sorafenib (Rx)

Brand and Other Names:Nexavar
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 200mg

Renal Cell Carcinoma

Indicated for advanced renal cell carcinoma

400 mg PO q12hr

If skin toxicity, discontinue/decrease dose frequency to qDay or every other day as recommended by Manufacturer

Hepatocellular Carcinoma

Indicated for unresectable hepatocellular carcinoma

400 mg PO q12hr

If skin toxicity, discontinue/decrease dose frequency to qDay or every other day as recommended by Manufacturer

Thyroid Cancer

Indicated for locally recurrent or metastatic, progressive, differentiated thyroid cancer (DTC) that is refractory to radioactive iodine treatment

400 mg PO q12hr

Dosage modification for DTC

  • Dose reduction for dermatologic toxicities (see prescribing information for specific toxicity grades 2 or 3 dosage modifications)
  • First dose reduction: 600 mg/day (divided as 2 doses of 400 mg and 200 mg 12 hr apart)
  • Second dose reduction: 200 mg q12hr
  • Third dose reduction: 200 mg qDay

Dosage Modifications

Dermatologic toxicities (HCC or RCC)

  • Grade 1
    • Any occurrence: Continue treatment and consider topical therapy for symptomatic relief
  • Grade 2
    • First occurrence: Continue treatment and consider topical therapy for symptomatic relief; if no improvement within 7 days, interrupt treatment and decrease dose (see below)
    • No improvement within 7 days or second or third occurrence: Withhold drug until toxicity resolves to grade 0-1, then decrease dose by 1 level (ie, 400 mg daily or 400 mg every7 other day)
    • Fourth occurrence: Discontinue
  • Grade 3
    • First or second occurrence: Withhold drug until toxicity resolves to grade 0-1, then decrease dose by 1 level (ie, 400 mg daily or 400 mg every7 other day)
    • Third occurrence: Discontinue

Dermatologic toxicities (DTC)

  • Dose reduction schedule
    • First reduction to 600 mg/day: 400 mg and 200 mg administered 12 h apart
    • Second reduction to 400 mg/day: 200 mg q12hr
    • Third reduction to 200 mg/day: 200 mg once daily
  • Grade 1
    • Any occurrence: Continue treatment
  • Grade 2
    • First occurrence: Decrease dose to 600 mg/day; if no improvement, see below
    • No improvement within 7 days at reduced dose or second occurrence: Withhold drug until toxicity resolves to grade 1; if drug resumed, decrease dose per schedule
    • Third occurrence: Withhold drug until toxicity resolves to grade 1; if drug resumed, decrease dose per schedule
    • Fourth occurrence: Discontinue
  • Grade 3
    • First occurrence: Withhold drug until toxicity resolves to grade 1; if drug resumed, decrease dose by 1 dose level
    • Second occurrence: Withhold drug until toxicity resolves to grade 1; if drug resumed, decrease dose by 2 dose levels
    • Third occurrence: Discontinue

Renal Impairment

  • Mild-to-moderate: Dose adjustment not necessary
  • Severe: Not studied

Hepatic Impairment

  • Mild-to-moderate: Dose adjustment not necessary
  • Severe: Not studied

Melanoma (Orphan)

Treatment of stage IIB through stage IV melanoma

Orphan indication sponsor

  • EMD Serono, Inc; One Technology Plc; Rockland, MA 02370

Desmoid Tumors aggressive fibromatosis (Orphan)

Orphan designation for treatment of desmoid tumors or aggressive fibromatosis

Orphan sponsor

  • Bayer HealthCare Pharmaceuticals, Inc; 100 Bayer Boulevard, P.O. Box 915; Whippany, New Jersey 07981

Safety and efficacy not established

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Interactions

Interaction Checker

and sorafenib

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            Contraindicated (6)

            • dronedarone

              sorafenib and dronedarone both increase QTc interval. Contraindicated.

            • lefamulin

              lefamulin will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated. Lefamulin is contraindicated with CYP3A substrates know to prolong the QT interval.

            • pimozide

              sorafenib and pimozide both increase QTc interval. Contraindicated.

            • saquinavir

              saquinavir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Contraindicated.

            • thioridazine

              sorafenib and thioridazine both increase QTc interval. Contraindicated.

            • ziprasidone

              sorafenib and ziprasidone both increase QTc interval. Contraindicated.

            Serious - Use Alternative (47)

            • abametapir

              abametapir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. For 2 weeks after abametapir application, avoid taking drugs that are CYP3A4 substrates. If not feasible, avoid use of abametapir.

            • alfuzosin

              alfuzosin and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.

            • amiodarone

              sorafenib and amiodarone both increase QTc interval. Avoid or Use Alternate Drug.

            • apalutamide

              apalutamide will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Coadministration of apalutamide, a strong CYP3A4 inducer, with drugs that are CYP3A4 substrates can result in lower exposure to these medications. Avoid or substitute another drug for these medications when possible. Evaluate for loss of therapeutic effect if medication must be coadministered. Adjust dose according to prescribing information if needed.

            • aripiprazole

              aripiprazole and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.

            • artemether

              artemether and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.

            • atomoxetine

              atomoxetine and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.

