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Pharmacologic class: Multikinase inhibitor

Therapeutic class: Antineoplastic

Pregnancy risk category D


Decreases tumor cell proliferation in vitro and inhibits tumor growth of murine renal cell carcinoma; interacts with multiple intracellular and cell-surface kinases, several of which are involved with angiogenesis


Tablets: 200 mg

Indications and dosages

Advanced renal cell carcinoma; unresectable hepatocellular carcinoma

Adults: 400 mg P.O. twice daily, continued until patient no longer benefits from therapy or experiences unacceptable toxicity

Dosage adjustment

• Bleeding event

• Cardiac ischemia or infarction

• Severe or persistent hypertension

• Skin toxicity

• Major surgery

Off-label uses

• Advanced pancreatic cancer

• Recurrent epithelial ovarian cancer

• Hepatocellular, breast, colon, colorectal, non-small-cell lung, and thyroid cancers

• Melanoma and sarcoma


• Hypersensitivity to drug or its components

• Combination with carboplatin and paclitaxel in patients with squamous cell lung cancer


Use cautiously in:

• skin toxicities, hypertension, bleeding, cardiac ischemia, myocardial infarction (MI), congestive heart failure (CHF), bradyarrhythmias, or electrolyte abnormalities

• congenital long QT syndrome (avoid use)

• concurrent use of gemcitabine/cisplatin in patients with squamous cell lung cancer (not recommended)

• concurrent use of drugs known to prolong QT interval (including Class Ia and III antiarrhythmics), CYP3A4 inducers, or CYP2B6 and CYP2C8 substrates

• patients undergoing surgery

• pregnant or breastfeeding patients

• children (safety and efficacy not established).


• Administer without food (1 hour before or 2 hours after eating).

Adverse reactions

CNS: fatigue, sensory neuropathy, headache, asthenia, depression

CV: hypertension, myocardial ischemia, MI, heart failure, hypertensive crisis, prolonged QT/QTc interval

EENT: hoarseness

GI: nausea, vomiting, diarrhea, constipation, abdominal pain, mouth pain, mucositis, stomatitis, dyspepsia, dysphagia, anorexia, GI perforation (uncommon)

GU: erectile dysfunction

Hepatic: drug-induced hepatitis

Hematologic: lymphopenia, anemia, leukopenia, thrombocytopenia, neutropenia, hemorrhage

Musculoskeletal: arthralgia, myalgia

Respiratory: cough, dyspnea

Skin: rash, desquamation, palmar-plantar erythrodysesthesia (PPE), alopecia, pruritus, dry skin, erythema, acne, flushing, exfoliative dermatitis, Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN)

Other: decreased appetite, weight loss, flulike syndrome, fever, hypersensitivity (including angioedema, anaphylactic reaction)


Drug-drug. CYP3A4 inducers (such as carbamazepine, dexamethasone, phenytoin, phenobarbital, rifampin): increased sorafenib metabolism and decreased blood level

Docetaxel: increased docetaxel area under the curve (AUC) and plasma concentration

Neomycin: decreased sorafenib mean area under the curve

Warfarin: increased risk of bleeding, elevated INR

Drug-diagnostic tests. Amylase, bilirubin, lipase: increased

Hemoglobin, platelets, serum phosphates, WBCs: decreased

Liver enzymes: increased

Drug-food. High-fat meal: reduced drug bioavailability

Drug-herbs. St. John's wort: decreased sorafenib blood level

Patient monitoring

• Monitor CBC with differential, platelets, serum phosphate, INR, amylase, lipase, and liver enzyme levels.

• Watch closely for PPE.

• Measure blood pressure weekly during first 6 weeks of therapy and thereafter as needed.

Monitor for cardiac symptoms, especially prolonged QT interval, in patients with CHF, bradyarrhythmias, electrolyte abnormalities, and concurrent use of drugs known to prolong QT interval. If cardiac ischemia or infarction occurs, consider temporarily or permanently discontinuing drug.

If GI perforation occurs, discontinue drug and initiate appropriate measures.

