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From BeneCard PBF staff

Many clients have seen an increase in utilization of GLP-1 receptor agonists such as Ozempic, Saxenda and Wegovy. As the prescribing trends of these medications continue to grow, we are also seeing increased media coverage warning about the risk of side effects associated with these agents. Benecard is committed to ensuring safe and appropriate utilization of these medications. Here are some important facts that you should know:

What are Glucagon-like peptide 1 (GLP-1) receptor agonists and how do they work?

GLP-1 receptor agonists bind to the GLP-1 receptor and work by mimicking GLP-1, a hormone that’s naturally made by the body. GLP-1 agents stimulate glucose-dependent insulin release which leads to a reduction of blood glucose. GLP-1 agonists also slow the passage of food through the stomach which helps people feel full longer, leading to weight loss.

How are these agents accessible?

GLP-1 receptor agonists have been used to treat type 2 diabetes for more than 15 years and for the
treatment of obesity for eight years.
• Saxenda (liraglutide) and Wegovy (semaglutide) are GLP-1 receptor agonists that are FDA approved for chronic weight management.
• Ozempic (semaglutide, injectable), Rybelsus (semaglutide, oral), Trulicity (dulaglutide), and Victoza (liraglutide) are GLP-1 receptor agonists that are FDA approved for patients with type 2 diabetes.
• Mounjaro (tirzeptatide) is a dual glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist (GIP/GLP-1 RA), which is FDA approved for patients with type 2 diabetes.

What are the risks associated with utilization of GLP-1s?

• The most common side effects are gastrointestinal, including nausea, diarrhea, and vomiting. These adverse effects are generally mild to moderate for most patients and improve over time. GLP-1s cause a delay in gastric emptying, but in rare cases, this has resulted in more severe side effects such as gastroparesis (stomach paralysis) and cyclic vomiting. Gastroparesis is a condition that affects the nerves and muscles of the stomach and leads to food sitting in the stomach for too long.

Gastroparesis can have many causes, including diabetes, which makes it difficult to determine how much of a role these drugs play in affecting patients who have reported these side effects. It is believed that reports of extreme side effects such as gastroparesis could be a result of the drug worsening existing “slow stomach” that patients may have but have been unaware of. The FDA says that the benefits of the medication may still outweigh the risks even for this population. Due to the known delay in gastric emptying that GLP-1s cause, the American Society of Anesthesiologists has recently released interim guidance that suggests that patients who are undergoing elective surgery should stop taking these medications at least 1 week prior to surgery, to reduce the risk of nausea, vomiting, and aspiration while under anesthesia.

• GLP-1s also include a warning about suicidal behavior and ideation. The prescribing information for these agents includes a recommendation that patients should be monitored for depression or suicidal thoughts and that therapy should be discontinued if symptoms develop. It is important that patients and prescribers are aware of this recommendation to ensure that they are aware of signs and symptoms of depression, if they should occur.

• Social media influence and celebrities who are promoting the use of GLP-1 agents in addition to drug shortages have contributed to an increase in off-label use and unauthorized versions of these drugs. The FDA has warned that there are potential safety risks associated with using “compounded” GLP-1s, which are now gaining popularity.

• GLP-1s are contraindicated in patients with a personal or family history of medullary thyroid carcinoma (MTC) or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Patients taking GLP-1s should be monitored for symptoms of hypoglycemia, acute pancreatitis, gallbladder disease, and kidney injury.

Benecard’s Continued Commitment to Patient Safety

BeneCard PBF now conducts clinical reviews on all GLP-1 medications to ensure that the appropriate medication is being prescribed for its intended FDA approved use. GLP-1 agents for the treatment of obesity require initial clinical review and continued reauthorizations to ensure that the appropriate dose titration schedule is being followed and that patients are being monitored for unwanted side effects.

Reviews of updated safety data and recommendations are conducted so that, as new safety concerns for these agents arise, we can add these new monitoring parameters or warnings to our clinical review policies. Patient safety and quality healthcare for the patient are always our top priorities.

