Enter drug's generic or brand name below. Results will appear here. Note: all drug related information obtained on this page is provided by RX List.
Using the RX LIST database:
(1) Enter the drug name in the search box below and hit ENTER
(2) The rx list web site will open here with the drug search completed. Next, scroll down the page to locate the link to the drug you are searching for and then click on the link.
Neffy contains epinephrine, a sympathomimetic catecholamine. Chemically, epinephrine is (-)3,4-dihydroxy-α-[(methylamino)methyl] benzyl alcohol with molecular weight of 183.21 g/mol and the following structure:
 |
Neffy (epinephrine nasal spray) is supplied as a single-dose nasal spray containing 2 mg of epinephrine in 0.1 mL solution for nasal administration.
Inactive ingredients include benzalkonium chloride, disodium edetate, n-dodecyl beta-Dmaltoside, sodium chloride, sodium metabisulfite, and hydrochloric acid or sodium hydroxide to adjust pH, in water for injection. The pH range is approximately 3 to 5.5.
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.
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].
Table 1: Recommended Dosage of Neffy Based on Patient's Weight
| 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.
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].
Nasal spray:
Neffy (epinephrine nasal spray) is available in 1 mg and 2 mg strengths as described in Table 4.
Table 4: Neffy Strengths and Package Configurations
| Strength | Package Configuration | NDC |
| 1 mg/0.1 mL | Carton containing two (2) blister packages each with a single-dose nasal spray for 1 time use | NDC 82580-010-02 |
| 2 mg/0.1 mL | Carton containing two (2) blister packages each with a single-dose nasal spray for 1 time use | NDC 82580-020-02 |
Store at 68°F to 77°F (20°C to 25°C). Excursions permitted up to 122°F (50°C). Do not freeze. Neffy freezes below 5°F (-15°C). If neffy freezes, it will not deliver epinephrine.
Manufactured for ARS Pharmaceuticals Operations, Inc., 11682 El Camino Real, San Diego, CA 92130. Revised: Mar 2025
The following clinically significant adverse reactions are described elsewhere in the labeling:
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 and may not reflect the rates observed in practice.
The safety of neffy 2 mg is 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 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.
Table 2: Adverse Reactions with One or Two Dose(s) of Neffy with Incidence Greater than or Equal to 2% in Adults [Studies 1, 2, 3, and 4]
| Adverse Reaction** | Neffy 2 mg One Dose N =134*** |
Neffy 2 mg Two Doses* N =85*** |
||
| Nasal discomfort | 13 | (10%) | 11 | (13%) |
| Headache | 8 | (6%) | 15 | (18%) |
| Rhinorrhea | 4 | (3%) | 6 | (7%) |
| Dizziness | 4 | (3%) | 2 | (2%) |
| Nausea | 4 | (3%) | 2 | (2%) |
| Vomiting | 3 | (2%) | 2 | (2%) |
| Throat irritation | 2 | (2%) | 16 | (19%) |
| Feeling jittery | 1 | (1%) | 9 | (11%) |
| Abdominal pain | 1 | (1%) | 3 | (4%) |
| Tremor | 0 | (0%) | 7 | (8%) |
| Nasal pruritus | 0 | (0%) | 3 | (4%) |
| Sneezing | 0 | (0%) | 3 | (4%) |
| Gingival pain | 0 | (0%) | 3 | (4%) |
| Hypoesthesia oral | 0 | (0%) | 3 | (4%) |
| Nasal Congestion | 0 | (0%) | 2 | (2%) |
| * Two nasal doses of neffy 2 mg were administered 10 minutes apart ** Data include subjects with nasal allergen challenge induced rhinitis *** The trials used a crossover design and therefore the total number of subjects do not match the number of unique subjects (n = 175) |
||||
A single-arm clinical pharmacology study (Study 5) in pediatric subjects 4 to 17 years of age who weigh 15 kg or greater with type I allergy without anaphylaxis was conducted to assess the pharmacokinetic/pharmacodynamic (PK/PD) of neffy 1 mg and 2 mg [see CLINICAL PHARMACOLOGY]. Pediatric subjects (n=21) who weigh 30 kg or greater received one nasal dose of neffy 2 mg and common adverse reactions reported in these subjects include nasal discomfort (19%), intranasal paresthesia (19%), rhinorrhea (19%), sneezing (14%), epistaxis (10%), rhinalgia (10%), paresthesia (10%), fatigue (10%), and feeling jittery (10%). Pediatric subjects (n=21) who weigh 15 to less than 30 kg received one nasal dose of neffy 1 mg and common adverse reactions reported in these subjects include nasal congestion (19%), upper respiratory tract congestion (14%), dry throat (10%), nasal dryness (10%), and paresthesia (10%).
