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Pulse Newsletter

Your source for the latest industry trends and drug information news.

Volume 6 | Issue 6
March 15, 2024

Chief Authors: Rebecca Waite, PharmD
Contributing Authors: Gabrielle Graca, PharmD/MBA Candidate and Salome Mawi, PharmD/MBA Candidate

Clinical Pharmacy Update

FDA Approves Medication to Reduce Risk of Allergic Reactions to Food

On February 16, 2024, the U.S. Food and Drug Administration (FDA) approved Xolair® (omalizumab) to reduce the risk of anaphylaxis, a life-threatening allergic reaction due to accidental exposure to offending foods in adults and children 1 year and older with food allergies. The Centers for Disease Control and Prevention (CDC) has determined that nearly 6% of people in the United States have a severe food allergy, a condition for which there is currently no cure. Xolair® is not intended for the immediate emergent treatment of an allergic reaction, which is typically managed with rapidly acting epinephrine products like Epi-Pen. Instead, it should be used regularly to reduce the risk of a severe allergic reaction in case of accidental exposure to a triggering food allergen. Patients using Xolair® for this indication are still advised to avoid these foods. Xolair® works by binding to and blocking the immunoglobulin E (IgE) antibodies responsible for triggering the allergic reaction. It was initially approved by the FDA in 2003 for managing severe, persistent asthma related to airborne allergens. More recently, Xolair® was studied in patients who were allergic to peanuts as well as at least two other foods including eggs, milk, cashews, hazelnuts, walnuts or wheat. When given a single serving of peanut protein, 68% of patients treated with Xolair® did not have moderate to severe allergic symptoms such as vomiting, whole body hives or persistent coughing. Strict allergen avoidance is still necessary as 17% of treated patients did not have a significant change in their allergic reaction to peanut protein. Similar results were seen with other food allergens. 67% of patients who also had an egg allergy, 42% with a cashew allergy and 66% with a milk allergy were able to consume one serving of these products without moderate to severe allergic symptoms. The most common side effects of Xolair® were fever and injection site reactions. It also has a warning for anaphylaxis, as this has been reported in patients both when receiving the first dose and up to a year into treatment. As a result, Xolair® must be administered in a healthcare setting initially before being able to consider self-administration.

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Drug Safety

Voluntary Recall of Eye Ointment Products

On February 22, 2024, Brassica Pharma announced a voluntary recall of several eye ointment products, including Equate Lubricant Eye Ointment, Equate Stye Lubricant Eye Ointment, CVS Health Lubricant Eye Ointment and AACE Pharmaceuticals Lubricant PM Ointment. Recalled items have an expiration date ranging from February 2024 through September 2025. Details of specific lot numbers being recalled can be found on the FDA’s website. The facility where the recalled products were manufactured was unable to assure sterile practices at the time of production, increasing the risk of contamination and eye infections in users. There have not been any reports of adverse events related to this recall to date. Consumers of any recalled products should stop using and may return them at the place of purchase. Adverse reactions associated with this recall should be discussed with a health care provider and may be reported to the FDA’s MedWatch Adverse Event Reporting program.

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From the Pharmaceutical Industry

CDC Simplifies RSV Recommendations

On March 1, 2024, the CDC released updated recommendations on preventing the spread of respiratory viruses such as COVID-19, respiratory syncytial virus (RSV) and influenza. The U.S. has seen a decrease in hospitalizations and deaths associated with COVID-19, but it is still critical that everyone takes precaution in protecting themselves and others from serious illnesses caused by respiratory viruses. The CDC updated their recommendations, making them easier to follow while still protecting those who are at risk. Core prevention strategies include staying up to date with vaccinations, practicing good personal hygiene and taking steps for cleaner air. It is recommended that people stay home when sick, but they can return to normal activities if the symptoms have improved and have been fever free for at least 24 hours. After resuming normal activities, additional steps should be taken for the next 5 days to control disease spread. Additional steps include purifying the air, enhancing hygiene practices, masking, distancing from others and getting tested for respiratory viruses. These additional steps and precautions are especially important to protect people who are over 65 years old and people with weakened immune systems, as they have a higher risk for severe illness. Following the CDC’s recommendations will help control the spread of respiratory viruses and can protect the community from experiencing severe illness caused by respiratory viruses. 

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FDA Approvals

New FDA Approvals

New Drug: SIMLANDI® (adalimumab-ryvk) injection

Subcutaneous injection approved as an interchangeable high-concentration biosimilar to Humira® (adalimumab) for the treatment of multiple inflammatory autoimmune disorders, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, hidradenitis suppurativa and uveitis in certain patients. [2/23/24 – TEVA] 

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New Generics

New Generics Entering the Marketplace

Emflaza® (deflazacort)

Indication: Treatment of Duchenne muscular dystrophy in patients 2 years and older

Dosage Form/Strength: 36mg tablet 

Average Wholesale Price (AWP): Generic = $19,190 | Brand = $21,322