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The Growing Storm B:8.625 in T:8.375 in S:7.75 In Magellan Rx Spring Immune Globulin Managing the Cost Treating Antiretroviral 2013 Therapy: Managed of Reproductive Castration-Resistant Adherence in Care Implications Therapies Prostate Cancer Patients with HIV Repo rt Spring 2013 Magellan Rx Report MEDICAL AND PHARMACY BENEFIT MANAGEMENT Specialty Management: The Growing Storm www.magellanhealth.com B:8.625 in T:8.375 in S:7.75 in NEW INDICATION: ZYTIGA® (abiraterone acetate) is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). ADRENALS NOW APPROVED FOR PATIENTS WITH mCRPC WHO HAVE PROGRESSED ON ADT T:10.875 in PROSTATE T:10.875 in B:11.125 in TUMOR TISSUE S:10.25 in S:10.25 in TESTES ADT = androgen-deprivation therapy. IMPORTANT SAFETY INFORMATION Contraindications—ZYTIGA® is not indicated for use in women. with mineralocorticoid excess seen in patients treated with ZYTIGA® can cause fetal harm (Pregnancy Category X) when ZYTIGA®. Perform appropriate tests, if indicated, to confi rm AI. administered to a pregnant woman and is contraindicated in Increased dosages of corticosteroids may be used before, during, women who are or may become pregnant. and after stressful situations. Hypertension, Hypokalemia, and Fluid Retention Due to Hepatotoxicity—Monitor liver function and modify, withhold, Mineralocorticoid Excess—Use with caution in patients with or discontinue ZYTIGA® dosing as recommended (see Prescribing a history of cardiovascular disease or with medical conditions Information for more information). Measure serum transaminases that might be compromised by increases in blood pressure, [alanine aminotransferase (ALT) and aspartate aminotransferase hypokalemia, or fl uid retention. ZYTIGA® may cause hypertension, (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, hypokalemia, and fl uid retention as a consequence of increased every two weeks for the fi rst three months of treatment, and mineralocorticoid levels resulting from CYP17 inhibition. Safety monthly thereafter. Promptly measure serum total bilirubin, AST, has not been established in patients with LVEF < 50% or New and ALT if clinical symptoms or signs suggestive of hepatotoxicity York Heart Association (NYHA) Class III or IV heart failure (in develop. Elevations of AST, ALT, or bilirubin from the patient’s study 1) or NYHA Class II to IV heart failure (in study 2) because these patients were excluded from these randomized clinical baseline should prompt more frequent monitoring. If at any time trials. Control hypertension and correct hypokalemia before and AST or ALT rise above fi ve times the upper limit of normal (ULN) or during treatment. Monitor blood pressure, serum potassium, and the bilirubin rises above three times the ULN, interrupt ZYTIGA® symptoms of fl uid retention at least monthly. treatment and closely monitor liver function. Adrenocortical Insuffi ciency (AI)—AI was reported in patients Increased ZYTIGA® Exposures With Food—ZYTIGA® must receiving ZYTIGA® in combination with prednisone, after an be taken on an empty stomach. No food should be eaten for at interruption of daily steroids and/or with concurrent infection least two hours before the dose of ZYTIGA® is taken and for at or stress. Use caution and monitor for symptoms and signs of least one hour after the dose of ZYTIGA® is taken. Abiraterone AI if prednisone is stopped or withdrawn, if prednisone dose is Cmax and AUC0-∞ (exposure) were increased up to 17- and 10-fold reduced, or if the patient experiences unusual stress. Symptoms higher, respectively, when a single dose of abiraterone acetate and signs of AI may be masked by adverse reactions associated was administered with a meal compared to a fasted state. 2 CDMI Report | Spring 2013 Date: 01/17/13 Customer Code: 08Z12264A Group 360 Job #: 677265 File Name: 08Z12264A _677265_v1 (PG1-LH PAGE) Brand: Zytiga Size: 8.375" x 10.875" Colors: CMYK Description: Now Approved Pub: CDMI Report (January 2013 issue) K P G75 M50 K75 Y50 GN M25 B C75 M75 K25 Y C50 M G25 C Y75 K50 C25 G50 Y25 R B:8.625 in B:8.625 in T:8.375 in T:8.375 in S:7.75 in S:7.75 in NEW INDICATION: ZYTIGA® (abiraterone acetate) is indicated in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). ADRENALS INTRODUCING More than 20,000 patients with mCRPC have received ZYTIGA® (post-chemotherapy with AN EXPANDED 1 docetaxel) to date.† OF MECHANISM OF ACTION BODY ZYTIGA® is a CYP17 (17�-hydroxylase/C17, 20-lyase) inhibitor that inhibits androgen NOW APPROVED production at 3 sources: the testes, adrenal FOR PATIENTS WITH mCRPC WHO HAVE PROGRESSED ON ADT EVIDENCE glands, and the prostate tumor tissue itself. NEW EFFICACY DATA —In a recent Phase 3 clinical trial in patients with mCRPC who had progressed on ADT and had not received chemotherapy.