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neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs or greater.

WHAT IS neffy?

</head> <body> WHAT IS neffy? neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs or greater. What is the most important information that I should know about neffy? </head> <body> IMPORTANT SAFETY INFORMATION 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. Always carry two neffy nasal sprays with you because you may not know when anaphylaxis may happen and because you may need a second dose of neffy if symptoms continue or come back. Each neffy contains a single dose of epinephrine. neffy is for use in the nose only. Use neffy right away, as soon as you notice symptoms of an allergic reaction. If symptoms continue or get worse after the first dose of neffy, a second dose is needed. If needed, administer a second dose using a new neffy in the same nostril starting 5 minutes after the first dose. Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after using neffy. Tell your healthcare provider if you have underlying structural or anatomical nasal conditions, about all the medicines you take, and about all your medical conditions, especially if you have heart problems, kidney problems, low potassium in your blood, Parkinson's disease, thyroid problems, high blood pressure, diabetes, are pregnant or plan to become pregnant, or plan to breastfeed. Tell your healthcare provider if you take or use other nasal sprays or water pills (diuretics) or if you take medicines to treat depression, abnormal heart beats, Parkinson's disease, heart disease, thyroid disease, medicines used in labor, and medicines to treat allergies. neffy and other medications may affect each other, causing side effects. neffy may affect the way other medicines work, and other medicines may affect how neffy works. What are the 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. Common side effects of neffy include: nasal discomfort, headache, throat irritation, chest and nasal congestion, feeling overly excited, nervous or anxious, nose bleed, nose pain, sneezing, runny nose, dry nose or throat, tingling sensation, including in the nose, feeling tired, dizziness, nausea, and vomiting. Tell your healthcare provider if you have any side effects that bother you or that do not go away after using neffy. These are not all of the possible side effects of neffy. Call your healthcare provider for medical advice about side effects. To report side effects, contact ARS Pharmaceuticals Operations, Inc. at <a href="tel:18776963339" style="text-decoration: underline;">1-877-MY-NEFFY (877-696-3339)</a> or the FDA at 1-800-FDA-1088 or <a href="https://www.fda.gov/medwatch" target="_blank" style="text-decoration: underline;">www.fda.gov/medwatch</a>. Please see the full <a href="https://www.ars-pharma.com/wp-content/uploads/pdf/Prescribing_Information.pdf" style="text-decoration: underline;">Prescribing Information</a> and <a href="https://www.ars-pharma.com/wp-content/uploads/pdf/Patient_Information_Leaflet.pdf" style="text-decoration: underline;">Patient Information</a> for neffy.

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Drospirenone and Estetrol tablets 3 mg/14.2 mg

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neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs or greater. IMPORTANT SAFETY INFORMATION What is the most important information that 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.

neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and old who weigh 33 lbs or greater. neffy is the only needle-free epinephrine nasal spray. Talk to a doctor online to find out if neffy is right for you.

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neffy is a compact, ready-to-use nasal spray that delivers epinephrine.

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</head> <body> WHAT IS neffy? neffy is a nasal spray used for emergency treatment of allergic reactions including anaphylaxis, in adults and children aged 4 years and older who weigh 33 lbs or greater. </head> <body> IMPORTANT SAFETY INFORMATION What is the most important information that I should know about neffy? </head> <body> 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. Always carry two neffy nasal sprays with you because you may not know when anaphylaxis may happen and because you may need a second dose of neffy if symptoms continue or come back. Each neffy contains a single dose of epinephrine. neffy is for use in the nose only. Use neffy right away, as soon as you notice symptoms of an allergic reaction. If symptoms continue or get worse after the first dose of neffy, a second dose is needed. If needed, administer a second dose using a new neffy in the same nostril starting 5 minutes after the first dose. Get emergency medical help for further treatment of the allergic emergency (anaphylaxis), if needed after using neffy. Tell your healthcare provider if you have underlying structural or anatomical nasal conditions, about all the medicines you take, and about all your medical conditions, especially if you have heart problems, kidney problems, low potassium in your blood, Parkinson's disease, thyroid problems, high blood pressure, diabetes, are pregnant or plan to become pregnant, or plan to breastfeed. Tell your healthcare provider if you take or use other nasal sprays or water pills (diuretics) or if you take medicines to treat depression, abnormal heart beats, Parkinson's disease, heart disease, thyroid disease, medicines used in labor, and medicines to treat allergies. neffy and other medications may affect each other, causing side effects. neffy may affect the way other medicines work, and other medicines may affect how neffy works. What are the 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. Common side effects of neffy include: nasal discomfort, headache, throat irritation, chest and nasal congestion, feeling overly excited, nervous or anxious, nose bleed, nose pain, sneezing, runny nose, dry nose or throat, tingling sensation, including in the nose, feeling tired, dizziness, nausea, and vomiting. Tell your healthcare provider if you have any side effects that bother you or that do not go away after using neffy. These are not all of the possible side effects of neffy. Call your healthcare provider for medical advice about side effects. To report side effects, contact ARS Pharmaceuticals Operations, Inc. at <a href="tel:18776963339" style="text-decoration: underline;">1-877-MY-NEFFY (877-696-3339)</a> or the FDA at 1-800-FDA-1088 or <a href="https://www.fda.gov/medwatch" target="_blank" style="text-decoration: underline;">www.fda.gov/medwatch</a>. Please see the full <a href="https://www.ars-pharma.com/wp-content/uploads/pdf/Prescribing_Information.pdf" style="text-decoration: underline;">Prescribing Information</a> and <a href="https://www.ars-pharma.com/wp-content/uploads/pdf/Patient_Information_Leaflet.pdf" style="text-decoration: underline;">Patient Information</a> for neffy.

