For people who are allergic to peanuts, treatment with PALFORZIA can help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA does not treat allergic reactions and should not be given during an allergic reaction. Patients must also maintain a strict peanut-free diet and must always carry injectable epinephrine while taking PALFORZIA.

If you’re considering PALFORZIA for your child, PALFORZIA can help gradually decrease your child’s sensitivity to peanuts over time through a process called oral immunotherapy or OIT. Treatment may be started in children aged 4 through 17 years old. And although PALFORZIA is not a cure for peanut allergy, it can help make your child’s reaction to accidental exposure less severe. Note that if your child turns 18 years of age while on PALFORZIA treatment, they should continue taking it unless otherwise instructed by a doctor. 

The first phase of the treatment process, called Initial Dose Escalation, takes place in the allergist’s office and lasts about four hours. Your child will be given small doses of peanut protein from 0.5 mg to 6 mg. If they can tolerate at least 3 mg, they can move to the next step.   

The next phase of the process, called Up-Dosing, takes about six months, with consistent, precise amounts of peanut protein given every day. There are 11 different dose levels of peanut protein, starting with 3 mg at level 1 and finishing with 300 mg at level 11. The dose will slowly be increased every couple of weeks during visits to the allergist’s office. If your child tolerates the first dose of a new dose level, you’ll continue to give your child that dose level at home, to be taken at approximately the same time each day.  

To prepare a dose for your child, mix the contents of one or more capsules that contain each day’s pre-measured dose into soft foods like yogurt, applesauce, or pudding. The food you use can be refrigerated or room temperature at an amount that can be completely taken in a few spoonfuls.  

After completing the Up-Dosing phase, your child will start taking a daily Maintenance dose; this dose is in a single small sachet that you can open and administer in soft food, as usual. PALFORZIA must be taken every day for it to be effective.

Because PALFORZIA is not a cure, children who use it still need to carry injectable epinephrine and maintain a strict peanut-free diet.

 
The PALISADE Clinical Trial

(Study 1 described in the PI)

The PALISADE clinical trial is the largest randomized, double-blind, placebo-controlled trial of an oral peanut allergy treatment. The PALISADE trial:

  • Lasted for about a year (52 weeks)

  • Looked at two participants groups:

    • Participants in the trial: 496 participants aged 4 through 17 years old—372 of those participants received PALFORZIA and 124 participants received a placebo (an inactive treatment that did not contain the study medication). This group included participants who may have started the trial but did not complete it.

    • Participants who completed the full trial: 296 participants received PALFORZIA and 116 participants received a placebo. 79% of participants receiving PALFORZIA completed the trial.

Results from the PALISADE trial showed the effectiveness of PALFORZIA treatment. To evaluate results, participants were given a food challenge at the end of the trial to see if they were able to take greater amounts of peanut protein after treatment with PALFORZIA 300 mg daily.

  • The primary purpose of the trial was to see how many participants could tolerate a dose of 600 mg of peanut protein with no more than mild allergic symptoms.

  • Results showed that 67% (250 of 372) of all participants taking PALFORZIA could tolerate 600 mg of peanut protein with no more than mild symptoms (versus 4% [5 of 124] in the placebo group).

  • Gastrointestinal reactions were the most common reason leading to discontinuation of study product during the intervention period (6.5% PALFORZIA, 1.6% placebo), followed by respiratory disorders (3.0% PALFORZIA, 2.4% placebo) in the PALISADE trial.

Girl at her desk in school
PALISADE trial results graph

The PALISADE Clinical Trial

(Study 1 described in the PI)

The PALISADE clinical trial is the largest randomized, double-blind, placebo-controlled trial of an oral peanut allergy treatment. The PALISADE trial:

  • Lasted for about a year (52 weeks)

  • Looked at 2 participant groups:

    • All participants in the trial: 496 total participants aged 4 through 17 years—372 of those participants received PALFORZIA and 124 participants received a placebo (an inactive treatment that did not contain the study medication). This group included participants who may have started the trial, but did not complete it

    • Participants who completed the full trial: 296 participants received PALFORZIA and 116 participants received placebo. Most participants receiving PALFORZIA (79%) completed the trial

Results from the PALISADE trial showed the effectiveness of PALFORZIA treatment. To evaluate results, participants were given a food challenge at the end of the trial to see if they were able to take greater amounts of peanut protein after treatment with PALFORZIA 300 mg daily.

  • The primary purpose of the trial was to see how many participants could tolerate a dose of 600 mg of peanut protein with no more than mild allergy symptoms

  • Results showed that 67% (250 of 372) of all participants taking PALFORZIA could tolerate 600 mg of peanut protein with no more than mild symptoms (versus 4% [5 of 124] in the placebo group)

  • Gastrointestinal reactions were the most common reason leading to discontinuation of study product during the intervention period (6.5% PALFORZIA, 1.6% placebo), followed by respiratory disorders (3.0% PALFORZIA, 2.4% placebo) in the PALISADE trial.

PALISADE trial results graph

One Family's Story

HEAR ABOUT THEIR CLINICAL TRIAL PARTICIPATION AND TREATMENT EXPERIENCE

Find out why this family enrolled their son Reiland — who has peanut allergy — in a clinical trial for PALFORZIA.

One participant's experience. Results may vary.

