Sorafenib

What is Sorafenib?

• Sorafenib (Nexavar) is a kinase inhibitor used for the treatment of primary kidney cancer (advanced renal cell carcinoma), advanced primary liver cancer (hepatocellular carcinoma), FLT3-ITD positive AML and radioactive iodine resistant advanced thyroid carcinoma.

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What are the uses of this medicine?

This medicine is used to treat:

• a type of liver cancer called hepatocellular carcinoma (HCC) that cannot be removed by surgery
• a type of kidney cancer called renal cell carcinoma (RCC)
• a type of thyroid cancer called differentiated thyroid carcinoma (DTC) that can no longer be treated with radioactive iodine and is progressing

How does this medicine work?

• Sorafenib (soe raf’ e nib) is an orally available, small molecule, multi-specific tyrosine kinase inhibitor with activity against vascular endothelial growth factors (VEGF) receptors -1, -2 and -3 as well as against the receptor for platelet derived growth factor (PDGF) and several Raf kinases.
• Inhibition of these kinases decreases angiogenesis, which plays an important role in the growth and spread of several forms of solid tumors.

Who Should Not Use this medicine ?

This medicine cannot be used in patients who:

• are allergic to sorafenib or any of the other ingredients in Nexavar.
• have squamous cell lung cancer and receive carboplatin and paclitaxel.

What drug interactions can this medicine cause?

• Avoid concomitant use of Nexavar with strong CYP3A4 inducers, when possible, because these drugs can decrease the systemic exposure to sorafenib.
• Avoid concomitant use of Nexavar with neomycin.
• The concomitant use of Nexavar and warfarin may increase the risk of bleeding or increased the INR.
• Avoid coadministration of Nexavar with medicinal products with a known potential to prolong QT/QTc interval.

Is this medicine FDA approved?

• Sorafenib received approval for use in the United States in 2005 for therapy of advanced renal cell carcinoma, and indications were subsequently expanded to hepatocellular carcinoma in 2007 and refractory thyroid cancer in 2014.

How should this medicine be used?

Recommended Dosage:

• The recommended dosage of Nexavar is 400 mg orally twice daily without food (at least 1 hour before or 2 hours after a meal) until the patient is no longer clinically benfiting from therapy or until unacceptable toxicity.

Administration

• Take Nexavar exactly as your healthcare provider tells you to take it.
• Take Nexavar 2 times a day. Your healthcare provider may change your dose, temporarily stop treatment or completely stop treatment with Nexavar if you have side effects.
• Take Nexavar without food (at least 1 hour before or 2 hours after a meal).
• If you miss a dose of Nexavar, skip the missed dose, and take your next dose at your regular time. Do not double your dose of Nexavar.
• If you take too much Nexavar call your doctor or go to the nearest hospital emergency room right away.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As Tablets: 200 mg

This medicine is available in fallowing brand namesː

• Nexavar

What side effects can this medication cause?

The most common side effects of this medicine include:

• fertility problems in males

Nexavar may cause serious side effects, including:

• decreased blood flow to the heart, heart attack and heart failure
• increased risk of bleeding
• high blood pressure
• skin problems
• an opening in the wall of your stomach or intestines (gastrointestinal perforation)
• risk of wound healing problems
• changes in the electrical activity of your heart called QT prolongation
• liver problems (drug-induced hepatitis)
• change in thyroid hormone levels

What special precautions should I follow?

• Discuss with patients that cardiac ischemia and/or infarction and congestive heart failure, have been reported during Nexavar treatment, and that they should immediately report any episodes of chest pain or other symptoms of cardiac ischemia or congestive heart failure.
• Inform patients that Nexavar can increase the risk of bleeding and that they should promptly report any episodes of bleeding.
• Inform patients that hypertension can develop during Nexavar treatment, especially during the first six weeks of therapy, and that blood pressure should be monitored regularly during treatment.
• Advise patients of the possible occurrence of hand-foot skin reaction and rash during Nexavar treatment and appropriate countermeasures.
• Advise patients that cases of gastrointestinal perforation have been reported in patients taking Nexavar.
• Advise patients that Nexavar may impair wound healing. Advise patients to inform their healthcare provider of any planned surgical procedure.
• Inform patients with a history of prolonged QT interval that Nexavar can worsen the condition.
• Inform patients that Nexavar can cause hepatitis which may result in hepatic failure and death. Advise patients that liver function tests should be monitored regularly during treatment and to report signs and symptoms of hepatitis.
• Advise patients not to breastfeed while taking Nexavar and for 2 weeks after receiving the last dose of Nexavar.
• Nexavar may cause fetal harm. Advise patients of the potential risk to a fetus and to use effective contraception.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• diarrhea
• dermatologic symptoms

Management of overdosage:

• In cases of suspected overdose, withhold Nexavar and institute supportive care.

Can this medicine be used in pregnancy?

• Nexavar may cause fetal harm when administered to a pregnant woman.
• There are no available data in pregnant women to inform a drug-associated risk.

Can this medicine be used in children?

• The safety and effectiveness of Nexavar have not been established in pediatric patients.

What are the active and inactive ingredients in this medicine?

• Active Ingredient: sorafenib tosylate
• Inactive Ingredients: croscarmellose sodium, ferric oxide red, hypromellose, magnesium stearate, microcrystalline cellulose, sodium lauryl sulphate, polyethylene glycol, and titanium dioxide.

Who manufactures and distributes this medicine?

• Manufactured for:
• Bayer HealthCare Pharmaceuticals Inc.
• Whippany, NJ
• Manufactured in Germany

What should I know about storage and disposal of this medication?

• Store Nexavar tablets at room temperature between 68° F to 77° F (20° C to 25° C).
• Store Nexavar tablets in a dry place.
• Keep Nexavar and all medicines out of the reach of children.

• Dailymed label info on Sorafenib
• FDA Sorafenib

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