Be aware that drug-induced hepatitis may result in hepatic failure and death. Discontinue drug if there is no alternative explanation for significant transaminase elevations (such as viral hepatitis or progressing, underlying malignancy).

Monitor patient for SJS and TEN; discontinue drug if either of these conditions, which may be life-threatening, occur.

Watch for bleeding. If bleeding necessitates medical intervention, consider discontinuing drug.

Patient teaching

• Instruct patient to take drug 1 hour before or 2 hours after eating.

Urge patient to immediately report irregular heartbeats or signs and symptoms of liver disorder or hypersensitivity, including rash, bleeding, or chest pain.

• Advise patient to report symptoms of PPE (redness, pain, swelling, or blisters on hands and soles). Mention that these symptoms may warrant dosage decrease.

• Stress importance of weekly blood pressure checks during first 6 weeks of therapy.

• Instruct males and females to use effective birth control during therapy.

• Tell female with childbearing potential to avoid pregnancy during therapy and for at least 2 weeks after.

• Advise breastfeeding patient to stop breastfeeding during therapy.

• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, foods, and herbs mentioned above.

McGraw-Hill Nurse's Drug Handbook, 7th Ed. Copyright © 2013 by The McGraw-Hill Companies, Inc. All rights reserved


(so-ra-fe-nib) ,


(trade name)


Therapeutic: antineoplastics
Pharmacologic: kinase inhibitors
Pregnancy Category: D


Advanced renal cell carcinoma.Unresectable hepatocellular carcinoma.Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine therapy.


Inhibits tumor growth by inhibiting multikinase enzyme, some of which are involved in angiogenesis.

Therapeutic effects

Decreased growth and spread of advanced renal cell carcinoma, hepatocellular carcinoma and DTC.


Absorption: 38–49% absorbed following oral administration; absorption decreased by high fat meals.
Distribution: Unknown.
Protein Binding: 995% bound to plasma proteins.
Metabolism and Excretion: Mostly metabolized by the liver (CYP3A4 and UGT1A9 systems), some metabolites are pharmacologically active. Absorbed drug is eliminated in feces (51%); of absorbed drug, 77% is excreted in feces and 19% is renally eliminated.
Half-life: 25–48 hr.

Time/action profile ( blood levelss)

POunknown3 hr12 hr


Contraindicated in: Hypersensitivity; Concurrent use with carboplatin and paclitaxel in patients with squamous cell lung cancer; Congenital long QT syndrome; Obstetric / Lactation: Pregnancy or lactation.
Use Cautiously in: History of cardiovascular disease; Drugs that affect the CYP3A4 or UGT1A9 systems; may result in significant interactions; Heart failure, bradycardia, concurrent use of QT-interval prolonging drugs, or electrolyte abnormalities (↑ risk of QT interval prolongation); Obstetric: Childbearing potential; Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • depression (most frequent)
  • fatigue (most frequent)
  • weakness (most frequent)


  • interstitial lung disease (life-threatening)
  • hoarseness (most frequent)


  • torsades de pointes (life-threatening)
  • hypertension (most frequent)
  • heart failure
  • myocardial ischemia
  • QT interval prolongation


  • hepatotoxicity (life-threatening)
  • anorexia (most frequent)
  • constipation (most frequent)
  • diarrhea (most frequent)
  • dyspepsia (most frequent)
  • dysphagia (most frequent)
  • ↑ lipase/amylase
  • mucositis/stomatitis (most frequent)
  • nausea (most frequent)
  • vomiting


  • erectile dysfunction
  • nephrotic syndrome
  • proteinuria
  • renal failure


  • stevens-johnson syndrome (life-threatening)
  • toxic epidermal necrolysis (life-threatening)
  • acne (most frequent)
  • erythema (most frequent)
  • exfoliative dermatitis (most frequent)
  • flushing (most frequent)
  • hand-foot skin reaction (most frequent)
  • (most frequent)
  • pruritus (most frequent)
  • rash (most frequent)
  • dry skin

Fluid and Electrolyte

  • hypocalcemia (most frequent)
  • hypophosphatemia (most frequent)
  • hypokalemia


