Nexavar Generic Name & Formulations
Legal Class
Rx
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
Legal Class
Rx
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
Legal Class
Rx
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
Images