            • carbamazepine

              carbamazepine decreases levels of sorafenib by increasing metabolism. Avoid or Use Alternate Drug.

              carbamazepine will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • clarithromycin

              clarithromycin will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • dabrafenib

              sorafenib increases levels of dabrafenib by decreasing metabolism. Avoid or Use Alternate Drug. Strong CYP2C8 inhibitors may increase dabrafenib levels.

            • dofetilide

              dofetilide increases toxicity of sorafenib by QTc interval. Avoid or Use Alternate Drug.

            • efavirenz

              efavirenz will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • entrectinib

              sorafenib and entrectinib both increase QTc interval. Avoid or Use Alternate Drug.

            • enzalutamide

              enzalutamide will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • erdafitinib

              sorafenib will increase the level or effect of erdafitinib by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug. If coadministration of a strong CYP2C9 inhibitors is unavoidable, closely monitor adverse reactions and modify dose of erdafitinib accordingly. If strong CYP2C9 inhibitor is discontinued, consider increasing erdafitinib dose in the absence of any drug-related toxicities.

            • escitalopram

              escitalopram increases toxicity of sorafenib by QTc interval. Avoid or Use Alternate Drug.

            • fexinidazole

              fexinidazole and sorafenib both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of fexinidazole with drugs known to block potassium channels or prolong QT interval.

              fexinidazole will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Fexinidazole inhibits CYP3A4. Coadministration may increase risk for adverse effects of CYP3A4 substrates.

            • fosphenytoin

              fosphenytoin will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • glasdegib

              sorafenib and glasdegib both increase QTc interval. Avoid or Use Alternate Drug. If coadministration unavoidable, monitor for increased risk of QTc interval prolongation.

            • hydroxychloroquine sulfate

              hydroxychloroquine sulfate and sorafenib both increase QTc interval. Avoid or Use Alternate Drug.

            • idelalisib

              idelalisib will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Idelalisib is a strong CYP3A inhibitor; avoid coadministration with sensitive CYP3A substrates

            • inotuzumab

              inotuzumab and sorafenib both increase QTc interval. Avoid or Use Alternate Drug. If unable to avoid concomitant use, obtain ECGs and electrolytes before and after initiation of any drug known to prolong QTc, and periodically monitor as clinically indicated during treatment.

            • ivosidenib

              ivosidenib and sorafenib both increase QTc interval. Avoid or Use Alternate Drug. Avoid coadministration of QTc prolonging drugs with ivosidenib or replace with alternate therapies. If coadministration of a QTc prolonging drug is unavoidable, monitor for increased risk of QTc interval prolongation.

              ivosidenib will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration of sensitive CYP3A4 substrates with ivosidenib or replace with alternative therapies. If coadministration is unavoidable, monitor patients for loss of therapeutic effect of these drugs.

            • ketoconazole

              ketoconazole will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • lonafarnib

              lonafarnib will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid coadministration with sensitive CYP3A substrates. If coadministration unavoidable, monitor for adverse reactions and reduce CYP3A substrate dose in accordance with product labeling.

            • lopinavir

              lopinavir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • macimorelin

              macimorelin and sorafenib both increase QTc interval. Avoid or Use Alternate Drug. Macimorelin causes an increase of ~11 msec in the corrected QT interval. Avoid coadministration with drugs that prolong QT interval, which could increase risk for developing torsade de pointes-type ventricular tachycardia. Allow sufficient washout time of drugs that are known to prolong the QT interval before administering macimorelin.

            • palifermin

              palifermin increases toxicity of sorafenib by Other (see comment). Avoid or Use Alternate Drug. Comment: Palifermin should not be administered within 24 hr before, during infusion of, or within 24 hr after administration of antineoplastic agents. Coadministration of palifermin within 24 hr of chemotherapy resulted in increased severity and duration of oral mucositis.

            • panobinostat

              sorafenib and panobinostat both increase QTc interval. Avoid or Use Alternate Drug. Panobinostat is known to significantly prolong QT interval. Panobinostat prescribing information states use with drugs known to prolong QTc is not recommended.

            • phenobarbital

              phenobarbital will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • phenytoin

              phenytoin will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • pitolisant

              sorafenib and pitolisant both increase QTc interval. Avoid or Use Alternate Drug.

            • posaconazole

              posaconazole will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • primidone

              primidone will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • ribociclib

              ribociclib will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

              ribociclib increases toxicity of sorafenib by QTc interval. Avoid or Use Alternate Drug.

            • rifabutin

              rifabutin decreases levels of sorafenib by increasing metabolism. Avoid or Use Alternate Drug.

              rifabutin will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • rifampin

              rifampin decreases levels of sorafenib by increasing metabolism. Avoid or Use Alternate Drug.

              rifampin will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • rifapentine

              rifapentine will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • selinexor

              selinexor, sorafenib. unspecified interaction mechanism. Avoid or Use Alternate Drug. Patients treated with selinexor may experience neurological toxicities. Avoid taking selinexor with other medications that may cause dizziness or confusion.

            • siponimod

              sorafenib will increase the level or effect of siponimod by affecting hepatic enzyme CYP2C9/10 metabolism. Avoid or Use Alternate Drug. Coadministration of siponimod with drugs that cause moderate CYP2C9 AND a moderate or strong CYP3A4 inhibition is not recommended. Caution if siponimod coadministered with moderate CYP2C9 inhibitors alone.

