Neffy
(epinephrine)Dosage & Administration
The recommended dosage for patients 4 years of age and older who weigh 15 kg or greater is based on weight. Neffy is for nasal administration.
| Patient's Weight | Dosage |
|---|---|
| 30 kg or Greater | One spray of neffy 2 mg |
| 15 kg to less than 30 kg | One spray of neffy 1 mg |
In absence of clinical improvement or if symptoms worsen after initial treatment, administer a second dose of neffy in the same nostril with a new nasal spray starting 5 minutes after the first dose.
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Neffy Prescribing Information
Neffy is indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients aged 4 years and older who weigh 15 kg or greater.
Recommended Dosage
The recommended dosage for patients aged 4 years and older who weigh 15 kg or greater is based on weight and the dosage is provided in Table 1. For nasal administration [see Dosage and Administration (2.2)].
| Patients Weight | Dosage |
|---|---|
| 30 kg or Greater | One spray of neffy 2 mg |
| 15 kg to less than 30 kg | One spray of neffy 1 mg |
In the absence of clinical improvement or if symptoms worsen after the initial treatment, a second dose of neffy may be administered in the same nostril with a second nasal spray starting 5 minutes after the first dose.
- Advise patients when to seek emergency medical assistance for close monitoring of the anaphylactic episode and in the event further treatment is required.
- It is recommended that patients are prescribed and have immediate access to two neffy nasal sprays at all times.
Administration Instructions
- Neffy is for nasal use only.
- Each neffy nasal spray is for single use and delivers the entire dose upon activation.
- Do not prime or attempt to reuse neffy for more than one administration.
- Administer neffy by inserting the nozzle of the nasal spray fully into one nostril until fingers touch the nose (see Figure 1).
- Hold the nasal spray straight into the nose - do not angle the nasal spray to the inside septum or outer wall of the nose as some medication may be lost.
- Press the plunger firmly to activate.
- Avoid sniffing during and after administration.
- If a second dose of neffy is needed, administer a new nasal spray into the same nostril starting 5 minutes after the first dose (see Figure 1).
- More than two sequential doses of epinephrine should be administered under direct medical supervision.
- Refer patients and caregivers to the Instructions for Use for detailed administration instructions.
Figure 1: Administration of Neffy
If neffy is frozen and is needed in an emergency, do not wait to thaw, seek emergency medical care immediately [see How Supplied/Storage and Handling (16)].
Nasal spray:
- 1 mg/0.1 mL of epinephrine per spray in a single-dose nasal spray
- 2 mg/0.1 mL of epinephrine per spray in a single-dose nasal spray
Pregnancy
Risk Summary
Prolonged experience with epinephrine use in pregnant women over several decades, based on published literature, have not identified a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. There are risks to the mother and fetus associated with anaphylaxis, and treatment with epinephrine should not be delayed (see Clinical Considerations). In animal reproduction studies, epinephrine administered by the subcutaneous route to pregnant rabbits, mice, and hamsters, during the period of organogenesis, resulted in adverse developmental effects (including gastroschisis, and embryonic lethality, and delayed skeletal ossification) at doses approximately 2 times the maximum recommended daily intramuscular, subcutaneous, or intravenous dose (see Data).
The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the United States general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations
Disease-Associated Maternal and Embryo/Fetal Risk
During pregnancy, anaphylaxis can be catastrophic and can lead to hypoxic-ischemic encephalopathy and permanent central nervous system damage or death in the mother and, more commonly, in the fetus or neonate. Treatment of anaphylaxis during pregnancy should not be delayed.
Data
Animal Data
In an embryofetal development study with pregnant rabbits dosed during the period of organogenesis (on days 3 to 5, 6 to 7 or 7 to 9 of gestation), epinephrine caused teratogenic effects (including gastroschisis) at doses approximately 15 times the maximum recommended intramuscular, subcutaneous, or intravenous dose (on a mg/m2 basis at a maternal subcutaneous dose of 1.2 mg/kg/day for two to three days). Animals treated on days 6 to 7 had decreased number of implantations.