The following adverse reactions have been identified during postapproval 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.
Cardiovascular: angina, arrhythmias (including fatal ventricular fibrillation), cerebral hemorrhage, hypertension, pallor, palpitations, tachyarrhythmia, tachycardia, vasoconstriction, ventricular ectopy, and stress cardiomyopathy
Metabolism and Nutrition Disorders: transient hyperglycemia, sweating
Neurological: disorientation, impaired memory, panic, psychomotor agitation, sleepiness, tingling, weakness
Psychiatric: anxiety, apprehensiveness, restlessness
Respiratory: respiratory difficulties
Neffy may alter nasal mucosa for up to 2 weeks after administration, and thus may increase systemic absorption of nasal products, including neffy, potentially increasing the risk of adverse reactions associated with these products.
Patients who receive epinephrine while concomitantly taking cardiac glycosides, diuretics, or anti-arrhythmics should be observed carefully for the development of cardiac arrhythmias [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].
The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, certain antihistamines, notably chlorpheniramine, tripelennamine, and diphenhydramine, and catechol-O-methyl transferase (COMT) inhibitors such as entacapone.
The cardiostimulating and bronchodilating effects of epinephrine are antagonized by betaadrenergic blocking drugs, such as propranolol.
The vasoconstricting and hypertensive effects of epinephrine are antagonized by alphaadrenergic blocking drugs, such as phentolamine.
Ergot alkaloids may also reverse the pressor effects of epinephrine.
Included as part of the "PRECAUTIONS" Section
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.
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 and ADVERSE REACTIONS].
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.
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.
Advise the patient to read the FDA-approved patient labeling (PATIENT INFORMATION and Instructions for Use).
Advise patients with coexisting conditions (cardiac arrhythmia, coronary artery disease, hypertension, pulmonary edema, hyperthyroidism, renal impairment, Parkinson’s disease, diabetes), for increased risks that may be associated with use of epinephrine [see WARNINGS AND PRECAUTIONS].
Long-term studies to evaluate the carcinogenic potential of epinephrine have not been conducted. Epinephrine and other catecholamines have been shown to have mutagenic potential in vitro. Epinephrine was positive in the Salmonella bacterial reverse mutation assay, positive in the mouse lymphoma assay, and negative in the in vivo micronucleus assay. Epinephrine is an oxidative mutagen based on the E. coli WP2 Mutoxitest bacterial reverse mutation assay. This should not prevent the use of epinephrine where indicated [see INDICATIONS]. The potential for epinephrine to impair reproductive performance has not been evaluated, but epinephrine has been shown to decrease implantation in female rabbits dosed subcutaneously with 1.2 mg/kg/day (15-fold the highest human intramuscular or subcutaneous daily dose) during gestation days 3 to 9.
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.
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.
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).
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.
The safety and effectiveness of neffy for emergency treatment of type I allergic reactions, including anaphylaxis, have been established in pediatric patients who weigh 30 kg or greater. Use of neffy for this indication is supported by 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 with neffy in pediatric patients who weigh 30 kg or greater [see ADVERSE REACTIONS and CLINICAL PHARMACOLOGY].
The safety and effectiveness of neffy have not been established in pediatric patients who weigh less than 30 kg.
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.
Overdosage of epinephrine has been reported to produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients. Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Epinephrine overdosage can also cause transient bradycardia followed by tachycardia which may be accompanied by fatal cardiac arrhythmias; premature ventricular contractions followed by multifocal ventricular tachycardia; atrial tachycardia and occasionally by atrioventricular block; extreme pallor and coldness of the skin; metabolic acidosis; kidney failure.
Epinephrine is rapidly inactivated in the body and treatment following overdosage with epinephrine is primarily supportive. Treatment of epinephrine associated pulmonary edema consists of a rapidly acting alpha-adrenergic blocking drug (such as phentolamine mesylate) and respiratory support. Treatment of epinephrine associated arrhythmias consists of administration of a beta-adrenergic blocking drug (such as propranolol). If necessary, pressor effects may be counteracted by rapidly acting vasodilators or αÂadrenergic blocking drugs. If prolonged hypotension follows such measures, it may be necessary to administer another pressor drug.
Consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations.
None.
Epinephrine acts on both alpha and beta-adrenergic receptors.
Through its action on alpha-adrenergic receptors, epinephrine lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluid volume and hypotension.
Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation and helps alleviate bronchospasm, wheezing and dyspnea that may occur during anaphylaxis.
Epinephrine alleviates pruritus, urticaria, and angioedema. It may also relieve gastrointestinal and genitourinary symptoms associated with anaphylaxis because of its relaxer effects on the smooth muscle of the stomach, intestine, uterus, and urinary bladder.
Four clinical pharmacology studies of neffy in adults and one clinical pharmacology study in pediatric subjects who weigh 30 kg or greater are described below. All doses were administered by study staff unless otherwise stated.
Study 1 was conducted in healthy adult subjects (N=42) that compared the pharmacokinetics (PK) [see CLINICAL PHARMACOLOGY] and pharmacodynamics (PD) (i.e., pulse rate (PR) and systolic blood pressure (SBP)) of epinephrine following:
In Study 1, SBP and PR responses were assessed as change from baseline over 60 minutes.
Results following one dose of all epinephrine products demonstrated an increase from baseline SBP and PR as shown in Figure 2. The median/mean increase in SBP and PR for neffy were within the range of both epinephrine injection treatments during the first 10 minutes post-dose. Thereafter, the median/mean SBP and PR responses for neffy were higher than both epinephrine injection treatments through 60 minutes post-dose.
Figure 2: Median Pulse Rate (PR) and Systolic Blood Pressure (SBP) Change from Baseline Following One Dose of Epinephrine in Healthy Subjects [Study 1]
![Median Pulse Rate (PR) and Systolic Blood Pressure (SBP) Change from Baseline Following One Dose of Epinephrine in Healthy Subjects [Study 1] Illustration](https://images.rxlist.com/images/rxlist/neffy3.jpg) |
Results following two nasal doses of neffy (in the same naris or opposite nares) in comparison to two intramuscular doses of epinephrine injection (using an auto-injector) showed a similar trend in median/mean SBP and PR responses.
The clinical meaning of SBP and PR responses observed in healthy subjects is unclear in the context of treating anaphylaxis.
Study 2 was conducted in adult patients with type I allergy without anaphylaxis (N=42) that compared the PK and PD of epinephrine following self-administered one nasal dose of neffy 2 mg to staff-administered one intramuscular dose of epinephrine injection 0.3 mg (using a needle-syringe product).
In Study 2, SBP and PR responses were assessed as a change from baseline over 60 minutes. The SBP and PR responses results in Study 2 were similar to Study 1.
Study 3 and Study 4 were conducted in adult subjects with seasonal allergic rhinitis outside of allergy season (neffy is not approved for the treatment of allergic rhinitis). Subjects were required to have seasonal allergic rhinitis which was confirmed with a nasal allergen challenge (NAC) during screening and did not have any allergy symptoms prior to treatment. Allergic rhinitis symptoms were induced by spraying the known allergen into the subject’s nostrils in which a minimum Total Nasal Symptom Score (TNSS) of ≥ 5 out of 12, with a congestion component of ≥ 2 out of 3 had to be reached.
Study 3 enrolled 36 subjects. In this cross-over study, subjects received epinephrine as each of the following:
In Study 3, SBP and PR responses were assessed as a change from baseline over 60 minutes. Results showed the following:
Study 4 enrolled 43 subjects. In this cross-over study, subjects received the following:
In Study 4, SBP and PR responses were assessed as a change from baseline over 60 minutes. Results showed the following:
Figure 3: Median Change from Baseline for Pulse Rate (PR) and Systolic Blood Pressure (SBP) Following Two Doses of Epinephrine Administered 10 Minutes Apart in Subjects with and without Nasal Allergen Challenge (NAC) Induced Rhinitis [Study 4]
![Median Change from Baseline for Pulse Rate (PR) and Systolic Blood Pressure (SBP) Following Two Doses of Epinephrine Administered 10 Minutes Apart in Subjects with and without Nasal Allergen Challenge (NAC) Induced Rhinitis [Study 4] Illustration](https://images.rxlist.com/images/rxlist/neffy4.jpg) |
Study 5 was a single-arm study conducted in pediatric patients who weighed 15 kg or greater (age range: 4 to 17 years) with type I allergy without anaphylaxis (N=42) that assessed the PK and PD of epinephrine following one nasal dose of neffy 1 mg (for subjects who weigh 15 kg to < 30 kg) and 2 mg (for subjects who weigh 30 kg or greater). The median change in SBP from baseline over the 60 minutes post-dose were numerically lower than in adults who received neffy 2 mg in Study 1 and 2, while the median change in PR from baseline over 60 minutes post-dose was within the range of adults who received neffy 2 mg in Study 1 and 2.
