This website is intended for a U.S. audience only

About

PALFORZIA

What is PALFORZIA?

PALFORZIA is a prescription medicine derived from peanuts. It 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 is intended to gradually decrease your sensitivity to small amounts of peanuts that may be hidden in foods.

PALFORZIA is a medication that must be taken daily to maintain the treatment effect.

PALFORZIA is only intended to treat people with peanut allergy—it is not effective against other food allergies you may have.

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.

What is PALFORZIA REMS?

PALFORZIA is only available through a restricted program called the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) Program. Before you can receive PALFORZIA, you must:

Enroll in this program.

Receive education about the risk of a severe allergic reaction (anaphylaxis) by a healthcare provider who practices in a setting that is certified through the REMS program.

Understand that you will be monitored in a healthcare setting during and after the Initial Dose Escalation and for the first dose of each Up-Dosing level (see Dosing Information).

Receive education about how to maintain a peanut-free diet. You must attest that you will continue to avoid peanuts at all times.

Fill the prescription your healthcare provider gives you for the injectable epinephrine. You must attest that epinephrine will be available to you at all times.

Talk to your healthcare provider for more information about the PALFORZIA REMS program and how to enroll.

How does PALFORZIA work?

PALFORZIA works by helping your child gradually decrease their sensitivity to peanuts over time through a process called oral immunotherapy, or OIT.

Who should not use PALFORZIA?

You should NOT take PALFORZIA if:

You have uncontrolled asthma.

You ever had eosinophilic esophagitis (EoE) or other eosinophilic gastrointestinal disease.

What should I tell my doctor before using PALFORZIA?

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. You should tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal supplements. Keep a list of them and show it to your doctor and pharmacist each time you get a new supply of PALFORZIA.

Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

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.

Who created PALFORZIA?

PALFORZIA was created by Aimmune Therapeutics, Inc. Learn more about Aimmune and our story.

BENEFITS

AND RISKS

What are the benefits of PALFORZIA?

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. 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.

The effectiveness of PALFORZIA has been proven in the largest, randomized, double-blind, placebo-controlled clinical trial of an oral peanut allergy treatment. Learn more about the PALISADE clinical trial.

What is the most important information I should know about PALFORZIA?

PALFORZIA can cause severe allergic reactions 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

For home administration of PALFORZIA, your doctor will prescribe injectable epinephrine, a medicine you must inject if you have a severe allergic reaction after taking PALFORZIA. Your doctor will train and instruct you on the proper use of injectable epinephrine.

Talk to your doctor and read the epinephrine patient information if you have any questions about the use of injectable epinephrine.

What are the possible side effects of PALFORZIA?

The most commonly reported 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.

PALFORZIA can cause severe allergic reactions that may be life-threatening. Symptoms of allergic reactions to PALFORZIA can include:

Trouble breathing or wheezing

Chest discomfort or tightness

Throat tightness or swelling

Trouble swallowing or speaking

Swelling of your face, lips, eyes, or tongue

Dizziness or fainting

Severe stomach cramps or pain, vomiting, or diarrhea

Skin rash, itching, or raised bumps on skin

Severe flushing of the skin

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 may report side effects to the U.S. Food and Drug Administration (FDA) at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSING &

STARTING TREATMENT

Can I take PALFORZIA with other medications I am taking?

Your doctor will tell you if you can take other medicines with PALFORZIA, such as other allergy treatments, medicines for your stomach, or medicines for any other conditions that you have.

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.

Tell your doctor about any medical conditions you have. Also tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal supplements. Keep a list of them and show it to your doctor and pharmacist each time you get a new supply of PALFORZIA.

How should I take PALFORZIA?

Prepare and take PALFORZIA exactly as instructed by your doctor.

PALFORZIA is an oral powder that is mixed with refrigerated or room temperature soft food such as applesauce, yogurt, pudding, or other food.

PALFORZIA is provided as either capsules or sachets.

PALFORZIA oral powder should be completely emptied from the capsules or sachets into the food before mixing.

Do not swallow the capsules.

Do not breathe in the powder. This could cause breathing problems (worsening of asthma) or cause an allergic reaction.

How often is PALFORZIA given?

There are three different phases of dosing with PALFORZIA: Initial Dose Escalation, Up-Dosing, and Maintenance Dosing.

Initial Dose Escalation:

The first 5 doses (Initial Dose Escalation) of PALFORZIA will be administered on a single day in your doctor’s office. If you do not tolerate the Initial Dose Escalation, your doctor may not continue your treatment with PALFORZIA.

