Select therapeutic use:

Bladder, kidney, and other urologic cancers:

Indications for NEXAVAR:

Advanced renal cell carcinoma.

Adult:

Take on an empty stomach. 400mg twice daily. If dose reduction is needed, may reduce to 400mg once daily; if further reduction required, may reduce to 400mg every other day. Dose modifications for adverse reactions: see full labeling.

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. Embryo-fetal toxicity. Use effective contraception during and for 6 months (females) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).

Pharmacologic Class:

Multikinase inhibitor.

Interactions:

See Contraindications. Avoid strong CYP3A4 inducers (eg, carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, rifabutin, St. John's wort) 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. May prolong QT interval with Class Ia and III antiarrhythmics.

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

Pricing for NEXAVAR

200mg tablet (Qty: 120)
Appx. price $19386
GoodRx

Colorectal and other GI cancers:

Indications for NEXAVAR:

Unresectable hepatocellular carcinoma.

Adult:

Take on an empty stomach. 400mg twice daily. If dose reduction is needed, may reduce to 400mg once daily; if further reduction required, may reduce to 400mg every other day. Dose modifications for adverse reactions: see full labeling.

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. Embryo-fetal toxicity. Use effective contraception during and for 6 months (females) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).

Pharmacologic Class:

Multikinase inhibitor.

Interactions:

See Contraindications. Avoid strong CYP3A4 inducers (eg, carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, rifabutin, St. John's wort) 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. May prolong QT interval with Class Ia and III antiarrhythmics.

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

Pricing for NEXAVAR

200mg tablet (Qty: 120)
Appx. price $19386
GoodRx

Pancreatic, thyroid, and other endocrine cancers:

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 dose reduction is needed, may reduce to 400mg and 200mg 12hrs apart (either dose can come first); if second reduction is required, may reduce to 200mg twice daily; if third reduction is required, may reduce to 200mg once daily. Dose modifications for adverse reactions: see full labeling.

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. Embryo-fetal toxicity. Use effective contraception during and for 6 months (females) or 3 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).

Pharmacologic Class:

Multikinase inhibitor.

Interactions:

See Contraindications. Avoid strong CYP3A4 inducers (eg, carbamazepine, dexamethasone, phenobarbital, phenytoin, rifampin, rifabutin, St. John's wort) 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. May prolong QT interval with Class Ia and III antiarrhythmics.

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

Pricing for NEXAVAR

200mg tablet (Qty: 120)
Appx. price $19386
GoodRx