I am a patient or caregiver

Please click here for Palforzia.com

I am a U.S. healthcare professional

This website is intended for U.S. healthcare professionals only. To enable certain features and improve your experience with us, this website requires cookies to be stored on your computer. To find out more about the cookies we use, please see our Privacy Notice. Please confirm you are a U.S. healthcare professional to proceed. By choosing this option, you are accepting our cookie policy.

The information in this webpage is intended for US healthcare professionals only.

Peanut allergy: 

one of the most
common food
allergies in children1

The patient images are AI generated and are not real patients treated with PALFORZIA.
Individual results will vary with each patient.

Understanding peanut prevalence

Illustrative image

80% of
children

with a peanut allergy have been shown to be burdened with managing their allergy throughout their lifetime.2

Illustrative image

1.5 million children

in the United States are affected.3,4

Illustrative image

And this prevalence
has been

increasing

over the years.3

Accidental peanut
exposure is difficult to
avoid and may have
serious consequences  

Accidental peanut exposure is the leading cause of death
from anaphylaxis caused by food.5

While peanut avoidance is key for managing peanut
allergy,1 it can be challenging due to:

Widespread use of peanuts
in common food items6,7

Cross-contact in kitchens8

Inconsistent food labeling9

Accidental ingestion of peanut, leading to allergic reaction
symptoms, may occur in most patients over time5,10

These symptoms may lead to anaphylactic reactions requiring emergency
room (ER) visits and hospital admissions.10–13

Illustrative image

60% of
children

with a peanut allergy had an
adverse reaction due to
accidental peanut
exposure.10*

Illustrative image

35% of
children

experienced an
anaphylactic reaction
within 5 years.11†

Illustrative image

23% of
children

with a peanut allergy had at
least one peanut-related ER 
visit within 1 year.12‡

Illustrative image

154%
increase

in rate of ER visits/hospital
admissions of children for
food-related anaphylaxis.13§

*In a study that followed children (n=102) with peanut allergy.10
†In an epidemiologic analysis of 1,070 children with confirmed peanut allergy or sensitization over 5 years.11
‡In a U.S. representative sample of 38,408 children <18 years with peanut allergy (surveyed in 2015–2016).12
§Among children 0–19 years old with peanut allergy over 5 years (2008 to 2012).13

The role of oral
immunotherapy (OIT) in
treating peanut allergy

Unlike avoidance alone, OIT introduces controlled
exposure to the allergen with the aim of increasing the
body’s tolerability to it, to help reduce the risk of allergic
reactions that may occur from an accidental exposure to
that allergen.14

The patient images are AI generated and are not real
patients treated with PALFORZIA. Individual results will
vary with each patient.

Illustrative image Illustrative image

Downloadable resources
for understanding peanut allergy

PALFORZIA HCP Brochure

DOWNLOAD THE PDF

PALFORZIA Toddler Indication Brochure

DOWNLOAD THE PDF

PALFORZIA REMS Program Overview Brochure

DOWNLOAD THE PDF

Explore PALFORZIA for your
patients

LEARN MORE

The patient images are AI generated and are not real
patients treated with PALFORZIA. Individual results will
vary with each patient.

Illustrative image Illustrative image

References:  

  1. Food Allergy Research & Education (FARE). Available here.
  2. Peters RL, et al. J Allergy Clin Immunol. 2015;135:1257–66.e1–2.
  3. Gupta R, et al. Pediatrics. 2011;128:e9–17.
  4. Federal Interagency Forum on Child and Family Statistics. Available here.
  5. Iglesia IGA, et al. JAMA. 2024;331:510–521.
  6. Lieberman JA, et al. Allergy. 2021;76:1367–84.
  7. Dyer AA, et al. Allergy Asthma Proc. 2015;36:58–64.
  8. Miller TA, et al. Ann Allergy Asthma Immunol. 2022;128:439–442.
  9. Stankovich GA, et al. Frontiers in Allergy. 2023;4:1060932.
  10. Vander Leek TK, et al. J Pediatr. 2000;137:749–55.
  11. Leickly FE, et al. J Pediatr. 2018;192:223–8.e1.
  12. Gupta RS, et al. Pediatrics. 2018;142:e20181235.
  13. Dyer AA, et al. Ann Allergy Asthma Immunol. 2015;115:56–62.
  14. American Academy of Allergy Asthma & Immunology. Available here.