Up-Dosing:

If you tolerate the Initial Dose Escalation phase, you will return to your doctor’s office the next day to start the Up-Dosing phase. There are 11 different dose levels of Up-Dosing, starting with PALFORZIA 3 mg (Level 1) and finishing with PALFORZIA 300 mg (Level 11). The first dose of each Up-Dosing level is given in your doctor’s office. If you tolerate the first dose of a new dose level, your doctor will ask you to continue to take that dose level every day at home. PALFORZIA should be taken at approximately the same time each day.

During Up-Dosing, you will return to your doctor’s office approximately every 2 weeks to be assessed for a new Up-Dosing level. Dose levels cannot be skipped. 

Maintenance Dosing:

If you tolerate all dose levels of the Up-Dosing phase, your doctor will ask you to continue taking PALFORZIA at a 300 mg dose every day as Maintenance therapy.

PALFORZIA must be taken every day for it to be effective.

Your doctor will tell you if you can take other medicines with PALFORZIA, such as other allergy treatments, medicines for your stomach, or medicines for any other conditions that you have.

How am I supposed to prepare my dose of PALFORZIA?

Open the daily dose of PALFORZIA capsule(s) or sachet and empty the full dose of PALFORZIA oral powder on to refrigerated or room temperature soft food such as applesauce, yogurt, or pudding. Do not use liquid (e.g., milk, water, juice) to prepare. Mix well.

The amount of food for mixing must enable you to take the full dose of PALFORZIA in a few spoonfuls.

You should take PALFORZIA immediately after mixing.

Wash your hands immediately after handling PALFORZIA capsules or sachets.

PALFORZIA must be stored in a refrigerator.

What happens if I miss my dose?

If you miss taking PALFORZIA, contact your doctor. Do not take additional doses on the same day to make up for missed doses.

Can I continue normal activities after taking PALFORZIA?

Do not exercise or have a hot bath or shower within 3 hours after taking PALFORZIA.

If you have been exercising or have taken a hot bath or shower and are feeling hot, or you are sweating and your heart is beating fast, do not take PALFORZIA until you have cooled down and your heart is beating normally.

Certain conditions may increase the likelihood of an allergic reaction. These include:

Having an illness, such as a viral infection

Being very tired or missing sleep

Being stressed

Having your menstrual period

Exercising

Taking certain pain medications, such as aspirin or ibuprofen

Drinking alcohol

How should I store PALFORZIA?

Refrigerate PALFORZIA at 2°C to 8°C (36°F to 46°F). Do not freeze. Store in the original packaging until use to protect from moisture.

Keep PALFORZIA out of the reach of children.

Throw away any unused PALFORZIA after the expiration date.

Where do I get PALFORZIA?

PALFORZIA is only available through a restricted program called the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) Program.

Once you and your allergist have made the decision to start PALFORZIA, your allergist will write you a prescription, which can either be shipped directly to your home or to your allergist’s office by the pharmacy.

PALFORZIA prescriptions are filled by a specialty pharmacy, which has expertise in dispensing medications like PALFORZIA and is different from your usual pharmacy. Specialty pharmacies that dispense PALFORZIA must also be certified in the PALFORZIA REMS Program.

SUPPORT

What if I need help paying for PALFORZIA?

Aimmune is committed to helping patients gain access to PALFORZIA. That’s why we offer the PALFORZIA Pathway program. This program provides resources to help you understand your insurance coverage and find information on sources of financial support for eligible patients.

Your allergist’s office will assist in getting you enrolled in PALFORZIA Pathway and will require your consent so our customer representatives can help make it a smooth process to gain access to PALFORZIA.

PALFORZIA Pathway is staffed with customer representatives who can assist eligible patients in enrolling in the PALFORZIA Pathway Co-Pay Savings Program or the PALFORZIA Pathway Patient Assistance Program.

Ask your allergist how to get started in our program.

What is a specialty pharmacy?

In order for your family member to receive PALFORZIA in a timely manner, the prescription must be fulfilled by a specialty pharmacy. Specialty pharmacies have expertise in dispensing medications like PALFORZIA and are different from your usual pharmacy. After receiving the prescription, the specialty pharmacy ships the drug to your preferred location.

Note: You, your allergist, and your allergist’s practice must be enrolled in the PALFORZIA REMS Program before getting your prescription.

Who do I call if I have more questions?

Call 1-844-PALFORZ [1-844-725-3679] with any questions about PALFORZIA.

