Palforzia

1 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX I 

 

SUMMARY OF PRODUCT CHARACTERISTICS 



 

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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 for how to report adverse reactions. 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

PALFORZIA 0.5 mg oral powder in capsules for opening 

PALFORZIA 1 mg oral powder in capsules for opening 

PALFORZIA 10 mg oral powder in capsules for opening 

PALFORZIA 20 mg oral powder in capsules for opening 

PALFORZIA 100 mg oral powder in capsules for opening 

PALFORZIA 300 mg oral powder in sachet 

 

 

2. QUALITATIVE AND QUANTITATIVE COMPOSITION 

 

PALFORZIA 0.5 mg oral powder in capsules for opening 

 

Each capsule contains 0.5 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

PALFORZIA 1 mg oral powder in capsules for opening 

 

Each capsule contains 1 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

PALFORZIA 10 mg oral powder in capsules for opening 

 

Each capsule contains 10 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

PALFORZIA 20 mg oral powder in capsules for opening 

 

Each capsule contains 20 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

PALFORZIA 100 mg oral powder in capsules for opening 

 

Each capsule contains 100 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

PALFORZIA 300 mg oral powder in sachet 

 

Each sachet contains 300 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

For the full list of excipients, see section 6.1. 

 

 

3. PHARMACEUTICAL FORM 

 

White to beige oral powder in capsules for opening or sachet. 

 



 

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PALFORZIA 0.5 mg oral powder in capsules for opening 

 

Oral powder in white opaque hard capsules (16 x 6 mm) 

 

PALFORZIA 1 mg oral powder in capsules for opening 

 

Oral powder in red opaque hard capsules (16 x 6 mm) 

 

PALFORZIA 10 mg oral powder in capsules for opening 

 

Oral powder in blue opaque hard capsules (23 x 9 mm) 

 

PALFORZIA 20 mg oral powder in capsules for opening 

 

Oral powder in white opaque hard capsules (23 x 9 mm) 

 

PALFORZIA 100 mg oral powder in capsules for opening 

 

Oral powder in red opaque hard capsules (23 x 9 mm) 

 

PALFORZIA 300 mg oral powder in sachet 

 

Oral powder 

 

 

4. CLINICAL PARTICULARS 

 

4.1 Therapeutic indications 

 

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. 

 

4.2 Posology and method of administration 

 

This medicine should be administered under the supervision of a health care professional qualified in 

the diagnosis and treatment of allergic diseases. 

 

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. 

 

Self-injectable adrenaline (epinephrine) must be available to the patient at all times. 

 

Posology 

 

Treatment with PALFORZIA is administered in 3 sequential phases: Initial dose escalation, up-dosing, 

and maintenance.  

 

For each dose level during up-dosing, the doses given in clinic and at home should be from the same 

batch to avoid variations in the potency range (see section 4.4). 

 

The dose configurations for each phase of dosing are provided in Table 1, Table 2, and Table 3. 

 

A dose level can be considered tolerated if no more than transient symptoms are observed with no or 

minimal medical intervention/therapy required. 

 



 

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Initial dose escalation phase 

 

Initial dose escalation is administered on a single day under the supervision of a health care 

professional in a health care setting with the ability to manage potentially severe allergic reactions, 

including anaphylaxis.  

 

Initial dose escalation is administered in sequential order on a single day beginning at 0.5 mg and 

completing with 6 mg (see Table 1).  

 

Table 1:  Dose and capsule presentation for initial dose escalation 

Dose Capsule presentation per dose 

0.5 mg 1 × 0.5 mg capsule 

1 mg 1 × 1 mg capsule 

1.5 mg 1 × 0.5 mg capsule + 1 × 1 mg capsule 

3 mg 3 × 1 mg capsules 

6 mg 6 × 1 mg capsules 

 

Each dose should be separated by an observation period of 20 to 30 minutes.  

 

No dose level should be omitted.  

 

Patients must be observed after the last dose for at least 60 minutes until suitable for discharge.  

 

Treatment must be discontinued if symptoms requiring medical intervention (e.g., use of adrenaline) 

occur with any dose during initial dose escalation. 

 

Patients who tolerate at least the 3 mg single dose PALFORZIA during initial dose escalation must 

return to the health care setting for initiation of up-dosing. 

