Sorafenib

Sorafenib is a prescription medicine used in the treatment of hepatocellular carcinoma (a type of liver cancer), renal cell carcinoma (a type of kidney cancer), and differentiated thyroid carcinoma (a type of thyroid cancer).

• Sorafenib is available under the following different brand names: Nexavar

Adult dosage

Tablet

• 200mg

Renal Cell Carcinoma

Adult dosage

• 400 mg orally every 12 hours

Hepatocellular Carcinoma

Adult dosage

• 400 mg orally every 12 hours

Thyroid Cancer

Adult dosage

• 400 mg orally every 12 hours

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Sorafenib include:

• diarrhea (frequent or loose bowel movements),
• tiredness,
• infection,
• hair thinning or patchy hair loss,
• rash,
• weight loss,
• loss of appetite,
• nausea,
• abdominal pain, and 
• low blood calcium levels in people with differentiated thyroid cancer.

Serious side effects of Sorafenib include:

• high blood pressure,
• skin problems-rash, redness, pain or swelling, blistering and peeling of the skin and inside the mouth, blisters on the palms and soles of the feet,
• liver problems-yellowing of the skin and whites of the eyes, dark ‘tea-colored’ urine, light-colored bowel movements, worsening nausea and vomiting, pain in the right side of the abdomen, loss of appetite, and bleeding or bruising more easily than normal,
• increased risk of bleeding-coffee-grounds vomiting, pink or brown urine, tarry stools, heavier menstrual cycles, unusual vaginal bleeding, frequent nose bleeds, coughing up blood, and bruising,
• decreased blood flow to the heart-chest pain, shortness of breath, racing heartbeat, swelling in lower legs, feet, and abdomen, lightheadedness, tiredness, nausea, vomiting, and increased sweating,
• changes in electrocardiogram,
• change in thyroid hormone levels, and
• gastrointestinal perforation.

Rare side effects of Sorafenib include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Sorafenib has severe interactions with the following drugs:
  • dronedarone
  • lefamulin
  • pimozide
  • saquinavir
  • thioridazine
  • ziprasidone
• Sorafenib has serious interactions with at least 56 other drugs.
• Sorafenib has moderate interactions with at least 170 other drugs.
• Sorafenib has minor interactions with the following drugs:
  • chloroquine
  • cocaine
  • ketoconazole
  • levoketoconazole

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

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 the addition of sorafenib

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Sorafenib?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Sorafenib?”

Cautions

• Osteonecrosis of the 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 before 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 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 the 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 more than 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 was 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

Pregnancy and Lactation

• There are no available data in pregnant women to inform a drug-associated risk
• Pregnancy testing
  • Verify pregnancy status of females of reproductive potential before 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 the last dose of the 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 the presence of drug or its metabolites in human milk, or its effects on a breastfed child or milk production; the drug was present in the milk of lactating rats; because of the potential for serious adverse reactions in a breastfed child from the drug, advise lactating women not to breastfeed during treatment and for 2 weeks after the last dose