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  • NEXAVAR is contraindicated in patients with known severe hypersensitivity to sorafenib or other element of NEXAVAR
  • NEXAVAR in conjunction with carboplatin and paclitaxel is contraindicated in patients with squamous cell cancer of the lung
  • Cardiac ischemia and/or myocardial infarction can happen. The incidence of cardiac ischemia/infarction in NEXAVAR-treated versus placebo-treated patients was 2.7% versus 1.3%, 2.9% versus .4%, and 1.9% versus % within the HCC, RCC, and DTC studies, correspondingly. Temporary or permanent stopping of NEXAVAR should be thought about in patients who develop cardiac ischemia and/or myocardial infarction
  • An elevated chance of bleeding can happen following NEXAVAR administration. The next bleeding side effects were reported within the NEXAVAR-treated versus placebo-treated patients, correspondingly, within the HCC study: bleeding from esophageal varices (2.4% versus 4%) and bleeding with fatal outcome at any web site (2.4% versus 4%) within the RCC study: bleeding no matter causality (15.3% versus 8.2%), Grade 3 bleeding (2.% versus 1.3%), Grade 4 bleeding (% versus .2%), and something fatal hemorrhage in every treatment group within the DTC study: bleeding (17.4% versus 9.6%) and Grade 3 bleeding (1% versus 1.4%). There wasn’t any Grade 4 bleeding reported there was one fatal hemorrhage inside a placebo-treated patient. If bleeding necessitates medical intervention, consider permanent stopping of NEXAVAR. Because of the danger of bleeding, tracheal, bronchial, and esophageal infiltration ought to be given local therapy just before administering NEXAVAR in patients with DTC
  • Monitor bloodstream pressure weekly throughout the first 6 days and periodically after that, and treat, if needed. Within the HCC study, hypertension was reported in roughly 9.4% of NEXAVAR-treated patients and 4.3% of patients within the placebo-treated group. Within the RCC study, hypertension was reported in roughly 16.9% of NEXAVAR-treated patients and 1.8% of patients within the placebo-treated group. Within the DTC study, hypertension was reported in 40.6% of NEXAVAR-treated patients and 12.4% from the placebo-treated patients. Hypertension was usually mild to moderate, happened early throughout treatment, and it was managed with standard antihypertensive therapy. In the event of severe or persistent hypertension despite institution of antihypertensive therapy, consider temporary or permanent stopping of NEXAVAR
  • Hands-feet skin reaction and rash are the most typical side effects related to NEXAVAR. Management can include topical therapies for symptomatic relief. In the event associated with a severe or persistent side effects, temporary treatment interruption, dose modification, or permanent stopping of NEXAVAR should be thought about. There has been reports of severe dermatologic toxicities, including Stevens-Manley syndrome (SJS) and toxic epidermal necrolysis (TEN). These cases might be existence-threatening. Discontinue NEXAVAR if SJS or TEN are suspected
  • Gastrointestinal perforation was an infrequent adverse reaction and it has been reported in under 1% of patients taking NEXAVAR. Discontinue NEXAVAR in case of a gastrointestinal perforation
  • Infrequent bleeding or elevations within the Worldwide Normalized Ratio (INR) happen to be reported in certain patients taking warfarin during NEXAVAR. Monitor patients taking concomitant warfarin regularly for alterations in prothrombin time (PT), INR, or clinical bleeding episodes
  • Temporary interruption of NEXAVAR treatments are suggested in patients undergoing major surgical treatments
  • Inside a subset analysis of two randomized controlled trials in chemotherapy-naive patients with Stage IIIB-IV non-small cell cancer of the lung, patients with squamous cell carcinoma experienced greater mortality with the help of NEXAVAR when compared with individuals given carboplatin/paclitaxel alone (HR 1.81, 95% CI 1.19–2.74) and gemcitabine/cisplatin alone (HR 1.22, 95% CI .82–1.80). NEXAVAR, in conjunction with gemcitabine/cisplatin, isn’t suggested in patients with squamous cell cancer of the lung. The security and effectiveness of NEXAVAR is not established in patients with non-small cell cancer of the lung
  • NEXAVAR can prolong the QT/QTc interval and make ventricular arrhythmias. Avoid use within patients with hereditary lengthy QT syndrome and monitor electrolytes and electrocardiograms in patients with congestive heart failure, bradyarrhythmias, drugs recognized to prolong the QT interval, including Class Ia and III antiarrhythmics, and electrolyte abnormalities. Correct electrolyte abnormalities (magnesium, potassium,calcium). Interrupt NEXAVAR if QTc interval is more than 500 milliseconds or a rise from baseline of 60 milliseconds or greater
