Sandoz extends SYMJEPI (epinephrine) Injection launch to U.S. pharmacies

July 11, 2019

Sandoz Inc., a Novartis division, has announced the U.S. retail launch of SYMJEPI (epinephrine) 0.3 mg and 0.15 mg Injections, making both the adult and pediatric doses immediately available in local pharmacies across the nation.

SYMJEPI is a small, single-dose, pre-filled syringe and device combination as an alternative to epinephrine auto-injectors for the emergency treatment of allergic reactions (Type 1), including anaphylaxis, a severe reaction that can lead to death if left untreated.

Epinephrine is a critical medicine for many people nationwide, including the 200,000 people in the U.S. who require emergency medical care for allergic reactions to food each year. The availability of SYMJEPI may provide confidence to patients given its small size and ease of use to encourage it being on-person when needed, and confidence in its use.

The Food and Drug Administration (FDA) recently highlighted ongoing shortages of epinephrine auto-injectors from several drug manufacturers, which can put people’s lives in jeopardy if they have a severe allergic reaction and do not have access to this life-saving medicine.

Sandoz launched SYMJEPI 0.3 mg Injection in the institutional (hospital) setting earlier this year, and has a certified sales force educating hospital providers on the device, demonstrating its use and advising on how to write a prescription to include epinephrine injections. Sandoz large wholesaler customers are now fully stocked to supply hospitals and clinics with both SYMJEPI 0.3 mg and 0.15 mg Injections inventory in the U.S.

Doctors who determine that epinephrine medicine alternatives are appropriate for their patients should write the prescription as “epinephrine injection” rather than “epinephrine auto-injector,” so that pharmacies can ensure patients receive epinephrine medicine alternatives during their first attempt to fill their prescription.

In addition to physicians writing the prescription for the greatest access to epinephrine injections, federal and state legislation in 18 states should change to allow for more alternatives such as SYMJEPI by amending the definition of “auto-injectors.” By limiting the definition to only permit the use of auto-injectors, federal and states are inadvertently restricting what schools and other entities could have on hand. These narrowly worded laws will not allow for new products that may be cost efficient and effective to be dispensed. Sandoz, in partnership with other stakeholders, has had early success amending existing legislation in multiple U.S. states.

SYMJEPI 0.3 mg and 0.15 mg Injections are indicated for the emergency treatment of allergic reactions (Type 1) including anaphylaxis to stinging and biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances and other allergens, as well as idiopathic or exercise-induced anaphylaxis. SYMJEPI 0.3 mg and 0.15 mg Injections are intended for immediate administration in patients who weigh approximately 66 pounds or more, and who weigh between 33 and 65 pounds, respectively, who are determined to be at an increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.