Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. TOKYO, May 12, 2023 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved VEOZAHTM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) due to menopause1 on May 12. For more information, ask your healthcare provider or pharmacist. Monitor maternal blood glucose levels regularly. 5705185. CYP3A inducers (e.g., including, but not limited to, rifampin, rifabutin). A complete list of Astellas oncology products and their related assistance programs is provided in the Table. to female patients treated with tacrolimus immediate-release product. Blood glucose concentrations should be monitored closely in patients using PROGRAF. Monitor maternal blood glucose levels regularly. Padcev Copay Assistance . Write a review. Your healthcare provider may instruct you to check your blood pressure at home. Calcium-channel blocking agents may increase tacrolimus blood concentrations and therefore require dosage reduction of PROGRAF. Nervous system problems are a serious and common side effect of PROGRAF. medicines called aminoglycosides that are used to treat bacterial infections, antiviral medicines called nucleoside reverse transcriptase inhibitors, antiviral medicines called protease inhibitors. Your healthcare provider may do blood tests to check for diabetes. RESOURCE PORTAL As a part of our commitment to providing support to healthcare professionals and patients, we've developed resources for various stages of patient care. People who take PROGRAF have sometimes been given the wrong type of tacrolimus product. Wear protective clothing and use a sunscreen with a high sun protection factor (SPF). Monitor EBV serology during treatment. ASTAGRAF XL can lower the ability of your immune system to fight infections. Call your healthcare provider right away if you have symptoms of an infection such as: Increased risk of death in females who have had a liver transplant. from Astellas and I understand that I may opt out of Astellas emails at any time. Longitudinal analysis of the association between vasomotor symptoms and race/ethnicity across the menopausal transition: study of women's health across the nation. VEOZAH is the first nonhormonal neurokinin 3 (NK3) receptor antagonist approved to treat VMS due to menopause. Check your ASTAGRAFXL when you get a new prescription to make sure you have received the right medicine. Medication errors, including substitution and dispensing errors, between tacrolimus immediate-release products and ASTAGRAFXL the risk of infection. Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Renal dysfunction, transient neonatal hyperkalemia and low birth weight have been reported at the time of delivery in infants of mothers taking PROGRAF. The completed application can either be uploaded through the prescriber portal or faxed to 877-747-6843. 2005;3:47. provider may do certain tests to check your kidney function while you take ASTAGRAFXL. Males who have female partners who are able to become pregnant should also use effective birth control before and during treatment with ASTAGRAF XL. The risk for nephrotoxicity may increase when PROGRAF is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole blood concentrations) or drugs associated with nephrotoxicity (e.g., aminoglycosides, ganciclovir, amphotericin B, cisplatin, nucleotide reverse transcriptase inhibitors, protease inhibitors). Do not use ASTAGRAFXL for a condition for which it was not prescribed. Climacteric. Find information to help educate your patients on a treatment option. dosage adjustments. Astellas are not responsible for the information or services on this site. Your healthcare provider will monitor your blood pressure and may prescribe blood pressure medicine for you, if needed. Your healthcare provider should decide what medicine is right for you. Providing answers to you and your patients' billing, claims, and patient assistance questions regarding Astellas products. Astellas has already reflected the impact from this approval in its financial forecast of the current fiscal year ending March 31, 2024. Patients must have prescription drug coverage for PROGRAF or ASTAGRAFXL. If you get the granules or prepared oral suspension in your eyes, rinse with plain water. Kidney Transplant: The most common adverse reactions (30%) were infection, tremor, hypertension, abnormal renal function, constipation, diarrhea, headache, abdominal pain, insomnia, nausea, hypomagnesemia, urinary tract infection, hypophosphatemia, peripheral edema, asthenia, pain, hyperlipidemia, hyperkalemia, and anemia. Myrbetriq Support Solutionsa offers benefits verification assistance to evaluate a patient's insurance coverage for Myrbetriq (mirabegron extended-release tablets). Once benefits verification is complete, we will send a Summary of Benefits. Hepatic/Renal Impaired Patients: If you are a healthcare professional,visit our HCP Portal. Cases of pure red cell aplasia (PRCA) have been reported in patients treated with tacrolimus. Astellas Pharma Support SolutionsSM offers access and reimbursement support to help patients overcome challenges to accessing Astellas products. VEOZAH may affect the way other medicines work, and