The FDA has approved a 0.15mg dosage of Symjepi, an epinephrine injection, for the emergency treatment of serious allergic reactions in children.
The US Food and Drug Administration (FDA) today approved Symjepi, a 0.15 mg epinephrine injection for the emergency treatment of allergic reactions (Type 1) in children.
The pediatric epinephrine injection is indicated for emergency treatment in response to anaphylaxis to stinging and biting insects, allergen immunotherapy, foods, drugs, diagnostic testing substances and other allergens, as well as idiopathic or exercise-induced anaphylaxis.
"Today's approval of Symjepi in the pediatric setting is a huge step forward to treat children at increased risk for anaphylaxis as it represents an affordable alternative to current treatment offerings at a time when patients need access to this medicine most," said Carol Lynch, President of Sandoz Inc, in a statement.
The epinephrine injection is intended for use in patients who weight between 33 and 65 pounds and for intramuscular or subcutaneous injection into the anterolateral aspect of the thigh. Each pre-filled single dose syringe is intended for a single-use injection. Sandoz will distribute Symjepi in the 0.15 mg dose as well as a 0.3 mg dose in the United States.
The FDA approved an epinephrine injection of 0.1mg for the treatment of severe allergic reactions in infants and small children weighting between 16.5 to 33 pounds in November 2017. In addition to a lower dose of epinephrine, the AUVI-Q auto-injector included a voice prompt system to guide the caregiver and a shorter needle length.
The Symjepi epinephrine injection Prescribing Information does not list any contraindications. The information includes a warning not to inject intravenously nor into buttock, digits, hands, or feet. Caregivers are advised to hold the child’s leg securely to reduce movement prior to and while administering the injection in young children.
Adverse reactions for the epinephrine injection include anxiety, apprehensiveness, restlessness, tremor, weakness, dizziness, sweating, palpitations, pallor, nausea and vomiting, headache, and/or respiratory difficulties.
"We are committed to reimagining their care by bringing this valuable, life-saving medicine in a pre-filled epinephrine syringe to the US market as soon as possible," added Lynch.