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NEXAVAR
Bladder, kidney, and other urologic cancers
Colorectal and other GI cancers
Pancreatic, thyroid, and other endocrine cancers
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Drug Name:

NEXAVAR Rx

Generic Name and Formulations:
Sorafenib 200mg; tabs.

Company:
Bayer and Onyx

Therapeutic Use:

Indications for NEXAVAR:

Advanced renal cell carcinoma.

Adult:

Take on an empty stomach. 400mg twice daily. If toxicity occurs, may reduce dose to 400mg once daily; if further dose reduction required, may reduce dose to 400mg every other day (see full labeling). Concomitant strong CYP3A4 inducers: consider increasing dose, monitor for toxicity.

Children:

Not established.

Contraindications:

Concomitant carboplatin/paclitaxel in patients with squamous cell lung cancer.

Warnings/Precautions:

Avoid in congenital long QT syndrome. Monitor patients with CHF, bradyarrhythmias, drugs known to prolong the QT interval, electrolyte abnormalities. Discontinue if severe dermatologic toxicity, hypertension, GI perforation, hemorrhage, cardiac ischemia, MI occurs. Suspend therapy before major surgery. Monitor BP weekly during the first 6 weeks and thereafter. Monitor hepatic function regularly; discontinue if transaminases significantly elevated. Severe hepatic impairment (Child-Pugh C) or on dialysis. Use effective contraception during and for 2 weeks after stopping treatment. Pregnancy (Cat.D), nursing mothers: not recommended.

Interactions:

See Contraindications. Avoid strong CYP3A4 inducers (eg, St. John's Wort, dexamethasone, phenytoin, carbamazepine, rifabutin, rifampin, phenobarbital) and neomycin; may decrease sorafenib levels. May potentiate warfarin (monitor PT & INR), other drugs metabolized by UGT1A1 or UGT1A9 pathway, or substrates of CYP2B6, CYP2C8, CYP2C9, P-gp. Concomitant Class Ia and III antiarrhythmics; may prolong QT interval.

Pharmacological Class:

Multikinase inhibitor.

Adverse Reactions:

Dermatologic toxicity (eg, rash, hand-foot skin reaction, alopecia, pruritus, dry skin, Stevens-Johnson syndrome, toxic epidermal necrolysis), fatigue, weight loss, diarrhea, anorexia, abdominal pain, hypertension, hemorrhage, electrolyte abnormalities; drug-induced hepatitis, QT prolongation.

Metabolism:

Hepatic (CYP3A4, UGT1A9); 99.5% protein bound.

Elimination:

Fecal (primary), renal.

Generic Availability:

NO

How Supplied:

Tabs—120

Indications for NEXAVAR:

Unresectable hepatocellular carcinoma.

Adult:

Take on an empty stomach. 400mg twice daily. If toxicity occurs, may reduce dose to 400mg once daily; if further dose reduction required, may reduce dose to 400mg every other day (see full labeling). Concomitant strong CYP3A4 inducers: consider increasing dose, monitor for toxicity.

Children:

Not established.

Contraindications:

Concomitant carboplatin/paclitaxel in patients with squamous cell lung cancer.

Warnings/Precautions:

Avoid in congenital long QT syndrome. Monitor patients with CHF, bradyarrhythmias, drugs known to prolong the QT interval, electrolyte abnormalities. Discontinue if severe dermatologic toxicity, hypertension, GI perforation, hemorrhage, cardiac ischemia, MI occurs. Suspend therapy before major surgery. Monitor BP weekly during the first 6 weeks and thereafter. Monitor hepatic function regularly; discontinue if transaminases significantly elevated. Severe hepatic impairment (Child-Pugh C) or on dialysis. Use effective contraception during and for 2 weeks after stopping treatment. Pregnancy (Cat.D), nursing mothers: not recommended.

Interactions:

See Contraindications. Avoid strong CYP3A4 inducers (eg, St. John's Wort, dexamethasone, phenytoin, carbamazepine, rifabutin, rifampin, phenobarbital) and neomycin; may decrease sorafenib levels. May potentiate warfarin (monitor PT & INR), other drugs metabolized by UGT1A1 or UGT1A9 pathway, or substrates of CYP2B6, CYP2C8, CYP2C9, P-gp. Concomitant Class Ia and III antiarrhythmics; may prolong QT interval.

Pharmacological Class:

Multikinase inhibitor.

Adverse Reactions:

Dermatologic toxicity (eg, rash, hand-foot skin reaction, alopecia, pruritus, dry skin, Stevens-Johnson syndrome, toxic epidermal necrolysis), fatigue, weight loss, diarrhea, anorexia, abdominal pain, hypertension, hemorrhage, electrolyte abnormalities; drug-induced hepatitis, QT prolongation.

Metabolism:

Hepatic (CYP3A4, UGT1A9); 99.5% protein bound.

Elimination:

Fecal (primary), renal.

Generic Availability:

NO

How Supplied:

Tabs—120

Indications for NEXAVAR:

Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.

Adult:

Take on an empty stomach. 400mg twice daily. If toxicity occurs, may reduce dose to 400mg and 200mg 12hrs apart (either dose can come first); if second reduction is required, may reduce dose to 200mg twice daily; if third reduction is required, may reduce to 200mg once daily (see full labeling). Concomitant strong CYP3A4 inducers: consider increasing dose, monitor for toxicity.

Children:

Not established.

Contraindications:

Concomitant carboplatin/paclitaxel in patients with squamous cell lung cancer.

Warnings/Precautions:

Avoid in congenital long QT syndrome. Monitor patients with CHF, bradyarrhythmias, drugs known to prolong the QT interval, electrolyte abnormalities. Discontinue if severe dermatologic toxicity, hypertension, GI perforation, hemorrhage, cardiac ischemia, MI occurs. Suspend therapy before major surgery. Monitor BP weekly during the first 6 weeks and thereafter. Monitor hepatic function regularly; discontinue if transaminases significantly elevated. Severe hepatic impairment (Child-Pugh C) or on dialysis. Monitor TSH levels monthly and adjust thyroid therapy. Use effective contraception during and for 2 weeks after stopping treatment. Pregnancy (Cat.D), nursing mothers: not recommended.

Interactions:

See Contraindications. Avoid strong CYP3A4 inducers (eg, St. John's Wort, dexamethasone, phenytoin, carbamazepine, rifabutin, rifampin, phenobarbital) and neomycin; may decrease sorafenib levels. May potentiate warfarin (monitor PT & INR), other drugs metabolized by UGT1A1 or UGT1A9 pathway, or substrates of CYP2B6, CYP2C8, CYP2C9, P-gp. Concomitant Class Ia and III antiarrhythmics; may prolong QT interval.

Pharmacological Class:

Multikinase inhibitor.

Adverse Reactions:

Dermatologic toxicity (eg, rash, hand-foot skin reaction, alopecia, pruritus, dry skin, Stevens-Johnson syndrome, toxic epidermal necrolysis), fatigue, weight loss, diarrhea, anorexia, abdominal pain, hypertension, hemorrhage, electrolyte abnormalities; drug-induced hepatitis, QT prolongation.

Metabolism:

Hepatic (CYP3A4, UGT1A9); 99.5% protein bound.

Elimination:

Fecal (primary), renal.

Generic Availability:

NO

How Supplied:

Tabs—120

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