 

If possible, up-dosing should begin the day after initial dose escalation.  

 

If the patient is unable to begin up-dosing within 4 days, initial dose escalation should be repeated in a 

health care setting. 

 

Up-dosing phase 

 

Initial dose escalation must be completed before starting up-dosing. 

 

Up-dosing consists of 11 dose levels and is initiated at a 3 mg dose (see Table 2).  

 

The first dose of each new up-dosing level is administered under the supervision of a health care 

professional in a health care setting with the ability to manage potentially severe allergic reactions, 

including anaphylaxis. Patients should be observed for at least 60 minutes after administering the first 

dose of a new up-dosing level until suitable for discharge.  

 

If the patient tolerates the first dose of the increased dose level, the patient may continue that dose 

level at home.  

 

All the dose levels in Table 2 must be administered in sequential order at 2-week intervals if tolerated. 

No dose level should be omitted. Patients must not progress through up-dosing more rapidly than 

shown in Table 2.  

 



 

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Table 2:  Daily dosing configuration for up-dosing 

Dose level 

Total 

daily dose Presentation of dose (capsule colour) 

Dose duration 

(weeks) 

1 3 mg 3 × 1 mg capsules (red) 2 

2 6 mg 6 × 1 mg capsules (red) 2 

3 12 mg 2 × 1 mg capsules (red)  

1 × 10 mg capsule (blue) 

2 

4 20 mg 1 × 20 mg capsule (white) 2 

5 40 mg 2 × 20 mg capsules (white) 2 

6 80 mg 4 × 20 mg capsules (white) 2 

7 120 mg 1 × 20 mg capsule (white)  

1 × 100 mg capsule (red) 

2 

8 160 mg 3 × 20 mg capsules (white) 

1 × 100 mg capsule (red) 

2 

9 200 mg 2 × 100 mg capsules (red) 2 

10 240 mg 2 × 20 mg capsules (white)  

2 × 100 mg capsules (red) 

2 

11 300 mg 1 × 300 mg sachet 2 

 

No more than one dose should be consumed per day. Patients should be instructed not to consume a 

dose at home on the same day as a dose consumed in the clinic. 

 

Care should be taken to ensure that patients have only one dose level in their possession at any time. 

 

Dose modification or discontinuation should be considered for patients who do not tolerate up-dosing 

as described in Table 2 (see Dose modification instructions).  

 

Maintenance therapy 

 

All dose levels of up-dosing must be completed before starting maintenance.  

 

The maintenance dose of PALFORZIA is 300 mg daily.  

 

Table 3:  Daily dosing configuration for maintenance 

Presentation of dose Total daily dose 

1 × 300 mg sachet 300 mg 

 

Daily maintenance is required to maintain the tolerability and clinical effects of PALFORZIA.  

 

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. 

 

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.   

 

Dose modification instructions 

 

Dose modifications are not appropriate during initial dose escalation. 

 

Temporary dose modification of PALFORZIA may be required for patients who experience allergic 

reactions during up-dosing or maintenance or for practical reasons for patient management. Allergic 

reactions, including gastrointestinal reactions, that are severe, recurrent, bothersome, or last longer 

than 90 minutes during up-dosing or maintenance should be actively managed with dose 

modifications. Clinical judgment should be used to determine the best course of action on a patient by 



 

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patient basis. This can include maintaining the dose level for longer than 2 weeks, reducing, or 

withholding PALFORZIA doses.  

 

Management of consecutive missed doses 

 

Missed doses of PALFORZIA may pose a significant risk to patients due to potential loss of 

desensitisation. The guidelines in Table 4 are to be used for managing missed doses. 

 

Table 4:  Management of consecutive missed doses 

Consecutive missed doses Action 

1 to 2 days Patients may resume treatment at the same dose level at home. 

3 to 4 days Patients may resume treatment at the same dose level under 

medical supervision in a health care setting based on medical 

judgment. 

5 to 14 days Patients may resume up-dosing with PALFORZIA under 

medical supervision in a health care setting at a dose of 50% or 

less of the last tolerated dose. 

Greater than 14 days Patient compliance should be evaluated and it should be 

considered to re-start up-dosing at 3 mg under supervision in 

a health care setting or to discontinue treatment completely.  