* Efficacy was also demonstrated in a Phase 3 trial of patients who had received prior chemotherapy T:10.875 in T:10.875 in PROSTATE T:10.875 in T:10.875 in B:11.125 in B:11.125 in TUMOR TISSUE S:10.25 in S:10.25 in containing docetaxel.* S:10.25 in S:10.25 in TESTES ZytigaOne™ is your single source for personalized access services for you and your patients: Visit www.zytigaone.com or call 1-855-998-4421. ADT = androgen-deprivation therapy. IMPORTANT SAFETY INFORMATION Contraindications—ZYTIGA® is not indicated for use in women. with mineralocorticoid excess seen in patients treated with Adverse Reactions—The most common adverse reactions * Study Designs: ZYTIGA®, in combination with prednisone, was evaluated ZYTIGA® can cause fetal harm (Pregnancy Category X) when ZYTIGA®. Perform appropriate tests, if indicated, to confi rm AI. (≥ 10%) are fatigue, joint swelling or discomfort, edema, hot fl ush, in 2 Phase 3, randomized, double-blind, placebo-controlled, multicenter administered to a pregnant woman and is contraindicated in Increased dosages of corticosteroids may be used before, during, diarrhea, vomiting, cough, hypertension, dyspnea, urinary tract trials in patients with mCRPC. Study 1 enrolled patients who received prior women who are or may become pregnant. chemotherapy containing docetaxel (N = 1,195), whereas Study 2 enrolled and after stressful situations. infection, and contusion. patients who had not received prior chemotherapy (N = 1,088). In both Hypertension, Hypokalemia, and Fluid Retention Due to Hepatotoxicity—Monitor liver function and modify, withhold, The most common laboratory abnormalities (> 20%) are studies, patients were using a luteinizing hormone-releasing hormone agonist Mineralocorticoid Excess—Use with caution in patients with or discontinue ZYTIGA® dosing as recommended (see Prescribing anemia, elevated alkaline phosphatase, hypertriglyceridemia, or were previously treated with orchiectomy. In the active treatment arms, a history of cardiovascular disease or with medical conditions Information for more information). Measure serum transaminases lymphopenia, hypercholesterolemia, hyperglycemia, elevated patients received ZYTIGA® 1,000 mg orally once daily + prednisone 5 mg orally that might be compromised by increases in blood pressure, twice daily. In the control arms, patients received placebo orally once daily + [alanine aminotransferase (ALT) and aspartate aminotransferase AST, hypophosphatemia, elevated ALT, and hypokalemia. prednisone 5 mg orally twice daily. In Study 1, the primary efficacy endpoint hypokalemia, or fl uid retention. ZYTIGA® may cause hypertension, (AST)] and bilirubin levels prior to starting treatment with ZYTIGA®, Drug Interactions—ZYTIGA® is an inhibitor of the hepatic was overall survival. In Study 2, the coprimary efficacy endpoints were overall hypokalemia, and fl uid retention as a consequence of increased every two weeks for the fi rst three months of treatment, and drug-metabolizing enzyme CYP2D6. Avoid co-administration survival and radiographic progression-free survival. mineralocorticoid levels resulting from CYP17 inhibition. Safety monthly thereafter. Promptly measure serum total bilirubin, AST, with CYP2D6 substrates that have a narrow therapeutic index. † Estimate based on sales and use data from May 2011 to November 2012. has not been established in patients with LVEF < 50% or New and ALT if clinical symptoms or signs suggestive of hepatotoxicity If an alternative cannot be used, exercise caution and consider York Heart Association (NYHA) Class III or IV heart failure (in develop. Elevations of AST, ALT, or bilirubin from the patient’s a dose reduction of the CYP2D6 substrate. In vitro, ZYTIGA® Reference: 1. Data on file. Janssen Biotech, Inc. study 1) or NYHA Class II to IV heart failure (in study 2) because these patients were excluded from these randomized clinical baseline should prompt more frequent monitoring. If at any time inhibits CYP2C8. There are no clinical data on its use with drugs www.zytigahcp.com trials. Control hypertension and correct hypokalemia before and AST or ALT rise above fi ve times the upper limit of normal (ULN) or that are substrates of CYP2C8. Patients should be monitored the bilirubin rises above three times the ULN, interrupt ZYTIGA® closely for signs of toxicity related to the CYP2C8 substrate if Please see adjacent pages for brief summary during treatment. Monitor blood pressure, serum potassium, and of full Prescribing Information. symptoms of fl uid retention at least monthly. treatment and closely monitor liver function. used concomitantly with abiraterone acetate. Adrenocortical Insuffi ciency (AI)—AI was reported in patients Increased
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