Uses of Peanut Allergen Powder:

• It is used to help with allergies caused by peanuts. This medicine is not for use to treat an allergic reaction.

What do I need to tell my doctor BEFORE I take Peanut Allergen Powder?

• If you are allergic to peanut allergen powder; any part of peanut allergen powder; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you ever had a very bad allergic reaction.
• If you have ever had eosinophilic esophagitis.

This is not a list of all drugs or health problems that interact with peanut allergen powder.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take peanut allergen powder with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Peanut Allergen Powder?

• Tell all of your health care providers that you take peanut allergen powder. This includes your doctors, nurses, pharmacists, and dentists.
• Follow the diet plan that your doctor told you about.
• Talk with your doctor if you drink alcohol, have an illness like a viral infection, are fasting, are very tired or have missed sleep, have your menstrual period, or are taking an NSAID like aspirin or ibuprofen. The risk of an allergic reaction may be raised.
• Do not take peanut allergen powder within 3 hours before or 3 hours after you exercise or take a hot shower or bath. If you have exercised or have taken a hot shower or bath and you feel hot, are sweating, or have fast breathing or heartbeat, wait to take peanut allergen powder until these signs go away.
• If you have asthma and you have trouble breathing or your asthma gets harder to control, call your doctor right away.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Peanut Allergen Powder) best taken?

Use peanut allergen powder as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with a meal.
• Take peanut allergen powder at the same time of day. It is best if peanut allergen powder is taken in the evening.
• Do not swallow the capsules or inhale the powder.
• Open capsule or sachet and empty the contents onto a few spoonfuls of soft food like applesauce, yogurt, or pudding. Mix well. Do not mix with liquids.
• After mixing, take your dose right away. Do not store for future use.
• Keep taking peanut allergen powder as you have been told by your doctor or other health care provider, even if you feel well.
• Throw away any part left over after the dose is given.
• Wash your hands after use.
• If you are visiting your doctor for up-dosing, do not take your dose that day.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Trouble swallowing or speaking.
• Pain with swallowing.
• Heartburn.
• Chest pain or pressure, a fast heartbeat, or passing out.
• Dizziness.
• Flushing.
• Shortness of breath.
• Severe diarrhea.
• Stomach cramps.

What are some other side effects of Peanut Allergen Powder?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stomach pain.
• Upset stomach or throwing up.
• Itching in the ear, mouth, or tongue.
• Numbness or tingling in the mouth.
• Throat irritation.
• Cough.
• Runny nose.
• Sneezing.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Peanut Allergen Powder?

• Store in a refrigerator. Do not freeze.
• Store in original container.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time peanut allergen powder is refilled. If you have any questions about peanut allergen powder, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.