Peanut Allergen Powder

What is this medication?

PEANUT ALLERGEN (pee nuht AL er jen) reduces the severity of allergic reactions from peanut allergies. It works by exposing your immune system to small amounts of peanuts. This can help reduce your sensitivity to peanuts. Do not use it to treat an allergic reaction. Continue to follow a strict peanut-free diet.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Palforzia

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Eating less due to illness, surgery, dieting, or any other reason
• Heart disease
• High blood pressure
• History of eosinophilic esophagitis
• History of irregular heartbeat
• Infection (especially a viral infection)
• Lung or breathing disease, such as asthma
• Previous swelling of the tongue, face, or lips with difficulty breathing, difficulty swallowing, hoarseness, or tightening of the throat
• An unusual or allergic reaction to peanut allergen oral powder, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take this medication with a meal at the same time every day. It is best if it is taken in the evening. Do not swallow the capsules whole or breathe in the powder. Open the capsules or sachet and empty the full dose on to soft food such as applesauce, yogurt, or pudding. Do not mix with liquids. Once it is prepared, take the mixture right away. Wash your hands after handling the capsule or sachet. Take your medication every day to maintain the treatment effect. Do not take it more often than directed. Do not stop taking except on your care team's advice.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 1 year for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss any doses. Talk to your care team about what to do if you miss a dose.

What may interact with this medication?

Interactions are not expected.

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Allergic reactions are more likely to develop within 1 hour after taking this medication. Do not exercise or have a hot bath or shower within 3 hours after taking this medication. If you have been exercising, have taken a hot bath or shower, are feeling hot, or you are sweating and your heart is beating fast, do not take this medication until you have cooled down and your heart is beating normally. You may be more likely to have an allergic reaction if you have an illness, such as a viral infection, you are very tired or have missed sleep, you are having your menstrual period, or you are taking certain pain medications, such as aspirin or ibuprofen.

Your care team should prescribe auto-injectable epinephrine for you to keep at home for treating a severe allergic reaction if needed. Your care team will tell you how to use the auto-injectable epinephrine. Some medications may make epinephrine not work as well or worsen side effects.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heartburn, pain or trouble swallowing, chest pain that does not go away or gets worse

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Burning or tingling of the tongue, mouth, throat, or face
• Irritation inside the mouth or throat
• Itching of the mouth, lips, tongue, or ears
• Nausea
• Runny or stuffy nose
• Sneezing
• Stomach pain

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store in a refrigerator or at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not freeze. Avoid exposure to extreme heat. Keep this medication in the original container until you are ready to take it. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.