other medicines may affect how VEOZAH works. Astellas Cares is a trademark of Astellas Pharma US, Inc. The Astellas eService portal is where you can the Astellas Stock Replacement Program. Meet the programs financial eligibility requirements. higher whole blood trough concentrations and greater risk of serious adverse reactions (e.g., neurotoxicity, QT prolongation). Updated Astellas formswill be available 01-10-2017.Please check back then.We apologize for any inconvenience. Monitor and control blood Pediatric Use: The safety and effectiveness of PROGRAF have been established in pediatric liver, kidney, and heart transplant patients. an organ from a CMV seropositive donor are at highest risk of CMV viremia and CMV disease. Give the dose of PROGRAF Granules right after preparing. Risk Summary astellasresources.com, please fill in all the fields below. Thank you for registering. 6 Freeman EW, Sammel MD, Sanders RJ. Live vaccines such as flu vaccine through your nose, measles, mumps, rubella, polio by mouth, TB vaccine, yellow fever, chicken pox or typhoid. Children who have trouble swallowing capsules can be given PROGRAF Granules. Changes between tacrolimus immediate-release and extended-release dosage forms must occur under physician supervision. If it is longer than 14 hours, the missed dose should be skipped and the next dose should be taken the following morning at your regularly scheduled time. If you are able to become pregnant, you should use effective birth control before and during treatment with ASTAGRAF XL. Take ASTAGRAF XL at the same time each morning, preferably on an empty stomach at least 1 hour before, or at least 2 hours after, you have eaten a meal. The most common side effects of PROGRAF in people who have received a kidney, liver, heart, or lung transplant are: Tell your healthcare provider if you have any side effect that bothers you or that does not go away. Healthcare providers can enroll patients online. The Quick Start+ Program provides a one-time, 7-day supply of Xospata or a 14-day supply of Xtandi at no cost to new eligible patients who experience a delay in insurance coverage. You are encouraged to report negative side effects of prescription drugs to the FDA. The website you are about to visit is not owned or controlled by Astellas. It may harm them. Serious viral infections reported include: Monitor for the development of infection and adjust the immunosuppressive regimen to balance the risk of rejection with the risk of infection. African-American and Hispanic kidney transplant patients are at an increased risk. If you have any questions specific to cases regarding XTANDI (enzalutamide), please call XTANDI Support Solutions at 1-855-898-2634. Through advocacy, service, and charitable giving, our people make essential, meaningful contributions. Females and Males of Reproductive Potential: PROGRAF can cause fetal harm when administered to pregnant women. The most common side effects of ASTAGRAFXL are diarrhea, constipation, nausea, swelling of the hands, ankles, or legs, and tremors (shaking of the body). Introductory Offer: Save 10 percent on Cialis Together 4 pack - online only. Please refer to the full Prescribing Information, including Boxed Warning, for: INDICATION AND IMPORTANT SAFETY INFORMATION FOR PROGRAF, PROGRAF Granules (tacrolimus for oral suspension). transcriptase inhibitors, protease inhibitors). VEOZAH and the Wave logo are trademarks of Astellas US LLC. Under the Program: You must have a valid prescription for PROGRAF capsules or ASTAGRAF XL, meet the eligibility requirements, and present the copay card to your pharmacist b Males who have female partners who are able to become pregnant should also use effective birth control before and during treatment with PROGRAF. Updated Astellas formswill be available 01-10-2017.Please check back then.We apologize for any inconvenience. SKYLIGHT 4 (NCT04003389) is a 52-week double-blinded, placebo-controlled study designed to investigate the long-term safety of fezolinetant. Under the Program: aEligible participants in the Copay Card Program (Program) may receive annual savings up to $3000 for PROGRAF or ASTAGRAFXL. Myrbetriq is a registered trademark of Astellas Pharma Inc. Visit the Patient Portalto help you understand yourcoverage and reimbursementoptions when prescribedan Astellas medication. The Medication Guide summarizes the most important information about ASTAGRAFXL. Myrbetriq, XOSPATA, serum creatinine and tacrolimus whole blood trough concentrations greater than the recommended range. You can ask your pharmacist or healthcare provider for information about PROGRAF that is written for health professionals. Astellas Pharma Support Solutions may assist healthcare providers with navigating a patient's insurance access and affordability issues through support with Benefits Verification, Prior Authorization, Billing and Coding, Forms and Documents, and patient financial assistance options. Theres something special about Astellas Oncologywe call it the Astellas Way. We are available Monday-Friday, 9 AM - 8 PM ET. This condition appears reversible in most cases following dose reduction or discontinuance of therapy. For help with