About

PALFORZIA

What is PALFORZIA?

PALFORZIA is a prescription medicine derived from peanuts. It 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 is intended to gradually decrease your sensitivity to small amounts of peanuts that may be hidden in foods.

PALFORZIA is a medication that must be taken daily to maintain the treatment effect.

PALFORZIA is only intended to treat people with peanut allergy—it is not effective against other food allergies you may have.

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.

What is PALFORZIA REMS?

PALFORZIA is only available through a restricted program called the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) Program. Before you can receive PALFORZIA, you must:

Enroll in this program.

Receive education about the risk of a severe allergic reaction (anaphylaxis) by a healthcare provider who practices in a setting that is certified through the REMS program.

Understand that you will be monitored in a healthcare setting during and after the Initial Dose Escalation and for the first dose of each Up-Dosing level (see Dosing Information).

Receive education about how to maintain a peanut-free diet. You must attest that you will continue to avoid peanuts at all times.

Fill the prescription your healthcare provider gives you for the injectable epinephrine. You must attest that epinephrine will be available to you at all times.

Talk to your healthcare provider for more information about the PALFORZIA REMS program and how to enroll.

How does PALFORZIA work?

PALFORZIA works by helping your child gradually decrease their sensitivity to peanuts over time through a process called oral immunotherapy, or OIT.

Who should not use PALFORZIA?

You should NOT take PALFORZIA if:

You have uncontrolled asthma.

You ever had eosinophilic esophagitis (EoE) or other eosinophilic gastrointestinal disease.

What should I tell my doctor before using PALFORZIA?

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. You should tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal supplements. Keep a list of them and show it to your doctor and pharmacist each time you get a new supply of PALFORZIA.

Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding.

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.

Who created PALFORZIA?

PALFORZIA was created by Aimmune Therapeutics, Inc. Learn more about Aimmune and our story.

BENEFITS

AND RISKS

What are the benefits of PALFORZIA?

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. 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.

The effectiveness of PALFORZIA has been proven in the largest, randomized, double-blind, placebo-controlled clinical trial of an oral peanut allergy treatment. Learn more about the PALISADE clinical trial.

What is the most important information I should know about PALFORZIA?

PALFORZIA can cause severe allergic reactions 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

For home administration of PALFORZIA, your doctor will prescribe injectable epinephrine, a medicine you must inject if you have a severe allergic reaction after taking PALFORZIA. Your doctor will train and instruct you on the proper use of injectable epinephrine.

Talk to your doctor and read the epinephrine patient information if you have any questions about the use of injectable epinephrine.

What are the possible side effects of PALFORZIA?

The most commonly reported 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.

PALFORZIA can cause severe allergic reactions that may be life-threatening. Symptoms of allergic reactions to PALFORZIA can include:

Trouble breathing or wheezing

Chest discomfort or tightness

Throat tightness or swelling

Trouble swallowing or speaking

Swelling of your face, lips, eyes, or tongue

Dizziness or fainting

Severe stomach cramps or pain, vomiting, or diarrhea

Skin rash, itching, or raised bumps on skin

Severe flushing of the skin

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 may report side effects to the U.S. Food and Drug Administration (FDA) at 1-800-FDA-1088 or www.fda.gov/medwatch.

DOSING &

STARTING TREATMENT

Can I take PALFORZIA with other medications I am taking?

Your doctor will tell you if you can take other medicines with PALFORZIA, such as other allergy treatments, medicines for your stomach, or medicines for any other conditions that you have.

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.

Tell your doctor about any medical conditions you have. Also tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal supplements. Keep a list of them and show it to your doctor and pharmacist each time you get a new supply of PALFORZIA.

How should I take PALFORZIA?

Prepare and take PALFORZIA exactly as instructed by your doctor.

PALFORZIA is an oral powder that is mixed with refrigerated or room temperature soft food such as applesauce, yogurt, pudding, or other food.

PALFORZIA is provided as either capsules or sachets.

PALFORZIA oral powder should be completely emptied from the capsules or sachets into the food before mixing.

Do not swallow the capsules.

Do not breathe in the powder. This could cause breathing problems (worsening of asthma) or cause an allergic reaction.

How often is PALFORZIA given?

There are three different phases of dosing with PALFORZIA: Initial Dose Escalation, Up-Dosing, and Maintenance Dosing.

Initial Dose Escalation:

The first 5 doses (Initial Dose Escalation) of PALFORZIA will be administered on a single day in your doctor’s office. If you do not tolerate the Initial Dose Escalation, your doctor may not continue your treatment with PALFORZIA.

