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PALFORZIA is the first and only FDA-approved treatment to help reduce the severity of allergic reactions to peanuts, including anaphylaxis, in children aged 4 through 17.

PALFORZIA works by helping your child gradually decrease their sensitivity to peanuts over time through a process called oral immunotherapy, or OIT. Although PALFORZIA is not a cure for peanut allergies, it can help make your child’s reaction to accidental exposure less severe.

The first part of the process, called Initial Dose Escalation, takes place in the office and lasts about 4 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 part of the process, called Up-Dosing, takes about 6 months, with consistent, precise amounts of peanut protein given every day. You will mix the contents of one or more capsules that contain each day’s pre-measured dose of peanut protein into a few spoonfuls of soft food like applesauce or yogurt. The dose will slowly be increased every couple of weeks during visits to the allergist’s office.

After completing the Up-Dosing phase, your child will start taking a Maintenance dose every day; this dose is in a single small sachet that you open and administer in soft food, as usual. The Maintenance phase continues over time to help your child maintain their decreased sensitivity to peanut allergens.

Because PALFORZIA is not a cure, kids who use it still need to carry epinephrine and avoid eating peanuts.

The PALISADE Clinical Trial

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 patient groups:

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

    • Patients who completed the full trial: 296 patients received PALFORZIA and 116 patients 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 patients taking PALFORZIA could tolerate 600 mg of peanut protein with no more than mild symptoms (versus 4% [5 of 124] in the placebo group)

The PALISADE Clinical Trial

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 patient groups:

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

    • Patients who completed the full trial: 296 patients received PALFORZIA and 116 patients 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 patients taking PALFORZIA could tolerate 600 mg of peanut protein with no more than mild symptoms (versus 4% [5 of 124] in the placebo group)

Different amounts of peanuts can trigger an
Accidental exposure

Benefits And Risks

PALFORZIA works to reduce the frequency and 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 such as yogurt or applesauce. Taking PALFORZIA every day follows a practice called oral immunotherapy (OIT). Although it is not known exactly how OIT works, it can help kids with a peanut allergy gradually decrease their sensitivity to peanuts over time.

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.

PALFORZIA is approved in the United States.

PALFORZIA is the first and only FDA-approved treatment to help reduce the severity of allergic reactions to peanuts, including anaphylaxis, in children aged 4 through 17.

Side effects are an expected part of PALFORZIA treatment.

Because PALFORZIA treatment relies on the intentional exposure to peanut allergen, 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.

Although uncommon, 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); severe flushing of the skin.

Most side effects are mild to moderate, and usually resolve within 40 minutes.

For most kids, mild or moderate side effects start within 4 minutes of taking PALFORZIA and resolve after about 37 minutes. During the Up-Dosing phase, the administration 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 2-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.

See How Treatment Works

IMPORTANT SAFETY INFORMATION

PALFORZIA can cause severe allergic reactions called anaphylaxis that may be life-threatening.

  • You will receive your first dose in a healthcare setting under the observation of trained healthcare staff.

  • You will receive the first dose of all dose increases in a healthcare setting.

  • In the healthcare setting, you will be observed for at least 1 hour for signs and symptoms of a severe allergic reaction.

  • If you have a severe reaction during treatment, you will need to receive an injection of epinephrine immediately and get emergency medical help right away.

  • You will return to the healthcare setting for any trouble tolerating your home doses.

Stop taking PALFORZIA and get emergency medical treatment right away if you have any of the following symptoms after taking PALFORZIA:

  • 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)

  • Severe flushing of the skin

WHAT IS PALFORZIA?

PALFORZIA is a treatment for people who are allergic to peanuts. PALFORZIA can help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA may be started in patients aged 4 through 17 years old. If you turn 18 years of age while on PALFORZIA treatment you should continue taking PALFORZIA unless otherwise instructed by your doctor.

PALFORZIA does NOT treat allergic reactions and should not be given during an allergic reaction.

You must maintain a strict peanut-free diet while taking PALFORZIA.

Because of the risk of severe allergic reactions, PALFORZIA is only available through a restricted program called the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) Program. Talk to your healthcare provider for more information about the PALFORZIA REMS program and how to enroll.

You should NOT take PALFORZIA if you have uncontrolled asthma, or if you ever had eosinophilic esophagitis (EoE) or other eosinophilic gastrointestinal disease.

Tell your doctor if you are not feeling well prior to starting treatment with PALFORZIA. Your doctor may decide to delay treatment until you are feeling better. Also tell your doctor about any medical conditions you have and if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal supplements.