References

Goodman, B 2023, ‘They took blockbuster drugs for weight loss and diabetes. Now their stomachs are paralyzed’, CNN Health, 25 July, accessed 15 August 2023, They took blockbuster drugs for weight loss and diabetes. Now their stomachs are paralyzed | CNN

Redmond, K 2023, ‘Potential Wegovy, Ozempic link to suicidal thoughts prompts EU investigation’, NJBIZ, 14 July, accessed 15 August 2023, Potential Wegovy, Ozempic link to suicidal thoughts prompts EU investigation – NJBIZ

Constantino, A 2023, ‘People should stop taking Ozempic, Wegovy obesity drugs before surgery, doctors group says’, CNBC, 30 June, accessed 15 August 2023, Stop taking Ozempic, Wegovy before surgery: Doctors (cnbc.com)

KVK-Tech, Inc. is voluntarily recalling one lot (Batch Number: 17853A of Betaxolol Tablets, USP 10 mg, White, Round, film coated biconvex tablets, debossed “K” above bisect “13” on one side and plain on the other side” to the consumer level. The batch was distributed nationwide to wholesalers and retailers. The batch is being recalled as a precautionary measure due to a single Oxycodone HCl tablet 5 mg foreign tablet found on the packaging line during the line clearance, after the subject batch was packaged. KVK has not received any reports of foreign tablets in any bottle of Betaxolol Tablets, USP 10 mg (Batch Number 17853A).

Risk Statement: The betaxolol package insert warns about slowing in the heart rate in elderly patients which is likely to be exacerbated by inadvertent opioid administration. Additionally, some patients prescribed low-dose betaxolol might have compromised heart and lung function that is also likely to be exacerbated by an opioid. Furthermore, there are minor differences in appearance between betaxolol 10 mg tablets and oxycodone 5 mg tablets, not likely to be noticed by a regular user of the 10 mg betaxolol tablet. Specific patient populations such as those with opioid use disorder (OUD) or at risk of OUD, infants, children, and the elderly are likely to be negatively affected by inadvertently receiving an opioid, especially if a substantial number of oxycodone tablets have been introduced into a bottle labeled as betaxolol.

Therefore, inadvertent exposure to a controlled substance, such as oxycodone, in that patient population is likely to result in significant slowing in breathing, known as respiratory depression, which is a serious health risk.

Betaxolol HCl Tablets are packaged in 50 CC White High-Density Polyethylene (HDPE) bottles, 100 Tablets and 10702-013-01. The affected Betaxolol Tablets, USP 10 mg lot 17853A has labeled expiration as June 2027. The product can be identified by using the images of tablets and labels provided below.

KVK notified its distributors and customers by a Recall Notification Letter via email and FedEx overnight mail on 09/26/2023 and is arranging for the return of all recalled products. KVK believes that a small number of bottles may have been distributed to retail pharmacies. Consumers that may have received Betaxolol Tablets, USP 10 mg (Batch Number: 17853A), should stop using and immediately return the product to KVK-Tech, Inc., 110 Terry Drive, Newtown, PA 18940. KVK will arrange to reimburse customers for their costs in purchasing the product.

Consumers with questions regarding this recall can contact KVK-Tech Inc., at (215) 579-1842 Ext: 6002 Monday – Friday, 8:00 am – 6:00 pm EST or by email at customerservice@kvktech.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

No clients/members of BeneCard PBF were affected by these recalls.

FDA Reporting

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Complete and submit the report Online: www.fda.gov/medwatch/report.htm

• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-
1088 to request a reporting form, then complete and return to the address on the pre-addressed
form, or submit by fax to 1-800-FDA-0178

Hospira, Inc., a Pfizer company, is voluntarily recalling the lots listed below of 4.2% Sodium Bicarbonate Injection, USP, 5 mEq/10mL vial; 1% Lidocaine HCl Injection, USP, 50 mg/5mL vial; and 2% Lidocaine HCl Injection, USP, 100 mg/5mL vial to the user level. The recall was initiated due to the potential for presence of glass particulate matter.

There is an unlikely probability for serious adverse events, including death, should a patient receive an injectable product found to contain particulate matter identified as glass. Potential complications related to injection of visible and subvisible inert particles include inflammation of a vein, granuloma, and blockage of blood vessels or life-threatening blood clot events. The frequency and severity of these adverse events could vary depending upon a variety of factors including the size and number of particles in the drug product, patient comorbidities (such as age, compromised organ function), and presence or absence of vascular anomalies. The risk is reduced by the possibility of detection, as the label contains a clear statement directing the healthcare professional to visually inspect the product for particulate matter and discoloration prior to administration.

To date, Hospira, Inc. has not received reports of any adverse events associated with this issue for these lots.

Healthcare Professionals with questions regarding this recall can contact Pfizer using the information
below.

