Tasigna Capsules (Hard Gelatin)
Nilotinib
200mg
Novartis Pharma AG
| Pack size | 112's [28's Box (14's Blister x 2)] x 4) |
|---|---|
| Dispensing mode | POM |
| Source | SWITZERLAND |
| Agent | CITY MEDICAL STORE |
| Retail Price | 26455.50 AED |
Available as:
Indications
Tasigna Capsules (Hard Gelatin) is used for:
Chronic myelogenous leukaemia
Adult Dose
Oral
Chronic Myeloid Leukemia (CML), Newly Diagnosed
Indicated for initial treatment of newly diagnosed Philadelphia chromosome positive chronic phase chronic myeloid leukemia (Ph+ CP-CML)
300 mg PO q12hr
Chronic Myeloid Leukemia (CML), Resistant/Intolerant
Indicated for treatment of chronic phase and accelerated pase Ph+ CML in patients resistant to or intolerant to prior therapy that included imatinib
400 mg PO q12hr
Hepatic Impairment
Newly diagnosed Ph+ CML (chronic phase at 300 mg BID)
Mild, moderate, or severe hepatic impairment: Start initial dose at 200 mg BID; if tolerated, may increase to 300 mg BID
Resistant or intolerant Ph+ CML (chronic phase or accelerated phase at 400 mg BID)
Mild or moderate hepatic impairment: Start initial dose at 300 mg BID; if tolerated, may increase to 400 mg BID
Severe hepatic impairment: Start initial dose at 200 mg BID; if tolerated, may increase to 300 mg BID, and then 400 mg BID
Child Dose
<18 years old: Not recommended
Renal Dose
Administration
Should be taken on an empty stomach. Avoid food at least 2 hr before & at least 1 hr after a dose. Swallow whole, do not chew/crush. Avoid grapefruit products.
Contra Indications
Patients with hypokalaemia, hypomagnaesemia or long QT syndrome. Pregnancy.
Precautions
Patient w/ history of pancreatitis, w/ total gastrectomy. Hepatic impairment. Maintain adequate hydration and correct uric acid levels, hypomagnesaemia, hypokalaemia and other electrolyte imbalances prior to therapy. Pregnancy and lactation. Monitoring Parameters Monitor ECG, CBC, hepatic function, serum lipase regularly. Monitor electrolyte periodically during therapy.
Lactation: not known if excreted in breast milk; do not nurse
Pregnancy-Lactation
Interactions
Drugs that inhibit gastric acid secretion (e.g. PPIs) may reduce solubility and bioavailability of nilotinib.
Potentially Fatal: Concomitant use w/ potent CYP3A4 inhibitors or antiarrhythmics (e.g. amiodarone, disopyramide, quinidine, sotalol, ketoconazole, clarithromycin, atazanavir) and other QT prolonging drugs (e.g. chloroquine, haloperidol, methadone, moxifloxacin, pimozide) may increase nilotinib serum levels and/or increase the risk of QT prolongation. Concomitant use w/ potent CYP3A4 inducers (e.g. rifampcin, phenobarbital, carbamazepine, phenytoin) may decrease nilotinib serum levels.
Adverse Effects
Side effects of Nilotinib :
>10%
Rash (33%), Headache (31%), Nausea (31%), Pruritus (29%), Fatigue (28%), Pyrexia (24%), Diarrhea (22%), Constipation (21%), Vomiting (21%), Arthralgia (18%), Cough (17%), Extremity pain (16%), Asthenia (14%), Muscle spasms (14%), Myalgia (14%), Abdominal pain (13%), Bone pain (13%), Back pain (12%), Dyspnea (11%), Nasopharyngitis (11%), Peripheral edema (11%)
1-10% (selected)
Dizziness, Insomnia, Paresthesia, QT interval prolongation, HTN, Palpitations, QT interval prolongation, Hyperglycemia, Hyperkalemia, Hypomagnesemia, Neutropenia, Pancytopenia
<1%
Peripheral arterial occlusive disease, Tumor lysis syndrome, Aortic valve sclerosis, Abscess, Amnesia, Dehydration
Potentially Fatal: QT prolongation and sudden deaths.
Mechanism of Action
Nilotinib is a potent inhibitor of BCR-ABL tyrosine kinase. It binds to and stabilises the inactive conformation of the kinase domain of Abl protein.
Note
Tasigna 200mg Capsules (Hard Gelatin) manufactured by Novartis Pharma AG. Its generic name is Nilotinib. Tasigna is availble in United Arab Emirates.
Farmaco UAE drug index information on Tasigna Capsules (Hard Gelatin) is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.