Palforzia 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.

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

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

You should not use Palforzia if you have uncontrolled asthma, or problems with your esophagus or digestive tract due to increased eosinophils (a type of white blood cell).

Palforzia 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.

Call your doctor or get emergency medical help if you have an allergic reaction, even if you have used epinephrine to treat it.

Take Palforzia exactly as prescribed by your doctor. 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.

When you start using Palforzia (and any time your dose is increased) you will receive your first dose in a hospital or clinic setting. Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely for at least 60 minutes after your dose.

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

Do not swallow a Palforzia capsule whole or inhale the powder medicine. Open the capsule or powder packet and sprinkle the medicine into a spoonful of applesauce, yogurt, or pudding (do not mix with liquid). Stir well and swallow the mixture right away without chewing. Do not save it for later use.

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

Wash your hands after handling a capsule or powder packet.

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 Palforzia while any of the above conditions exists.

Store Palforzia in the original packaging in a refrigerator, do not freeze.

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

Usual Pediatric Dose for Allergic Reaction:

4 to 17 years:
Initial dose escalation: Single doses of 0.5 mg, then 1 mg, 1.5 mg, 3 mg, and 6 mg orally
-Doses are administered on a single day under healthcare supervision.
-Separate doses with observation periods of 20 to 30 minutes.
-Do not omit any dose levels.
-Observe patient for at least 60 minutes after last dose until suitable for discharge.
-Discontinue if medical intervention is required after any dose.
-Patients who tolerate at least the 3 mg single dose must return to the healthcare setting for Up-dosing initiation.
-If possible, begin Up-dosing the day after initial dose escalation.
-Repeat initial dose escalation if patient does not begin Up-dosing within 4 days.

4 to 17 years: Up-dosing:
Dose level 1: 3 mg orally daily for 2 weeks
Dose level 2: 6 mg orally daily for 2 weeks
Dose level 3: 12 mg orally daily for 2 weeks
Dose level 4: 20 mg orally daily for 2 weeks
Dose level 5: 40 mg orally daily for 2 weeks
Dose level 6: 80 mg orally daily for 2 weeks
Dose level 7: 120 mg orally daily for 2 weeks
Dose level 8: 160 mg orally daily for 2 weeks
Dose level 9: 200 mg orally daily for 2 weeks
Dose level 10: 240 mg orally daily for 2 weeks
Dose level 11: 300 mg orally daily for 2 weeks
-Complete initial dose escalation prior to Up-dosing.
-The first dose of each new dosing level should be administered under healthcare supervision; observe patient for at least 60 minutes after dose until suitable for discharge.
-If first dose of each dose level is tolerated, patient may continue that dose level at home.
-Doses should be consumed with a meal at approximately the same time each day, preferably in the evening.
-Administer dose levels in sequential order; do not omit dose levels or progress more rapidly.
-Consider dose modification or discontinuation for patients who do not tolerate Up-dosing.

4 years and older: Maintenance dose: 300 mg orally daily
-Daily maintenance is required to maintain effect
-Assess patient at regular intervals for adverse effects.

Comments:
-Prior to initiation, verify that patient has injectable epinephrine and has been instructed on its appropriate use.
-Use in conjunction with a peanut-avoidant diet.
-Not indicated for emergency treatment of allergic reactions or anaphylaxis.

Use: Mitigation of allergic reactions, including anaphylaxis, to accidental peanut exposure in patients with confirmed peanut allergy.

You should not use Palforzia if you have:

• 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 Palforzia 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.

To make sure Palforzia is safe for you, tell your doctor if you have:

• asthma; or

• any disease related to increased eosinophils.

Tell your doctor if you are pregnant or breastfeeding.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

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

Palforzia can cause a severe or life-threatening allergic reaction. Stop using this medicine and get emergency medical help if you have signs of an allergic reaction to Palforzia:

• 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.

Also call your doctor at once if you have symptoms of inflammation in your stomach or esophagus:

• vomiting undigested food;

• trouble swallowing (food getting stuck in throat);

• feeling sick; or

• burning in your mouth, throat, or chest.

Common Palforzia 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.

Other drugs may interact with 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.