One participant's experience. Results may vary.

Benefits
And
Risks

Dose mixing icon
PALFORZIA can help reduce the severity of allergic reactions to accidental peanut exposure.

Each PALFORZIA dose contains consistent, precise amounts of peanut protein that will be mixed into soft foods like yogurt, applesauce, or pudding. Taking PALFORZIA every day follows a practice called oral immunotherapy (OIT). Although it is not known exactly how OIT works, it can help children with a peanut allergy gradually decrease their sensitivity to small amounts of peanuts that may be hidden in foods.

Dosing levels icon
PALFORZIA dosing is consistent and precise.

Treatment with PALFORZIA is designed for consistency, so at each dosing level, every dose is exactly the same. This provides a gradual and controlled exposure to peanut allergens over time.

Approval icon
PALFORZIA is approved in the United States.

PALFORZIA is the first and only FDA-approved treatment to help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut in children aged 4 through 17 years old with a confirmed diagnosis of peanut allergy.

Side effects icon
Side effects are an expected part of PALFORZIA treatment.

There is a risk of severe allergic reactions requiring immediate medical attention, including anaphylaxis, which may be life-threatening. Because of this risk, children taking PALFORZIA should still have injectable epinephrine with them at all times. Signs of a severe allergic reaction include trouble breathing or wheezing; chest discomfort or tightness; throat tightness; trouble swallowing or speaking; swelling of your face, lips, eyes, or tongue; dizziness or fainting; severe stomach cramps or pain, vomiting, or diarrhea; hives (itchy, raised bumps on skin); and severe flushing of the skin.

Because PALFORZIA treatment relies on the intentional exposure to peanut allergens, side effects should be expected. In clinical studies, common side effects were stomach pain, vomiting, feeling sick, itching or burning in the mouth, throat irritation, cough, runny nose, sneezing, throat tightness, wheezing, shortness of breath, itchy skin, hives, and/or itchy ears. In clinical studies, most side effects were mild to moderate.*,

Monitoring icon
Close monitoring is necessary.

During the Up-Dosing phase, the administration of the first dose of each new dose level is carefully supervised in the allergist's office. This enables the allergist to monitor your child's reaction to the new dose level, before providing the next two-week supply for daily administration at home.

At home, you will need to monitor your child after giving them each dose every day and be prepared to manage any reactions. Your child's allergist will help you understand what to look for.

*Data on file. AMPZ003.
†Vickery et al. AR101 Oral Immunotherapy for Peanut Allergy. New England Journal of Medicine. 2018;379(21):1991-2001. doi:10.1056/nejmoa1812856 

THE 3 STEPS OF
PALFORZIA TREATMENT

Initial Dose Escalation icon
Starting Small
 
 
 
 

At your child's first treatment appointment, your child's allergist will start by administering small, increasing doses of PALFORZIA. If these doses are tolerated, your child can continue on to the next step in the treatment pathway.

Up-Dosing icon
Decreasing Sensitivity Over Time

You will return to the allergist's office the next day, so your child can begin the Up-Dosing phase of treatment. Your child's allergist will administer the first dose of PALFORZIA and monitor carefully to make sure your child can keep taking PALFORZIA.

Starting on the next day, you will give your child the same dose of PALFORZIA every day at home, mixed into a small amount of soft food, until it is time to visit the allergist again (about 2 weeks later) to see if your child is ready for the next, higher dose. It will take at least 6 months to make it through all the Up-Dosing levels.

Maintenance icon
Maintaining Treatment Effect

After your child has completed Up-Dosing, they will likely show a decreased sensitivity to peanut allergens. To maintain this treatment effect, they will still need to continue taking PALFORZIA every day. This is called the Maintenance Dose. Your child must continue to maintain a strict peanut-free diet while taking PALFORZIA.

THE 3 STEPS OF
PALFORZIA TREATMENT

 
 
Up-Dosing icon
Starting Small

At your child's first treatment appointment, your child's allergist will start by administering small, increasing doses of PALFORZIA. If these doses are tolerated, your child can continue on to the next step in the treatment pathway.

 
 
Up-Dosing icon
Decreasing Sensitivity Over Time

You will return to the allergist's office the next day, so your child can begin the Up-Dosing phase of treatment. Your child's allergist will administer the first dose of PALFORZIA and monitor carefully to make sure your child can keep taking PALFORZIA.

Starting on the next day, you will give your child the same dose of PALFORZIA every day at home, mixed into a small amount of soft food, until it is time to visit the allergist again (about 2 weeks later) to see if your child is ready for the next, higher dose. It will take at least 6 months to make it through all the Up-Dosing levels.

 
 
Maintenance icon
Maintaining Treatment Effect

After your child has completed Up-Dosing, they will likely have a decreased sensitivity to small amounts of peanut. To maintain this treatment effect, they will still need to continue taking PALFORZIA every day. This is called the Maintenance Dose. Your child must continue to maintain a strict peanut-free diet while taking PALFORZIA.

Could
PALFORZIA Be
Right
FOR YOUR CHILD?

If you’re not sure, take a quick quiz to find out if PALFORZIA may be appropriate for your child’s specific allergy diagnosis and talk to your child's allergist to learn more about whether PALFORZIA treatment could be appropriate for your child.