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QT PROLONGATION AND SUDDEN DEATHS
- Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies (see WARNINGS AND PRECAUTIONS). Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and follow any dose adjustments.
- Sudden deaths have been reported in patients receiving nilotinib (see WARNINGS AND PRECAUTIONS). Do not administer Tasigna to patients with hypokalemia, hypomagnesemia, or long QT syndrome (see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS).
- Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors.
- Patients should avoid food 2 hours before and 1 hour after taking dose (see WARNINGS AND PRECAUTIONS).
Tasigna (nilotinib) belongs to a pharmacologic class of drugs known as kinase inhibitors.
Nilotinib drug substance, a monohydrate monohydrochloride, is a white to slightly yellowish to slightly greenish yellow powder with the anhydrous molecular formula and weight, respectively, of C28H22F3N7O•HCl• H2O and 584. The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is notoptically active. The pKa1 was determined to be 2.1; pKa2 was estimated to be 5.4.
The chemical name of nilotinib is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below:
Tasigna (nilotinib) Capsules, For Oral Use, contain 150 mg or 200 mg nilotinib base, anhydrous (as hydrochloride, monohydrate) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate and polyoxamer 188. The capsules contain gelatin, iron oxide (red), iron oxide (yellow), iron oxide (black) and titanium dioxide.
What are the possible side effects of nilotinib (Tasigna)?
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:
- feeling like you might pass out, fast or pounding heartbeat, seizure (convulsions);
- pale skin, weakness, feeling light-headed, 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...
What are the precautions when taking nilotinib capsules (Tasigna Capsules)?
Before taking nilotinib, tell your doctor or pharmacist if you are allergic to it; or to lactose/galactose; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: liver disease, pancreatitis.
Nilotinib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking...
Last reviewed on RxList: 1/9/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Tasigna Capsules Information
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