  • Sorafenib-caused hepatitis is characterised with a hepatocellular pattern of liver damage with significant increases of transaminases which may lead to hepatic failure and dying. Increases in bilirubin and INR might also occur. Liver function tests ought to be monitored regularly as well as in installments of elevated transaminases without alternative explanation NEXAVAR ought to be stopped
  • NEXAVAR could cause fetal harm when administered to some pregnant lady. Women of kid-bearing potential should be advisable to avoid getting pregnant during NEXAVAR
  • Female patients ought to be informed not to breastfeeding while receiving NEXAVAR
  • In DTC, NEXAVAR impairs exogenous thyroid suppression. Elevation of thyroid stimulating hormone (TSH) level above .5 mU/L was noticed in 41% of NEXAVAR-treated patients compared to 16% of placebo-treated patients within the DTC study. For patients with impaired TSH suppression while receiving NEXAVAR, 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 substitute medication when needed in patients with DTC
  • Within the HCC study, the most typical laboratory abnormalities noticed in the NEXAVAR arm in comparison to the placebo arm, correspondingly, were hypoalbuminemia (59% versus. 47%), lymphopenia (47% versus. 42%), thrombocytopenia (46% versus. 41%), elevation in INR (42% versus. 34%), elevated lipase (40% versus. 37%), hypophosphatemia (35% versus. 11%), elevated amylase (34% versus. 29%), hypocalcemia (27% versus. 15%), and hypokalemia (9.5% versus. 5.9%)
  • Within the RCC study, the most typical laboratory abnormalities noticed in the NEXAVAR arm in comparison to the placebo arm, correspondingly, were hypophosphatemia (45% versus. 11%), anemia (44% versus. 49%), elevated lipase (41% versus. 30%), elevated amylase (30% versus. 23%), lymphopenia (23% versus. 13%), neutropenia (18% versus. 10%), thrombocytopenia (12% versus. 5%), hypocalcemia (12% versus. 8%), and hypokalemia (5.4% versus. .7%)
  • Within the DTC study, the most typical laboratory abnormalities noticed in the NEXAVAR arm in comparison to the placebo arm, correspondingly, were elevated ALT (59% versus. 24%), elevated AST (54% versus. 15%), and hypocalcemia (36% versus. 11%).The relative increase for an additional laboratory abnormalities noticed in NEXAVAR-treated DTC patients when compared with placebo-treated patients is comparable to that noticed in the RCC and HCC studies: lipase, amylase, hypokalemia, hypophosphatemia, neutropenia, lymphopenia, anemia, and thrombocytopenia
  • Avoid concomitant utilization of strong CYP3A4 inducers, whenever possible, because inducers can reduce the systemic exposure of sorafenib. NEXAVAR exposure decreases when co-administered with dental neomycin. Results of other antibiotics on NEXAVAR pharmacokinetics haven’t been studied
  • Most typical side effects reported for NEXAVAR-treated patients versus placebo-treated patients in unresectable HCC, correspondingly, were: diarrhea (55% versus. 25%), fatigue (46% versus. 45%), abdominal discomfort (31% versus. 26%), weight reduction (30% versus. 10%), anorexia (29% versus. 18%), nausea (24% versus. 20%), and hands-feet skin reaction (21% versus. 3%). Grade 3/4 side effects were 45% versus. 32%
  • Most typical side effects reported for NEXAVAR-treated patients versus placebo-treated patients in advanced RCC, correspondingly, were: diarrhea (43% versus. 13%), rash/desquamation (40% versus. 16%), fatigue (37% versus. 28%), hands-feet skin reaction (30% versus. 7%), alopecia (27% versus. 3%), and nausea (23% versus. 19%). Grade 3/4 side effects were 38% versus. 28%
  • Most typical side effects reported for NEXAVAR-treated patients versus placebo-treated patients in DTC, correspondingly, were: palmar-plantar erythrodysesthesia syndrome (PPES) (69% versus. 8%), diarrhea (68% versus. 15%), alopecia (67% versus. 8%), weight reduction (49% versus. 14%), fatigue (41% versus. 20%), hypertension (41% versus. 12%), rash (35% versus. 7%), decreased appetite (30% versus. 5%), stomatitis (24% versus. 3%), nausea (21% versus. 12%), pruritus (20% versus. 11%), and abdominal discomfort (20% versus. 7%). Grade 3/4 side effects were 65% versus. 30%
  • For important risk and employ details about NEXAVAR, please visit the entire Prescribing Information.

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