NEFFY

). neffy should be administered with caution in elderly patients who are at greater risk for developing adverse reactions after epinephrine administration. 6%). None of the adverse drug reactions observed in the clinical studies were serious.

2 Clinical Trial Adverse Reactions Clinical trials are conducted under very specific conditions. Therefore, the frequencies of adverse reactions observed in the clinical trials may not reflect the frequencies observed in clinical practice and should not be compared to the frequencies reported in clinical trials of another drug.

The safety of neffy 2 mg is primarily based on four clinical pharmacology studies in 175 healthy adults and adults with type I allergy without anaphylaxis, who did not have structural or anatomical nasal conditions (see 10 CLINICAL PHARMACOLOGY).

The four clinical pharmacology studies were designed to compare the pharmacokinetic (PK) and pharmacodynamic (PD) profiles of one dose of neffy 2 mg sprayed into one nostril or two doses of neffy 2 mg sprayed into either the same or opposite nostril, administered 10 minutes apart, with PK and PD profiles of one or two dose(s) of epinephrine injection administered intramuscularly.

The common adverse reactions that occurred with neffy 2 mg after one and two dose(s) are listed in Table 2. 1 Clinical Trial Adverse Reactions – Pediatrics A single-arm PK/PD study (EPI 10) in pediatric subjects 8 to 17 years of age who weigh 30 kg or greater with type I allergy without anaphylaxis was conducted to assess the PK/PD of neffy 2 mg.

A total of 42 pediatric subjects who weigh 30 kg or greater (body weight range: 31 kg to 95 kg; age range: 8 to 17 years) were enrolled, including 21 subjects who received one nasal dose of neffy 2 mg . Common adverse reactions reported in these subjects who received one dose of neffy 2 mg include nasal discomfort (19%), intranasal paresthesia (19%), rhinorrhea (19%), sneezing (14%), paresthesia (10%), fatigue (10%), and feeling jittery (10%).

There were no clinically relevant differences in the safety between the pediatric and adult populations treated with neffy 2 mg. 5 Post-Market Adverse Reactions The following adverse reactions have been identified during use of epinephrine.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. g. […]