JERSEY CITY, NJ, June 25, 2021 / PRNewswire / – Mitsubishi Tanabe Pharma America, Inc. (MTPA) today announced that PANTHERx Rare Pharmacy has been selected as the Exclusive Specialty Pharmacy Services Provider for EXSERVANâ¢ (riluzole), an oral film formulation of riluzole for the treatment of amyotrophic lateral sclerosis (ALS).
âAs we explored partner specialty pharmacy options for the distribution of EXSERVAN, it was important to find an organization with specific knowledge and experience that could better support the ALS community,â said Kevin o’brien, Vice President of Market Access, MTPA. âPANTHERx is able to deliver on both fronts, in addition to having an unwavering dedication to patients. This is closely linked to our commitment to helping patients. “
Once a patient is prescribed EXSERVAN, they can be enrolled in access to information services. Upon registration, PANTHERx will provide patients with a review and summary of insurance benefit options, including information on eligibility for the Personal Assistance Program for EXSERVAN.
MTPA plans to make EXSERVAN available to patients by the end of June 2021.
âPANTHERx is proud to focus on people living with the implications of a rare disease,â said Rob snyder, President of PANTHERx. âWe hope our vast experience will have a positive impact on the members of the ALS community we aim to serve through our distribution of EXSERVAN. We look forward to working with the MTPA to help meet the needs of those affected by this devastating disease.
About EXSERVANâ¢ (riluzole) oral film
EXSERVAN, an oral film formulation of riluzole, was approved by the United States Food and Drug Administration (FDA) in November 2019. EXSERVAN was developed by Aquestive Therapeutics, Inc. using its PharmFilmÂ® innovative drug delivery technology. The oral film is placed on the patient’s tongue and dissolves. Pursuant to a licensing and supply agreement, MTPA markets EXSERVAN in the United States and Aquestive is the sole manufacturer and exclusive supplier of the product. For more information visit www.EXSERVAN.com.
EXSERVAN â¢ (riluzole) is indicated for the treatment of amyotrophic lateral sclerosis (ALS).
IMPORTANT SAFETY INFORMATION
Do not use if you are allergic to riluzole or any of its ingredients.
Before using EXSERVAN, tell your doctor about all the medicines you are taking and about any health problems, including if you:
- You have liver problems.
- you are taking certain medicines known to be strong or moderate inhibitors of CYP1A2 such as ciprofloxacin, enoxacin, fluvoxamine, methoxsalen, mexiletine, oral contraceptives, thiabendazole, vemurafenib or zileuton.
- If you are pregnant or intend to become pregnant while taking EXSERVAN, or if you are breast-feeding or intend to breast-feed while taking EXSERVAN.
EXSERVAN can cause serious side effects, including:
Liver problems: Cases of liver damage, some fatal, have occurred in patients taking riluzole. See your doctor promptly if you experience unexplained nausea, vomiting, stomach (abdominal) pain, fatigue, weight loss (anorexia), jaundice (yellowing of the skin or the whites of the eyes) and / or dark urine.
Low number of white blood cells (neutropenia): Tell your doctor if you develop a fever while taking EXSERVAN.
Serious lung problems (interstitial lung disease): Tell your doctor if you have lung or breathing problems such as a dry cough and difficult or labored breathing. Stop EXSERVAN immediately if you develop interstitial lung disease.
The most common side effects include numbness in the mouth or tongue, muscle weakness, nausea, lung problems, high blood pressure, and stomach (abdominal) pain.
These are not all of the possible side effects of EXSERVAN. Consult your doctor for medical advice on side effects.
To report side effects, contact Mitsubishi Tanabe Pharma America, Inc. at 1-888-292-0058 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Use EXSERVAN as prescribed. The recommended dose of EXSERVAN is 50 mg orally twice daily at least 1 hour before or 2 hours after a meal. Place the EXSERVAN oral film strip on top of the tongue where it will adhere and dissolve. Swallow normally. Do not cut or split the film or take liquids with EXSERVAN. Do not chew, spit or speak while EXSERVAN is dissolving. Read the EXSERVAN instructions for use.
Please Click here to view the full prescribing information for EXSERVAN.
About Mitsubishi Tanabe Pharma America, Inc.
Situated at Jersey City, New Jersey, Mitsubishi Tanabe Pharma America, Inc. (MTPA) is a wholly owned subsidiary of Mitsubishi Tanabe Pharma Corporation (MTPC), the 100% owned U.S. holding company, Mitsubishi Tanabe Pharma Holdings America, Inc. It was established by MTPC for market approved pharmaceutical products. in North America. For more information, please visit www.mt-pharma-america.com or follow us on Twitter, Facebook and LinkedIn.
Mitsubishi Tanabe Pharma Corporation overview
Mitsubishi Tanabe Pharma, founded in 1678, is headquartered in Doshomachi, Ossaka, which is the birthplace of from Japan pharmaceutical industry. With a business focused on ethical pharmaceuticals, Mitsubishi Tanabe Pharma is a well-established company with one of the longest histories of pharmaceutical companies in Japan.1 In line with the business philosophy of “contributing to healthier lives of people around the world through the creation of pharmaceutical products”, the Company formulated the key concept of Open Up the Future as part of the management plan in the medium term 2016-2020. Through the discovery of drugs that address unmet medical needs, focused on its priority disease areas – immune and inflammatory diseases, diabetes and kidney, central nervous system and vaccines – Mitsubishi Tanabe Pharma will strive to contribute to the health of people. patients around the world. MTPC is the parent company of MTPA. For more information, visit https://www.mt-pharma.co.jp/e/.
PharmFilmÂ® and the Aquestive logo are registered trademarks of Aquestive Therapeutics, Inc. All other trademarks referenced herein are the property of their respective owners.
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SOURCE Mitsubishi Tanabe Pharma America, Inc.