neffy
Generic: EPINEPHRINE
Basic Information
Manufacturer
Sportpharm LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
NASAL
FDA Set ID
2052f9db-7d76-443b-b702-b6b499f9a4b8
Indications & Usage
1 INDICATIONS AND USAGE 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.
Neffy is an alpha and beta-adrenergic receptor agonist indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients 4 years of age and older who weigh 15 kg or greater.
( 1 )
Neffy is an alpha and beta-adrenergic receptor agonist indicated for emergency treatment of type I allergic reactions, including anaphylaxis, in adult and pediatric patients 4 years of age and older who weigh 15 kg or greater.
( 1 )
Adverse Reactions
6 ADVERSE REACTIONS 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 and may not reflect the rates observed in practice.
Most common adverse reactions are: Adults (incidence ≥ 2%): nasal discomfort, headache, rhinorrhea, dizziness, nausea, vomiting, and throat irritation.
( 6 ) Pediatric patients 4 years of age and older who weigh 15 kg or greater (incidence ≥10%): nasal discomfort, nasal congestion, paresthesia, rhinorrhea, sneezing, upper respiratory tract congestion, epistaxis, rhinalgia, nasal dryness, dry throat, fatigue, and feeling jittery.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact ARS Pharmaceuticals Operations, Inc.
at 1-877-MY-NEFFY (877-696-3339) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Adverse Reactions with Neffy in Adult Subjects 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 (12.2 , 12.3) ] .
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 Data include subjects with nasal allergen challenge induced rhinitis Neffy 2 mg One Dose Neffy 2 mg Two Doses Two nasal doses of neffy 2 mg were administered 10 minutes apart N = 134 The trials used a crossover design and therefore the total number of subjects do not match the number of unique subjects (n = 175) 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%) Adverse Reactions with Neffy in Pediatric Subjects 4 Years of Age and Older Weighing 15 kg or Greater 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 (12.2 , 12.3) ] .
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%).
Adverse Reactions from Postapproval Use of Epinephrine Products 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
Most common adverse reactions are: Adults (incidence ≥ 2%): nasal discomfort, headache, rhinorrhea, dizziness, nausea, vomiting, and throat irritation.
( 6 ) Pediatric patients 4 years of age and older who weigh 15 kg or greater (incidence ≥10%): nasal discomfort, nasal congestion, paresthesia, rhinorrhea, sneezing, upper respiratory tract congestion, epistaxis, rhinalgia, nasal dryness, dry throat, fatigue, and feeling jittery.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact ARS Pharmaceuticals Operations, Inc.
at 1-877-MY-NEFFY (877-696-3339) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Adverse Reactions with Neffy in Adult Subjects 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 (12.2 , 12.3) ] .
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 Data include subjects with nasal allergen challenge induced rhinitis Neffy 2 mg One Dose Neffy 2 mg Two Doses Two nasal doses of neffy 2 mg were administered 10 minutes apart N = 134 The trials used a crossover design and therefore the total number of subjects do not match the number of unique subjects (n = 175) 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%) Adverse Reactions with Neffy in Pediatric Subjects 4 Years of Age and Older Weighing 15 kg or Greater 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 (12.2 , 12.3) ] .
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%).
Adverse Reactions from Postapproval Use of Epinephrine Products 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