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).
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).
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
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.
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.
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.
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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