  • anemia (most frequent)
  • bleeding (most frequent)
  • leukopenia (most frequent)
  • thrombocytopenia (most frequent)
  • lymphopenia (most frequent)


  • arthralgia (most frequent)
  • myalgia (most frequent)


  • neuropathy (most frequent)


  • angioedema (life-threatening)
  • pain (most frequent)
  • weight loss


Drug-Drug interaction

May ↑ risk of bleeding with warfarin.Metabolism is ↑ by and blood levels ↓ by inducers of CYP3A4 including rifampin, phenytoin, phenobarbital, carbamazepine, and dexamethasone.↑ blood levels and may ↑ effects of irinotecan, docetaxel, and doxorubicin.Neomycin ↓ blood levels.Metabolism is ↑ by and blood levels ↓ by St. John's wort.


Oral (Adults) 400 mg twice daily; dose ↓ recommended for skin toxicity and/or neuropathy.


Tablets: 200 mg

Nursing implications

Nursing assessment

  • Monitor BP weekly during first 6 wks and then periodically during therapy. May cause hypertension. If unresponsive to antihypertensives, may require temporary or permanent discontinuation of sorafenib.
  • Monitor ECG in patients with HF, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities.
  • Assess for dermatologic toxicities. Treat any occurrence of Grade 1 (numbness, dysesthesia, parathesia, tingling, painless swelling, erythema or discomfort of hands or feet which does not disrupt patient's normal activities) with topical symptomatic therapy. Treat the first occurrence of Grade 2 (painful erythema and swelling of hands or feet and/or discomfort affecting patient's normal activities) with topical symptomatic therapy. If no improvement in 7 days or 2nd or 3rd occurrence, interrupt sorafenib therapy until resolves to Grade 0–1. Resume treatment with decreasing dose by one level. If 4th occurrence, discontinue therapy. If Grade 3 toxicity (moist desquamation, ulceration, blistering or severe pain of the hands or feet, or severe discomfort that causes the patient to be unable to work or perform activities of daily living) occurs 1st or 2nd occurrence, interrupt sorafenib therapy until resolves to Grade 0–1. Resume therapy by decreasing dose by one level. If 3rd occurrence, discontinue sorafenib therapy.
  • Monitor for bleeding. If any bleeding requires medical intervention, consider permanent discontinuation of sorafenib.
  • Assess for chest pain. Consider temporary or permanent discontinuation in patients who develop cardiac ischemia and/or infarction.
  • Monitor for signs and symptoms of interstitial lung diseases (dyspnea, cough).
  • Lab Test Considerations: Monitor serum magnesium, potassium, calcium periodically in patients with HF, bradyarrhythmias and drugs known to prolong QT interval. May cause hypocalcemia and hypokalemia.
    • May ↑ TSH in patients with DTC. Monitor TSH levels monthly.
    • Commonly causes hypophosphatemia, ↑ serum lipase and amylase. Pancreatitis rarely occurs.
    • Frequently causes lymphopenia, anemia, and thrombocytopenia.

Potential Nursing Diagnoses

Risk for impaired skin integrity (Adverse Reactions)


  • Do not confuse Nexavar (sorafenib) with Nexium (esomeprazole). Do not confuse sorafenib with sunitinib.
  • Oral: Administer 2 tablets (400 mg) twice daily on an empty stomach, at least 1 hr before or 2 hr after eating. Tablets should be swallowed whole and taken with water; do not crush, break or chew.
    • If dose reduction is necessary due to adverse reactions, reduce to 400 mg once daily. If additional dose reduction is required, reduce to 400 mg every other day.

