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How treatment with PALFORZIA works

Learning how to tolerate small amounts of peanut protein with no more than mild symptoms takes time. Slowly exposing the body to more and more of an allergen over a long period of time is part of a process called oral immunotherapy, or OIT. Treatment with PALFORZIA starts with a build-up process that takes place over the course of about 6 months with increasing dose levels and then continues with a daily Maintenance Dose.

Children playing games

THE 3 STEPS OF

PALFORZIA TREATMENT

Initial Dose Escalation icon
Starting Small

At your child's first treatment appointment, your 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 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.

THE 3 STEPS OF

PALFORZIA TREATMENT

Up-Dosing icon
Starting Small

At your child's first treatment appointment, your 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 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.

Getting ready

for your first appointment

To find out if PALFORZIA is the right choice to treat your child's peanut allergy, you will need to talk to your allergist. Before your initial consultation, gather the information your allergist will need to get a clear picture of your child's allergy history. It is also a good idea to make notes about the questions you will have about treatment.

Could PALFORZIA be right for your family?

If you are not sure, you can take a quick quiz to find out if PALFORZIA is a good match for your child's specific allergy diagnosis and needs.

Little boy climbing at the playground
Questions your allergist might ask

When was the last time your child had a reaction and what caused it?

Is your child allergic to anything else?

Does your child have any other medical conditions?

Does your child ever have trouble swallowing or feel like there’s food stuck in his or her throat?

Can you commit to coming to the office every 2 weeks for about 6 months?

Can you commit to giving your child a dose of PALFORZIA every day?

Will your child and your family be able to handle the possible side effects?

Questions you might want to ask

Will my child still need to carry injectable epinephrine?

How soon does PALFORZIA start working?

How will we know it’s working?

Is there an ideal age to start this treatment?

What happens during the appointments?

What are some of the more common side effects?

What are the most severe side effects?

Can my child take other medications while being treated?

What if my child has other allergies?

Are there any other FDA-approved treatment alternatives?

Are there dietary restrictions during the treatment?

What follow-up tests are there?

Support and Resources

Want to learn more about possible next steps if your doctor prescribes 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.

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.