            • St John's Wort

              St John's Wort decreases levels of sorafenib by increasing metabolism. Avoid or Use Alternate Drug.

            • toremifene

              sorafenib and toremifene both increase QTc interval. Avoid or Use Alternate Drug.

            • tucatinib

              tucatinib will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Avoid concomitant use of tucatinib with CYP3A substrates, where minimal concentration changes may lead to serious or life-threatening toxicities. If unavoidable, reduce CYP3A substrate dose according to product labeling.

            • umeclidinium bromide/vilanterol inhaled

              sorafenib increases toxicity of umeclidinium bromide/vilanterol inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

            • vilanterol/fluticasone furoate inhaled

              sorafenib increases toxicity of vilanterol/fluticasone furoate inhaled by QTc interval. Avoid or Use Alternate Drug. Exercise extreme caution when vilanterol coadministered with drugs that prolong QTc interval; adrenergic agonist effects on the cardiovascular system may be potentiated.

            • voriconazole

              voriconazole will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug.

            • voxelotor

              voxelotor will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Avoid or Use Alternate Drug. Voxelotor increases systemic exposure of sensitive CYP3A4 substrates. Avoid coadministration with sensitive CYP3A4 substrates with a narrow therapeutic index. Consider dose reduction of the sensitive CYP3A4 substrate(s) if unable to avoid.

            Monitor Closely (169)

            • albuterol

              albuterol and sorafenib both increase QTc interval. Use Caution/Monitor.

            • alfuzosin

              sorafenib and alfuzosin both increase QTc interval. Use Caution/Monitor.

            • amitriptyline

              sorafenib and amitriptyline both increase QTc interval. Use Caution/Monitor.

            • amobarbital

              amobarbital decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • amoxapine

              sorafenib and amoxapine both increase QTc interval. Use Caution/Monitor.

            • apomorphine

              sorafenib and apomorphine both increase QTc interval. Use Caution/Monitor.

            • arformoterol

              sorafenib and arformoterol both increase QTc interval. Use Caution/Monitor.

            • arsenic trioxide

              sorafenib and arsenic trioxide both increase QTc interval. Use Caution/Monitor.

            • artemether/lumefantrine

              sorafenib and artemether/lumefantrine both increase QTc interval. Use Caution/Monitor.

            • artesunate

              sorafenib will increase the level or effect of artesunate by decreasing metabolism. Use Caution/Monitor. Coadministration may increase active artesunate metabolite (DHA) by inhibiting UGT. Monitor for increased adverse effects.

            • asenapine

              sorafenib and asenapine both increase QTc interval. Use Caution/Monitor.

            • atazanavir

              atazanavir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • azithromycin

              sorafenib and azithromycin both increase QTc interval. Use Caution/Monitor.

            • bedaquiline

              sorafenib and bedaquiline both increase QTc interval. Modify Therapy/Monitor Closely. ECG should be monitored closely

            • bevacizumab

              bevacizumab, sorafenib. Other (see comment). Use Caution/Monitor. Comment: Monitor for development of hand-foot skin reactions during combination therapy.

            • bosentan

              bosentan decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • budesonide

              budesonide decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • bupropion

              sorafenib, bupropion. decreasing metabolism. Use Caution/Monitor. Incr levels of bupropion, but decr levels of active metabolites. .

            • butabarbital

              butabarbital decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • butalbital

              butalbital decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • cenobamate

              cenobamate will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Increase dose of CYP3A4 substrate, as needed, when coadministered with cenobamate.

            • chlorpromazine

              sorafenib and chlorpromazine both increase QTc interval. Use Caution/Monitor.

            • ciprofloxacin

              sorafenib and ciprofloxacin both increase QTc interval. Use Caution/Monitor.

            • citalopram

              sorafenib and citalopram both increase QTc interval. Use Caution/Monitor.

            • clarithromycin

              sorafenib and clarithromycin both increase QTc interval. Use Caution/Monitor.

            • clomipramine

              sorafenib and clomipramine both increase QTc interval. Use Caution/Monitor.

            • clozapine

              sorafenib and clozapine both increase QTc interval. Use Caution/Monitor.

            • cortisone

              cortisone decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • crizotinib

              sorafenib and crizotinib both increase QTc interval. Use Caution/Monitor.

            • cyclophosphamide

              sorafenib will increase the level or effect of cyclophosphamide by affecting hepatic enzyme CYP2B6 metabolism. Use Caution/Monitor.

            • darunavir

              darunavir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • dasatinib

              sorafenib and dasatinib both increase QTc interval. Use Caution/Monitor.

            • deflazacort

              deflazacort decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • degarelix

              sorafenib and degarelix both increase QTc interval. Use Caution/Monitor.

            • denosumab

              sorafenib, denosumab. Other (see comment). Use Caution/Monitor. Comment: Caution should be taken in patients on concomitant immunosuppressants or with impaired immune systems because of increased risk for serious infections.

            • desipramine

              sorafenib and desipramine both increase QTc interval. Use Caution/Monitor.

            • dexamethasone

              dexamethasone decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • dichlorphenamide

              dichlorphenamide and sorafenib both decrease serum potassium. Use Caution/Monitor.

            • disopyramide

              sorafenib and disopyramide both increase QTc interval. Use Caution/Monitor.

