Tasigna Capsules (Nilotinib Capsules) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 10, 2012

Tasigna

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Tasigna Capsules User Reviews >>

Tasigna Capsules

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Tasigna®
(nilotinib) Capsules

WARNING: QT PROLONGATION AND SUDDEN DEATHS

Tasigna prolongs the QT interval (5.2). Sudden deaths have been reported in patients receiving nilotinib (5.3). Tasigna should not be used in patients with hypokalemia, hypomagnesemia, or long QT syndrome (4). Hypokalemia or hypomagnesemia must be corrected prior to Tasigna administration and should be periodically monitored (5.2). Drugs known to prolong the QT interval and strong CYP3A4 inhibitors should be avoided (5.7). Patients should avoid food 2 hours before and 1 hour after taking dose (5.8). A dose reduction is recommended in patients with hepatic impairment (5.9). ECGs should be obtained to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, as well as following any dose adjustments.

DRUG DESCRIPTION

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 not optically active. The pK_al was determined to be 2.1; pK_a2 was estimated to be 5.4.

The chemical name of nilotinib is 4-methyl-N-[3-(4-methyl-lH-imidazol-l-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride, monohydrate. Its structure is shown below:

Tasigna® (nilotinib) Structural Formula Illustration

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.

Call your doctor at once if you have any of these serious side effects:

dizziness and 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,...

Read All Potential Side Effects and See Pictures of Tasigna Capsules »

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...

Read All Potential Precautions of Tasigna Capsules »

Last reviewed on RxList: 11/14/2011
This monograph has been modified to include the generic and brand name in many instances.