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Generic Name
Sorafenib
Brand Names
Nexavar, Sorafenib Tosylate
FDA approval date: December 20, 2005
Classification: Kinase Inhibitor
Form: Tablet
What is Nexavar (Sorafenib)?
NEXAVAR is a kinase inhibitor indicated for the treatment of Unresectable hepatocellular carcinoma.
Approved To Treat
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Brand Information
Nexavar (sorafenib)
1DOSAGE FORMS AND STRENGTHS
Tablets:
- 200 mg sorafenib, round, biconvex, red film-coated tablets, debossed with the “Bayer cross” on one side and “200” on the other side.
- 200 mg sorafenib, round, faceted biconvex, red film-coated tablets, debossed with the “Bayer cross” on one side and “200” on the other side.
2CONTRAINDICATIONS
- NEXAVAR is contraindicated in patients with known severe hypersensitivity to sorafenib or any other component of NEXAVAR.
- NEXAVAR in combination with carboplatin and paclitaxel is contraindicated in patients with squamous cell lung cancer
3ADVERSE REACTIONS
The following clinically significant adverse reactions are discussed elsewhere in the labeling:
- Cardiovascular events
- Hemorrhage
- Hypertension
- Dermatologic toxicities
- Gastrointestinal perforation
- QT interval prolongation
- Drug-induced liver injury
- Impairment of TSH suppression in DTC
3.1Clinical Trials Experience
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
The data described reflect exposure to NEXAVAR in 955 patients who participated in placebo-controlled studies in hepatocellular carcinoma (N=297), advanced renal cell carcinoma (N=451), or differentiated thyroid carcinoma (N = 207). The most common adverse reactions (≥20%), which were considered to be related to NEXAVAR, in patients with HCC, RCC or DTC are diarrhea, fatigue, infection, alopecia, hand-foot skin reaction, rash, weight loss, decreased appetite, nausea, gastrointestinal and abdominal pains, hypertension, and hemorrhage.
3.1.1Hepatocellular Carcinoma
Table 4 shows the percentage of patients in the SHARP (HCC) study experiencing adverse reactions
- Adverse reactions graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0).
Hypertension was reported in 9% of patients treated with NEXAVAR and 4% of those receiving placebo. Grade 3 hypertension was reported in 4% of NEXAVAR-treated patients and 1% of those receiving placebo.
Hemorrhage/bleeding was reported in 18% of those receiving NEXAVAR and 20% of patients receiving placebo. The rates of Grade 3 and 4 bleeding were also higher in patients receiving placebo (Grade 3 – 3% NEXAVAR and 5% placebo and Grade 4 – 2% NEXAVAR and 4% placebo). Bleeding from esophageal varices was reported in 2.4% in NEXAVAR-treated patients and 4% of patients receiving placebo.
Renal failure was reported in <1% of patients treated with NEXAVAR and 3% of patients receiving placebo. Clinical pancreatitis was reported in 1 of 297 NEXAVAR-treated patients (Grade 2).
The rate of adverse reactions (including those associated with progressive disease) resulting in permanent discontinuation was similar in both the NEXAVAR-treated patients and those receiving placebo (32% of NEXAVAR-treated patients and 35% of patients receiving placebo).
Laboratory test abnormalities reported in SHARP are presented in Table 5.
- Laboratory parameters graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0).
NR = not reported
3.1.2Renal Cell Carcinoma
Table 6 shows the percentage of patients in the TARGET (RCC) study experiencing adverse reactions that were reported in at least 10% of patients and at a higher rate in NEXAVAR-treated patients arm than in those receiving placebo.
The rate of adverse reactions (including those associated with progressive disease) resulting in permanent discontinuation was similar in both the NEXAVAR-treated patients and patients receiving placebo (10% and 8%, respectively).
Clinical pancreatitis was reported in 3 of 451 NEXAVAR-treated patients (one Grade 2 and two Grade 4).
- Adverse reactions graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0).
Laboratory test abnormalities reported in TARGET are presented in Table 7.
- Laboratory parameters graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0).
3.1.3Differentiated Thyroid Carcinoma
The safety of NEXAVAR was evaluated in DECISION in 416 patients with locally recurrent or metastatic, progressive differentiated thyroid carcinoma (DTC) refractory to radioactive iodine (RAI) treatment randomized to receive 400 mg twice daily NEXAVAR (n=207) or matching placebo (n=209) until disease progression or intolerable toxicity in a double-blind trial
Dose interruptions for adverse reactions were required in 66% of patients receiving NEXAVAR and dose reductions were required in 64% of patients. Adverse reactions that resulted in treatment discontinuation were reported in 14% of NEXAVAR-treated patients compared to 1.4% of patients receiving placebo.
Table 8 shows the percentage of DTC patients experiencing adverse reactions at a higher rate in NEXAVAR-treated patients than in patients receiving placebo in the double-blind phase of the DECISION study. Grade 3 adverse reactions occurred in 53% of NEXAVAR-treated patients compared to 23% of patients receiving placebo. Grade 4 adverse reactions occurred in 12% of NEXAVAR-treated patients compared to 7% of patients receiving placebo.
