A resource to help physicians, advocates, and patients access free medications through pharmaceutical company patient assistance programs. XTANDI treats men with a type of advanced prostate cancer that no longer responds to a medical or. XTANDI Support Solutions SM is a component of Astellas Access. XTANDI Support Solutions . XTANDI can cause fetal harm when administered to a pregnant woman. Warnings and Precautions. Seizure In Study 1, conducted in patients with metastatic castration- resistant prostate cancer (CRPC) who previously received docetaxel, seizure occurred in 0. XTANDI patients and 0% of placebo patients. In Study 2, conducted in patients with chemotherapy- naive metastatic CRPC, seizure occurred in 0. XTANDI patients and 0. There is no clinical trial experience re- administering XTANDI to patients who experienced a seizure, and limited safety data are available in patients with predisposing factors for seizure. Study 1 excluded the use of concomitant medications that may lower threshold; Study 2 permitted the use of these medications. Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity during which sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment. Astellas Access Program Xtandi Patient
Astellas Access Program Xtandi DrugAstellas Pharma’s Xtandi Support Solutions program offers patient assistance services to eligible patients who are prescribed Xtandi (enza Posterior Reversible Encephalopathy Syndrome (PRES) In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES. Adverse Reactions. The most common adverse reactions (. Discontinuations due to adverse events were reported for 1. XTANDI patients and 1. In Study 2, Grade 3- 4 adverse reactions were reported in 4. XTANDI patients and 3. Discontinuations due to adverse events were reported for 6% of both study groups. Grade 1- 4 thrombocytopenia occurred in 6% of XTANDI patients (0. Grade 3- 4) and 5% of placebo patients (0. Grade 3- 4). Grade 1- 4 elevations in ALT occurred in 1. XTANDI patients (0. Grade 3- 4) and 1. Grade 3- 4). Grade 1- 4 elevations in bilirubin occurred in 3% of XTANDI patients (0. Grade 3- 4) and 2% of placebo patients (no Grade 3- 4). Infections: In Study 1, 1% of XTANDI patients compared to 0. In Study 2, 1 patient in each treatment group (0. Falls (including fall- related injuries), occurred in 9% of XTANDI patients and 4% of placebo patients. Falls were not associated with loss of consciousness or seizure. Fall- related injuries were more severe in XTANDI patients, and included non- pathologic fractures, joint injuries, and hematomas. Hypertension occurred in 1. XTANDI patients and 4% of placebo patients. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of all patients. Drug Interactions. Effect of Other Drugs on XTANDI Avoid strong CYP2. C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co- administration is necessary, reduce the dose of XTANDI. If co- administration is necessary, increase the dose of XTANDI. If XTANDI is co- administered with warfarin (CYP2. C9 substrate), conduct additional INR monitoring.
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January 2017
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