Nexavar

— THERAPEUTIC CATEGORIES —
  • Bladder, kidney, and other urologic cancers
  • Colorectal and other GI cancers
  • Pancreatic, thyroid, and other endocrine cancers

Nexavar Generic Name & Formulations

General Description

Sorafenib 200mg; tabs.

Pharmacological Class

Kinase inhibitor.

How Supplied

Tabs—120

Manufacturer

Generic Availability

NO

Nexavar Indications

Indications

Advanced renal cell carcinoma.

Nexavar Dosage and Administration

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.

Nexavar Contraindications

Contraindications

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

Nexavar Boxed Warnings

Not Applicable

Nexavar Warnings/Precautions

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 Pharmacokinetics

See Literature

Nexavar Interactions

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.

Nexavar Adverse Reactions

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.

Nexavar Clinical Trials

See Literature

Nexavar Note

Not Applicable

Nexavar Patient Counseling

See Literature

Nexavar Generic Name & Formulations

General Description

Sorafenib 200mg; tabs.

Pharmacological Class

Kinase inhibitor.

How Supplied

Tabs—120

Manufacturer

Generic Availability

NO

Nexavar Indications

Indications

Unresectable hepatocellular carcinoma.

Nexavar Dosage and Administration

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.

Nexavar Contraindications

Contraindications

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

Nexavar Boxed Warnings

Not Applicable

Nexavar Warnings/Precautions

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 Pharmacokinetics

See Literature

Nexavar Interactions

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.

Nexavar Adverse Reactions

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.

Nexavar Clinical Trials

See Literature

Nexavar Note

Not Applicable

Nexavar Patient Counseling

See Literature

Nexavar Generic Name & Formulations

General Description

Sorafenib 200mg; tabs.

Pharmacological Class

Kinase inhibitor.

How Supplied

Tabs—120

Manufacturer

Generic Availability

NO

Nexavar Indications

Indications

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

Nexavar Dosage and Administration

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.

Nexavar Contraindications

Contraindications

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

Nexavar Boxed Warnings

Not Applicable

Nexavar Warnings/Precautions

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 Pharmacokinetics

See Literature

Nexavar Interactions

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.

Nexavar Adverse Reactions

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.

Nexavar Clinical Trials

See Literature

Nexavar Note

Not Applicable

Nexavar Patient Counseling

See Literature

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