In an embryofetal development study, pregnant mice were administered epinephrine (0.1 to 10 mg/kg/day) on Gestation Days 6 to 15. Teratogenic effects, embryonic lethality, and delays in skeletal ossification were observed at approximately 3 times the maximum recommended intramuscular, subcutaneous, or intravenous dose (on a mg/m2 basis at maternal subcutaneous dose of 1 mg/kg/day for 10 days). These effects were not seen in mice at approximately 2 times the maximum recommended daily intramuscular or subcutaneous dose (on a mg/m2 basis at a subcutaneous maternal dose of 0.5 mg/kg/day for 10 days).
In an embryofetal development study with pregnant hamsters dosed during the period of organogenesis from gestation days 7 to 10, epinephrine produced reductions in litter size and delayed skeletal ossification at doses approximately 2 times the maximum recommended intramuscular, subcutaneous, or intravenous dose (on a mg/m2 basis at a maternal subcutaneous dose of 0.5 mg/kg/day).
Lactation
Risk Summary
There are no data on the presence of epinephrine or its metabolite in human milk, the effects on the breastfed infant, or the effects on human milk production. However, due to its poor oral bioavailability and short half-life, transfer of epinephrine into breastmilk is expected to be low. Treatment for anaphylaxis in breastfeeding patients should not be delayed.
Pediatric Use
The safety and effectiveness of neffy for emergency treatment of type I allergic reactions, including anaphylaxis, have been established in pediatric patients aged 4 years and older who weigh 15 kg or greater. Use of neffy for this indication is supported by extrapolation from the clinical pharmacology studies in adults that compared the PK/PD profile of neffy to epinephrine injection products with established safety and effectiveness for this indication and clinical pharmacology data (Study 5) in pediatric patients aged 4 years and older who weigh 15 kg or greater [see Adverse Reactions (6) and Clinical Pharmacology (12.2, 12.3)].
The safety and effectiveness of neffy have not been established in pediatric patients less than 4 years of age and who weigh less than 15 kg.
Geriatric Use
Clinical pharmacology studies of neffy for the emergency treatment of type I allergic reactions, including anaphylaxis, did not include a sufficient number of subjects aged 65 and over to determine whether they respond differently from younger adult subjects. However, other reported clinical experience with use of epinephrine for the treatment of anaphylaxis has identified that geriatric patients may be particularly sensitive to the effects of epinephrine. Neffy should be administered with caution in elderly patients who are at greater risk for developing adverse reactions after epinephrine administration.
None.
Potential Altered Absorption of Neffy in Patients with Underlying Structural or Anatomical Nasal Conditions
Clinical pharmacology studies with neffy included subjects with history of allergic rhinitis, but did not include subjects with underlying structural and anatomical nasal conditions (e.g., polyps, history of nasal fractures or injuries, or history of nasal surgery). Absorption of neffy may be affected by underlying structural and anatomical nasal conditions. Consider use of other epinephrine products given by other routes of administration for patients with underlying structural or anatomical nasal conditions.
Risks Associated with Use of Epinephrine in Certain Coexisting Conditions
Some patients may be at greater risk for developing adverse reactions after epinephrine administration. Despite these concerns, it should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation. Therefore, patients with these conditions, and/or any other person who might be in a position to administer neffy to a patient experiencing anaphylaxis should be carefully instructed in regard to the circumstances under which epinephrine should be used.
Epinephrine should be administered with caution to patients who have heart disease, including patients with cardiac arrhythmias, coronary artery disease, or hypertension. In such patients, or in patients who are on drugs that may sensitize the heart to arrhythmias, epinephrine may precipitate or aggravate angina pectoris, as well as produce ventricular arrhythmias [see Drug Interactions (7) and Adverse Reactions (6)].
Epinephrine can temporarily exacerbate the underlying condition or increase symptoms in patients with the following: hyperthyroidism, Parkinson's disease, diabetes, renal impairment. Epinephrine should be administered with caution in patients with these conditions, including elderly patients and pregnant women.
Allergic Reactions Associated with Sulfite
Epinephrine is the preferred treatment for serious allergic or other emergency situations even though neffy contains sodium metabisulfite, a sulfite that may in other products cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons. The alternatives to using epinephrine in a life-threatening situation may not be satisfactory. The presence of a sulfite(s) in neffy should not deter administration of the drug for treatment of serious allergic or other emergency situations.