Nexavar 200 mg Tablets

Sorafenib tablets are a kinase inhibitor indicated for the treatment of Unresectable hepatocellular carcinoma(1.1) Locally recurrent or metastatic, progressive, differentiated thyroid carcinoma (DTC) refractory to radioactive iodine treatment (1.3) 1.1 Hepatocellular Carcinoma Sorafenib tablets are indicated for the treatment of patients with unresectable hepatocellular carcinoma (HCC). 1.3 Differentiated Thyroid Carcinoma Sorafenib tablets are indicated for the treatment of patients with locally recurrent or metastatic, progressive,differentiated thyroid carcinoma (DTC) that is refractory to radioactive iodine treatment.

• The recommended dosage is 400 mg orally twice daily without food
• Recommended Dosage The recommended dosage of sorafenib tablets is 400 mg orallytwice daily without food (at least 1 hourbefore or 2 hours after a meal) until the patient is no longer clinically benfiting from therapy or untilunacceptable toxicity
• Dose Modifications for Adverse Reactions Recommended Dosage Modifications The recommended dosage modifications for adverse reactions are provided in Tables 1, 2, and 3
• Table 1: Recommended Dose Reductions forAdverse Reactions Dose Reduction Hepatocellular Carcinoma Differentiated Thyroid Carcinoma First Dose Reduction 400 mg orally once daily 400 mg orally in the morning and 200 mg orally in the evening about 12 hours apart OR 200 mg orally in the morning and 400 mg orally in the evening about 12 hours apart Second Dose Reduction 200 mg orally once daily OR 400 every other day 200 mg orally twice daily Third Dose Reduction None 200 mg orally once daily Table 2: Recommended Dosage Modifications of Sorafenib Tablets for Adverse Reactions Adverse Reaction Severity 1 Sorafenib T ablets Dosage M odification Cardiovascular Events [see Warnings and Precautions ] Cardiac Ischemia and/or Infarction Grade 2 and above Permanently discontinue
• Congestive Heart Failure Grade 3 Interrupt2 until Grade 1 or less, resume at reduced dose by 1 dose level.3 Grade 4 Permanently discontinue
• Hemorrhage [see Warnings and Precautions ] Grade 2 and above requiring medical intervention Permanently discontinue. …

Tablets: 200 mg (3) 3 DOSAGE FORMS AND STRENGTHS Sorafenib Tablets USP, 200 mg are round, pink, film-coated tablets, debossed with “YB” on one side and “201” on the other side.

• Advise the patient to read FDA-approved patient labeling (Patient Information)
• Cardiovascular Events Discuss with patients that cardiac ischemia and/or infarction and congestive heart failure, have been reported during sorafenib tablets treatment, and that they should immediately report any episodes of chest pain or other symptoms of cardiac ischemia or congestive heart failure [see Warnings and Precautions ]
• B leeding Inform patients that sorafenib tablets can increase the risk of bleeding and that they should promptly report any episodes of bleeding [see Warnings and Precautions ] . …

• Sorafenib tablets are contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of sorafenib tablets
• Sorafenib tablets in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer. 4 CONTRAINDICATIONS Sorafenib tablets are contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of sorafenib tablets. …

Strong CYP3A Inducers: Avoid strong CYP3A4 inducers.(7.1) 7.1 Effect of Other Drugs on Sorafenib Tablets Strong CYP3A4 Inducers The concomitant use of sorafenib tablets with rifampin, a strong CYP3A4 inducer decreased the mean AUC of sorafenib, which may decrease the antitumor activity [see Clinical Pharmacology (12.3)]. Avoid concomitant use of sorafenib tablets with strong CYP3A4 inducers, when possible, because these drugs can decrease the systemic exposure to sorafenib. Neomycin The concomitant use of sorafenib tablets with neomycin decreased the mean AUC of sorafenib, which may decrease the antitumor activity. Avoid concomitant use of sorafenib tablets with neomycin. …

Cardiovascular Events: Consider temporary or permanent discontinuation of sorafenib tablets.(2.2, 5.1) Hemorrhage: Discontinue sorafenib tablets if needed. (5.2) Hypertension: 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.(5.3) Dermatologic Toxicities: Interrupt and/or decrease dose. Discontinue for severe or persistent reactions, or if Stevens-Johnson syndrome and toxic epidermal necrolysis is suspected.(5.4) Gastrointestinal Perforation: Discontinue sorafenib tablets. …

The most common adverse reactions (≥20%) are diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains, hypertension, and hemorrhage. (6) To report SUSPECTED ADVERSE REACTIONS, contact Yabao Pharmaceutical Co., Ltd. Beijing at 914-656-3049 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6 ADVERSE REACTIONS The following clinically significant adverse reactions are discussed elsewhere in the labeling: Cardiovascular events [see Warnings and Precautions ( 5.1 )] Hemorrhage [see Warnings and Precautions ( 5.2 )] Hypertension [see Warnings and Precautions ( 5.3 )] Dermatologic toxicities [see Warnings and …

Lactation: Advise women not to breastfeed. (8.2) 8.1 Pregnancy Risk Summary Based on findings from animal studies and its mechanism of action [see Clinical Pharmacology (12.1)], sorafenib tablets may cause fetal harm when administered to a pregnant woman. There are no available data in pregnant women to inform a drug-associated risk. …

The adverse reactions observed at a dose of 800 mg twice daily (2 times the recommended dose) were primarily diarrhea and dermatologic. No information is available on symptoms of acute overdose in animals because of the saturation of absorption in oral acute toxicity studies conducted in animals. In cases of suspected overdose, withhold sorafenib tablets and institute supportive care.

Take it when you remember, unless it is nearly time for the next dose. Then skip the missed one. Never take two doses at once to make up for it. Check your leaflet, as some medicines are different.