Nexavar Dosage & Drug Information

Concise Prescribing Info Full Prescribing Info Contents Description Action Indications/Uses Dosage/Direction for Use Overdosage Contraindications Special Precautions Use In Pregnancy & Lactation Adverse Reactions Drug Interactions Storage MIMS Class ATC Classification Regulatory Classification Presentation/Packing

Concise Prescribing Info

Contents

Sorafenib tosylate

Indications/Uses

Treatment of advanced renal cell carcinoma, hepatocellular carcinoma, locally advanced or metastatic differentiated thyroid carcinoma refractory to radioactive iodine.

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Dosage/Direction for Use

400 mg bid. May be reduced to 400 mg once daily if necessary.

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Overdosage

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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, HTN, hemorrhage, wound healing complications, cardiac ischemia &/or infarction, QT/QTc interval prolongation, GI perforation, hepatic impairment. Regularly monitor for changes in prothrombin time, INR & clinical bleeding episodes w/ concomitant warfarin use. Hypocalcaemia, TSH supression in differentiated thyroid carcinoma (DTC). Concomitant use w/ compd metabolized/eliminated predominantly by the UGT1A1 pathway, docetaxel, neomycin. Pregnancy & lactation. Childn.

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Use In Pregnancy & Lactation

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Adverse Reactions

Diarrhea, rash, alopecia, hand-foot skin syndrome; MI/ischemia, GI perforation, drug-induced hepatitis, hemorrhage, HTN/hypertensive crisis.

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Drug Interactions

Reduced AUC w/ rifampin. Increased metabolism (decreased conc) w/ St. John's wort, phenytoin, carbamazepine, phenobarb, dexamethasone. Increases AUC of doxorubicin or irinotecan; AUC & C_max of docetaxel. Decreased exposure w/ neomycin. Infrequent bleeding events or elevations in INR w/ warfarin.

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Storage

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Description

View Nexavar description for details of the chemical structure and excipients (inactive components).

Action

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MIMS Class

Targeted Cancer Therapy

ATC Classification

L01EX02 - sorafenib ; Belongs to the class of other protein kinase inhibitors. Used in the treatment of cancer.

Regulatory Classification

Presentation/Packing

Form

Nexavar FC tab 200 mg

Packing/Price

60's

Nexavar

sorafenib

Manufacturer:

Bayer

Distributor:

Bayer