 

Following a dose reduction due to missed doses, up-dosing should be resumed as described in Table 2. 

 

Special populations 

 

Elderly 

 

The safety and efficacy of PALFORZIA therapy initiated in patients aged over 17 years has not been 

established. 

 

Paediatric population 

 

The safety and efficacy of PALFORZIA therapy in children aged less than 4 years have not yet been 

established. No data are available. 

 

Method of administration  

 

The powder must be taken orally after mixing with an age-appropriate soft food. 

 

Capsules are not to be ingested. Inhalation of the powder must be avoided. 

 

To empty the contents of each capsule, the two ends of the capsule should be pulled apart gently, and 

gently rolled between the finger and thumb. Sachets should be opened by carefully cutting or tearing 

along the line indicated. 

 

The entire dose of PALFORZIA powder should be emptied onto a few spoonfuls of refrigerated or 

room temperature semisolid food (e.g., fruit puree, yogurt, rice-pudding) and mixed well. Liquid 

(e.g., milk, water, juice) must not be used. 

 

Hands should be washed immediately after handling PALFORZIA capsule(s) or sachets. 

 

Each dose taken at home should be consumed daily with a meal at approximately the same time each 

day, preferably in the evening. PALFORZIA should not be taken on an empty stomach or after fasting.  

 

Alcohol should not be taken for 2 hours before or 2 hours after a dose (see section 4.4, Table 5). 

 



 

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4.3 Contraindications 

 

• Current severe or uncontrolled asthma 

• A history of, or current, eosinophilic oesophagitis (EoE); other eosinophilic gastrointestinal 

disease; chronic, recurrent, or severe gastroesophageal reflux disease (GERD); dysphagia 

• A history of, or current, severe mast cell disorder 

• Severe or life-threatening anaphylaxis within 60 days before initiating treatment with 

PALFORZIA  

• Hypersensitivity to any of the excipients listed in section 6.1 

 

4.4 Special warnings and precautions for use 

 

PALFORZIA is not intended for, and does not provide, immediate relief of allergic symptoms. 

Therefore, this medicinal product is not to be used for emergency treatment of allergic reactions, 

including anaphylaxis. 

 

Patients should not have active wheezing, uncontrolled severe atopic disease (e.g., atopic dermatitis or 

eczema), a flare of atopic disease or suspected intercurrent illness prior to initiation of therapy. 

 

Traceability 

 

In order to improve the traceability of biological medicinal products, the name and the batch number 

of the administered product should be clearly recorded. 

 

Adrenaline 

 

Self-injectable adrenaline must be prescribed to patients receiving this medicinal product. Patients 

must be instructed to carry self-injectable adrenaline at all times. Patients and caregivers must be 

instructed to recognise the signs and symptoms of an allergic reaction and in the proper use of self-

injectable adrenaline. Patients should be instructed to seek immediate medical care upon its use and to 

stop treatment until they have been evaluated by a physician. 

 

PALFORZIA may not be suitable for patients who are taking medications that can inhibit or potentiate 

the effect of adrenaline (see the SmPC of adrenaline for further information). 

 

Systemic allergic reactions including anaphylaxis 

 

When treated with PALFORZIA, peanut-allergic patients are exposed to peanut allergens that cause 

allergic symptoms. Therefore, allergic reactions to this medicinal product are expected in these 

patients. These reactions mostly occur during the first 2 hours after ingestion of the dose and are 

usually mild or moderate; however, more severe reactions may occur. Patients aged 12 years or older 

and/or with high sensitivity to peanut may be at higher risk of experiencing allergic symptoms during 

treatment. 

 

Dose modifications should be considered for patients who experience moderate or severe adverse 

allergic reactions to PALFORZIA. For dose modification instructions, see section 4.2. 

 

PALFORZIA can cause systemic allergic reactions including anaphylaxis, which may be life-

threatening.  

 

Severe adverse reactions such as difficulty swallowing, difficulty breathing, changes in voice or 

feeling of fullness in the throat, dizziness or fainting, severe stomach cramps or pain, vomiting, 

diarrhoea, or severe flushing or itching of the skin require immediate treatment, including use of 

adrenaline and subsequent medical evaluation. 