XOSPATA,please call 1-844-632-9272. Astellas is not affiliated with and does not endorse any of the listed organizations or resources. Post-transplant lymphoproliferative disorder (PTLD), associated with Epstein-Barr Virus (EBV), has been reported in 4 Williams RE, Kalilani L, DiBenedetti DB, et al. Consider obtaining electrocardiograms and monitoring electrolytes (magnesium, potassium, calcium) periodically during treatment in patients The UK is the first country to allow OTC access to Sanofi's tadalafil-based erectile dysfunction drug Cialis following a successful switch. high blood pressure. Astellas is not responsible for the content or services on this site. These statements are based on management's current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. THIS SITE IS INTENDED FOR US AUDIENCES ONLY. Learn more and access relevant resources. Psychosocial and socioeconomic burden of vasomotor symptoms in menopause: a comprehensive review. To enroll your patient in the Xospata Patient Assistance Program, download the application and fax the completed application to 844-730-8816. PROGRAF is not recommended for use with sirolimus: Interactions with CYP3A Inhibitors and Inducers. Check with the pharmacist and call your healthcare provider if you think you were given the wrong medicine. There is an increased risk for premature delivery (<37 weeks) following transplantation and maternal exposure to ASTAGRAFXL. PROGRAF patients who reside in the states of Massachusetts and California are not eligible to participate in the Program. viral infections reported include: Monitor for the development of infection and adjust the immunosuppressive regimen to balance the risk of rejection with The information provided by Astellas is for informational purposes only and is not meant to replace the advice of your healthcare team. If you receive your prescriptions for PROGRAF or ASTAGRAFXL by mail, you may be eligible for the copay card. Please read our privacy policy for more information on the cookies we use, the processing of your personal data and how to delete or block the use of cookies. Share this page with someone who might find it interesting. * AmBisome is a registered trademark of Gilead Sciences, Inc. Look for your first email shortly. This balance regulates the body's temperature control center located in a specific area of the brain. See what makes our company different. However, this Program offer is not valid for patients whose prescription claims are reimbursed, in whole or in part, by any federal or state-government funded prescription drug benefit program including but not limited to Medicaid, Medicare, Medigap, Veterans Affairs (VA), Department of Defense (DoD), TRICARE, Puerto Rico Government Insurance, or any state patient or pharmaceutical assistance program. Serious PROGRAF may affect the way other medicines work, and other medicines may affect how PROGRAF works. Monitor and control blood pressure. For help with XTANDI,please call 1-855-898-2634. For help with PADCEV,please call 1-888-402-0627. The most severe neurotoxicities include posterior reversible encephalopathy syndrome (PRES), delirium, seizure and coma. and XTANDI are registered trademarks of Astellas Pharma Inc. Monitor renal function and consider dosage reduction if nephrotoxicity occurs. Risk SummaryControlled lactation studies have not been conducted in humans; however, tacrolimus has been reported to be present in human milk. potassium level while you take ASTAGRAFXL. Others include tremors, paresthesias, headache, mental status changes, and changes in motor and sensory functions. Use of PROGRAF with amiodarone has been reported to result in increased tacrolimus whole blood concentrations with or without concurrent QT prolongation. Inactivated vaccines noted to be safe for administration after transplantation may not be sufficiently immunogenic during treatment with PROGRAF. Our employees are part of this commitment, and Changing Tomorrow Day reflects their passion for giving back. The risk for nephrotoxicity may increase when ASTAGRAFXL is concomitantly administered with CYP3A inhibitors (by increasing tacrolimus whole Serious infections can happen in people receiving ASTAGRAF XL that can cause death. 1. If you take too much PROGRAF, call your healthcare provider or go to the nearest hospital emergency room right away. Astellas Online Privacy Statement based on adequate and well-controlled studies of ASTAGRAFXL in adult kidney transplant patients and supported by pharmacokinetic and safety data of ASTAGRAFXL in By sending this email address, you are requesting that we contact the person named on your behalf. You are encouraged to report negative side effects of prescription drugs to the FDA. and patients, weve developed resources for various stages of patient care. The patient's insurance coverage requirements for Myrbetriq, Requirements for prior authorization, step edit, or other coverage restrictions, if any, Cost-sharing responsibility, including deductibles, coinsurance or copayment, and out-of-pocket maximums, Application to Request Benefits Verification Assistance. The site uses cookies to provide you with a more responsive and personalized service