Up-Dosing:

If you tolerate the Initial Dose Escalation phase, you will return to your doctor’s office the next day to start the Up-Dosing phase. There are 11 different dose levels of Up-Dosing, starting with PALFORZIA 3 mg (Level 1) and finishing with PALFORZIA 300 mg (Level 11). The first dose of each Up-Dosing level is given in your doctor’s office. If you tolerate the first dose of a new dose level, your doctor will ask you to continue to take that dose level every day at home. PALFORZIA should be taken at approximately the same time each day.

During Up-Dosing, you will return to your doctor’s office approximately every 2 weeks to be assessed for a new Up-Dosing level. Dose levels cannot be skipped. 

Maintenance Dosing:

If you tolerate all dose levels of the Up-Dosing phase, your doctor will ask you to continue taking PALFORZIA at a 300 mg dose every day as Maintenance therapy.

PALFORZIA must be taken every day for it to be effective.

Your doctor will tell you if you can take other medicines with PALFORZIA, such as other allergy treatments, medicines for your stomach, or medicines for any other conditions that you have.

How am I supposed to prepare my dose of PALFORZIA?

Open the daily dose of PALFORZIA capsule(s) or sachet and empty the full dose of PALFORZIA oral powder on to refrigerated or room temperature soft food such as applesauce, yogurt, or pudding. Do not use liquid (e.g., milk, water, juice) to prepare. Mix well.

The amount of food for mixing must enable you to take the full dose of PALFORZIA in a few spoonfuls.

You should take PALFORZIA immediately after mixing.

Wash your hands immediately after handling PALFORZIA capsules or sachets.

PALFORZIA must be stored in a refrigerator.

What happens if I miss my dose?

If you miss taking PALFORZIA, contact your doctor. Do not take additional doses on the same day to make up for missed doses.

Can I continue normal activities after taking PALFORZIA?

Do not exercise or have a hot bath or shower within 3 hours after taking PALFORZIA.

If you have been exercising or have taken a hot bath or shower and are feeling hot, or you are sweating and your heart is beating fast, do not take PALFORZIA until you have cooled down and your heart is beating normally.

Certain conditions may increase the likelihood of an allergic reaction. These include:

Having an illness, such as a viral infection

Being very tired or missing sleep

Being stressed

Having your menstrual period

Exercising

Taking certain pain medications, such as aspirin or ibuprofen

Drinking alcohol

How should I store PALFORZIA?

Refrigerate PALFORZIA at 2°C to 8°C (36°F to 46°F). Do not freeze. Store in the original packaging until use to protect from moisture.

Keep PALFORZIA out of the reach of children.

Throw away any unused PALFORZIA after the expiration date.

Where do I get PALFORZIA?

PALFORZIA is only available through a restricted program called the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) Program.

Once you and your allergist have made the decision to start PALFORZIA, your allergist will write you a prescription, which can either be shipped directly to your home or to your allergist’s office by the pharmacy.

PALFORZIA prescriptions are filled by a specialty pharmacy, which has expertise in dispensing medications like PALFORZIA and is different from your usual pharmacy. Specialty pharmacies that dispense PALFORZIA must also be certified in the PALFORZIA REMS Program.

SUPPORT

What if I need help paying for PALFORZIA?

Aimmune is committed to helping patients gain access to PALFORZIA. That’s why we offer the PALFORZIA Pathway program. This program provides resources to help you understand your insurance coverage and find information on sources of financial support for eligible patients.

Your allergist’s office will assist in getting you enrolled in PALFORZIA Pathway and will require your consent so our customer representatives can help make it a smooth process to gain access to PALFORZIA.

PALFORZIA Pathway is staffed with customer representatives who can assist eligible patients in enrolling in the PALFORZIA Pathway Co-Pay Savings Program or the PALFORZIA Pathway Patient Assistance Program.

Ask your allergist how to get started in our program.

What is a specialty pharmacy?

In order for your family member to receive PALFORZIA in a timely manner, the prescription must be fulfilled by a specialty pharmacy. Specialty pharmacies have expertise in dispensing medications like PALFORZIA and are different from your usual pharmacy. After receiving the prescription, the specialty pharmacy ships the drug to your preferred location.

Note: You, your allergist, and your allergist’s practice must be enrolled in the PALFORZIA REMS Program before getting your prescription.

Who do I call if I have more questions?

Call 1-844-PALFORZ [1-844-725-3679] with any questions about 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.