NEFFY

Pharmacokinetics assessments were performed in the clinical pharmacology studies described in the Pharmacodynamics subsection [see Clinical Pharmacology (12.2) ] . Pharmacokinetics in Healthy Adult Subjects (Study 1) See Pharmacodynamics (12.2) for a description for Study 1. Following one nasal dose of neffy 2 mg in Study 1, the geometric mean plasma epinephrine concentration-time profile was overall within the range of that following one intramuscular dose of epinephrine injection 0.3 mg (using...

The following clinically significant adverse reactions are described elsewhere in the labeling: Risks Associated with Use of Epinephrine in Certain Coexisting Conditions [see Warnings and Precautions (5.2) ] Allergic Reactions Associated with Sulfite [see Warnings and Precautions (5.3) ] Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug...

None. None ( 4 )

Absorption of neffy may be affected by underlying structural and anatomical nasal conditions. ( 5.1 ) Administer with caution in patients with heart disease; may aggravate angina pectoris or produce ventricular arrhythmias. ( 5.2 ) May aggravate certain coexisting conditions. ( 5.2 ) The presence of a sulfite in this product should not deter use. ( 5.3 ) 5.1 Potential Altered Absorption of Neffy in Patients with Underlying Structural or Anatomical Nasal Conditions Clinical pharmacology studies w...

7 DRUG INTERACTIONS Neffy may alter nasal mucosa for up to 2 weeks after administration and increase systemic absorption of nasal products, including neffy. ( 7.1 ) Cardiac glycosides, diuretics or anti-arrhythmics: observe for development of cardiac arrhythmias. ( 7.2 ) Tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, certain antihistamines, and catechol-O-methyl tra...