FDA Approves Erenumab – First Among a New Class of Drugs to Prevent Migraines
Learning Objectives and CME/Disclosure Information
This activity is intended for healthcare providers delivering care to women and their families.
After completing this activity, the participant should be better able to:
1. Describe how erenumab works for the prevention of migraine headaches 2. State the dosage and administration of erenumab
Estimated time to complete activity: 0.25 hours
Susan J. Gross, MD, FRCSC, FACOG, FACMG President and CEO, The ObG Project
Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.
Faculty: Susan J. Gross, MD, receives consulting fees from Cradle Genomics, and has financial interest in The ObG Project, Inc.
Planners and Managers: The PIM planners and managers, Trace Hutchison, PharmD, Samantha Mattiucci, PharmD, CHCP, Judi Smelker-Mitchek, MBA, MSN, RN, and Jan Schultz, MSN, RN, CHCP have nothing to disclose.
Method of Participation and Request for Credit
Fees for participating and receiving CME credit for this activity are as posted on The ObG Project website. During the period from June 4 2018 through June 4 2021, participants must read the learning objectives and faculty disclosures and study the educational activity.
If you wish to receive acknowledgment for completing this activity, please complete the post-test and evaluation. Upon registering and successfully completing the post-test with a score of 100% and the activity evaluation, your certificate will be made available immediately.
For Pharmacists: Upon successfully completing the post-test with a score of 100% and the activity evaluation form, transcript information will be sent to the NABP CPE Monitor Service within 4 weeks.
Joint Accreditation Statement
In support of improving patient care, this activity has been planned and implemented by the Postgraduate Institute for Medicine and The ObG Project. Postgraduate Institute for Medicine is jointly accredited by the Accreditation Council for Continuing Medical Education (ACCME), the Accreditation Council for Pharmacy Education (ACPE), and the American Nurses Credentialing Center (ANCC), to provide continuing education for the healthcare team.
Physician Continuing Medical Education
Postgraduate Institute for Medicine designates this enduring material for a maximum of 0.25 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Continuing Pharmacy Education
Postgraduate Institute for Medicine designates this continuing education activity for 0.25 contact hour(s) (0.25 CEUs) of the Accreditation Council for Pharmacy Education. (Universal Activity Number – JA4008162-9999-18-159-H01-P)
Type of Activity: Knowledge
Continuing Nursing Education
The maximum number of hours awarded for this Continuing Nursing Education activity is 0.2 contact hours.
Designated for 0.1 contact hours of pharmacotherapy credit for Advance Practice Registered Nurses.
On May 17, 2018, the FDA approved erenumab, the first drug to prevent migraines by targeting and blocking the activity of calcitonin gene-related peptide (CGRP-R), an important molecule involved in migraine attacks. Studies demonstrated that using monthly self-administered injections, migraine sufferers experienced a reduction in monthly migraine days (see data below under ‘Supporting Studies’)
For the preventive treatment of migraine in adults
70mg once monthly subcutaneously
Some patients may benefit from a dosage of 140mg once monthly administered once monthly as two consecutive injections of 70mg each
Administer in the abdomen, thigh, or upper arm subcutaneously
FDA approval based on 3 studies
955 participants with a history of episodic migraine
Methods: Compared Erenumab to placebo over 6 months
Findings: Erenumab-treated patients experienced, on average, one to two fewer monthly migraine days than those on placebo
577 patients with a history of episodic migraine
Methods: Compared Erenumab to placebo over 3 months
Results: Erenumab-treated patients experienced, on average, one fewer migraine day per month than those on placebo
667 patients with a history of chronic migraine
Methods: Compared Erenumab to placebo over 3 months
Results: Patients treated with Erenumab experienced, on average, 2 ½ fewer monthly migraine days than those receiving placebo
Most Common Side Effects
≥3% of patients experienced injection site reactions and constipation
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Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.
The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.
Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information
presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patient’s conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.
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