• Monitor BP weekly during first 6 wk and then periodically during therapy. May cause hypertension. If Grade 2 (symptomatic/persistent) OR Grade 2 symptomatic increase by >20 mm Hg (diastolic) or >140/90 mm Hg if previously within normal limits OR Grade 3 hypertension occurs, hold sorafenib until symptoms resolve and diastolic BP <90 mm Hg; then resume at reduced dose by 1 dose level. If needed, reduce another dose level. If Grade 4 hypertension occurs, discontinue sorafenib permanently.
• Monitor ECG in patients with HF, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. If Grade 3 HF occurs, hold sorafenib until Grade 1 or less; resume at reduced dose by 1 dose level. If Grade 4 HF occurs, permanently discontinue sorafenib. If QT interval >500 milliseconds OR increase from baseline of ≥60 milliseconds occurs, hold therapy and correct electrolyte abnormalities (magnesium, potassium, calcium). Consider condition of patient before restarting.
• Assess for dermatologic toxicities. Treat any occurrence of Grade 1 (numbness, dysesthesia, paresthesia, tingling, painless swelling, erythema or discomfort of hands or feet that 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) for patients with hepatocellular and renal cell carcinoma, with topical symptomatic therapy. If no improvement in 7 days or 2nd or 3rd occurrence, hold sorafenib therapy until resolves to Grade 0–1. Resume treatment with decreasing dose by one level. If 4th occurrence, discontinue therapy. For patients with hepatocellular and renal cell carcinoma,decrease sorafenib to 600 mg daily. If no improvement within 7 days at reduced dose OR 2nd and 3rd occurrence, for patients with hepatocellular and renal cell carcinoma,hold sorafenib until resolved to Grade 0 or 1. Resume therapy with decrease by 1 dose level. For patients with differentiated thyroid carcinoma,hold sorafenib until completely resolved or improved to Grade 1. When resuming therapy, decrease dose by 1 dose level for 2nd occurrence and 2 doses levels for 3rd occurrence. For 4th occurrence, discontinue sorafenib. 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, for 1st occurrence, for patients with hepatocellular and renal cell carcinoma,hold sorafenib therapy until resolves to Grade 0–1. Resume therapy by decreasing dose by one level. If 3rd occurrence, discontinue sorafenib therapy. For patients with differentiated thyroid carcinoma, hold sorafenib until completely resolved or improved to Grade 1. Resume therapy by decreasing dose by 1 dose level. For second occurrence, for patients with hepatocellular and renal cell carcinoma, hold sorafenib until resolved or improved to Grade 0 or 1. Resume therapy by decreasing dose by 1 dose level. For patients with differentiated thyroid carcinoma, hold sorafenib until completely resolved or improved to Grade 1. Resume therapy by decreasing dose by 2 dose levels. If 3rd occurrence, discontinue sorafenib.
• Monitor for bleeding. If Grade 2 and above hemorrhage requiring medical intervention occurs, permanently discontinue sorafenib.
• Assess for chest pain. If cardiac ischemia or MI occur at Grade 2 and above, permanently discontinue sorafenib.
• Monitor for signs and symptoms of interstitial lung diseases (dyspnea, cough).

Lab Test Considerations:

• Verify a negative pregnancy test before starting therapy.Monitor serum magnesium, potassium, and calcium periodically in patients with HF, bradyarrhythmias, and drugs known to prolong QT interval. May cause hypocalcemia and hypokalemia.
  • May cause liver injury. Monitor liver function regularly during therapy. If AST and ALT significantly ↑ without alternative explanation (viral hepatitis, progressing underlying malignancy), discontinue sorafenib.
  • May ↑ TSH in patients with differentiated thyroid carcinoma. Monitor TSH levels monthly.
  • Commonly causes hypophosphatemia and ↑ serum lipase and amylase. Pancreatitis rarely occurs.
  • Frequently causes lymphopenia, anemia, and thrombocytopenia.