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WARNING: CIGARETTE SMOKING AND SERIOUS CARDIOVASCULAR EVENTS
&nbsp;
See full prescribing information for complete boxed warning. 
Females over 35 years old who smoke should not use NEXTSTELLIS
&nbsp;
Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive (COC) use.
<hr />
IMPORTANT SAFETY INFORMATION FOR NEXTSTELLIS® (drospirenone and estetrol tablets 3 mg/14.2 mg)
&nbsp;
HIGHLIGHTS OF PRESCRIBING INFORMATION
&nbsp;
These highlights do not include all the information needed to use NEXTSTELLIS safely and effectively. See full prescribing information for NEXTSTELLIS.
&nbsp;
NEXTSTELLIS (drospirenone and estetrol tablets), for oral use 
Initial U.S. Approval: 2021
&nbsp;
INDICATIONS AND USAGE
&nbsp;
NEXTSTELLIS is a combination of drospirenone, a progestin, and estetrol, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy.
&nbsp;
Limitations of Use
&nbsp;
NEXTSTELLIS may be less effective in females with a BMI ≥30 kg/m2. In females with BMI ≥30 kg/m2, decreasing effectiveness may be associated with increasing BMI.
&nbsp;
DOSAGE AND ADMINISTRATION
<ul>
<li>Take one tablet by mouth at the same time every day.</li>
<li>Take tablets in the order directed on the blister pack.</li>
</ul>
DOSAGE FORMS AND STRENGTHS
NEXTSTELLIS consists of 28 tablets in the following order:
<ul>
<li>24 pink active tablets each containing drospirenone 3 mg and estetrol 14.2 mg</li>
<li>4 white inert tablets</li>
</ul>
CONTRAINDICATIONS
<ul>
<li>A high risk of arterial or venous thrombotic diseases</li>
<li>Current or history of a hormonally-sensitive malignancy (e.g., breast cancer)</li>
<li>Hepatic adenoma, hepatocellular carcinoma, acute hepatitis or decompensated cirrhosis</li>
<li>Co-administration with hepatitis C drug combinations containing ombitasvir/paritaprevir/ritonavir, with or without dasabuvir</li>
<li>Abnormal uterine bleeding that has an undiagnosed etiology</li>
<li>Renal impairment</li>
<li>Adrenal insufficiency</li>
</ul>
WARNINGS AND PRECAUTIONS
<ul>
<li>Thromboembolic Disorders and Other Vascular Problems: Stop NEXTSTELLIS if a thrombotic or thromboembolic event occurs. Start no earlier than 4 weeks after delivery. Consider all cardiovascular risk factors before initiating in any female, particularly in the presence of multiple risk factors.</li>
<li>Hyperkalemia: Check serum potassium concentration during the first NEXTSTELLIS treatment cycle in females on long-term treatment with medications that may increase serum potassium concentration.</li>
<li>Hypertension: Monitor blood pressure periodically and stop use if blood pressure rises significantly.</li>
<li>Migraine: Discontinue if new, recurrent, persistent, or severe migraines occur.</li>
<li>Hormonally-Sensitive Malignancy: Discontinue NEXTSTELLIS if a hormonally-sensitive malignancy is diagnosed.</li>
<li>Liver Disease: Withhold or permanently discontinue for persistent or significant elevation of liver enzymes.</li>
<li>Glucose Tolerance and Hypertriglyceridemia: Monitor glucose in females with prediabetes or diabetes. Consider an alternate contraceptive method for females with hypertriglyceridemia.</li>
<li>Gallbladder Disease and Cholestasis: Consider discontinuing NEXTSTELLIS in females with symptomatic gallbladder or cholestatic disease.</li>
<li>Bleeding Irregularities and Amenorrhea: May cause irregular bleeding or amenorrhea. Evaluate for other causes if symptoms persist.</li>
</ul>
ADVERSE REACTIONS
Most common adverse reactions (≥2%): bleeding irregularities, mood disturbance, headache, breast symptoms, dysmenorrhea, acne, weight increased, and libido decreased
