Sorafenib


Concise Prescribing Info
Indications/Uses
Advanced renal cell carcinoma.
Dosage/Direction for Use
Adult : PO 400 mg twice daily. Continue till patient is no longer responding or unacceptable toxicity occurs.
Dosage Details
Oral
Advanced renal cell carcinoma
Adult: 400 mg bid. May continue until no clinical benefit is seen or until unacceptable toxicity occurs. Temporary interruption and/or dosage reduction may be necessary for management of adverse drug reactions.
Hepatic Impairment
No safety data is available for use in patients with Child-Pugh C hepatic impairment.
Administration
Should be taken on an empty stomach. May be taken w/ a low or moderate fat meal. If the patient intends to have a high fat meal, sorafenib should be taken on an empty stomach at least 1 hr before or 2 hr after meals. Swallow whole, do not chew/crush.
Special Precautions
Interrupt teatment if patient develops cardiac infarction, ischaemia and/or bleeding fatalities. Regular monitoring of BP, CBC and platelet is recommended. Monitor INR in patients who are on treatment with warfarin. Adequate contraception should be used during and for at least 2 wk after stopping treatment. May need to discontinue treatment if severe or persistent hypertension occurs.
Adverse Reactions
Rash and hand-foot skin reactions. Hypophosphataemia, hypertension, bleeding, tinnitus, depression and erectile dysfunction. Alopecia, pruritus, dry skin, erythema, acne, flushing, exfoliative dermatitis, hoarseness, GI disturbances, arthralgia, myalgia, asthenia, pain and peripheral neuropathy.
Potentially Fatal: Bleeding fatalities. Hypertensive crisis.
Overdosage
Withhold treatment and institute supportive care.
Drug Interactions
Inducers of isoenzyme CYP3A4 e.g. carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampicin may decrease sorafenib plasma concentration. Coadmin with sorafenib may increase the plasma concentration of doxorubicin and irinotecan.
Food Interaction
St John's wort may decrease the plasma concentration of sorafenib
Lab Interference
May increase lipase and amylase levels. Transient changes in liver function tests.
Action
Description: Sorafenib inhibits cell surface and intracellular kinases to reduce proliferation of tumour cells.
Pharmacokinetics:
Absorption: Peak plasma concentration is achieved 3 hr after oral admin.
Distribution: 99.5% bound to plasma protein.
Metabolism: Primarily metabolised by isoenzyme CYP3A4 and, to a smaller extent, by glucuronidation.
Excretion: About 77% in the faeces as unchanged drug and 19% in the urine as glucuronidated metabolites. Elimination half-life: 25-48 hr.
Storage
Store at 25°C.
Disclaimer: This information is independently developed by MIMS based on Sorafenib from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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