sorafenib (Rx)

Brand and Other Names:Nexavar
  • Print

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 200mg
more...

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

Safety and efficacy not established

Next:

Interactions

Interaction Checker

and sorafenib

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 
            Previous
            Next:

            Adverse Effects

            >10%

            Thrombocytopenia (12-46%)

            Anemia (44%)

            Diarrhea (43%)

            Rash/desquamation (40%)

            Fatigue (37%)

            Abd 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

            Previous
            Next:

            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

            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

            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

            Previous
            Next:

            Pregnancy & Lactation

            Pregnancy Category: D

            Lactation: not known whether distributed in breast milk, discouraged

            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.

            more...
            Previous
            Next:

            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%

            Previous
            Next:

            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

            Previous
            Next:

            Images

            Previous
            Next:

            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.
            Additional Offers
            Email to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Email Forms to Patient

            From:

            To:

            The recipient will receive more details and instructions to access this offer.

            By clicking send, you acknowledge that you have permission to email the recipient with this information.

            Previous
            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.