            • dofetilide

              sorafenib and dofetilide both increase QTc interval. Use Caution/Monitor.

            • dolasetron

              sorafenib and dolasetron both increase QTc interval. Use Caution/Monitor.

            • doxorubicin

              sorafenib, doxorubicin. unknown mechanism. Use Caution/Monitor. In clinical studies, an increase of 21% and 47% and no changes in the AUC of doxorubicin were observed with coadministration of sorafenib 400 mg twice daily. The clinical importance of these findings is unknown.

            • doxorubicin liposomal

              sorafenib, doxorubicin liposomal. unknown mechanism. Use Caution/Monitor. In clinical studies, an increase of 21% and 47% and no changes in the AUC of doxorubicin were observed with coadministration of sorafenib 400 mg twice daily. The clinical importance of these findings is unknown.

            • droperidol

              sorafenib and droperidol both increase QTc interval. Use Caution/Monitor.

            • efavirenz

              efavirenz decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • elagolix

              elagolix decreases levels of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Elagolix is a weak-to-moderate CYP3A4 inducer. Monitor CYP3A substrates if coadministered. Consider increasing CYP3A substrate dose if needed.

            • encorafenib

              encorafenib, sorafenib. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Encorafenib both inhibits and induces CYP3A4 at clinically relevant plasma concentrations. Coadministration of encorafenib with sensitive CYP3A4 substrates may result in increased toxicity or decreased efficacy of these agents.

            • erythromycin base

              sorafenib and erythromycin base both increase QTc interval. Use Caution/Monitor.

            • erythromycin ethylsuccinate

              sorafenib and erythromycin ethylsuccinate both increase QTc interval. Use Caution/Monitor.

            • erythromycin lactobionate

              sorafenib and erythromycin lactobionate both increase QTc interval. Use Caution/Monitor.

            • erythromycin stearate

              sorafenib and erythromycin stearate both increase QTc interval. Use Caution/Monitor.

            • escitalopram

              sorafenib and escitalopram both increase QTc interval. Use Caution/Monitor.

            • eslicarbazepine acetate

              eslicarbazepine acetate decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • ethotoin

              ethotoin decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • etravirine

              etravirine will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • ezogabine

              sorafenib and ezogabine both increase QTc interval. Use Caution/Monitor. Slight and transient QT-prolongation observed, particularly when ezogabine dose titrated to 1200mg/day.

            • fedratinib

              fedratinib will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Adjust dose of drugs that are CYP3A4 substrates as necessary.

            • fingolimod

              sorafenib increases effects of fingolimod by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Concomitant therapy is expected to increase the risk of immunosuppression. Use caution when switching patients from long-acting therapies with immune effects. .

            • flecainide

              sorafenib and flecainide both increase QTc interval. Use Caution/Monitor.

            • fluconazole

              sorafenib and fluconazole both increase QTc interval. Use Caution/Monitor.

            • fludrocortisone

              fludrocortisone decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • fluoxetine

              sorafenib and fluoxetine both increase QTc interval. Use Caution/Monitor.

            • fluphenazine

              sorafenib and fluphenazine both increase QTc interval. Use Caution/Monitor.

            • formoterol

              sorafenib and formoterol both increase QTc interval. Use Caution/Monitor.

            • foscarnet

              sorafenib and foscarnet both increase QTc interval. Use Caution/Monitor.

            • fosphenytoin

              fosphenytoin decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • fostemsavir

              sorafenib and fostemsavir both increase QTc interval. Use Caution/Monitor. QTc prolongation reported with higher than recommended doses of fostemsavir.

            • gemifloxacin

              sorafenib and gemifloxacin both increase QTc interval. Use Caution/Monitor.

            • gemtuzumab

              sorafenib and gemtuzumab both increase QTc interval. Use Caution/Monitor.

            • goserelin

              goserelin increases toxicity of sorafenib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • grapefruit

              grapefruit will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • griseofulvin

              griseofulvin decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • haloperidol

              sorafenib and haloperidol both increase QTc interval. Use Caution/Monitor.

            • histrelin

              histrelin increases toxicity of sorafenib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • hydrocortisone

              hydrocortisone decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • ibutilide

              sorafenib and ibutilide both increase QTc interval. Use Caution/Monitor.

            • iloperidone

              sorafenib and iloperidone both increase QTc interval. Use Caution/Monitor.

            • indapamide

              sorafenib and indapamide both increase QTc interval. Use Caution/Monitor.

            • indinavir

              indinavir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • irinotecan

              sorafenib increases levels of irinotecan by Other (see comment). Use Caution/Monitor. Comment: Competition for UGT1A1 pathway.

            • irinotecan liposomal

              sorafenib increases levels of irinotecan liposomal by Other (see comment). Use Caution/Monitor. Comment: Competition for UGT1A1 pathway.

            • isradipine

              sorafenib and isradipine both increase QTc interval. Use Caution/Monitor.

            • istradefylline

              istradefylline will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Istradefylline 40 mg/day increased peak levels and AUC of CYP3A4 substrates in clinical trials. This effect was not observed with istradefylline 20 mg/day. Consider dose reduction of sensitive CYP3A4 substrates.

            • lapatinib

              sorafenib and lapatinib both increase QTc interval. Use Caution/Monitor.