Pharmacokinetics assessments were performed in the clinical pharmacology studies described in the Pharmacodynamics subsection [see CLINICAL PHARMACOLOGY].
See Pharmacodynamics 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 a needle-syringe product and an auto-injector product) 60 minutes post-dose. The epinephrine plasma concentration versus time profiles are shown in Figure 4. The pharmacokinetic parameters of epinephrine are summarized in Table 3.
Figure 4: Epinephrine Geometric Mean (90% Confidence Interval) Plasma Concentration-Time Profiles Following One Dose of Epinephrine in Healthy Subjects [Study 1]
![Epinephrine Geometric Mean (90% Confidence Interval) Plasma Concentration-Time Profiles Following One Dose of Epinephrine in Healthy Subjects [Study 1] Illustration](https://images.rxlist.com/images/rxlist/neffy5.jpg) |
Table 3: Geometric Mean (CV%) Plasma PK Parameters Following One Dose of Epinephrine in Healthy Subjects [Study 1]
| Product | Pharmacokinetic Parameters [%CV] | |||||
| GeoMean Cmax (pg/mL) | Median Tmax (min) | GeoMean AUC0-10min (min*pg/mL)* | GeoMean AUC 0-20min (min*pg/mL) | GeoMean AUC 0-45min (min*pg/mL) | GeoMean AUC0- 60min (min*pg/mL) | |
| Epinephrine 0.3 mg (Needle-Syringe) (N=42) | 283 [62] | 45 | 879 [120] | 2032 [89] | 6172 [67] | 9217 [59] |
| Neffy 2 mg (N=42) | 341 [114] | 30 | 704 [92] | 2548 [102] | 8156 [115] | 10916 [116] |
| Epinephrine 0.3 mg (Auto-Injector) (N=42) | 604 [79] | 8 | 2771 [115] | 5818 [83] | 12227 [60] | 14762 [57] |
| *Note: Based on within-study comparison results from Studies 1, 2, and 3, the epinephrine exposures in the first 10 minutes following neffy administration were generally within the range observed following epinephrine injection 0.3 mg (needle-syringe) | ||||||
Following two nasal doses of neffy 2 mg, administered 10 minutes apart, either into the same naris or opposite nares under normal nasal conditions, the Cmax and AUC0-60 min increased approximately dose proportionally compared to one nasal dose of neffy 2 mg in healthy adults. The systemic exposures of two doses of neffy 2 mg administered into the same naris or the opposite nares under normal nasal conditions were generally similar and comparable to that of two intramuscular injections of epinephrine 0.3 mg (using an auto-injector product), administered 10 minutes apart, after 20 to 30 minutes post-dose.
See the Pharmacodynamics for a description for Study 2.
The geometric mean plasma epinephrine concentration time profile following one self-administered nasal dose of neffy 2 mg was numerically higher than that of one staff-administered intramuscular dose of epinephrine injection 0.3 mg (using a needle-syringe product) during the first 60 minutes post-dose (Study 2). The systemic exposure of epinephrine following one self-administered dose of neffy 2 mg in adult patients with type I allergy without anaphylaxis was similar to that following one staff-administered dose of neffy 2 mg in healthy adult subjects from Study 1.
See the Pharmacodynamics for a description of Studies 3 and 4.
Figure 5: Epinephrine Geometric Mean Plasma Concentration-Time Profiles Following One or Two Dose(s) of Epinephrine in Adult Subjects with and without Nasal Allergen Challenge Induced Rhinitis [Study 3 and Study 4]
![Epinephrine Geometric Mean Plasma Concentration-Time Profiles Following One or Two Dose(s) of Epinephrine in Adult Subjects with and without Nasal Allergen Challenge Induced Rhinitis [Study 3 and Study 4] Illustration](https://images.rxlist.com/images/rxlist/neffy6.jpg) |
See the Pharmacodynamics for a description for Study 5.
