Medicine Overview of Nilonix 200mg Capsule
Nilonix 200 is used in the treatment of blood cancer (chronic myeloid leukaemia). It is used in patients whose disease could not be treated with other medications for leukaemia or who cannot take these medications because of side effects.
Nilonix 200 should be taken on an empty stomach, but try to have it at the same time every day to get the most benefits. Your doctor will decide what dose is necessary and how often you need to take it. This will depend on what you are being treated for and may change from time to time. You should take it exactly as your doctor has advised. Taking it in the wrong way or taking too much can cause very serious side effects. It may take several weeks or months for you to see or feel the benefits but do not stop taking it unless your doctor tells you to.
Headache, nausea, abdominal pain, and rash are very common side effects of this medicine. If you experience severe diarrhea, consult with your doctor or drink plenty of fluids while on treatment. This medicine may reduce the number of blood cells (decrease red blood and white blood cells) in your blood, thereby, increasing the susceptibility to infections. Regular blood tests are required to check your blood cells along with heart, liver and blood uric acid levels and blood sugar or fat level in the body.
Before taking it, tell your doctor if have heart disease, liver, or kidney problems or are taking any medicines to treat infections. Many other medicines can affect, or be affected by, this medicine so let your healthcare team know all medications you are using. This medicine is not recommended during pregnancy or while breastfeeding. Use of effective contraception by both males and females during treatment is important to avoid pregnancy.
- Blood cancer (Chronic myeloid leukaemia)
- Headache
- Nausea
- Abdominal pain
- Rash
- Itching
- Hair loss
- Muscle pain
- Fatigue
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Nilonix 200 is used for the treatment of thyroid cancer.
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Take it with or without food, preferably at the same time each day.
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Diarrhea may occur as a side effect. Drink plenty of fluids and inform your doctor if it doesn’t stop or if you find blood in your stools.
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Use a reliable contraceptive method to prevent pregnancy while you are taking this medicine and for a month after you stop taking it.
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Monitor your blood pressure regularly while taking this medication. Inform your doctor if you notice symptoms of very high blood pressure such as severe headache, confusion, problems with your eyesight, nausea or vomiting.
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It may cause serious bleeding problem. Inform your doctor if you get headaches, stomach pain or if you notice blood in your urine or stools.
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Do not take this medicine if you are pregnant, planning to conceive or breastfeeding.
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.
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
<18 years old: Not recommended
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
>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.
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.
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