PALFORZIA® is currently the
first† and only‡ approved oral
immunotherapy that helps
mitigate the severity of allergic
reactions, including anaphylaxis,
that may occur with accidental
exposure to peanuts.1-4
PALFORZIA is indicated for the treatment of
patients aged 4 to 17 years with a confirmed
diagnosis of peanut allergy. PALFORZIA may be
continued in patients 18 years of age and older.
PALFORZIA should be used in conjunction with
a peanut-avoidant diet.1
Go Inside Palforzia®

†Date of first authorization: 17/12/20201

‡Only OIT at 28/10/2024.


PALFORZIA is not intended for, and does not provide, immediate relief of allergic symptoms, and therefore is not to be
used for emergency treatment of allergic reactions, including anaphylaxis.1


This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 of the summary of the product characteristics for how to report adverse reactions

2024_089EN01 October 2024
PALFORZIA is the first† and only‡ approved
oral immunotherapy that:
Desensitises progressively,
via controlled increments of allergens1,3,4
Is manufactured in a way that
yields a product containing a
range of the major and minor
protein allergens
found in
peanuts.2,5
Is supported by 9 phase II and III trials,
with over 2300 patients, including
PALISADE, the largest ever* peanut
allergy clinical trial and ARTEMIS, an
efficacy and safety study across 7
European countries.2-4,6-15
Let's get personal
†Date of first authorization: 17/12/20201
‡Only OIT at 28/10/2024
†Date of first authorization: 17/12/20201
‡Only OIT at 28/10/2024
†Date of first authorization: 17/12/20201
‡Only OIT at 28/10/2024
*To date (28/10/2024) in North America and Europe
Treat him
Oliver, 5 y.o.
The highly reaction patient
Treat her
Anna, 12 y.o.
The budding athlete
The following medical history is fictional. The presentation is based on typically occurring
circumstances. The treatment and the success of the therapy depicted represent an idealized course.
This possible course of therapy has been confirmed by clinical studies. Nevertheless, each patient and
each course of disease is highly individual and a corresponding effect cannot be
expected and guaranteed for all patients.
Oliver is a quiet five-year-
old who faces significant
challenges in his formative
years due to his severe
peanut allergy
This is Oliver
Oliver is a quiet five-year-old who
faces significant challenges in his
formative years due to his severe
peanut allergy.
Oliver, unable to fully comprehend
the dangers, relies on the diligence
of teachers and caregivers to keep
him safe.
Since Oliver started school, his
mother struggles with entrusting his
safety to others, dreading every
phone call in fear of a reaction.​
Help him
Clinical History

Oliver was first diagnosed with a peanut
allergy aged 2 after having a severe
allergic reaction from a small amount of
peanut protein. ​

His allergy demands vigilant monitoring by
his caregivers. Oliver also has a history of
mild asthma which is controlled.

Most recent exposure ​

Oliver’s most recent exposure to peanuts occurred during a
family dinner at a restaurant. Despite his mum thoroughly
checking the restaurant’s menu beforehand and informing the
staff of his allergy, Oliver consumed a meal with trace amounts
of peanuts. ​

This incident led to an allergic reaction and a trip to the
emergency room, reinforcing the need for constant vigilance
and proactive management of his allergy.

Treat
Pre-treatment consultation​
At clinician’s discretion​
Treat
Initial dose
escalation ​
Occurs on the first day of PALFORZIA dosing,
in the clinic*, lasting about 4 hours ​
*Palforzia should be administered under the supervision of a health care professional qualified in
the diagnosis and treatment of allergic diseases.1
Initial dose escalation and the first dose of each new up-dosing level are to be administered in a health
care setting prepared to manage potential severe allergic reactions.1
Up-dose
Up-dosing​
Combines dose increase in the clinic* and continuing
at that dose level at home.
Dose increases are made every 2 weeks at the clinic
for approximately 6 months.1
*Palforzia should be administered under the supervision of a health care professional qualified in
the diagnosis and treatment of allergic diseases.1
Initial dose escalation and the first dose of each new up-dosing level are to be administered in a health
care setting prepared to manage potential severe allergic reactions.1
Maintenance treatment
Maintenance 
Starts after all Up-Dosing levels are
complete; continued daily.1
Maintenance dosing is required to
maintain the tolerability and clinical
effects of the product.1
The effect of stopping treatment on maintenance of clinical efficacy has not been evaluated.
If treatment with PALFORZIA is stopped, patients must continue to carry self-injectable adrenaline
at all times.1
Learn about Palforzia benefits
Anna is a sporty and driven
first-year high school
student with a diagnosed
peanut allergy.
This is Anna
She’s a rock climber, training and
competing several times a week.
Anna experiences frustration with
the restrictions placed on her
attendance at sports competitions
because of her allergy.
Anna’s parents grapple with
constant fear regarding her risk of
having a reaction out of their care.​
Help her
Clinical History

Anna was first diagnosed with a peanut
allergy aged 4 following a reaction to a
snack containing peanuts. Since then, she
adheres diligently to a strict avoidance
diet and communicates this requirement
to her teachers and coaches at school
and sporting events. ​​

Anna also has a history of eczema and
mild asthma, which are both well
controlled.