In pediatric patients with type I allergy without anaphylaxis who weigh 15 kg or greater (age range: 4 to 17 years), following one nasal dose of neffy 1 mg (for subjects who weigh 15 kg to < 30 kg) or 2 mg (for subjects who weigh 30 kg or greater) (Study 5), the geometric mean plasma epinephrine concentration time profiles for both weight groups were numerically higher than that of adults who received neffy 2 mg (Study 1 and 2).
Metabolism
Epinephrine is extensively metabolized with only a small amount excreted unchanged.
Epinephrine is rapidly degraded to vanillylmandelic acid, an inactive metabolite, by monoamine oxidase and catechol-O-methyltransferase that are abundantly expressed in the liver, kidneys and other extraneuronal tissues. The tissues with the highest contribution to removal of circulating exogenous epinephrine are the liver (32%), kidneys (25%), skeletal muscle (20%), and mesenteric organs (12%).
In a PK study of 45-minute epinephrine intravenous infusions given to healthy male subjects aged 20 to 25 years and healthy male subjects aged 60 to 65 years, the mean plasma metabolic clearance rate of epinephrine at steady state was greater among the older male subjects compared to younger male subjects (144.8 versus 78 mL/kg/minute, respectively, for a 0.0143 mcg/kg/minute infusion).
Body weight has been found to influence epinephrine PK. Higher body weight was associated with a higher plasma epinephrine clearance and a lower concentration plateau.
In a single-dose nasal toxicity study, treatment of neffy in rats induced epinephrine-related histopathology changes in the nose, such as minimal ulceration of the exposed mucosa (at ≥2.3Âfold the recommended clinical dose of neffy 2 mg based on local surface area), and nasal passages, such as minimal to mild necrosis in the nasal turbinate and parietal wall in the rostralÂmost level (at ≥1.2-fold the recommended clinical dose of neffy 2 mg based on local surface area) on day 2. These findings were often associated with minimal to mild neutrophilic inflammation and were reversible after 14 days post-dose.
NEFFY™
(ne'fee)
(epinephrine nasal spray)
For allergic emergencies (anaphylaxis)
Read this Patient Information leaflet carefully before you start using neffy and each time you get a refill. There may be new information. You, your caregiver, or others who may be in a position to administer neffy should know how to use it before you have an allergic emergency. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.
1. What is the most important information I should know about neffy?
Neffy contains epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life-threatening, can happen in minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or other unknown causes. Symptoms of anaphylaxis may include:
2. Always carry neffy with you because you may not know when anaphylaxis may happen. It is recommended that you carry 2 neffy devices because you may need a second dose of neffy if symptoms continue or come back. Talk to your healthcare provider if you need additional devices to keep at work, school, or other locations. Tell your family members, caregivers, and others where you keep your neffy device and how to use it before you need it. You may be unable to speak in an allergic emergency.
3. When you have an allergic emergency (anaphylaxis)
What is neffy?
Before using neffy, tell your healthcare provider about all your medical conditions, especially if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins and herbal supplements. Tell your healthcare provider of all known allergies.
Especially tell your healthcare provider if you take or use:
Neffy and other medicines may affect each other, causing side effects. Neffy may affect the way other medicines work, and other medicines may affect how neffy works.
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.
Use neffy for the treatment of anaphylaxis as prescribed by your healthcare provider, regardless of your medical conditions or medicine you take.
How should I use neffy?
What are the possible side effects of neffy?
Neffy may cause serious side effects.
If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have more or longer lasting side effects when you use neffy. Talk to your healthcare provider about all your medical conditions.
Tell your healthcare provider if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of neffy. For more information, ask your healthcare provider or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store neffy?
Keep neffy and all medicines out of the reach of children.
General information about the safe and effective use of neffy.
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use neffy for a condition for which it was not prescribed. Do not give neffy to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about neffy that is written for health professionals.
What are the ingredients in neffy?
Active Ingredient: epinephrine
Inactive Ingredients: benzalkonium chloride, disodium edetate, n-dodecyl beta-D-maltoside, sodium chloride, sodium metabisulfite, and hydrochloric acid or sodium hydroxide to adjust pH, in water for injection.
This Patient Information has been approved by the U.S. Food and Drug Administration