- National Cancer Institute Common Terminology Criteria for Adverse Events Version 3.0
- Includes the following terms: abdominal pain, abdominal discomfort, hepatic pain, esophageal pain, esophageal discomfort, abdominal pain lower, abdominal pain upper, abdominal tenderness, abdominal rigidity
- Includes the following terms: stomatitis, aphthous stomatitis, mouth ulceration, mucosal inflammation
- Includes the following terms: oral pain, oropharyngeal discomfort, glossitis, burning mouth syndrome, glossodynia
- Palmar-plantar erythrodysesthesia syndrome (Hand-foot skin reaction)
- Includes the following terms: hypertension, blood pressure increased, blood pressure systolic increased
The relative increase for the following laboratory abnormalities observed in NEXAVAR-treated patients as compared to patients receiving placebo in the DECISION study is similar to that observed in the RCC and HCC studies: lipase, amylase, hypokalemia, hypophosphatemia, neutropenia, lymphopenia, anemia, and thrombocytopenia. Hypocalcemia was more frequent and more severe in patients with DTC, especially those with a history of hypoparathyroidism, compared to patients with RCC or HCC. Other laboratory test abnormalities reported in DECISION are presented in Table 9
- Laboratory parameters graded according to National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 (NCI CTCAE v3.0).
3.1.4Additional Data from Multiple Clinical Trials
The following additional drug-related adverse reactions and laboratory abnormalities were reported from clinical trials of NEXAVAR (
Cardiovascular:
Dermatologic:
Digestive:
Note that elevations in lipase are very common (41%, see below); a diagnosis of pancreatitis should not be made solely on the basis of abnormal laboratory values
General Disorders:
Hematologic:
Hepatobiliary disorders:
Hypersensitivity:
Metabolic and Nutritional:
Musculoskeletal:
Nervous System and Psychiatric:
Renal and Genitourinary:
Reproductive:
Respiratory:
In addition, the following medically significant adverse reactions were uncommon during clinical trials of NEXAVAR: transient ischemic attack, arrhythmia, and thromboembolism. For these adverse reactions, the causal relationship to NEXAVAR has not been established.
*adverse reactions may have a life-threatening or fatal outcome.
†reported in 1.9% of patients treated with NEXAVAR (N= 2276).
3.2Postmarketing Experience
The following adverse reactions have been identified during postapproval use of NEXAVAR. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
Blood and lymphatic disorders: Thrombotic microangiopathy (TMA)
Dermatologic: Stevens-Johnson syndrome and toxic epidermal necrolysis (TEN)
Hypersensitivity: Angioedema
Musculoskeletal: Rhabdomyolysis, osteonecrosis of the jaw
Respiratory: Interstitial lung disease-like events (which may have a life-threatening or fatal outcome)
Vascular: Arterial (including aortic) aneurysms, dissections, and rupture
4OVERDOSAGE
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 NEXAVAR and institute supportive care.
5DESCRIPTION
Sorafenib, a kinase inhibitor, is the tosylate salt of sorafenib. Sorafenib tosylate has the chemical name 4-(4-{3-[4-Chloro-3-(trifluoromethyl)phenyl]ureido}phenoxy)N2-methylpyridine-2-carboxamide 4-methylbenzenesulfonate. The molecular formula of sorafenib tosylate is C
Sorafenib tosylate is a white to yellowish or brownish solid. Sorafenib tosylate is practically insoluble in aqueous media, slightly soluble in ethanol and soluble in PEG 400.
NEXAVAR (sorafenib), for oral use is supplied as film-coated tablets containing 200 mg sorafenib equivalent to 274 mg sorafenib tosylate and the following inactive ingredients: croscarmellose sodium, ferric oxide red, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol sodium lauryl sulphate, and titanium dioxide.
6HOW SUPPLIED/STORAGE AND HANDLING
NEXAVAR is supplied in bottles of 120:
- 200 mg, round, biconvex, red film-coated tablets, debossed with the “Bayer cross” on one side and “200” on the other side. NDC 50419-488-58
- 200 mg, round, faceted, biconvex, red film-coated tablets, debossed with the “Bayer cross” on one side and “200” on the other side. NDC 50419-489-01
Store at 20°C to 25° C (68°F to 77° F); excursions permitted to 15°C to 30° C (59°F to 86° F) [see USP controlled room temperature]. Store in a dry place.
7PATIENT COUNSELING INFORMATION
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 NEXAVAR treatment, and that they should immediately report any episodes of chest pain or other symptoms of cardiac ischemia or congestive heart failure
Bleeding
Inform patients that NEXAVAR can increase the risk of bleeding and that they should promptly report any episodes of bleeding
Inform patients that bleeding or elevations in the International Normalized Ratio (INR) have been reported in some patients taking warfarin while on NEXAVAR and that their INR should be monitored regularly
Hypertension
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
Skin Reactions
Advise patients of the possible occurrence of hand-foot skin reaction and rash during NEXAVAR treatment and appropriate countermeasures
Gastrointestinal Perforation
Advise patients that cases of gastrointestinal perforation have been reported in patients taking NEXAVAR
Risk of Impaired Wound Healing
Advise patients that NEXAVAR may impair wound healing. Advise patients to inform their healthcare provider of any planned surgical procedure
QT Interval Prolongation
Inform patients with a history of prolonged QT interval that NEXAVAR can worsen the condition
Drug-Induced Liver Injury
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
Embryo-Fetal Toxicity
Advise females to inform their healthcare provider if they are pregnant or become pregnant. Inform female patients of the risk to a fetus and potential loss of pregnancy
Lactation
Advise patients not to breastfeed while taking NEXAVAR and for 2 weeks after receiving the last dose of NEXAVAR
Missed Doses
Instruct patients that if a dose of NEXAVAR is missed, the next dose should be taken at the regularly scheduled time, and not double the dose.
8Patient Package Insert
This Patient Information has been approved by the U.S. Food and Drug Administration. Revised 6/2020
9PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Nexavar 200 mg Bottle Label
Rx Only
NDC 50419-489-01
Nexavar®
(sorafenib) tablets
(sorafenib) tablets
Each tablet contains
120 Tablets
10PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
Nexavar 200 mg Bottle Label
Rx Only
NDC 50419-488-58
Nexavar®
(sorafenib) tablets
(sorafenib) tablets
Each tablet contains
120 Tablets