and to analyze site traffic. The most common adverse reactions were diarrhea (13.9%), headache (13.9%), and cough (11.4%). For media inquiries and reporter requests, please click here to fill out a request form. These are not all the possible side effects of ASTAGRAFXL. Race or Ethnicity: African-American patients may need to be titrated to higher dosages to attain comparable trough concentrations compared to Caucasian patients. Talk to your healthcare provider before starting treatment with PROGRAF about birth control methods that may be right for you. As a part of our commitment to providing support to healthcare professionals For help with XTANDI,please call 1-855-898-2634. See Important Safety Information and Indication for PROGRAF below, See Important Safety Information and Indication for ASTAGRAF XL below, Important Safety Information for ASTAGRAFXL, Prescribing Information, including Boxed Warning, Health Risks and Prevention After a Transplant, Returning to Daily Activities: Your New Normal, Polyoma virus-associated nephropathy (PVAN), mostly due to BK virus infection, JC virus-associated progressive multifocal leukoencephalopathy (PML). By using this site, you accept our use of cookies as described in our privacy policy. We stand with the community in the face of cancers complexitiesthinking big and searching for better ways to help. Healthcare seeking and treatment for menopausal symptoms in the United States. serum potassium levels periodically during treatment. VEOZAH helps to restore the balance by blocking NKB in the temperature control center to reduce the number and intensity of hot flashes. ASTAGRAFXL may cause a spectrum of neurotoxicities. All other trademarks or registered trademarks are the property of their respective owners. The following organizations are dedicated to providing helpful information. PROGRAF may exacerbate hypertension in pregnant women and increase pre-eclampsia. The use of live vaccines should be avoided during treatment with tacrolimus; examples include (not limited to) the following: intranasal influenza, measles, mumps, rubella, oral polio, BCG, yellow fever, varicella, and TY21a typhoid vaccines. Pediatrics You are now leaving www.astellasoncology.com. If you are able to become pregnant, you should use effective birth control before and during treatment with PROGRAF. ASTAGRAF XL passes into your breast milk. For more information, ask your healthcare provider or pharmacist. You must have a valid prescription for PROGRAF capsules or ASTAGRAFXL, meet the eligibility requirements, and present the copay card to your pharmacist, You may pay as little as $0 and save up to $3000 per year, Annual reenrollment in the Program is required and subject to eligibility, Once your healthcare provider gives you the copay card, eligible patients, A copay card will also be sent in the mail. The Xtandi Patient Savings Program helps commercially insured patients cover their out-of-pocket prescription costs for Xtandi. Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. Results from the SKYLIGHT 1 and SKYLIGHT 2 pivotal trials characterize the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS due to menopause. Lexiscan is a pharmacologic stress agent indicated for radionuclide myocardial perfusion imaging (MPI) in patients unable to undergo adequate . Furthermore, we are also looking beyond our foundational Rx focus to create Rx+ healthcare solutions that combine our expertise and knowledge with cutting-edge technology in different fields of external partners. New onset diabetes after transplantation may be reversible in some patients. If you cannot swallow are pregnant or plan to become pregnant. The effects of tacrolimus on the breastfed Increased risk for developing serious infections and malignancies with PROGRAF or other immunosuppressants that may lead to hospitalization or death. Tell your healthcare provider right away if you get any of these symptoms of heart problems: severe low red blood cell count (anemia). Please see the Patient Information and full Prescribing Information, including Boxed Warning, for PROGRAF. If PRCA is diagnosed, consider discontinuation of ASTAGRAFXL. This information is intended for US Healthcare professionals. Not Interchangeable With Extended-Release Tacrolimus Products - Medication Errors. greater risk of rejection. with hyperkalemia (e.g., potassium-sparing diuretics, ACE inhibitors, angiotensin receptor blockers) may increase the risk for hyperkalemia. ASTAGRAFXL is indicated for the prophylaxis of organ rejection in kidney transplant patients in combination (tacrolimus extended-release capsules) were reported outside the U.S. Annual reenrollment in the Program is required and subject to eligibility. These are not all the possible side effects of PROGRAF. African-American patients may need to be titrated to higher dosages to attain comparable trough concentrations compared to Caucasian patients. PROGRAF was shown to cause new onset diabetes mellitus in clinical trials of kidney, liver, and heart transplantation. The use of sirolimus with PROGRAF in studies of. Your personal information will not be stored. 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