peanut allergen extract

What is the most important information I should know about peanut allergen extract?

Peanut allergen extract can cause a severe or life-threatening allergic reaction. Your doctor may prescribe epinephrine injection to keep on hand in case you have an allergic reaction.

What is peanut allergen extract?

Peanut allergen extract is used to help reduce the severity of an allergic reaction (including anaphylaxis) when you are accidentally exposed to peanuts. This medicine will not treat an allergic reaction that has already begun.

Peanut allergen extract is for use in adults and children at least 4 years old who have been diagnosed with an actual peanut allergy. Peanut allergen extract will not affect allergic reactions to other foods. Always seek emergency medical attention if you have an allergic reaction.

Peanut allergen extract is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Peanut allergen extract may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking peanut allergen extract?

• untreated or uncontrolled asthma; or
• problems with your esophagus or digestive tract that are caused by higher than normal levels of eosinophils (a type of white blood cell).

You may not be able to use peanut allergen extract if:

• you are unable to give yourself an epinephrine injection in the case of an allergic reaction; or
• an allergic reaction would be life-threatening to you because of a medical condition you have or a medicine you use.

Tell your doctor if you have ever had:

• asthma; or
• any disease related to increased eosinophils.

Tell your doctor if you are pregnant or breastfeeding.

How should I take peanut allergen extract?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Your dose may need to be postponed if you are not feeling well before starting this treatment.

You may need to use up to 6 capsules to get the correct dose. Follow your doctor's dosing instructions very carefully.

You may be more likely to have an allergic reaction:

• if you have uncontrolled asthma;
• if you are sick with a virus;
• during your menstrual period;
• during vigorous exercise or exposure to hot water;
• if you are not getting enough sleep;
• if you are not getting enough to eat; or
• if you are taking an NSAID (nonsteroidal anti-inflammatory drug).

The timing of your doses may need to be adjusted to avoid using peanut allergen extract while any of the above conditions exists.

You must keep injectable epinephrine with you at all times while you are using peanut allergen extract. Read and carefully follow any Instructions for Use provided with your epinephrine. Ask your doctor or pharmacist if you don't understand all instructions.

What happens if I miss a dose?

What happens if I overdose?

Overdose symptoms may include trouble swallowing, trouble breathing, changes in your voice, or a feeling of fullness in your throat.

What should I avoid while taking peanut allergen extract?

In addition to taking this medicine, you should avoid peanuts in your diet.

What are the possible side effects of peanut allergen extract?

• chest discomfort, wheezing, trouble breathing;
• tightness in your throat;
• trouble speaking or swallowing;
• swelling of your face, lips, eyes, or tongue;
• itchy, raised bumps on your skin;
• flushing (sudden warmth, redness, or tingly feeling);
• severe stomach pain, vomiting, or diarrhea; or
• a light-headed feeling, like you might pass out.

Your doctor may prescribe epinephrine injection to keep on hand in case you have an allergic reaction. Get emergency medical help if you have an allergic reaction, even if you have used epinephrine to treat it.

• vomiting undigested food;
• trouble swallowing (food getting stuck in throat);
• feeling sick; or
• burning in your mouth, throat, or chest.

Common side effects may include:

• itching or burning in your mouth;
• cough, wheezing, trouble breathing;
• tightness or irritation in your throat;
• rash, itchy skin;
• itching in or around your ear;
• runny nose, sneezing; or
• stomach pain, nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect peanut allergen extract?

Other drugs may affect peanut allergen extract, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Where can I get more information?

Your pharmacist can provide more information about peanut allergen extract.