            • lenvatinib

              sorafenib and lenvatinib both increase QTc interval. Use Caution/Monitor. Lenvatinib prescribing information recommends monitoring ECG closely when coadministered with QT prolonging drugs.

            • letermovir

              letermovir increases levels of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • leuprolide

              leuprolide increases toxicity of sorafenib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • levofloxacin

              sorafenib and levofloxacin both increase QTc interval. Use Caution/Monitor.

            • lopinavir

              sorafenib and lopinavir both increase QTc interval. Use Caution/Monitor.

            • lumefantrine

              sorafenib and lumefantrine both increase QTc interval. Use Caution/Monitor.

            • maprotiline

              sorafenib and maprotiline both increase QTc interval. Use Caution/Monitor.

            • mefloquine

              sorafenib and mefloquine both increase QTc interval. Use Caution/Monitor.

            • methadone

              sorafenib and methadone both increase QTc interval. Use Caution/Monitor.

            • methylprednisolone

              methylprednisolone decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • mifepristone

              mifepristone, sorafenib. QTc interval. Modify Therapy/Monitor Closely. Use alternatives if available.

              mifepristone will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • mitotane

              mitotane decreases levels of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Mitotane is a strong inducer of cytochrome P-4503A4; monitor when coadministered with CYP3A4 substrates for possible dosage adjustments.

            • modafinil

              modafinil decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • moxifloxacin

              sorafenib and moxifloxacin both increase QTc interval. Use Caution/Monitor.

            • nafcillin

              nafcillin decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • nefazodone

              nefazodone will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • nelfinavir

              nelfinavir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • neomycin PO

              neomycin PO decreases levels of sorafenib by unknown mechanism. Use Caution/Monitor. AUC decreased by 54% in healthy volunteers.

            • nevirapine

              nevirapine decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • nilotinib

              sorafenib and nilotinib both increase QTc interval. Use Caution/Monitor.

            • nortriptyline

              sorafenib and nortriptyline both increase QTc interval. Use Caution/Monitor.

            • octreotide

              sorafenib and octreotide both increase QTc interval. Use Caution/Monitor.

            • ofatumumab SC

              ofatumumab SC, sorafenib. Either increases effects of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Consider the risk of additive immune system effects when coadministering immunosuppressive therapies with coadministration. When switching from therapies with immune effects, take into account the duration and mechanism of action of these therapies when initiating ofatumumab SC.

            • ofloxacin

              sorafenib and ofloxacin both increase QTc interval. Use Caution/Monitor.

            • olanzapine

              sorafenib and olanzapine both increase QTc interval. Use Caution/Monitor. Limited data, including some case reports, suggest that olanzapine may be associated with a significant prolongation of the QTc interval in rare instances

            • ondansetron

              sorafenib and ondansetron both increase QTc interval. Use Caution/Monitor.

            • osilodrostat

              osilodrostat and sorafenib both increase QTc interval. Use Caution/Monitor.

            • osimertinib

              osimertinib and sorafenib both increase QTc interval. Use Caution/Monitor. Conduct periodic monitoring with ECGs and electrolytes in patients taking drugs known to prolong the QTc interval.

            • oxaliplatin

              oxaliplatin will increase the level or effect of sorafenib by Other (see comment). Use Caution/Monitor. Monitor for ECG changes if therapy is initiated in patients with drugs known to prolong QT interval.

            • oxcarbazepine

              oxcarbazepine decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • ozanimod

              ozanimod and sorafenib both increase QTc interval. Modify Therapy/Monitor Closely. The potential additive effects on heart rate, treatment with ozanimod should generally not be initiated in patients who are concurrently treated with QT prolonging drugs with known arrhythmogenic properties.

            • paclitaxel

              sorafenib will increase the level or effect of paclitaxel by Other (see comment). Modify Therapy/Monitor Closely. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

            • paclitaxel protein bound

              sorafenib will increase the level or effect of paclitaxel protein bound by Other (see comment). Modify Therapy/Monitor Closely. Paclitaxel levels/toxicity may increase when coadministered with CYP2C8 inhibitors

            • paliperidone

              sorafenib and paliperidone both increase QTc interval. Use Caution/Monitor.

            • pasireotide

              sorafenib and pasireotide both increase QTc interval. Modify Therapy/Monitor Closely.

            • pazopanib

              sorafenib and pazopanib both increase QTc interval. Use Caution/Monitor.

            • pentamidine

              sorafenib and pentamidine both increase QTc interval. Use Caution/Monitor.

            • pentobarbital

              pentobarbital decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • perphenazine

              sorafenib and perphenazine both increase QTc interval. Use Caution/Monitor.

            • phenobarbital

              phenobarbital decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • phenytoin

              phenytoin decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • posaconazole

              sorafenib and posaconazole both increase QTc interval. Use Caution/Monitor.

            • prednisolone

              prednisolone decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • prednisone

              prednisone decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • primidone

              primidone decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • procainamide

              sorafenib and procainamide both increase QTc interval. Use Caution/Monitor.

            • propafenone

              sorafenib and propafenone both increase QTc interval. Use Caution/Monitor.

            • protriptyline

              sorafenib and protriptyline both increase QTc interval. Use Caution/Monitor.