 

Patients must be educated to recognise the signs and symptoms of allergic reactions. Patients and 

caregivers should be instructed to contact a health care professional before administering the next dose 



 

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of PALFORZIA if symptoms of an escalating or persistent allergic reaction occur. Any reaction must 

be treated promptly (e.g., with self-administration of intramuscular adrenaline) in case a severe 

adverse reaction develops and immediate medical attention should be sought directly afterwards. In 

the emergency department, treatment should follow the anaphylaxis guidelines. 

 

Patients may be more likely to experience allergy symptoms after dosing of PALFORZIA in the 

presence of a medical event such as an intercurrent illness (e.g., viral infection), exacerbation of 

asthma, or in the presence of other co-factors (e.g., exercise, menstruation, stress, fatigue, sleep 

deprivation, fasting, intake of nonsteroidal anti-inflammatory drugs or alcohol). Patients should be 

counselled proactively about the potential for the increased risk of anaphylaxis in the presence of these 

co-factors, which may be modifiable or non-modifiable. On an individual basis and when needed, the 

time of dosing should be adjusted to avoid modifiable cofactors. If it is not possible to avoid any of the 

modifiable cofactors or if affected by non-modifiable co-factors, withholding or decreasing the 

PALFORZIA dose temporarily should be considered. Table 5 provides guidance on recommended 

actions to mitigate the risks associated with co-factors whilst on treatment. 

 

Table 5:  Guidelines on management of co-factors 

Modifiable co-factors Recommended action to be taken 

Hot bath or shower Hot showers or baths should be avoided immediately prior to or 

following 3 hours of treatment. 

Exercise Exercise should be avoided immediately prior to or for 3 hours 

following treatment. 

After strenuous exercise signs of a hypermetabolic state 

(e.g., flushing, sweating, rapid breathing, rapid heart rate) must 

have subsided before taking a dose. 

Fasting or empty stomach Each dose should be consumed with a meal. 

Alcohol Alcohol should not be taken for 2 hours before or 2 hours after 

a dose. 

Intake of non-steroidal anti-

inflammatory medicines 

The potential for allergic reactions to occur if taking non-

steroidal anti-inflammatory medicines whilst on PALFORZIA 

treatment should be considered.  

Non-modifiable co-factors 

Intercurrent illness Patients should be instructed to seek medical advice before 

taking their next dose of PALFORZIA. Exacerbation of asthma 

Menstruation Withholding or decreasing the PALFORZIA dose temporarily 

should be considered based on individual patient needs. Stress 

Fatigue or sleep deprivation 

 

Desensitisation response 

 

Strict daily, long-term dosing in conjunction with a peanut-avoidant diet is required to achieve 

desensitisation and maintain the treatment effect of PALFORZIA. Treatment interruptions, including 

non-daily dosing, may potentially lead to an increased risk of allergic reactions or even anaphylaxis. 

 

As with any immunotherapy treatment, clinically meaningful desensitisation may not occur in all 

patients (see section 5.1). 

 

Asthma 

 

In patients with asthma, treatment may only be initiated when the asthma status is controlled. 

Treatment 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. Patients who have recurrent asthma exacerbations should be re-evaluated and 

discontinuation considered. This medicinal product has not been studied in patients on long-term 

systemic corticosteroid therapy. 

 



 

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Concomitant illnesses 

 

This medicinal product may not be suitable for patients with certain medical conditions that may 

reduce the ability to survive a severe allergic reaction or increase the risk of adverse reactions after 

adrenaline administration. Examples of these medical conditions include, but are not limited to, 

markedly compromised lung function (chronic or acute; e.g., severe cystic fibrosis), unstable angina, 

recent myocardial infarction, significant arrhythmias, cyanotic congenital heart disease, uncontrolled 

hypertension, and inherited metabolic disorders. 

 

Gastro-intestinal adverse reactions including eosinophilic oesophagitis (EoE) 

 

If patients develop chronic or recurrent gastrointestinal symptoms, dose modification may be 

considered (see section 4.2). EoE has been reported in association with PALFORZIA (see section 4.8). 

