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Determining if PALFORZIA® is right for your patients

Three steps to consider if PALFORZIA could be an option for your patients

Models for illustrative purposes only.

1. Patient
   identification

  • PALFORZIA may be appropriate for patients aged 1 through 17 years with a confirmed diagnosis of peanut allergy and who do not demonstrate contraindications, such as uncontrolled asthma, history of eosinophilic gastrointestinal disease, or meet exclusion criteria.1-3
  • If patients have comorbidities, they should be manageable and controlled. Patients should also have the ability to commit to daily dosing, regular office visits, and always carry epinephrine.1
  • PALFORZIA should not be given to patients with uncontrolled asthma.1
  • A motivated caregiver is important to help ensure commitment and adherence to PALFORZIA protocol.

2. Patient
    education

  • It is important that patients and caregivers understand that PALFORZIA is not a cure for peanut allergy and is a treatment that may help mitigate the severity of allergic reactions through desensitization to peanut.1
  • PALFORZIA does NOT treat allergic reactions and should not be given during an allergic reaction. It is not effective against other food allergies that a patient may have.1

3. Patient REMS
    enrollment

  • Certified prescribers must enroll patients in the Risk Evaluation and Mitigation Strategy (REMS) program to administer PALFORZIA.
  • The PALFORZIA REMS Program is an FDA drug safety program that manages the risk of anaphylaxis associated with prescription medications such as PALFORZIA.
  • Learn more about PALFORZIA REMS here.

Help protect your patients from allergic
reactions, including anaphylaxis, during
their treatment journey

Select each patient to learn how to identify which types of patients in your practice may benefit
from PALFORZIA.

Meet Aaron*

Aged 2 years

Aspiring adventurer

Meet Oliver*

Aged 6 years

Hopeful student,
severely allergic

Meet Anna*

Aged 11 years

Budding athlete

Meet Lucy*

Aged 15 years

Independence seeker

Personal

  • Aaron is an active and adventurous toddler.
  • He loves to play, constantly putting things in his mouth.
  • His parents are looking to enroll him in daycare and want to be able to allow for more playdates with other kids but are afraid of the risks due to his allergy.
  • His parents are hoping treatment will help protect him against severe anaphylactic reactions due to accidental peanut exposure that may occur out of their care, whether in daycare or on a playdate.

Clinical

  • Diagnosed when he was 1 year old
  • Allergy demands vigilant monitoring
  • Hay fever, well controlled.

Most recent reaction

Shortly after snack time at a mother and baby group, Aaron consumed part of a muffin that contained peanuts that an older child had left on a nearby playmat. That led to his first allergic reaction and a visit to the emergency room. This was followed up at an allergy clinic where his peanut allergy was diagnosed.
 

Treatment with PALFORZIA

Aaron started treatment with PALFORZIA early at the age of 1. Upon a recheck of IgE after a year of treatment, Aaron showed improved immunomodulation which helped protect him after he accidentally ate another child’s peanut butter cookie on the playground.

Personal

  • Oliver is a quiet child who faces significant challenges due to his severe peanut allergy.
  • He is starting school but his mother struggles with entrusting his safety to others.
  • Has been bullied due to the stigma surrounding his peanut allergy.
  • His mother is determined to give Oliver greater freedom as he gets older.

Clinical

  • Diagnosed at 4 years old after a severe allergic reaction from a small amount of peanut butter
  • Allergy demands vigilant monitoring
  • Mild asthma, well controlled.

Most recent reaction

During a family outing to a restaurant, Oliver consumed a meal with trace amounts of peanuts, despite his mother thoroughly checking the menu and informing staff of his allergy. This resulted in a visit to the emergency room to treat his anaphylactic reaction.
 

Treatment with PALFORZIA

PALFORZIA increased Oliver’s tolerability to peanuts after 2 years on treatment and thereby decreasing his sensitivity.

Now, knowing he is better protected against accidental exposure, Oliver and his mom are able to focus on the excitement of a new school and new friendships instead of his peanut allergy.

Personal

  • Anna is a sporty and driven student who climbs competitively.
  • Recent accidental exposure at an overnight competition has led to her parents limiting her participation to only events in which they can attend with her.

Clinical

  • Diagnosed when she was 6 years old
  • Diligently adheres to a strict avoidance diet and communicates her allergy with her teachers and climbing coaches
  • History of eczema and mild asthma, both well controlled.

Most recent reaction

At a climbing competition away from home, Anna required epinephrine administration and a visit to the emergency room after she accidentally consumed a snack that unknowingly contained peanuts. The snack was given to her by a teammate, despite her team and coaches’ awareness of her allergy. This caused concerns from her parents about her safety out of their supervision.
 

Treatment with PALFORZIA

Building Anna’s tolerability to peanut has allowed her the opportunity to pursue her passion for rock climbing without requiring the strict supervision by her parents.

Personal

  • Lucy is confident, head-strong, and craves independence.
  • She enjoys new hobbies and activities.
  • She is preparing for college in 2 years and wants to navigate her world and explore new opportunities with less potential risk of accidental exposure.
  • Her parents are worried that being away from home and on her own in the near future will pose an added risk; they are considering having her live at home for college instead of letting her move out of state.

Clinical

  • Diagnosed when she was 9 years old
  • Diligently has followed a strict avoidance diet
  • Recently experienced several reactions that resulted in medical care
  • No other known health conditions.

Most recent reaction

While at a local festival, she was served fries cooked in peanut oil without proper allergy guidance, resulting in a significant reaction and the need for epinephrine to be administered.
 

Treatment with PALFORZIA

Since Lucy feels she has more protection against accidental exposures, her future college plans and living away from home are less of a concern for both Lucy and her parents.


*The patients portrayed and their associated data are fictional, hypothetical, and they have not actually been treated with PALFORZIA. Individual results will vary with each patient.

Why PALFORZIA?
Hear firsthand from a
family about their journey
with PALFORZIA.†

Discover how through shared decision making with their
allergist, they chose PALFORZIA treatment.

†Individual results will vary with each patient.

These are real caregivers of real patients who are taking or have taken PALFORZIA and have been compensated for their time.
Healthcare professionals featured are real physicians who treat or have treated patients with PALFORZIA and have been compensated for their time.

Learn more on how to get your practice started with PALFORZIA treatment

FIND OUT

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

IgE, immunoglobulin E; REMS, Risk Evaluation and Mitigation Strategy.

References:  

  1. PALFORZIA [package insert]. Lenoir, NC; Greer Laboratories, Inc.
  2. Du Toit G, et al. NEJM Evid. 2023;2(11):EVIDoa2300145.
  3. Vickery BP, et al. NEJM. 2018;379:1991–2001.

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.