Your doctor may decide that PALFORZIA is not the best treatment if:

  • You are unwilling or unable to receive (or self-administer) injectable epinephrine.

  • You have a condition or are taking a medication that reduces the ability to survive a severe allergic reaction.

What are the possible side effects of PALFORZIA?

The most commonly reported side effects of PALFORZIA 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.

PALFORZIA can cause severe allergic reactions called anaphylaxis that may be life-threatening.

PALFORZIA can cause stomach or gut symptoms including inflammation of the esophagus (called eosinophilic esophagitis). Symptoms of eosinophilic esophagitis can include:

  • Trouble swallowing

  • Food stuck in throat

  • Burning in chest, mouth, or throat

  • Vomiting

  • Regurgitation of undigested food

  • Feeling sick

For additional information on the possible side effects of PALFORZIA, talk with your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide, including an Important Warning about anaphylaxis.

WHAT IS PALFORZIA?

PALFORZIA is a treatment for people who are allergic to peanuts. PALFORZIA can help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA may be started in patients aged 4 through 17 years old. If you turn 18 years of age while on PALFORZIA treatment you should continue taking PALFORZIA unless otherwise instructed by your doctor.

PALFORZIA does NOT treat allergic reactions and should not be given during an allergic reaction.

You must maintain a strict peanut-free diet while taking PALFORZIA.

IMPORTANT SAFETY INFORMATION

PALFORZIA can cause severe allergic reactions called anaphylaxis that may be life-threatening.

  • You will receive your first dose in a healthcare setting under the observation of trained healthcare staff.

  • You will receive the first dose of all dose increases in a healthcare setting.

  • In the healthcare setting, you will be observed for at least 1 hour for signs and symptoms of a severe allergic reaction.

  • If you have a severe reaction during treatment, you will need to receive an injection of epinephrine immediately and get emergency medical help right away.

  • You will return to the healthcare setting for any trouble tolerating your home doses.

Stop taking PALFORZIA and get emergency medical treatment right away if you have any of the following symptoms after taking PALFORZIA:

  • 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)

  • Severe flushing of the skin

WHAT IS PALFORZIA?

PALFORZIA is a treatment for people who are allergic to peanuts. PALFORZIA can help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA may be started in patients aged 4 through 17 years old. If you turn 18 years of age while on PALFORZIA treatment you should continue taking PALFORZIA unless otherwise instructed by your doctor.

PALFORZIA does NOT treat allergic reactions and should not be given during an allergic reaction.

You must maintain a strict peanut-free diet while taking PALFORZIA.

Because of the risk of severe allergic reactions, PALFORZIA is only available through a restricted program called the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) Program. Talk to your healthcare provider for more information about the PALFORZIA REMS program and how to enroll.

You should NOT take PALFORZIA if you have uncontrolled asthma, or if you ever had eosinophilic esophagitis (EoE) or other eosinophilic gastrointestinal disease.

Tell your doctor if you are not feeling well prior to starting treatment with PALFORZIA. Your doctor may decide to delay treatment until you are feeling better. Also tell your doctor about any medical conditions you have and if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal supplements.

Your doctor may decide that PALFORZIA is not the best treatment if:

  • You are unwilling or unable to receive (or self-administer) injectable epinephrine.

  • You have a condition or are taking a medication that reduces the ability to survive a severe allergic reaction.

What are the possible side effects of PALFORZIA?

The most commonly reported side effects of PALFORZIA 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.

PALFORZIA can cause severe allergic reactions called anaphylaxis that may be life-threatening.

PALFORZIA can cause stomach or gut symptoms including inflammation of the esophagus (called eosinophilic esophagitis). Symptoms of eosinophilic esophagitis can include:

  • Trouble swallowing

  • Food stuck in throat

  • Burning in chest, mouth, or throat

  • Vomiting

  • Regurgitation of undigested food

  • Feeling sick

For additional information on the possible side effects of PALFORZIA, talk with your doctor or pharmacist.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.

Please see full Prescribing Information and Medication Guide, including an Important Warning about anaphylaxis.

WHAT IS PALFORZIA?

PALFORZIA is a treatment for people who are allergic to peanuts. PALFORZIA can help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA may be started in patients aged 4 through 17 years old. If you turn 18 years of age while on PALFORZIA treatment you should continue taking PALFORZIA unless otherwise instructed by your doctor.

PALFORZIA does NOT treat allergic reactions and should not be given during an allergic reaction.

You must maintain a strict peanut-free diet while taking PALFORZIA.