For chronic/recurrent gastrointestinal symptoms, especially upper gastrointestinal symptoms (nausea, 

vomiting, dysphagia), the potential for a diagnosis of EoE should be considered. In patients who 

experience severe or persistent gastrointestinal symptoms, including dysphagia, gastroesophageal 

reflux, chest pain, or abdominal pain, treatment must be discontinued and a diagnosis of EoE should 

be considered. 

 

Concomitant allergen immunotherapy 

 

This medicinal product has not been studied in patients receiving concomitant allergen 

immunotherapy. Caution should be exercised when administering this medicinal product in 

conjunction with other allergen immunotherapies as the potential for severe allergic reactions may be 

enhanced.  

 

Oral inflammation or wounds 

 

Patients with acute severe inflammation of the mouth or oesophagus, or with oral wounds may be at 

greater risk of severe systemic allergic reactions following ingestion of peanut protein. Initiation of 

treatment should be postponed in these patients and ongoing treatment should be temporarily 

interrupted to allow healing of the oral cavity. 

 

Chronic urticaria 

 

Chronic urticaria, especially in the presence of severe exacerbations may confound the safety 

assessment of treatment. 

 

4.5 Interaction with other medicinal products and other forms of interaction 

 

No interaction studies have been performed. Interactions with other medicinal products are not 

expected. 

 

Severe allergic reactions may be treated with adrenaline (see section 4.4). Please refer to the SmPC for 

adrenaline for further information on medicines that may potentiate or inhibit the effects of adrenaline. 

 

4.6 Fertility, pregnancy and lactation 

 

Pregnancy 

 

There are no data from defatted powder of Arachis hypogaea L., semen (peanuts) in pregnant women. 

 

Initiation of treatment with PALFORZIA is not recommended during pregnancy. 

 

Treatment with this medicinal product may cause anaphylaxis, which is a risk to pregnant women. 

Anaphylaxis can cause a dangerous decrease in blood pressure, which could result in compromised 



 

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placental perfusion and significant risk to a foetus during pregnancy. In addition, the effect of oral 

immunotherapy (OIT) on the immune system of the mother and foetus during pregnancy is unknown. 

 

For patients who are established on OIT and become pregnant, the benefits of remaining on OIT and 

retaining desensitisation should be weighed against the risks of an anaphylactic reaction while 

remaining on OIT. 

 

Breast-feeding 

 

Peanut allergens have been found in human milk after consumption of peanuts. There are no data 

available on the effects of PALFORZIA on the breastfed infant, or the effects on milk production. The 

developmental and health benefits of breastfeeding should be considered, along with the mother’s 

clinical need for treatment and any other potential adverse effects on the breastfed child from 

PALFORZIA or from the underlying maternal condition. 

 

Fertility 

 

There are no specific clinical or nonclinical data on the effects of defatted powder of Arachis 

hypogaea L., semen (peanuts) on fertility. 

 

4.7 Effects on ability to drive and use machines 

 

PALFORZIA has minor influence on the ability to drive and use machines. Caution should be 

exercised for 2 hours after dosing in case any symptoms of an allergic reaction occur that could impact 

the ability to drive or use machines.  

 

4.8 Undesirable effects 

 

Summary of the safety profile 

 

The most common adverse reactions (of any severity) are abdominal pain (49.4%), throat irritation 

(40.7%), pruritus (33.7%), nausea (33.2%), vomiting (28.5%), urticaria (28.5%), oral pruritus (26.0%), 

abdominal discomfort (22.9%), and abdominal pain upper (22.8%).  

 

The incidence of adverse reactions was higher during up-dosing (85.7%) than initial dose escalation 

(45.1%) and maintenance (57.7%).  

 

The median time from administration of PALFORZIA in a clinical setting to onset of the first 

symptom ranged from 4 to 8 minutes. The median time from onset of the first symptom to resolution 

of the last symptom ranged from 15 to 30 minutes. 

 

10.5% of subjects discontinued study product due to 1 or more adverse reactions. The most common 

adverse reactions leading to discontinuation of treatment were abdominal pain (3.8%), vomiting 

(2.5%), nausea (1.9%), and systemic allergic reaction (1.6%), including anaphylaxis. 

 

Tabulated list of adverse reactions 

 

Table 6 is based on data from clinical trials. Listed adverse reactions are divided into groups according 

to the MedDRA system organ class and frequency. Frequency categories are defined as: Very 

common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to 

< 1/1,000), and very rare (< 1/10,000). Within each frequency grouping, adverse reactions are 

presented in order of decreasing seriousness. 

