Peanut Allergen oral powder

What is this medication?

PEANUT ALLERGEN ORAL POWDER (pee nuht AL er jen awr-uh l pou-der) is used to help with allergies caused by peanuts. It is not used to treat an allergic reaction.

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, like 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 medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medication?

Take this medicine by mouth. Take this medicine 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 medicine every day to maintain the treatment effect. Do not take it more often than directed. Do not stop taking except on your doctor'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 pediatrician regarding the use of this medicine in children. While this drug may be prescribed for children as young as 4 years 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 health care professional 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 medicine. Do not exercise or have a hot bath or shower within 3 hours after taking this medicine. 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 medicine 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, like 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 doctor or healthcare professional should prescribe auto-injectable epinephrine for you to keep at home for treating a severe allergic reaction if needed. Your healthcare professional will tell you how to use the auto-injectable epinephrine. Some medicines 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 doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• breathing problems
• chest pain or chest tightness
• dizziness
• facial flushing
• fast, irregular heartbeat
• nausea, vomiting
• severe cough
• severe stomach pain
• trouble swallowing

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

• throat irritation
• upset stomach

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.

Store between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. Keep this medicine in the original container. Throw away any unused medicine after the expiration date.

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.