Symjepi Offers New Option for Injectable Epinephrine

As back-to-school season approaches, concerns about serious food allergies are on the minds of many parents, school administrators, and teachers. Although research on exact figures is conflicting, the prevalence of severe allergies is growing, with a 2011 survey of 38,480 children suggesting that the incidence of food allergies could be as high as about 8%.¹ These data were on the higher end of the estimations, but other studies suggest the rate is between 1% and 5%.

A serious complication of life-threatening allergies is anaphylaxis upon exposure to the allergen. The first-line treatment for anaphylaxis is intramuscular (IM) epinephrine.² Epinephrine auto-injectors (EAIs) are the most commonly prescribed IM epinephrine products. Brand names Adrenaclick, Auvi-Q, and EpiPen, as well as several generics, have been on the market. Adrenaclick and Auvi-Q are not interchangeable with each other, EpiPen, or EpiPen Mylan- and Teva-brand generics. These products are available as 0.3-mg adult doses and 0.15-mg pediatric doses, with the exception of the Teva-generic epinephrine, which is available in only adult doses.

Symjepi is an IM epinephrine option that is not an EAI but instead operates like a syringe. Offered by Sandoz Inc, it features a compact size, a mechanism available in adult and pediatric dosing, a thinner needle than that of some other EAIs, and a window that shows whether the dose has been given.³

BARRIERS TO ACCESS

Access to IM epinephrine products is critical to caregivers and patients in the event of a severe allergic response, but they are often met with barriers because of drug shortages and high medication costs. Products such as EpiPen and generic EAIs have been in perpetual shortage since May 2018.⁴ As recently as June 5, 2019, Mylan and Pfizer coordinated with the FDA to extend the expiration dates of several epinephrine products to address issues with shortages. This marks the third time in a 1-year period, following February 27, 2019, and August 21, 2018, that this kind of measure was needed.⁵

The cost of the medications is another common barrier for caregivers and patients. The annual direct costs for EAIs were esti- mated to be nearly 25% of the annual cost to treat several allergic reactions in 2010.⁶

An analysis of out-of-pocket expenses for 191.2 million commercially insured patients between 2007 and 2014 showed an increase from about $33 to over $75 for annual out-of-pocket spending per EpiPen, per patient. The same analysis found that the percentage of patients having to pay more than $100 increased nearly 400%, and those having to pay more than $250 increased more than 5000%. Annual EpiPen total spending per patient increased from $124.9 to $468.7.⁷

ALTERNATIVES

Epinephrine auto-injectors are the most commonly prescribed medication for severe allergic reactions, but 1-mg ampoules and vials are also sometimes used in hospitals and other medical environments. The concern with these products, however, is that the contents must be drawn into a syringe before being injected, which in a stressful situation that could lead to injection of incorrect doses.⁸

In 2014, the National Comprehensive Cancer Network called for the use of EAIs in member hospitals to avoid wrong-dose and wrong-route errors (eg, intravenous [IV] instead of IM).⁸ In a review of more than 600 cases reported to the Pennsylvania Patient Safety Reporting System, wrong-route errors involving IV administration instead of IM or subcutaneous injection were responsible for 25.4% of all epinephrine adverse events and 63.3% of the harmful events.⁸

With Symjepi, Sandoz aims to create another option. Granted FDA approval in 2018, Symjepi’s 0.3-mg and 0.15-mg doses were made available in hospitals and clinics earlier this year.

“Our collaboration with retail partners will enable patients and their caregivers to conveniently access Symjepi, a cost-effective treatment option with a compact and user-friendly design,” Carol Lynch, president of Sandoz US, said in a statement.⁹

Symjepi has a lower wholesale acquisition cost than EAIs, about 17% below that of the most widely used one.¹⁰

The device uses a 4-step process to ensure proper medication administration and user safety.