 



 

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Table 6:  Adverse reactions 

MedDRA system organ class Frequency Adverse reaction 

Immune system disorders Very common Anaphylactic reaction (systemic allergic 

reaction; any severity)   

Common Anaphylactic reaction, severe (anaphylaxis; 

systemic allergic reaction, severe)  

Respiratory, thoracic, and 

mediastinal disorders 

Very common Throat tightness 

Cough 

Sneezing 

Throat irritation 

Common Dyspnoea 

Wheezing 

Gastrointestinal disorders Very common Vomiting 

Abdominal pain 

Abdominal pain upper 

Nausea 

Abdominal discomfort 

Paraesthesia oral 

Oral pruritus 

Lip pruritus 

Uncommon Eosinophilic oesophagitis 

Skin and subcutaneous tissue 

disorders 

Very common Urticaria 

Pruritus 

 

Description of selected adverse reactions 

 

Systemic allergic reactions (Anaphylactic reactions)  

 

For the purpose of reporting the clinical study results, the term systemic allergic reaction is used to 

describe anaphylactic reaction events of any severity and the term anaphylaxis is used to distinguish 

anaphylactic reaction events that were severe. 

 

Systemic allergic reactions of any severity were reported in 15.1% of subjects, including 0.6% during 

initial dose escalation, 8.7% during up-dosing, and 9.9% during maintenance. The majority of subjects 

who had systemic allergic reactions had reactions of mild or moderate severity. Severe systemic 

allergic reaction (anaphylaxis) was reported in 10 subjects (1.1% overall), including 4 subjects (0.4%) 

during up-dosing and 6 (0.8%) during maintenance at 300 mg/day. 1.6% discontinued due to systemic 

allergic reaction including 0.3% with anaphylaxis. Of the total population, 10.6% of subjects reported 

a single episode of systemic allergic reaction and 4.6% reported two or more systemic allergic 

reactions. Existing data suggest an increased risk of systemic allergic reaction for adolescents (21.9%) 

than for children (≤ 11 years; 11.9%). 

 

In the clinical trials, the most commonly reported symptoms of systemic allergic reactions included 

skin disorders (urticaria, flushing, pruritis, face swelling, rash), respiratory disorders (dyspnea, 

wheezing, cough, throat tightness, rhinorrhea, throat irritation), and gastrointestinal disorders 

(abdominal pain, nausea, vomiting). The onset of most (87.0%) episodes of systemic allergic reaction 

was within 2 hours of the administration of the medication. 

 

Adrenaline use 

 

In the PALFORZIA safety population, 14.9% of subjects reported at least one episode of adrenaline 

use for any reason. 1.8% of patients reported at least one episode during initial dose escalation, 

9.1% during up-dosing, and 8.7% during maintenance. Of subjects who reported adrenaline usage, 

91.6% subjects required a single dose and 92.5% of adrenaline usage was for events of mild to 

moderate severity. 



 

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Eosinophilic oesophagitis (EoE) 

 

In clinical trials, 12 out of 1,217 subjects were diagnosed with biopsy-confirmed eosinophilic 

oesophagitis while receiving PALFORZIA compared with 0 of 443 subjects receiving placebo. After 

discontinuation of PALFORZIA, symptomatic improvement was reported in 12 of 12 subjects. In 

8 subjects with available follow-up biopsy results, eosinophilic oesophagitis was resolved in 6 subjects 

and improved in 2 subjects.  

 

Reporting of suspected adverse reactions 

 

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 

allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 

professionals are asked to report any suspected adverse reactions via the national reporting system 

listed in Appendix V. 

 

4.9 Overdose 

 

Administration of PALFORZIA at greater than recommended doses in peanut-allergic patients 

increases the risk of side effects, including the risk of systemic allergic reactions or severe 

single-organ allergic reactions. In the event of anaphylaxis at home, patients should self-administer 

intramuscular adrenaline and follow-up with an emergency medical evaluation. In an emergency 

department, the anaphylaxis guidelines should be followed. 