Patient/Family Teaching

  • Instruct patient to take sorafenib as directed. If a dose is missed, skip dose and take next dose at regular time; do not double dose. Do not share medication with others; may be harmful.
  • Inform patient of risk of hand-foot skin reactions, hypertension and requirement for monitoring, risk of bleeding and cardiac ischemia. Advise patient to notify health care professional promptly if bleeding or chest pain occurs.
  • Advise patient to notify health care professional immediately if signs and symptoms of hepatotoxicity (yellow skin or white part of eyes, dark “tea-colored” urine, light-colored bowel movements, worsening nausea, worsening vomiting, abdominal pain), rash, blistering or peeling of skin or inside of mouth, shortness or breath, cough, dizziness, fainting, or fever occur.
  • Advise patient to notify health care professional of therapy prior to treatment, dental procedure, or surgery. Sorafenib therapy should be interrupted in patients undergoing major surgery.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
  • Discuss with patient the possibility of hair loss. Explore coping strategies.
  • May cause teratogenic effects. Advise both male and female patients to use effective contraception during and for at least 2 wks after stopping therapy. Advise female patients to avoid breastfeeding during therapy.

Evaluation/Desired Outcomes

  • Decreased growth and spread of advanced renal cell, hepatocellular, and thyroid carcinoma.
Drug Guide, © 2015 Farlex and Partners


A drug that inhibits several kinases, used in the treatment of certain types of renal, liver, and thyroid cancer.
The American Heritage® Medical Dictionary Copyright © 2007, 2004 by Houghton Mifflin Company. Published by Houghton Mifflin Company. All rights reserved.
References in periodicals archive ?
In the PHOCUS study, patients were randomized to one of two treatment groups: one receiving Pexa-Vec followed by sorafenib and one receiving sorafenib alone.
The study's primary objective was to determine the overall survival of patients treated with Pexa-Vec, followed by sorafenib versus sorafenib alone.
The PHOCUS trial was designed to enroll 600 patients with advanced liver cancer (also called hepatocellular carcinoma, or 'HCC'), worldwide, who had not received prior systemic treatment for their cancer, and they were randomised to one of two treatment groups: one which received Pexa-Vec followed by sorafenib and one which received sorafenib alone.
Four Iranian-produced drugs for cancer and diabetes treatment, including Regorafenib and Sorafenib, were unveiled during a ceremony this morning at Eshtehard Industrial Town in Alborz Province.
Eli Lilly announced that the FDA has approved Cyramza as a single agent, for the treatment of patients with hepatocellular carcinoma, or HCC, who have an alpha-fetoprotein, or AFP of 400 ng/mL and have been treated with sorafenib. Concurrent with this FDA approval, the fifth for Cyramza, the FDA has also removed the boxed warning from the Cyramza labeling.
This approval was based on results from REFLECT (Study 304), an open-label, Phase III trial where LENVIMA demonstrated a treatment effect on overall survival (OS)(1) by statistical confirmation of non-inferiority when compared with the standard of care, sorafenib, in 954 patients with previously untreated unresectable HCC.
To the Editor: Sorafenib, a multikinase inhibitor of cell proliferation and angiogenesis, is expected to cause intratumoral necrosis and maintain stable disease in hepatocellular carcinoma (HCC).
The two sets of drugs were sorafenib, sunitinib malate, and pazopanib hydrochloride for metastatic renal cell cancer (mRCC) and dasatinib, imatinib mesylate, and nilotinib hydrochloride monohydrate for chronic myeloid leukemia (CML).
The EVEREST trial focused at mammalian target of rapamycin (m-TOR) inhibitor (everolimus) and was not included due to lack of reported findings- Of five trials that focused on adjuvant TKI therapy, three published their findings: ASSURE (sorafenib and sunitinib), S-TRAC (sunitinib) and PROTECT (pazopanib) and represent the focus of this report and of the meta-analysis.
Sorafenib is an oral tyrosine kinase inhibitor approved by the Food and Drug Administration for its use in treating advanced renal cell carcinoma (resurgical treatment),[5,6] thyroid cancer,[7] and unresectable HCC.[8] Sorafenib acts by inhibiting growth of tumor and angiogenesis by inhibiting cell surface kinase receptors and intracellular Raf kinases (RAF/MEK/ERK, vascular endothelial growth factor receptor, and platelet-derived growth factor receptor).[9,10] Hand-foot skin reaction is the common adverse effect seen in patients who are on sorafenib.
Sorafenib (a multikinase inhibitor) was the first agent to demonstrate overall survival and received regulatory approval in 2007.