DRUG INTERACTIONS
<ul>
<li>CYP3A Inducers: May lead to contraceptive failure and/or increase breakthrough bleeding. Avoid concomitant use. If concomitant use is unavoidable, use an alternative or back-up contraceptive method during co-administration and up to 28 days after discontinuation of the CYP3A inducer.</li>
<li>See full Prescribing Information for additional clinically significant drug interactions.</li>
</ul>
USE IN SPECIFIC POPULATIONS
<ul>
<li>Pregnancy: Discontinue if pregnancy occurs.</li>
<li>Lactation: Advise postpartum females that NEXTSTELLIS can decrease milk production.</li>
</ul>
To report SUSPECTED ADVERSE REACTIONS, contact Mayne Pharma at 1-844-825-8500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
See <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/214154s000lbl.pdf" target="_blank" rel="noopener">PATIENT COUNSELING INFORMATION and FDA-approved patient labeling</a>.
BMI=body mass index; COC=combined oral contraceptive; EU=European Union; HDL=high-density lipoprotein; LDL=low-density lipoprotein; LNG=levonorgestrel.
References
1. NEXTSTELLIS [package insert]. Greenville, NC: Mayne Pharma; April 2021. 2. Szarewski A, Mansour D, Shulman LP. 50 years of “The Pill”: celebrating a golden anniversary. J Fam Plann Reprod Health Care. 2010;36(4):231-238. 3. Hall KS, Trussell J. Types of combined oral contraceptives used by U.S. women. Contraception. 2012;86(6):659-665. 4. Coelingh Bennink HJT, Holinka CF, Diczfalusy E. Estetrol review: profile and potential clinical applications. Climacteric. 2008;11(suppl 1):47-58. 5. New data on NEXTSTELLIS presented at ISSWSH conference. News release. Mayne Pharma. Accessed May 21, 2021. https://www.maynepharma.com/investor-relations/company-announcements 6. Foidart JM, Gaspard U, Pequeux C, et al. Unique vascular benefits of estetrol, a native fetal estrogen with specific actions in tissues (NEST). In: Brinton RD, Genazzani AR, Simoncini T, Stevenson JC, eds. Sex Steroids’ Effects on Brain, Heart and Vessels Volume 6: Frontiers in Gynecological Endocrinology. New York, NY: Springer International Publishing; 2019:169‐195. 7. Data on file. Clinical study report MIT‐Es0001‐C302. Mayne Pharma US. Greenville, NC. 8. Data on file. Clinical study report MIT‐Es0001‐C201. Mayne Pharma US. Greenville, NC. 9. Arnal JF, Lenfant F, Metivier R, et al. Membrane and nuclear estrogen receptor alpha actions: from tissue specificity to medical implications. Physiol Rev. 2017;97(3):1045-1087. 10. Moggs JG, Orphanides G. Estrogen receptors: orchestrators of pleiotropic cellular responses. EMBO Rep. 2001;2(9):775-781. 11. Stanczyk FZ, Archer DF, Bhavnani BR. Ethinyl estradiol and 17β-estradiol in combined oral contraceptives: pharmacokinetics, pharmacodynamics and risk assessment. Contraception. 2013;87(6):706-727. 12. Food and Drug Administration. FDA label database. Accessed May 21, 2021. https://nctr-crs.fda.gov/fdalabel/ui/search 13. Abot A, Fontaine C, Buscato M, et al. The uterine and vascular actions of estetrol delineate a distinctive profile of estrogen receptor α modulation, uncoupling nuclear and membrane activation. EMBO Mol Med. 2014;6(10):1328-1346. 14. Ascenzi P, Bocedi A, Marino M. Structure-function relationship of estrogen receptor alpha and beta: impact on human health. Mol Aspects Med. 2006;27(4):299-402. 15. Coelingh Bennink HJT, Heegaard AM, Visser M, Holinka CF, Christiansen C. Oral bioavailability and bone-sparing effects of estetrol in an osteoporosis model. Climacteric. 2008;11(suppl 1):2-14. 