ce
New FDA Approved Drugs & Vaccines Indication and Mechanism of Action: Zavegepant is a nasal spray approved for the treatment of migraine, with or without aura. It is important to note that it should not be used for the prevention of migraine. The exact cause of migraine is unknown; however, during a migraine headache, there are high levels of calcitonin gene-related peptide (CGRP) receptors which cause pain, inflammation, and vasodilation. Zavegepant is a highly potent and selective third generation CGRP antagonist that blocks the activity of CGRP on these receptors. Administration: The recommended dose of zavegepant is 10 mg given as a single spray in one nostril, as needed, with a maximum dose of 10 mg in a 24-hour period (1 spray). It should not be used to treat more than 8 migraines in a 30-day period because safety has not been established. Counsel patients not to do a test spray, prime, or press the plunger before use, as this will waste the product.
How Supplied: Zavegepant is supplied as a ready- to-use, unit-dose disposable device (Figure 1). The device delivers one spray that should be used in one nostril. It should be stored at controlled room temperature. When dispensing zavegepant, it is important to provide the accompanying medication guide and to counsel the patient on proper administration, using the teach-back counseling method to ensure the patient fully understands prior to leaving the pharmacy. Safety: The most common adverse events observed with the use of zavegepant are taste disorders, nausea, nasal discomfort, and vomiting. Additional Notes: Counsel patients to avoid con- comitant use of nasal decongestants. If nasal decongestants must be used, wait to administer them for at least 1 hour after using zavegepant. Zavegepant may benefit patients who cannot toler- ate oral formulations due to nausea and vomiting or for whom oral formulations are not effective. 5
The FDA’s approval of zavegepant is based on two clinical trials. Patients enrolled in the studies were instructed to treat a migraine of moderate to severe headache pain intensity. Rescue medication (such as NSAIDs, acetaminophen, and/or an antiemetic) was allowed 2 hours after the initial treatment. The co-primary end points included freedom from pain and most bothersome symptom (MBS) at 2 hours post-dose. Around 23% of individuals were pain-free at 2 hours post-dose, which was clinically significant versus placebo.
ENDOCRINOLOGY
Brenzavvy (bexagliflozin) 12 Indication and Action: Bexagliflozin is approved as an adjunct to diet and exercise to improve glycemic control in adults with Type II diabetes mellitus (DM). The approval is based on results from a clinical program evaluating Mechanism of
the safety and efficacy of bexagliflozin in 23 clinical trials with more than 5,000 adults with type II DM. Phase III studies found that the treatment signifi- cantly reduced hemoglobin A1C and fasting blood glucose after 24 weeks either as monotherapy 13 or in combination with metformin, or as an add-on to stan- dard-of-care treatment with a variety of regimens (to
CPhT CONNECT
www.cphtconnect.com 30
Made with FlippingBook - PDF hosting