Neffy (Epinephrine): Uses, Side Effects and Dosage

What is neffy?

• Neffy is a nasal spray used to treat life-threatening, allergic emergencies including anaphylaxis in adults and children who weigh 33 pounds or more (15 kilograms or more), who are at risk for or have a history of serious allergic emergencies. Each neffy contains a single dose of epinephrine.
• Neffy is for immediate self (or caregiver) administration in an allergic emergency.
• Neffy is for people who have been prescribed this medicine by their healthcare provider.
• It is not known if neffy is safe and effective in children who weigh less than 33 pounds (15 kilograms).

Before using neffy, tell your healthcare provider about all your medical conditions, especially if you:

• have nasal problems including nasal polyps, history of injury such as a broken nose, or any past nasal surgery.
• have heart problems.
• have kidney problems.
• have low potassium levels in your blood.
• have Parkinson's disease.
• have thyroid problems.
• have high blood pressure.
• have diabetes.

• are pregnant or plan to become pregnant. It is not known if epinephrine will harm your unborn baby.

• are breastfeeding or plan to breastfeed. It is not known if epinephrine passes into your breastmilk.

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:

• other nasal sprays
• water pills (diuretics)
• medicines to treat depression such as tricyclic antidepressants or monoamine oxidase inhibitors (MAO inhibitors)
• medicines to treat abnormal heart beats (arrhythmias) such as cardiac glycosides
• medicines to treat Parkinson's disease such as catechol-O-methyl-transferase inhibitors (COMT inhibitors) and ergot alkaloids
• medicines for heart disease including alpha blockers (such as phentolamine) and beta blockers (such as propranolol)
• medicines for thyroid disease such as levothyroxine sodium
• medicines used in labor
• medicines to treat allergies such as diphenhydramine, tripelennamine or chlorpheniramine (antihistamines)

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?

• Read the Instructions for Use that come with neffy for detailed information about the right way to use the device.
• Use neffy exactly as your healthcare provider tells you to use it. Talk to your healthcare provider or pharmacist if you have questions about the use of neffy.
• Neffy is for use in the nose only. Do not spray in the eyes or mouth.
• Each neffy has 1 dose of medicine and cannot be reused. Do not test or prime (pre-spray) the device.
• Your neffy comes in a carton with 2 devices. You may need to use a second neffy if symptoms continue or get worse.
• You should always carry 2 neffy devices with you.
• Neffy is given as a single dose in either nostril. If a second dose of neffy is needed, it should be given in the same nostril, starting 5 minutes after the first dose.
• If any liquid drips out of the nose, you may not receive the full dose of medicine. If your symptoms continue or get worse, give a second dose of neffy in the same nostril, starting 5 minutes after the first dose.
• Important: If symptoms continue or get worse after the first dose of neffy, a second dose is needed, even if you did not see liquid drip out of the nose. Give the second dose in the same nostril, starting 5 minutes after the first dose.
• Get emergency help for further treatment of the anaphylactic episode, if needed, after using neffy. Before you receive neffy, your healthcare provider should talk to you about when to get emergency help.
• If you use too much neffy, call your healthcare provider or Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away.
• For more information and video instructions on the use of neffy, go to www.neffy.com or call 1-877-MY-NEFFY (1-877-696-3339).

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.

Common side effects of neffy include:

• nasal discomfort
• throat irritation
• headache
• 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
• vomiting

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?

• Store neffy nasal spray in the blister pack or neffy carry case until ready to use. Neffy carry case is included in the carton.
• Store neffy at room temperature between 68°F to 77°F (20°C to 25°C).
• Do not intentionally freeze to below 5°F (-15°C). If neffy is accidentally frozen, the device will not spray.
• Exposure of neffy to high temperatures up to 122°F (50°C) is allowed.
• Your neffy has an expiration date. Replace neffy before the expiration date.

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.