Most recent exposure ​

Anna’s most recent exposure took place at a competitive rock
climbing meet away from home.
Another parent brought snacks which they believed to not
contain peanuts, but after consuming one Anna experienced
trouble breathing. This led to epinephrine being administered
and a visit to the emergency room.

This event knocked Anna’s confidence and instilled fear in
her parents, leading them to now accompany her to every
sporting event. ​

Treat
Pre-treatment
consultation​
At clinician’s discretion​
Treat
Initial dose
escalation ​
Occurs on the first day of PALFORZIA dosing,
in the clinic*, lasting about 4 hours ​
*Palforzia should be administered under the supervision of a health care professional qualified in
the diagnosis and treatment of allergic diseases.1
Initial dose escalation and the first dose of each new up-dosing level are to be administered in a health
care setting prepared to manage potential severe allergic reactions.1
Up-dose
Up-dosing​
Combines dose increase in the clinic* and continuing
at that dose level at home.
Dose increases are made every 2 weeks at the clinic for approximately 6 months.1
*Palforzia should be administered under the supervision of a health care professional qualified in
the diagnosis and treatment of allergic diseases.1
Initial dose escalation and the first dose of each new up-dosing level are to be administered in a health
care setting prepared to manage potential severe allergic reactions.1
Maintenance treatment
Maintenance 
Starts after all Up-Dosing levels are
complete; continued daily.1
Maintenance dosing is required to
maintain the tolerability and clinical
effects of the product.1
The effect of stopping treatment on maintenance of clinical efficacy has not been evaluated.
If treatment with PALFORZIA is stopped, patients must continue to carry self-injectable adrenaline
at all times.1
Learn about Palforzia benefits
Building protection that
empowers, with Palforzia
Improving protection from accidental peanut
exposure* in the short term4
After 9 months of treatment**
Nearly 8 out of 10 patients tolerated 300mg
of peanut protein with no more than mild
symptoms during the exit DBPCFC1,3†​
Nearly half of the patients tolerated a single highest
dose of 1000mg peanut protein with no more than
mild allergic symptoms at an exit DBPCFC1,3†​​​
The median amount of peanut protein that causes a reaction during
accidental exposure is average 125 mg, less than half a kernel of peanut17
Building tolerance that lasts ​
Continued treatment up to 2 years with PALFORZIA​***
Demonstrated increasing desensitization to
peanut protein with 96% tolerating 1000mg
of peanut protein with no more than mild
symptoms at the exit DBPCFC6†​
More than 8 out of 10 patients tolerated 2000mg
of peanut protein with no more than mild
symptoms during exit DBPCFC 1,6†​
Learn about Safety
*Efficacy data currently are available for up to 24 months of treatment with PALFORZIA. No recommendation can be made about the duration of treatment beyond 24 months.1
**ARC010 was a phase 3, international, randomized, double-blind, placebo-controlled multicenter study at 18 sites in 10 countries in North America and Europe. … Read more Read less
***ARC004 was an international, multicenter, open-label, 2-arm follow-on Phase 3 study to ARC003, completed in North America and Europe. … Read more Read less
§One peanut kernel is equivalent to 300 mg4
†Data are descriptive only and are not included in the FDA- or EMA-approved labelling for PALFORZIA.
The safety profile of
PALFORZIA was consistent
across trials, manageable, and
improved over time4,6,9,11,16
The majority of
adverse events were
mild to moderate.2,4,11,16
Adverse events were more
frequently reported during Up-
Dosing with fewer reported during
Maintenance.1,2,4
Rates of severe
systemic allergic
reactions
(anaphylaxis)* were
low and remained
low over time.1,16
Warnings and Contraindications
Safety profile
Learn about Benefits
*For full safety information, please refer to the Summary of Product Characteristics.
This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report
any suspected adverse reactions. See section 4.8 of the Summary of Product Characteristics for how to report adverse reactions.
Persevering with PALFORZIA
treatment beyond 1.5 years leads
to clinically meaningful
improvements in self-reported and
caregiver-reported food allergy
-related quality of life6

Moderate-to-high levels of
treatment satisfaction are seen in
patients treated with Palforzia and
their caregivers18
Let us tell you all about it
PALFORZIA is not intended for, and does not provide, immediate relief of allergic symptoms, and therefore is not to be used for emergency treatment of allergic reactions, including anaphylaxis.1

Before prescribing consult the Summary of Product Characteristics available at the booth or flashing this QR code.
Read more Read less