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.
Indications and Dosage
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.
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Hepatic Impairment
No safety data is available for use in patients with Child-Pugh C hepatic impairment.
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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.
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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.
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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.
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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.
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Food Interaction
St John's wort may decrease the plasma concentration of sorafenib
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Lab Interference
May increase lipase and amylase levels. Transient changes in liver function tests.
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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.
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MIMS Class
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