- Bladder, kidney, and other urologic cancers
- Colorectal and other GI cancers
- Pancreatic, thyroid, and other endocrine cancers
Bladder, kidney, and other urologic cancers:
Indications for: NEXAVAR
Advanced renal cell carcinoma.
Adult Dosage:
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 Dosage:
Not established.
NEXAVAR Contraindications:
Concomitant carboplatin/paclitaxel in patients with squamous cell lung cancer.
NEXAVAR 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. Impaired wound healing: withhold for ≥10 days prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. 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). On dialysis. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) 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).
NEXAVAR Classification:
Kinase inhibitor.
NEXAVAR Interactions:
See Contraindications. Avoid concomitant 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. Avoid concomitant drugs known to prolong the QT interval including Class Ia and III antiarrhythmics.
Adverse Reactions:
Diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, GI and abdominal pains, hypertension, hemorrhage; lab abnormalities, dermatologic toxicity (eg, rash, hand-foot skin reaction, alopecia, pruritus, dry skin, Stevens-Johnson syndrome, toxic epidermal necrolysis), drug-induced hepatitis.
Generic Drug Availability:
NO
How Supplied:
Tabs—120
Colorectal and other GI cancers:
Indications for: NEXAVAR
Unresectable hepatocellular carcinoma.
Adult Dosage:
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 Dosage:
Not established.
NEXAVAR Contraindications:
Concomitant carboplatin/paclitaxel in patients with squamous cell lung cancer.
NEXAVAR 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. Impaired wound healing: withhold for ≥10 days prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. 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). On dialysis. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) 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).
NEXAVAR Classification:
Kinase inhibitor.
NEXAVAR Interactions:
See Contraindications. Avoid concomitant 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. Avoid concomitant drugs known to prolong the QT interval including Class Ia and III antiarrhythmics.
Adverse Reactions:
Diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, GI and abdominal pains, hypertension, hemorrhage; lab abnormalities, dermatologic toxicity (eg, rash, hand-foot skin reaction, alopecia, pruritus, dry skin, Stevens-Johnson syndrome, toxic epidermal necrolysis), drug-induced hepatitis.
Generic Drug Availability:
NO
How Supplied:
Tabs—120
Pancreatic, thyroid, and other endocrine cancers:
Indications for: NEXAVAR
Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma refractory to radioactive iodine treatment.
Adult Dosage:
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 Dosage:
Not established.
NEXAVAR Contraindications:
Concomitant carboplatin/paclitaxel in patients with squamous cell lung cancer.
NEXAVAR 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. Impaired wound healing: withhold for ≥10 days prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. 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). On dialysis. Monitor TSH levels monthly and adjust thyroid therapy. Embryo-fetal toxicity. Advise to use effective contraception during and for 6 months (females of reproductive potential) 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).
NEXAVAR Classification:
Kinase inhibitor.
NEXAVAR Interactions:
See Contraindications. Avoid concomitant 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. Avoid concomitant drugs known to prolong the QT interval including Class Ia and III antiarrhythmics.
Adverse Reactions:
Diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, GI and abdominal pains, hypertension, hemorrhage; lab abnormalities, dermatologic toxicity (eg, rash, hand-foot skin reaction, alopecia, pruritus, dry skin, Stevens-Johnson syndrome, toxic epidermal necrolysis), drug-induced hepatitis.
Generic Drug Availability:
NO
How Supplied:
Tabs—120
