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Nexavar多吉美

Nexavar

sorafenib

Manufacturer:

Bayer

Distributor:

Zuellig
/
Firma Chun Cheong
Concise Prescribing Info
Contents
Sorafenib
Indications/Uses
Treatment of patients w/ hepatocellular carcinoma (HCC), advanced renal cell carcinoma (RCC) & differentiated thyroid carcinoma (DTC).
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Dosage/Direction for Use
400 mg bd (total daily dose of 800 mg). Dose adjustments: HCC & RCC Reduce dose to 2 tab of 200 mg once daily. DTC Reduce dose to 600 mg in divided dose (two 200-mg tab or one 200-mg tab 12 hr apart).
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Overdosage
View Nexavar overdosage for action to be taken in the event of an overdose.
Administration
Should be taken on an empty stomach: Take on an empty stomach or w/ a low or moderate fat meal. If the patient intends to have a high fat meal, take at least 1 hr before or 2 hr after meals. Swallow whole, do not chew/crush.
Contraindications
Hypersensitivity.
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Special Precautions
Dermatological toxicities. Monitor BP regularly; severe or persistent HTN. Haemorrhage, cardiac ischemia &/or infarction, QT interval prolongation. Monitor periodically w/ on-treatment ECG & electrolytes. GI perforation. Concomitant warfarin, phenprocoumon, irinotecan, docetaxel, platinum-based chemotherapies, neomycin or other antibiotics therapy. Temporary interruption in major surgical procedures. Renal & hepatic impairment. Evaluate prognosis of DTC before initiating treatment. Treat tracheal, bronchial & oesophageal infiltration w/ localized therapy prior to administering sorafenib to patients w/ DTC. Close monitoring of blood Ca & TSH levels in patients w/ DTC. High risk RCC patients. Pregnancy & lactation. Elderly.
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Adverse Reactions
MI or myocardial ischaemia, GI perforation, drug-induced hepatitis & HTN or hypertensive crisis. Diarrhoea, fatigue, alopeica, infection, hand-foot skin reaction (palmar plantar erythrodysaesthesia sydrome) & rash. Lymphopenia. Anorexia, hypophosphataemia. Haemorrhage (including GI & resp tract & cerebral haemorrhage). Nausea, vomiting, constipation,. Dry skin, erythema, pruritus. Arthralgia. Mouth, abdominal, bone & tumour pain & headache, fever. Decreased wt, increased amylase & lipase.
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Drug Interactions
Decreased AUC w/ CYP3A4 inducers (eg rifampicin, St. John's wort, phenytoin, carbamazepine, phenobarb, dexamethasone). Increased plasma conc of P-gp substrates eg digoxin. Increased AUC of doxorubicin/irinotecan & docetaxel/indocetaxel. Decreased exposure w/ neomycin.
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Description
View Nexavar description for details of the chemical structure and excipients (inactive components).
Action
View Nexavar mechanism of action for pharmacodynamics and pharmacokinetics details.
MIMS Class
Targeted Cancer Therapy
ATC Classification
L01EX02 - sorafenib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.
Presentation/Packing
Form
Nexavar tab 200 mg
Packing/Price
60's
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