trial? XTANDI can cause harm to your unborn baby and loss of pregnancy (miscarriage). for? trial? The safety and efficacy of XTANDI have not been established in females. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. Enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors and inhibit androgen receptor nuclear translocation and interaction with DNA. Based on animal reproductive studies and mechanism of action, XTANDI can cause fetal harm and loss of pregnancy when administered to a pregnant female. trial? trial? XTANDI? trial? trial? If XTANDI (enzalutamide) is indicated for the treatment of patients with:Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If XTANDI (enzalutamide) is indicated for the treatment of patients with:XTANDI (enzalutamide) is an androgen receptor inhibitor that acts on multiple steps of the androgen receptor signaling pathway within the tumor cell.XTANDI is indicated for the treatment of patients with castration-resistant prostate cancer (CRPC) or metastatic In preclinical studies, enzalutamide inhibits androgen binding to the androgen receptor, inhibits androgen receptors from entering the nucleus, and inhibits androgen receptor binding to DNA.XTANDI is taken as 160 mg (four 40 mg capsules) orally, once daily.In the data from the 4 randomized placebo-controlled trials, the most common adverse reactions Yes, enzalutamide (XTANDI) is recognized in the guidelines for the treatment of prostate cancer by the†Defined as metastases involving the viscera or, in the absence of visceral lesions, The primary endpoint in the ARCHES trial was radiographic-progression free survival.In the ARCHES trial, there was a 61% reduction in the risk of radiographic disease progression or death in mCSPC patients treated with Overall survival data were not mature at the time of radiographic In the ARCHES trial, the most common adverse reactions that occurred at ‡Includes memory impairment, amnesia, cognitive disorder, dementia, disturbance in attention, transient global amnesia, dementia Alzheimer’s type, mental impairment, senile dementia, and vascular dementia.†Progression was defined as at least 3 rising PSA values Metastasis‑free survival was defined as the time from randomization to whichever of the following occurred first: In the PROSPER trial, there was a 71% reduction in the risk of metastasis or death The adverse reactions reported in PROSPER that occurred at a §Includes amnesia, memory impairment, cognitive disorder, and disturbance in attention.The 3 trials that studied XTANDI in the treatment of mCRPC wereThe primary endpoint of the AFFIRM trial was overall survival.In the AFFIRM trial, there was a 37% reduction in risk of death for patients receiving XTANDI + The adverse reactions reported in AFFIRM that occurred at a †Includes nasopharyngitis, upper respiratory tract infection, sinusitus, rhinitis, pharyngitis, and laryngitis.§Includes pneumonia, lower respiratory tract infection, bronchitis, and lung infection.||Includes amnesia, memory impairment, cognitive disorder, and disturbance in attention.The co-primary endpoints of the PREVAIL trial were overall survival and radiographic In the PREVAIL trial, there was a 23% reduction in the risk of death with Also in the PREVAIL trial, there was an 83% reduction in the risk of radiographic disease progression or death with The adverse reactions reported in PREVAIL that occurred at a †Includes nasopharyngitis, upper respiratory tract infection, sinusitus, rhinitis, pharyngitis, and laryngitis.§Includes dyspnea, exertional dyspnea, and dyspnea at rest.||Includes pneumonia, lower respiratory tract infection, bronchitis, and lung infection.¶Includes amnesia, memory impairment, cognitive disorder, and disturbance in attention.TERRAIN was a multinational, randomized, double-blind phase 2 trial of Progression-free survival was defined as the time from randomization to the first progression event, which included radiographic disease progression, In the TERRAIN trial, there was a 40% reduction in risk of radiographic progression or death with In the TERRAIN study, overall and common adverse reactions †Includes musculoskeletal pain and pain in extremity.‡Includes nasopharyngitis, upper respiratory tract infection, sinusitus, rhinitis, pharyngitis, and laryngitis.Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. trial? XTANDI is indicated for the treatment of patients with Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. trial?

XTANDI? Xtandi (enzalutamide) is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. trial? It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. Advise males with female partners of reproductive potential to use effective contraception during treatment with XTANDI trial?

trial? This link is provided as a convenience to the users of this site. trial? Important Safety Information. In a study of patients with predisposing factors for seizure, 2.2% of XTANDI-treated patients experienced a seizure. If XTANDI (enzalutamide) is indicated for the treatment of patients with:© 2020 Astellas Pharma US, Inc. and Pfizer Inc. All rights reserved. Warnings and Precautions. trial? XTANDI? Posterior Reversible Encephalopathy Syndrome (PRES)Posterior Reversible Encephalopathy Syndrome (PRES)Posterior Reversible Encephalopathy Syndrome (PRES) Posterior Reversible Encephalopathy Syndrome (PRES)Posterior Reversible Encephalopathy Syndrome (PRES)Posterior Reversible Encephalopathy Syndrome (PRES) If XTANDI (enzalutamide) is indicated for the treatment of patients with:Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. trial? trial? XTANDI, Astellas, and the flying star logo are registered trademarks of Astellas Pharma Inc.Neither Astellas nor Pfizer own nor control the websites, and neither are responsible for the content or services contained on the websites. If XTANDI (enzalutamide) is indicated for the treatment of patients with:Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. Seizure occurred in 0.5% of patients receiving XTANDI in seven randomized clinical trials. Males who have female partners who are able to become pregnant should use effective birth control (contraception) during treatment with XTANDI … Important Safety Information. Have a partner who is pregnant or may become pregnant. guidelines? trial? If XTANDI (enzalutamide) is indicated for the treatment of patients with:© 2020 Astellas Pharma US, Inc. and Pfizer Inc. All rights reserved. Hyperglycemia (78%) Asthenic conditions (40-51%) Hypermagnesemia (26%) Back pain (26%) Diarrhea (22%) Arthralgia (21%) Hot flush (13-20%) Hyponatremia (16%) Peripheral edema (15%) Musculoskeletal pain (15%) Hypertension (6.4-14%) Nausea (11-14%) Constipation (9.1-13%) Diarrhea (12%) Dizziness (9.5-12%) Upper respiratory tract infection (11-12%) Fall (11%) Weight loss (11%)

Mechanism of Action. trial? mCRPC? This link is provided as a convenience to the users of this site. XTANDI? trial? XTANDI, Astellas, and the flying star logo are registered trademarks of Astellas Pharma Inc.Neither Astellas nor Pfizer own nor control the websites, and neither are responsible for the content or services contained on the websites. It is unknown whether anti-epileptic medications will prevent seizures with XTANDI. trial? Warnings and Precautions. Seizure occurred in 0.5% of patients receiving XTANDI in seven randomized clinical trials. trial?

XTANDI is indicated for the treatment of patients with Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI.