vyepti package insert

Vyepti is an anti-CGRP (calcitonin gene-related peptide) monoclonal antibody – the fourth to be approved by the FDA. Bothell , W A; Lundbeck Seattle BioPharm. Indication VYEPTI® is indicated for the preventive treatment of migraine in adults. Important Safety Information CONTRAINDICATIONS • VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Medications for migraine prophylaxis. SEE CLINICAL RESULTS. CHRONIC MIGRAINE HEADACHE PROPHYLAXIS For initial authorization: 1. Pharmacol Res Perspect. All rights reserved. H��V[o�6~��# �/% E��Kf$j�"�C��]��j��w.�L)�;?X��~�B�9��h)^�::��.��_/�bv4��b��ح��v3��ZX��ƕ�_�1M�-��*DQ��B��k��T9�ȟ�.��oUڛB"��Ү0Q^��oL� YK)�D�8Q:�*��/@�K�}̟sR�`��I>i�8S:ؿQ!� �f�T$�s�{��b|C��k�q};�B��3Dg��C8��u�θ�B�dց�?��5S��Z��*��O�FJ�D��Kٱ��%�'��m��mi�"nV��n3O� |�t��t��.�u�l�� Deerfield, IL. ��B�W�\59��C \�� 6S��;��RT��\\c5@��T �|�� @+��łܬ��+W��ɥdzM�6�dnEێ1�ƺ2U�We�&�(H]��y�bCG��f�=JX4��dV��4>��y��X��i޴Cb��&�s��w/�f�K �u{��fJ�$�Teýt��d��2=6�y6Ѫ��Mm\��$�3td2�jk��`$��E�Z�*��A2%oyrӚ�uJ'��S��|r��,B��Ѱ�pZL�ߧ�{��`�H�� FErO-�N��BWc$?p�n��hL%�]0E(F�/��G��O/n�4��`Reb��0�.��X(��t�1� �.�� -��T�}OCt�@�{�s�(��(\�a�b�7�� 7��U�9�7\�)��Y�c? VYEPTI is for intravenous infusion only; infuse over approximately 30 minutes. CGRP, calcitonin gene-related peptide; MOA, mechanism of action. in adults. Vyepti [package insert]. A migraine is a type of headache that can be associated with nausea, vomiting, and/or sensitivity to light or sound. %%EOF 0 Bothell, WA: Lundbeck Seattle Bio Pharmaceuticals, Inc; February 2020. H��V�o�8~�_��d`V�ò�(�5�Ck7\� ov�6;ؖv��GJ�� zևڑ(�#��W�s��c攕��,7�ҵb��6��#�.lX)��L� v�[�=��K�[ O�ٻ��34��+�lg+�ܷt~�|��:"��ZqCh� ��,�:l��pP��#~C��ErǇ�_� ��F�� y�1j�,"�[r�P$�;��n�-�}��/P��ѣy��D�Lm��bv�F��\�_,D%��^,`-��L��d��L+��1��/��c-��J|� ;�N�bN`�r��_8p��&��Tik�f%�3P^c�*�. �o� VYEPTI is indicated for the preventive treatment of migraine in adults. ۶�K�L��_�?No?8��)�U�V�'�KQ.��D�� TI��/W�yʸ7��(o�]�d��ٺ*J��3wߌ�G��؀�BMV��dOƷ��k:��;� a }��V�h�U�]m�}$$��tE��M�F�x?��κ��M�y�7+~Ye`�2�n��-ߡ%�E�Z|��r��"xsN�z��,��x��|7�~ �w��pa�pIh��h��uh�#ill#k�X��X(� C��R:�u��e8Ni��>6�p� \(�eq��&ĉY�lL�� Some patients may benefit from a dosage … 2.4 Discontinuation of XCOPRI If XCOPRI is discontinued, the dosage should be gradually reduced over a period of at least 2 weeks, unless safety concerns require abrupt withdrawal [see Warnings and Precautions (5.1, 5.5)]. If a hypersensitivity reaction occurs, consider discontinuing VYEPTI, and institute appropriate therapy. Dilute only in 100 mL 0.9% Sodium Chloride Injection, USP. Vyepti single-do… This website is intended for US healthcare professionals only. Accessed March 2020. 6 FDA Approved: Yes (First approved February 21, 2020) Brand name: Vyepti Generic name: eptinezumab-jjmr Dosage form: Injection Company: Lundbeck Inc. O n February 21, 2020, the Food and Drug Administration (FDA) approved VYEPTI (eptinezumab-jjmr) for use in the prevention of episodic and chronic Migraine attacks. h��WYo�6�+|L�DR�!`�@b7�n�MA([MȖ!+E��wf(ɒ|�آ�Arn ?~��gR��0)�}�4��l��,��!S��3m�\ Most hypersensitivity reactions occurred during infusion and were not serious, but often led to discontinuation or required treatment. "r�@b�T"�3~0 Use appropriate aseptic technique when preparing VYEPTI solution for intravenous (IV) infusion. HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use ZEPOSIA safely and effectively. Vyepti [package insert]. VYEPTI is indicated for the preventive treatment of migraine Learn more. VYEPTI 100 mg dose: Withdraw 1 mL of VYEPTI from a single-dose vial using a sterile needle and syringe. © 2021 Lundbeck. See safety information including thrombosis, hypertension, & embryo-fetal toxicity. No other medications should be administered through the infusion set or mixed with VYEPTI. Population pharmacokinetic and exposure-response analysis of eptinezumab in the treatment of episodic and chronic migraine. Bothell, WA; Lundbeck Seattle; February 2020. VYEPTI (eptinezumab-jjmr) [package insert]. endstream endobj 194 0 obj <> endobj 195 0 obj <> endobj 196 0 obj <>stream 193 0 obj <> endobj 2020:8(2):e00567. VYEPTI is proven to help stop migraine headaches before they start. Tell your healthcare provider if you have any side effect that bothers you or that does not go away. VYEPTI (EPTINEZUMAB-JJMR) IV DOSAGE: 100 mL 0.9% Sodium Chloride 100 mg 300 mg Frequency: Every 3 months *Per package insert, start at 100mg Patient Name: DOB: / / Allergies: Weight: lbs / kg Height: Diagnosis: ICD-10: PATIENT INFORMATION Pre-Medications Not Usually Indicated. Population pharmacokinetic and exposure-response analysis of eptinezumab in the treatment of episodic and chronic migraine. 2 FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE REYVOW® is indicated for the acute treatment of migraine with or without aura in adults. It is not known if VYEPTI is safe and effective in children. "�Aܝ �8�(�Az�t��@� �� Migraine days may be cut by 75% or more 22% of people treated with VYEPTI achieved a 75% reduction of migraine days, compared to 16% treated with placebo, from Months 1 … Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc.: 2/2020 7. BLA 761143 Page 10 Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. See the end of this Patient Information leaflet for a complete list of ingredients in VYEPTI. Vyepti (eptinezumab-jjmr) is a non-preferred product and will only be considered for coverage under the medical benefit when the following criteria are met: Members must be clinically diagnosed with one of the following disease states and meet their individual criteria as stated. 2. Register for updates. Please see Indications, Important Safety Info, and Prescribing Info. References 1. VYEPTI is a prescription medicine used for the preventive treatment of migraine in adults. b��h�E��u_�5�@5H�B��Dt}��p�&��́��u�i\;�%.ĻK ��~"��A3��?��fO��>C��>��CZx @z��1%I�t�U��!Mr4f��.O˶u��P>�}i|F-yEy��ʱ|��X��-�p�n�9Ż&�tE[�9P,h|��o�'��F��*�l�A��n�k�i��V�NGL��=��~4�E��W� P`y_ In clinical trials, efficacy has been excellent. h�b```e``�g`a`�+fd@ A�+s```QR�t�ݸ�q��+�3��5n]!�c�W��0�D[�q��K8X'�q6��2��>��1ؑ�y�a��D��M��s�SO�EGCF�DGC�GcC�FG�DG�H��@�"XL;��A�~F5�E � u FULL PRESCRIBING INFORMATION 1 INDICATIONS AND USAGE OCREVUS is indicated for the treatment of: Relapsing forms of multiple sclerosis (MS), to includeclinically isolated syndrome, relapsing-remitting VYEPTI 100 mg dose:Withdraw 1 mL of VYEPTI from a single-dose vial using a sterile needle and syringe. Garcia-Martinez LF, Raport CJ, Ojala EW, et al. VYEPTI is a prescription medicine used for the preventive treatment of migraine in adults. Pharmacologic characterization of ALD403, a potent neutralizing humanized monoclonal antibody against the calcitonin gene-related peptide. ®Amerge [package insert]. Vyepti [package insert]. Vyepti FDA Approval History. See full prescribing information for ZEPOSIA. These are not all the possible side effects of VYEPTI. VYEPTI [package insert]. 1 AJOVY®HIGHLIGHTS OF PRESCRIBING INFORMATION (fremanezumab-vfrm) injection These highlights do not include all the information needed to use AJOVY safely and effectively. … VYEPTI requires dilution prior to administration. Modi S, Lowder DM. �lj>��#�`��AyIG� ��r�C�f"9� �J 2. Bothell, WA: Lundbeck Seattle Bio Pharmaceuticals, Inc; February 2020. Reactions have included angioedema. VYEPTI is a drug used for the preventive treatment of migraine in adults. 2 DOSAGE AND ADMINISTRATION 2.1 Recommended Dosing - The recommended dosage is 100 mg administered by intravenous infusion every 3 months. Serious hypersensitivity reactions may occur. �Cq��v��1ȡ�X�pl%3,�Q�C�~�:��?�[��>�2�7��C �8ǅB�c u6��{Wn7٤��:g�Z��k��"ΙW8'�4 xd�զ��t�N�=��$̟�cM��0.z��uȖFTu%�@�"�($�Oߩ~p_�7�ã�MeLq��'߃{(�0K��d��kJ1�P�Q? Vyepti [package insert]. For more information, please see the Prescribing Information and Patient Information. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc. Baker B, Schaeffler B, Beliveau M, et al. VYEPTI (eptinezumab-jjmr) [package insert]. See full prescribing information for AJOVY. VYEPTI is a 30-minute intravenous (IV) treatment given 4 times per year (every 3 months) by a trained healthcare professional. The infusion bags must be made of polyvinyl chloride (PVC), polyethylene (PE), or polyolefin (PO). Modi S, Lowder DM. Vyepti 100 mg/mL solution for injection; single-dose vial: 67386-0130-xx VII. Use appropriate aseptic technique when preparing Vyepti solution for intravenous infusion. Bothell, WA; Lundbeck Seattle; February 2020. VYEPTI is indicated for the preventive treatment of migraine in adults. 1. Accessed March 20 20 . h�bbd``b`V^@��9�`�$X*��.�� Inject the 1 mL content into a 100 mL bag of 0.9% Sodium Chloride Injection, USP. It is not known if VYEPTI is safe and effective in children. The most common side effects of VYEPTI include stuffy nose and scratchy throat, and allergic reactions. 6 6. Bothell, WA: Lundbeck Seattle BioPharmaceuticals, Inc. Baker B, Schaeffler B, Beliveau M, et al. The most common adverse reactions (≥2% and at least 2% or greater than placebo) in the clinical trials for the preventive treatment of migraine were nasopharyngitis and hypersensitivity. Vyepti™ [package insert]. Lundbeck; 2020. 229 0 obj <>stream endstream endobj 198 0 obj <>stream "d}fwY1� �_f�,P�|ťz��`i�#��~ ORENCIA® (abatacept) is a prescription medication that treats adult moderate to severe RA, adult active PsA, and for patients 2 years and older with moderate to severe polyarticular JIA. Limitations of Use REYVOW is not indicated for the preventive treatment of migraine. Vyepti requires dilution prior to administration. endstream endobj startxref %PDF-1.6 %�� S�a�D"�O:��HP�� 1jO�lϐ��x�\�s��&��L�l��g��&k��b�Ÿ�GAmt j_vQ \��C5a��WE�x��^Σ��M5zJJv ��[��R�];��t��n��6�Q��P �cD� �V ��NGd��=�-�_1�8�~�C�m��;঒�@|��C:��w� G�Ʈ��a8Y-o�n��V��?��ԟ�� m��m/}�?��#�G��v�.�V�֝B�g�Gog�x5�1dQ�m�284,��1>�7u]X|-SJ��ہc��ЎZ��9�C��nO�3��mF��bMצ��Pk�S�k� � ݁�9(ߡ-�8�ˏ�>�^ \�̯��>R5�WR�;�TJ7|�]��wH��z��W��$��.��X�{�X�a�n��k��=��Eu44GT$"��XU�>��U��:̪��լ��U}�*V�f3��9�c�z�5��ɛ��&� j9P Length of Authorization Coverage will be provided for six months and may be renewed. VYEPTI, VYEPTI CONNECT, and VYEPTI GO are trademarks of Lundbeck Seattle BioPharmaceuticals, Inc. EPT-B-100032v4, VYEPTI-Ready Provider and Infusion Center Locator. Medications for migraine prophylaxis. (erenumab - aooe)** or Vyepti (eptinezumab-jjmr)** for the preventive treatment of migraine when all of the following criteria are met: • Patient is ≥ 18 years of age AND • Patient has ≥ 4 migraine headache days per month (prior to initiating a migraine-preventative medication) AND 4 IV TREATMENTS PER YEAR. Vyepti may work fairly quickly (within hours to days). endstream endobj 199 0 obj <>stream H�\��j�0��~ Do not receive VYEPTI if you are allergic to eptinezumab-jjmr or any of the ingredients in VYEPTI. VYEPTI permanent J-code (J3032) is now available. Bothell, WA; Lundbeck Seattle BioPharm., Inc; February 2020. f|��~��E�D��B� ��!�&��`��皳��Q��t��S��;�XUTl>}B�)��ht�l�hjb��s*a#��\�f��pkA��_�EZf�ǳ�"]UY�=��lS�۳�E�{��:O��f�|.7s�Ε7��)�ˍ+!Yߤ��S��8u��6�:O7,�ϻ�*��8əp+&�u��t�|(�s'��TB endstream endobj 197 0 obj <>stream II. Reactions have included angioedema. B GET STARTED WITH VYEPTI. x Vyepti 100 mg/mL solution for injection ; single -dose vial : 67386 -0130 -xx VII. , Inc; February 20 20 . Am … Am … Reblozyl® (luspatercept-aamt) for injection for anemia in adult MDS patients with ring sideroblasts (MDS-RS) or anemia in adults with beta thalassemia patients requiring regular transfusions. VYEPTI is a prescription medicine used for the preventive treatment of migraine in adults. 1 INDICATIONS AND USAGE 1.1 Rheumatoid Arthritis (RA) ACTEMRA ® (tocilizumab) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more Disease-Modifying Anti-Rheumatic Drugs (DMARDs).. 1.2 Giant Cell Arteritis (GCA) ACTEMRA ® (tocilizumab) is indicated for the treatment of giant cell … Vyepti [package insert]. 212 0 obj <>/Filter/FlateDecode/ID[<8CF1596561D0FE41B803A5A7027B6FA4><9BA77F069767CA47BC22F659FDC89FFF>]/Index[193 37]/Info 192 0 R/Length 91/Prev 393195/Root 194 0 R/Size 230/Type/XRef/W[1 2 1]>>stream VYEPTI is a trademark of LUNDBECK SEATTLE BIOPHARMACEUTICALS, INC.. Filed in April 24 (2018), the VYEPTI covers Pharmaceutical preparations used for the prevention, management and treatment of headaches, migraines, pain, and neurological disorders and conditions Reviewed by J.Stewart BPharm.Last updated on March 22, 2020. Vyepti® (eptinezumab-jjmr) (Intravenous) Effective Date: 07/01/2020 Dates Reviewed: 06/15/2020, 9/9/2020 Revision Date: 06/15/2020, 9/9/2020 Scope: Medicaid, Exchange, Medicare-Medicaid Plan (MMP) I. POWERFUL MIGRAINE PREVENTION. Use appropriate aseptic technique when preparing VYEPTI solution for intravenous (IV) infusion. References 1. Vyepti [package insert]. VYEPTI is contraindicated in patients with serious hypersensitivity to eptinezumab-jjmr or to any of the excipients. Eptinezumab (Vyepti), a CGRP monoclonal preventive, was FDA approved in February 2020. See the end of this Patient Information leaflet for a complete list of ingredients in VYEPTI. Inject the 1 mL content into a 100 mL bag of 0.9% Sodium Chloride Injection, USP. Eptinezumab is the first intravenous formulation for the prevention of migraine in adults with a recommended dose of 100 mg every 3 months. Do not receive VYEPTI if you are allergic to eptinezumab-jjmr or any of the ingredients in VYEPTI. DRUG NAME Vyepti (eptinezumab-jjmr) BILLING CODE J3490 BENEFIT TYPE Medical SITE OF SERVICE ALLOWED Office/Outpatient COVERAGE REQUIREMENTS Prior Authorization Required (Non-Preferred Product) QUANTITY LIMIT — 300mg (3 vials) per 90 days LIST OF DIAGNOSES CONSIDERED NOT MEDICALLY NECESSARY Click Here Hypersensitivity reactions: Hypersensitivity reactions, including angioedema, urticaria, facial flushing, and rash, have occurred with VYEPTI in clinical trials. 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