16. Benoit T, Valera MC, Fontaine C, et al. Estetrol, a fetal selective estrogen receptor modulator, acts on the vagina of mice through nuclear estrogen receptor α activation. Am J Pathol. 2017;187(11):2499-2507. 17. Shoham Z, Kopernik G. Tools for making correct decisions regarding hormone therapy. Part I: background and drugs. Fertil Steril. 2004;81(6):1447-1457. 18. Visser M, Foidart JM, Coelingh Bennink JT. In vitro effects of estetrol on receptor binding, drug targets, and human liver cell metabolism. Climacteric. 2008;11(suppl 1):64-68. 19. Blair R, Fang H, Branham WS, et al. The estrogen receptor relative binding affinities of 188 natural and xenochemicals: structural diversity of ligands. Toxicol Sci. 2000;54:138-153. 20. Data on file. Clinical study report MIT‐Es0001‐C103. Mayne Pharma US. Greenville, NC. 21. Visser M, Holinka CF, Coelingh Bennink HJT. First human exposure to exogenous single-dose oral estetrol in early postmenopausal women. Climacteric. 2008;11(suppl 1):31-40. 22. Apter, D, Zimmerman Y, Beekman L, et al. Bleeding pattern and cycle control with estetrol-containing combined oral contraceptives: results from a phase II, randomised, dose-finding study (FIESTA). Contraception. 2016;94(4):366-373. 23. Regidor PA, Schindler A. Antiandrogenic and antimineralocorticoid health benefits of COC containing newer progestogens: dienogest and drospirenone. Oncotarget. 2017;8(47):83334-83342. 24. Blode H, Kowal K, Roth K, Reif S. Pharmacokinetics of drospirenone and ethinyl estradiol in Caucasian and Japanese women. Eur J Contracept Reprod Health Care. 2012;17(4):284-297. 25. Levy T, Yairi Y, Bar-Hava I, et al. Pharmacokinetics of the progesterone-containing vaginal tablet and its use in assisted reproduction. Steroids. 2000;65(10-11):645-649. 26. Kuhl H. Pharmacology of estrogens and progestogens: influence of different routes of administration. Climacteric. 2005;8(suppl 1):3-63. 27. Ortho Tri-Cyclen [package insert]. Titusville, NJ: Janssen Pharmaceuticals Inc; October 2013. 28. Aygestin [package insert]. Pomona, NY: Duramed Pharmaceuticals Inc; July 2007. 29. Data on file. Clinical study report MIT‐Es0001‐C301. Mayne Pharma US. Greenville, NC. 30. Data on file. Clinical study report MIT‐Es0001‐C202. Mayne Pharma US. Greenville, NC. 31. Food and Drug Administration. Prescription and over-the-counter drug product list: additions/deletions for prescription drug product list. August 2015. Accessed May 21, 2021. https://www.fda.gov/media/93516/download 32. Data on file. Clinical study report ES-C01/PR3095. Mayne Pharma US. Greenville, NC. 33. Data on file. Clinical study report ES-C02. Mayne Pharma US. Greenville, NC. 34. Mayne Pharma and Mithra announce FDA approval of new oral contraceptive NEXTSTELLIS®. News release. Mayne Pharma. Accessed May 21, 2021. https://www.maynepharma.com/media/2506/fda-approval-of-novel-oral-contraceptive-nextstellis.pdf 35. Electronic Code of Federal Regulations. IND safety reporting. 21 CFR §312.32. Accessed May 21, 2021. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.32 36. Data on file. NEXTSTELLIS New Drug Application, Module 2.5: Clinical Overview. Mayne Pharma US. Greenville, NC. 37. Holinka CF, Gurpide E. In vivo effects of estetrol on the immature rat uterus. Biology of Reproduction. 1979;20:242-246. 38. Coelingh Bennink HJT, Verhoeven C, Zimmerman Y. Pharmacokinetics of the fetal estrogen estetrol in a multiple-rising-dose study in postmenopausal women. Climacteric. 2017;20(3):285-289. 39. Food and Drug Administration. Labeling for combined hormonal contraceptives: guidance for industry. Accessed May 11, 2021. https://www.fda.gov/media/110050/download