            • quetiapine

              sorafenib and quetiapine both increase QTc interval. Use Caution/Monitor.

            • quinidine

              sorafenib and quinidine both increase QTc interval. Use Caution/Monitor.

            • quinine

              sorafenib and quinine both increase QTc interval. Use Caution/Monitor.

            • ranolazine

              sorafenib and ranolazine both increase QTc interval. Use Caution/Monitor.

            • rifapentine

              rifapentine decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • risperidone

              sorafenib and risperidone both increase QTc interval. Use Caution/Monitor.

            • ritonavir

              ritonavir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • romidepsin

              sorafenib and romidepsin both increase QTc interval. Use Caution/Monitor.

            • rucaparib

              rucaparib will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Adjust dosage of CYP3A4 substrates, if clinically indicated.

            • saquinavir

              sorafenib and saquinavir both increase QTc interval. Use Caution/Monitor.

            • secobarbital

              secobarbital decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • selpercatinib

              selpercatinib increases toxicity of sorafenib by QTc interval. Use Caution/Monitor.

            • sertraline

              sorafenib and sertraline both increase QTc interval. Use Caution/Monitor.

            • siponimod

              siponimod and sorafenib both increase immunosuppressive effects; risk of infection. Use Caution/Monitor. Caution if coadministered because of additive immunosuppressive effects during such therapy and in the weeks following administration. When switching from drugs with prolonged immune effects, consider the half-life and mode of action of these drugs to avoid unintended additive immunosuppressive effects.

            • sipuleucel-T

              sorafenib decreases effects of sipuleucel-T by pharmacodynamic antagonism. Modify Therapy/Monitor Closely.

            • solifenacin

              sorafenib and solifenacin both increase QTc interval. Use Caution/Monitor.

            • sotalol

              sorafenib and sotalol both increase QTc interval. Use Caution/Monitor.

            • stiripentol

              stiripentol, sorafenib. affecting hepatic/intestinal enzyme CYP3A4 metabolism. Modify Therapy/Monitor Closely. Stiripentol is a CYP3A4 inhibitor and inducer. Monitor CYP3A4 substrates coadministered with stiripentol for increased or decreased effects. CYP3A4 substrates may require dosage adjustment.

            • sunitinib

              sorafenib and sunitinib both increase QTc interval. Use Caution/Monitor.

            • tacrolimus

              sorafenib and tacrolimus both increase QTc interval. Use Caution/Monitor.

            • tazemetostat

              tazemetostat will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • tecovirimat

              tecovirimat will decrease the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor. Tecovirimat is a weak CYP3A4 inducer. Monitor sensitive CYP3A4 substrates for effectiveness if coadministered.

            • telavancin

              sorafenib and telavancin both increase QTc interval. Use Caution/Monitor.

            • thiothixene

              sorafenib and thiothixene both increase QTc interval. Use Caution/Monitor.

            • tipranavir

              tipranavir will increase the level or effect of sorafenib by affecting hepatic/intestinal enzyme CYP3A4 metabolism. Use Caution/Monitor.

            • trastuzumab

              trastuzumab, sorafenib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

            • trastuzumab deruxtecan

              trastuzumab deruxtecan, sorafenib. Either increases toxicity of the other by immunosuppressive effects; risk of infection. Use Caution/Monitor. Neutropenia or febrile neutropenia incidence were increased when trastuzumab was coadministered with myelosuppressive chemotherapy.

            • triamcinolone acetonide injectable suspension

              triamcinolone acetonide injectable suspension decreases levels of sorafenib by increasing metabolism. Use Caution/Monitor.

            • triclabendazole

              triclabendazole and sorafenib both increase QTc interval. Use Caution/Monitor.

            • trimipramine

              sorafenib and trimipramine both increase QTc interval. Use Caution/Monitor.

            • triptorelin

              triptorelin increases toxicity of sorafenib by QTc interval. Use Caution/Monitor. Increases risk of torsades de pointes.

            • vandetanib

              sorafenib and vandetanib both increase QTc interval. Use Caution/Monitor.

            • vardenafil

              sorafenib and vardenafil both increase QTc interval. Use Caution/Monitor.

            • vemurafenib

              sorafenib and vemurafenib both increase QTc interval. Use Caution/Monitor.

            • voclosporin

              voclosporin, sorafenib. Either increases effects of the other by QTc interval. Use Caution/Monitor.

            • voriconazole

              sorafenib and voriconazole both increase QTc interval. Use Caution/Monitor.

            • vorinostat

              sorafenib and vorinostat both increase QTc interval. Use Caution/Monitor.

            Minor (2)

            • chloroquine

              chloroquine increases toxicity of sorafenib by QTc interval. Minor/Significance Unknown.

            • cocaine

              sorafenib will increase the level or effect of cocaine by affecting hepatic enzyme CYP2B6 metabolism. Minor/Significance Unknown.

