The Company’s first FDA approved product is SYMJEPI. SYMJEPI intends to compete as a lower-cost epinephrine therapeutic alternative in the anaphylaxis market, with a small size and a user-friendly design.

Indication

SYMJEPI™ (epinephrine) 0.3mg Injection is 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 is intended for immediate administration in patients who weigh 66 pounds or more and who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions.
 

Important Safety Information

SYMJEPI is a single dose injection of epinephrine intended for immediate administration as emergency supportive therapy for emergency treatment of allergic reactions in patients who weigh 66 pounds or more and is not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision.

SYMJEPI should only be injected into the middle of the outer thigh (through clothing, if necessary). Do not inject intravenously, into buttocks, or into digits, hands, or feet. If you inject a young child with SYMJEPI, hold their leg firmly in place before and during the injection to prevent injuries. Seek immediate medical care in the case of accidental injection.

Rarely, patients who use SYMJEPI may develop infections at the injection site within a few days of an injection. Some of these infections can be serious. Call your healthcare provider right away if you have any of the following at an injection site: redness that does not go away, swelling, tenderness, or the area feels warm to the touch.

Epinephrine should be used with caution if you have heart disease or are taking certain medicines that can cause heart-related (cardiac) symptoms. Side effects may be increased in patients with certain medical conditions, or who take certain medicines. Tell your doctor if you have certain medical conditions such as asthma, depression, thyroid disease, Parkinson’s disease, diabetes, high blood pressure, heart disease, have any other medical conditions, are pregnant or plan to become pregnant, or are breastfeeding or plan to breastfeed.

The most common side effects include increased heart rate, stronger or irregular heartbeat, sweating, nausea, vomiting, difficulty breathing, paleness, dizziness, weakness, shakiness, headache, apprehension, nervousness, or anxiety. These side effects may go away if you rest, but if they do not, tell your healthcare professional.

Please see the full Prescribing Information and Patient Information below:

View Full Prescribing Information View Patient Information

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088