• Ready: Remove the cap to expose the needle. Do not touch the plunger until the needle is fully inserted to ensure that no accidental epinephrine leakage occurs.
• Steady: Holding by the finger grips on the body of the syringe, slowly insert the needle into the thigh, injecting through clothing if necessary.
• Go: After the needle is fully inserted, push the plunger all the way down until it clicks. Hold for 2 seconds, then remove the syringe and massage the area for 10 seconds. If the patient has pushed the plunger all the way down, the solution window will be at least partially blocked, indicating that the correct dose has been injected.
• Protect: Symjepi features a safety guard that patients can slide over the needle. Once the injection has been administered, cover the needle using 1 hand with the fingers behind it to slide the safety guard up until it clicks.¹¹

In a head-to-head study, adolescents were randomly assigned the use of EpiPen or Symjepi. The study found a statistically higher failure rate for EpiPen administration than for Symjepi, with errors such as sticking the thumb and not allowing adequate time for dosing after needle injection.¹²

THE PHARMACIST’S ROLE

Pharmacists can work with health care teams in recommending selection of appropriate products to prevent patient barriers to medication access. They play an important role in understanding available epinephrine options for allergies, as well as in increasing awareness of product selection to address patient medication barriers.

Brand-name and generic EAI prescriptions limit the dispensing capability of pharmacies to only a portion of epinephrine products, creating even more barriers for patients trying to access emergency rescue medication. To combat this limitation, pharmacists can educate patients to ask their doctors to indicate epinephrine or epinephrine injection on prescriptions to allow for a choice of whichever epinephrine products are in stock.

IM epinephrine products are a necessity for many patients in emergency situations. Pharmacists should also inform patients of online resources and advocacy groups, such as the Asthma and Allergy Foundation of America and the Food Allergy Research & Education organization, which can help patients label the medical device to safely transport it to a babysitter, camp, or school, for example.

Although many barriers still exist between epinephrine medications for severe allergic reactions and patients, pharmacists can leverage their relationships to improve education about appropriate options and proper use.

REFERENCES

• Gupta RS, Springston EE, Warrier MR, et al. The prevalence, severity, and distribution of childhood food allergy in the United States. Pediatrics. 2011;128(1):e9-17. doi:10.1542/peds.2011-0204.
• Simons FER, Ardusso LRF, Bilò MB, et al. World Allergy Organization guidelines for the assessment and management of anaphylaxis. World Allergy Organ J. 2011;4(2):13-37. doi: 10.1097/WOX.0b013e318211496c.
• Symjepi [prescribing information]. San Diego, CA: Adamis Pharmaceuticals Corp; 2018. www.accessdata.fda.gov/drugsatfda_docs/label/2017/207534lbl.pdf. Accessed July 19, 2019.
• FDA drug shortages. FDA website. www.accessdata.fda.gov/scripts/drugshortages/. Accessed June 20, 2019.
• Extended use dates provided by Pfizer. FDA website. www.fda.gov/Drugs/ DrugSafety/DrugShortages/ucm563360.htm. Updated June 5, 2019. Accessed June 20, 2019.
• Fromer L. Prevention of anaphylaxis: the role of the epinephrine autoinjector. Am J Med. 2016;129(12):1244-1250. doi: 10.1016/j.amjmed.2016.07.018.
• Chua KP, Conti RM. Out-of-pocket spending among commercially insured patients for epinephrine autoinjectors between 2007 and 2014. JAMA Intern Med. 2017;177(5):736-739. doi: 10.1001/jamainternmed.2017.0252.
• Grissinger M. EPINEPHrine for anaphylaxis: autoinjector versus 1-mg ampoule or vial. PT. 2017;42(12):724-725.
• New epinephrine injection launched in retail pharmacies. Contemporary Clinic® website. contemporaryclinic.pharmacytimes.com/news-views/new-epinephrine-injection-launched-in-retail-pharmacies. Published July 9, 2019. Accessed July 15, 2019.
• Symjepi (epinephrine injection). Symjepi website. symjepi.com. Accessed July 15, 2019.
• How to use Symjepi. Symjepi website. symjepi.com/#two. Accessed July 19, 2019.
• Moss RB, Daniels K, Moll T, Carlo DJ. Human Factors study in untrained adolescents comparing a recently approved single-dose epinephrine prefilled syringe with an approved autoinjector. Ann Allergy Asthma Immunol. 2018;120(5):540-541. doi: 10.1016/j.anai.2018.02.027.