Important Safety
Information

WARNING: ANAPHYLAXIS

  • PALFORZIA can cause anaphylaxis, which may be life-threatening and can occur at any time during PALFORZIA therapy. 
  • Prescribe injectable epinephrine, instruct and train patients on its appropriate use, and instruct patients to seek immediate medical care upon its use. 
  • Do not administer PALFORZIA to patients with uncontrolled asthma. 
  • Dose modifications may be necessary following an anaphylactic reaction. 
  • Observe patients during and after administration of the Initial Dose Escalation and the first dose of each Up-Dosing level, for at least 60 minutes. 
  • PALFORZIA is available only through a restricted program called the PALFORZIA REMS.

INDICATION

PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. 

PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. Initial Dose Escalation may be administered to patients aged 1 through 17 years. Up-Dosing and Maintenance may be continued in patients 1 years of age and older. 

PALFORZIA is to be used in conjunction with a peanut-avoidant diet. 

Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis. 

CONTRAINDICATIONS

PALFORZIA is contraindicated in patients with uncontrolled asthma, or with a history of eosinophilic esophagitis and other eosinophilic gastrointestinal disease. 

WARNINGS AND PRECAUTIONS 

ANAPHYLAXIS 

PALFORZIA can cause anaphylaxis, which may be life-threatening. PALFORZIA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the PALFORZIA REMS because of the risk of anaphylaxis. Only prescribers, healthcare settings, pharmacies, and patients certified and enrolled in the REMS Program can prescribe, receive, dispense or administer PALFORZIA. 

Anaphylaxis has been reported during all phases of PALFORZIA dosing, including Maintenance and in subjects who have undergone recommended Up-Dosing and dose modification procedures. 

Do not initiate PALFORZIA treatment in a patient who has had severe or life-threatening anaphylaxis within the previous 60 days. PALFORZIA may not be suitable for patients with certain medical conditions that may reduce the ability to survive anaphylaxis, including but not limited to markedly compromised lung function, severe mast cell disorder, or cardiovascular disease. In addition, PALFORZIA may not be suitable for patients taking medications that can inhibit or potentiate the effects of epinephrine. 

All Initial Dose Escalation doses and the first dose of each Up-Dosing level must be administered under observation in a certified health care setting. 

Patients may be more likely to experience allergic reactions following PALFORZIA administration in the presence of cofactors such as exercise, hot water exposure, intercurrent illness (e.g., viral infection), or fasting. Other potential cofactors may include menstruation, sleep deprivation, nonsteroidal anti-inflammatory drug use, or uncontrolled asthma. Patients should be proactively counseled about the potential for the increased risk of anaphylaxis in the presence of these cofactors. If possible, adjust the time of dosing to avoid these cofactors. If it is not possible to avoid these cofactors, consider withholding PALFORZIA temporarily. 

ASTHMA

Uncontrolled asthma is a risk factor for a serious outcome, including death, in anaphylaxis. Ensure patients with asthma have their asthma under control prior to initiation of PALFORZIA. 

PALFORZIA should be temporarily withheld if the patient is experiencing an acute asthma exacerbation. Following resolution of the exacerbation, resumption of PALFORZIA should be undertaken cautiously. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of PALFORZIA.

EOSINOPHILIC GASTROINTESTINAL DISEASE

Discontinue PALFORZIA and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastrointestinal symptoms, including dysphagia, vomiting, nausea, gastroesophageal reflux, chest pain, or abdominal pain.

GASTROINTESTINAL ADVERSE REACTIONS

Gastrointestinal adverse reactions were commonly reported in PALFORZIA-treated subjects, and dose modification should be considered for patients who report these reactions. For severe or persistent gastrointestinal symptoms consider a diagnosis of eosinophilic esophagitis. 

ADVERSE REACTIONS

The most common adverse reactions reported in subjects ages 1 through 3 years treated with PALFORZIA (incidence ≥5%) are cough, sneezing, rhinitis, nasal congestion, throat irritation, wheezing, abdominal pain, vomiting, diarrhea, oral pruritus, oropharyngeal pain, urticaria, rash, pruritus, and perioral dermatitis. 

The most common adverse events reported in subjects ages 4 through 17 years treated with PALFORZIA (incidence ≥ 5% and at least 5% greater than placebo) are abdominal pain, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, and ear pruritus. 

Please see full Prescribing Information, including Boxed WARNING and Medication Guide.