Biogen Inc. announced that the U.S. Food and Drug Administration has approved Tofidence (tocilizumab-bavi) intravenous formulation, a biosimilar monoclonal antibody referencing Actemra. The Tofidence intravenous formulation is approved for the treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.

Tofidence is the first tocilizumab biosimilar approved in the United States. Biosimilars are biologic products that have been demonstrated to have equivalent efficacy and comparable safety as the approved reference product, with the advantage that they may offer cost savings and promote expanded and sustainable access to therapies.

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FDA Approves Pombiliti (cipaglucosidase alfa-atga) + Opfolda (miglustat) for the Treatment of Late-Onset Pompe Disease

Amicus Therapeutics announced that the U.S. Food and Drug Administration has approved Pombiliti™ (cipaglucosidase alfa-atga) + Opfolda™ (miglustat) 65mg capsules. This two-component therapy is indicated for adults living with late-onset Pompe disease (LOPD) who are not improving on their current enzyme replacement therapy (ERT).

Pombiliti + Opfolda is a unique two-component therapy. Pombiliti is a recombinant human GAA enzyme (rhGAA) naturally expressed with high levels of bis-M6P (Mannose 6-Phosphate), designed for increased uptake into muscle cells. Once in the cell, Pombiliti can be properly processed into its most active and mature form to break down glycogen. Opfolda is an enzyme stabilizer designed to stabilize the enzyme in the blood. Amicus Therapeutics will launch Pombiliti with Opfolda immediately in the U.S.

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FDA Approves Exxua (gepirone) for the Treatment of Major Depressive Disorder in Adults

Fabre-Kramer Pharmaceuticals Inc. (Fabre-Kramer) announced that the U.S. Food and Drug Administration has approved Exxua (gepirone hydrochloride extended-release tablets) for the treatment of major depressive disorder (MDD) in adults.

Exxua represents a new class of antidepressant; the first and only approved antidepressant with a novel mechanism of action that selectively targets the serotonin 1A receptor, a key regulator of mood and emotion. Exxua has been shown to effectively relieve depressive symptoms, and its approved labeling does not contain warnings or adverse reactions regarding causing sexual dysfunction or weight gain vs. placebo.

Exxua is expected to be available in pharmacies in early 2024. Exxua is not approved for use in pediatric patients.

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Scynexis, Inc. is conducting a voluntary nationwide recall of 2 lots of BREXAFEMME® (ibrexafungerp tablets) to the consumer level in the US market due to potential cross contamination with a non-antibacterial ß-lactam drug substance in the ibrexafungerp citrate used to manufacture the BREXAFEMME® tablets.

Risk Statement: The potential cross contamination with a non-antibacterial beta-lactam drug substance could lead to hypersensitivity reactions such as swelling, rash, urticaria and anaphylaxis, a potentially life-threatening adverse reaction. To date, SCYNEXIS has not received any reports of adverse events established to be due to the possible beta-lactam cross contamination.

The affected BREXAFEMME® lots include the following lots and expiration dates: LF21000008 (expiration date 11/2023) and LF22000051 (expiration date 11/2025). The recalled lots were distributed nationwide to wholesalers across the US, beginning in December 2022.

Scynexis is engaging with Sedgwick to manage the recall of the product down to the consumer level. Sedgwick will be notifying BREXAFEMME® distributors via a recall notification letter and will be arranging for the return of the recalled lot from distributors, retailers, and consumers.

Consumers with questions regarding this recall can contact Sedgwick at 1-877-551-7154. Office hours: Monday to Friday, 8:00 AM to 5:00 PM ET.

Consumers should contact their healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

FDA Approves Ryzumvi (phentolamine) Ophthalmic Solution for the Treatment of Pharmacologically-Induced Mydriasis

Ocuphire Pharma, Inc., a clinical-stage ophthalmic biopharmaceutical company and Viatris Inc., announced that the U.S. Food and Drug Administration (FDA) has approved Ryzumvi™ (phentolamine ophthalmic solution) 0.75% for the treatment of pharmacologically-induced mydriasis produced by adrenergic agonists (e.g., phenylephrine) or parasympatholytic (e.g., tropicamide) agents.

In the U.S., an estimated 100 million comprehensive eye exams take place each year that involve pharmacologically-induced mydriasis (or dilation) of the pupils, which can last up 24 hours. Side effects of pharmacologically-induced mydriasis include sensitivity to light (photophobia) and blurred vision, which may make it difficult to read, work and drive. Ryzumvi is expected to be commercially available in the U.S. in the first half of 2024.

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