headache, itching, tiredness, diarrhea, constipation, pain in joints or muscles.

Also, patients should tell their doctor if they experience any of the following as these may be signs of a more serious side effect:

Irregularity in heart beat
Unexplained bleeding or bruising
Blood in urine or stool
Shortness of breath
Yellow skin and eyes (which may be signs of a liver disorder)
Severe abdominal pain (which may be a sign of acute pancreatitis)
Unexplained weakness

This is not a comprehensive list of all side effects recorded in clinical trials with Tasigna. Patients should report any unusual symptoms to their healthcare provider.

How will patients know if Tasigna is working?

Only the healthcare provider can tell whether Tasigna is working. Patients will have regular tests including blood tests during treatment. These will monitor the levels of blood cells (white blood cells, red blood cells and platelets) in the body to see how Tasigna is working. Physicians may also recommend periodic bone marrow samples.

How long should Tasigna be taken?

Patients should continue taking Tasigna every day for as long as their doctor tells them. This is intended to be a long-term treatment. Physicians will regularly monitor the patient's condition to check that the treatment is having the desired effect. If patients have questions about how long to take Tasigna, they should talk to their doctor. Patients should not stop taking Tasigna or change the amount of Tasigna that they take unless their doctor tells them to. Patients with any further questions on the use of this product should ask their doctor or pharmacist.

What should patients do if they have taken more Tasigna than they should?

If patients have taken more Tasigna than they should have or if someone who has not been prescribed Tasigna takes capsules, a doctor, pharmacist or poison control center should be contacted immediately. The pack of capsules should be shown to the doctor. Medical treatment may be necessary.

What should patients do if they forget to take their dose of Tasigna?

Patients who miss a dose should take the next dose as scheduled. Patients should not take a double dose to make up for the forgotten capsules.

How should Tasigna be stored?

Tasigna should be kept out of the reach and sight of children. Do not use Tasigna after the expiration date, which is stated on the carton after EXP. The expiration date refers to the last day of that month. Do not store capsules above 30°C (86°F). Store in the original package in order to protect from moisture. Do not use any pack that is damaged or shows signs of tampering.

Sources:

Tasigna^® (nilotinib) basic prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2007.

Tasigna^® (nilotinib) capsules US prescribing information. East Hanover, NJ: Novartis Pharmaceuticals Corporation; 2007.

Patient FAQ
Tasigna Patient Information Leaflet