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sorafenib (Rx)Brand and Other Names:Nexavar

 
 
 

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 200mg
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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

Melanoma (Orphan)

Treatment of stage IIB through stage IV melanoma

Orphan indication sponsor

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

Renal Impairment

Mild to moderate: Dose adjustment not necessary

Severe renal impairment: Not studied

Hepatic Impairment

Mild to moderate: Dose adjustment not necessary

Severe renal impairment: Not studied

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

Safety and efficacy not established

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Interactions

Interaction Checker

sorafenib and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            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

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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

            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

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            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.

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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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            Formulary

            FormularyPatient Discounts

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            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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