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            Adverse Effects

            >10%

            Thrombocytopenia (12-46%)

            Anemia (44%)

            Diarrhea (43%)

            Rash/desquamation (40%)

            Fatigue (37%)

            Abdominal pain (31%)

            Hand-foot skin reaction (30%)

            Weight loss (30%)

            Anorexia (29%)

            Alopecia (27%)

            Nausea (24%)

            Lymphopenia (23%)

            Neutropenia (18%)

            Hemorrhage (15-18%)

            Hypertension (9-17%)

            Vomiting (16%)

            Constipation (15%)

            Neuropathy (13%)

            Dry skin (11%)

            1-10%

            Headache (10%)

            Joint pain (10%)

            Congestive heart failure, MI (1.9%)

            QT prolonation (rare)

            <1%

            Acute renal failure

            Angioedema and arrhythmia may occur

            Bone pain reported

            Frequency Not Defined

            Stevens-Johnson Syndrome

            Hyperthyroidism

            Interstitial lung disease

            Postmarketing Reports

            Hypersensitivity: Angioedema, anaphylactic reaction

            Hepatobiliary disorders: Drug-induced hepatitis, including reports of hepatic failure and death

            Dermatologic: Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN)

            Musculoskeletal: Rhabdomyolysis, osteonecrosis of the jaw

            Respiratory: Interstitial lung disease-like events

            Blood and lymphatic disorders: Thrombotic microangiopathy (TMA)

            Vascular: Arterial (including aortic) aneurysms, dissections, and rupture

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            Warnings

            Contraindications

            Hypersensitivity

            Coadministration with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer; a randomized controlled trial comparing safety and efficacy of carboplatin and paclitaxel with or without sorafenib stopped early because overall survival was not improved with addition of sorafenib

            Cautions

            Osteonecrosis of jaw reported

            Increased risk of cardiac ischemia/HTN/hemorrhage; consider temporary or permanent discontinuation of therapy in patients who develop cardiovascular events

            Withhold therapy for at least 10 days prior to elective surgery; do not administer for at least 2 weeks following major surgery and until adequate wound healing; safety of resumption of therapy after resolution of wound healing complications has not been established

            Hepatitis reported; characterized by a hepatocellular pattern of liver damage with significant increases of transaminases which may result in hepatic failure and death

            QT Prolongation: Monitor for prolonged QT intervals with CHF, bradyarrhythmias, drugs known to prolong QT interval, and electrolyte abnormalities; avoid with congenital long QT syndrome

            Congestive heart failure reported; temporary or permanent discontinuation of therapy should be considered in patients who develop cardiovascular events

            Monitor blood pressure weekly during first 6 weeks and periodically thereafter; consider temporary or permanent discontinuation for severe or persistent hypertension despite antihypertensive therapy

            Avoid pregnancy

            High incidence of skin toxicity and rash

            Severe dermatologic toxicities, including Stevens-Johnson syndrome and toxic epidermal necrolysis reported

            Impairs exogenous thyroid suppression; for patients with impaired TSH suppression while receiving sorafenib, the median maximal TSH was 1.6 mU/L and 25% had TSH levels >4.4 mU/L; monitor TSH levels monthly and adjust thyroid replacement medication as needed in patients with disseminated thyroid cancer

            Temporarily discontinue before surgery, resumption should be based on adequate wound healing

            Monitor liver function tests regularly; discontinue for unexplained transaminase elevations

            An increased risk of bleeding may occur

            Gastrointestinal perforation reported in less than 1% of patients receiving therapy; in some cases this was not associated with apparent intra-abdominal tumor; in the event of gastrointestinal perforation, permanently discontinue

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            Pregnancy & Lactation

            Pregnancy

            There are no available data in pregnant women to inform a drug associated risk

            Animal data

            • Based on findings from animal studies and mechanism of action, therapy may cause fetal harm when administered to a pregnant woman; in animal reproduction studies, oral administration to pregnant rats and rabbits during period of organogenesis resulted in embryo-fetal toxicities at maternal exposures that were significantly lower than human exposures at recommended dose of 400 mg twice daily; apprise pregnant women and females of reproductive potential of potential risk to fetus

            Pregnancy testing

            • Verify pregnancy status of females of reproductive potential prior to initiation of therapy

            Contraception

            • Females: Therapy may cause fetal harm when administered to a pregnant woman; advise females of reproductive potential to use effective contraception during treatment and for 6 months following last dose of drug
            • Males: Based on genotoxicity and findings in animal reproduction studies, advise male patients with female partners of reproductive potential and pregnant partners to use effective contraception during treatment and for 3 months after the last dose

            Infertility

            • Males: Based on findings in animal studies, therapy may impair fertility in males of reproductive potential

            Lactation

            There are no data on presence of drug or its metabolites in human milk, or its effects on breast-fed child or on milk production; drug was present in milk of lactating rats; because of potential for serious adverse reactions in breastfed child from drug, advise lactating women not to breastfeed during treatment and for 2 weeks after last dose

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Multikinase inhibitor (including VEGF and PDGF receptor kinases), reduces tumor cell proliferation in vitro, may act at least partially by inhibiting tumor angiogenesis

            Absorption

            Bioavailability: 38-49%, reduced by high fat diet

            Peak Plasma Time: 3 hr

            Distribution

            Protein Bound: 99.5%

            Metabolism

            Metabolism: in liver by CYP3A4 & UGT1A9

            Elimination

            Half-Life, Elimination: 25-48 hr

            Excretion: Feces 77%; urine 19%

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            Administration

            Oral Administration

            Take 1 hr before or 2 hr after meals

            Although partially metabolized by CYP3A4, dose modification appears to be unnecessary if coadministered with CYP3A4 inhibitors

            Monitor: BP

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            Images

            BRAND FORM. UNIT PRICE PILL IMAGE
            Nexavar oral
            -
            200 mg tablet

            Copyright © 2010 First DataBank, Inc.

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            Patient Handout

            Patient Education
            sorafenib oral

            SORAFENIB - ORAL

            (soe-RAF-e-nib)

            COMMON BRAND NAME(S): Nexavar

            USES: Sorafenib is used to treat kidney, liver, and thyroid cancer. It works by slowing or stopping the growth of cancer cells.

            HOW TO USE: Read the Patient Information Leaflet if available from your pharmacist before you start taking sorafenib and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth on an empty stomach (at least 1 hour before or 2 hours after a meal) as directed by your doctor, usually twice a day.The dosage is based on your medical condition and response to treatment. Do not increase your dose or use this drug more often or for longer than prescribed. Your condition will not improve any faster, and your risk of serious side effects will increase.Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.

            SIDE EFFECTS: Weight loss, nausea/vomiting, diarrhea, loss of appetite, changes in taste, dry skin, mouth sores, hair loss, voice changes, or tiredness may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.People using this medication may have serious side effects. However, you have been prescribed this drug because your doctor has judged that the benefit to you is greater than the risk of side effects. Careful monitoring by your doctor may decrease your risk.This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high. Your doctor may control your blood pressure with medication.Treatment with this drug may sometimes cause your hands/feet to develop a skin reaction called hand-foot syndrome. Tell your doctor right away if you experience swelling, pain, redness, blisters, or tingling/burning of the hands/feet. Depending on how severe your hand-foot syndrome is, your doctor may give you an additional medication to reduce the symptoms, or may stop or delay your sorafenib treatment.This medication can affect how your thyroid works. Tell your doctor right away if you have signs of an underactive thyroid (such as weight gain, cold intolerance, slow heartbeat, constipation, or unusual tiredness) or signs of an overactive thyroid (such as mental/mood changes, heat intolerance, unusual weight loss).Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, signs of liver disease (such as nausea/vomiting that doesn't stop, stomach/abdominal pain, yellowing eyes/skin, dark urine), numb/tingling skin, slow wound healing, muscle spasms, signs of infection (such as sore throat that doesn't go away, fever), signs of heart failure (such as shortness of breath, swelling ankles/feet, unusual tiredness).Get medical help right away if you have any very serious side effects, including: chest/jaw/left arm pain, unusual sweating, fast/irregular heartbeat, severe dizziness, fainting, vomit that looks like coffee grounds, black/bloody stools, sudden/severe back pain or headache, weakness on one side of the body, sudden vision changes, trouble speaking, confusion.Sorafenib can commonly cause a rash that is usually not serious. However, you may not be able to tell it apart from a rare rash that could be a sign of a severe reaction. Get medical help right away if you develop any rash.A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

            PRECAUTIONS: Before taking sorafenib, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, recent surgery/injury, heart disease (such as heart attack, coronary artery disease), high blood pressure, blood vessel problems (such as an aneurysm or a tear/break in the aorta or other blood vessels), liver disease.Sorafenib may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can rarely cause serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away.The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may cause QT prolongation. Before using sorafenib, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using sorafenib safely.Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).This medication may cause wounds to heal slowly or poorly. Before having surgery, talk with your doctor about the risks and benefits of this medication. Your doctor may tell you to temporarily stop treatment with this medication at least 10 days before surgery. Ask your doctor for specific instructions about when to stop and when to restart treatment with sorafenib. Tell your doctor right away if you have wounds that are not healing well.Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above).Since this drug can be absorbed through the skin and lungs and may harm an unborn baby, women who are pregnant or who may become pregnant should not handle this medication or breathe the dust from the tablets.Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using sorafenib. Sorafenib may harm an unborn baby. Your doctor should order a pregnancy test before you start this medication. Females using this drug should ask about reliable forms of birth control during treatment and for 6 months after stopping treatment. Males using this drug should ask about reliable forms of birth control during treatment and for 3 months after stopping treatment. If you or your partner become pregnant, talk to your doctor right away about the risks and benefits of this medication.It is unknown if this drug passes into breast milk. Because of the possible risk to the infant, breast-feeding is not recommended while using this drug and for 2 weeks after stopping the drug. Consult your doctor before breast-feeding.

            DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.A product that may interact with this drug is: irinotecan.Other medications can affect the removal of sorafenib from your body, which may affect how sorafenib works. Examples include neomycin, rifamycins (such as rifampin, rifabutin), St. John's wort, drugs used to treat seizures (such as carbamazepine, phenytoin), among others.

            OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

            NOTES: Do not share this medication with others.Lab and/or medical tests (such as blood pressure, liver/thyroid function, complete blood count, electrolyte levels) should be done while you are taking this medication. Keep all medical and lab appointments. Consult your doctor for more details.

            MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.

            STORAGE: Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

            MEDICAL ALERT: Your condition can cause complications in a medical emergency. For information about enrolling in MedicAlert, call 1-888-633-4298 (US) or 1-800-668-1507 (Canada).

            Information last revised August 2021. Copyright(c) 2021 First Databank, Inc.

            IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

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            Formulary

            FormularyPatient Discounts

            Adding plans allows you to compare formulary status to other drugs in the same class.

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.