 

 

5. PHARMACOLOGICAL PROPERTIES 

 

5.1  Pharmacodynamic properties 

 

Pharmacotherapeutic group: not yet assigned 

ATC code: not yet assigned 

 

Mechanism of action 

 

The precise mechanism of desensitisation provided by defatted powder of Arachis hypogaea L., semen 

(peanuts) is not fully understood.  

 

A summary of immunoglobulin values reported for subjects aged 4 to 17 years treated with 

PALFORZIA for 12 months in the PALISADE study is provided in Table 7. 

 



 

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Table 7:  Change over time in immunoglobulin values in PALISADE (ITT population, 

PALFORZIA subjects, 4-17 years) 

Parameter Statistic 

Screening 

DBPCFC 

End  

of up-dosing 

Exit 

DBPCFC 

ps-IgE 

(kUA/L) 

n 372 305 272 

Geometric mean  

(SD) [1] 

51.40  

(5.965) 

101.33  

(8.134) 

48.61  

(7.799) 

Q1, Q3 18.6, 194.3 28.8, 491.0 12.2, 259.0 

ps-IgG4 

(mgA/L) 

n 353 305 274 

Geometric mean  

(SD) [1] 

0.538  

(3.4655) 

3.341  

(4.0450) 

5.557  

(4.4633) 

Q1, Q3 0.22, 1.21 1.72, 8.79 2.50, 14.70 

ps-IgE/ 

IgG4 

n 353 305 272 

Geometric mean  

(SD) [1] 

97.36  

(5.053) 

30.32  

(4.640) 

8.76  

(5.261) 

Q1, Q3 36.2, 310.0 11.6, 88.4 2.3, 26.3 

[1] Geometric means were calculated by computing the mean on the log10 scale and converting 

the mean to the original scale by calculating the antilog. 

ITT, intent-to-treat; ps, peanut specific; Q1, Q3, first quartile, third quartile; DBPCFC, double-

blind, placebo-controlled food challenge; SD, standard deviation. 

 

In the ARTEMIS study, the geometric mean (SD) peanut specific IgE of the PALFORZIA group was 

30.55 (7.794) kUA/L at the screening double-blind, placebo-controlled food challenge (DBPCFC), 

increasing to 44.28 (10.850) kUA/L at the end of Up-Dosing, thereafter decreasing to 

28.92 (9.908) kUA/L at the exit DBPCFC (following 3 months of PALFORZIA maintenance dosing 

at 300 mg daily). The geometric LS (least squares) mean ratio (exit/screening) was 1.18, 

95% confidence interval (CI) (0.97, 1.44). 

 

Immunologic parameters in long-term maintenance 

 

The sustained effects of PALFORZIA treatment on the immunologic parameters peanut-specific IgE, 

IgG4 and the IgE/IgG4 ratio for subjects who completed 12 and 18 months of PALFORZIA 

maintenance treatment with the ongoing therapeutic dose (300 mg daily) through participation in both 

PALISADE and the open-label follow-on study ARC004 are provided in Table 8. 

 

Table 8:  Immunologic parameters following continued maintenance at study exit (PALISADE 

and ARC004 completer populations, 4-17 years) 

 PALISADE ARC004 

 6-month maintenance 12-month maintenance 18-month maintenance 

n, Geometric Mean (SD) [1] 

ps-IgE 

kUA/L 

272 96 26 

48.61 (7.799) 27.87 (6.831)  13.42 (9.670) 

ps-IgG4 

mgA/L 

274 89 25 

5.557 (4.4633) 5.875 (4.3605) 8.900 (3.1294) 

ps-IgE/IgG4  272 89 25 

8.76 (5.261) 4.55 (6.189) 1.55 (5.462) 

[1] Geometric means were calculated by computing the mean on the log10 scale and converting the 

mean to the original scale by calculating the antilog. 

 

Clinical efficacy 

 

In all PALFORZIA clinical studies, efficacy was measured using a DBPCFC. This food challenge was 

performed according to the Practical Allergy (PRACTALL) guidelines with modification to include a 

600 mg protein dose (between the 300 mg and 1,000 mg challenge doses). 

 



 

14 

The efficacy of PALFORZIA was assessed in 2 randomised, double-blind, placebo-controlled, 

multicentre, phase 3 pivotal studies PALISADE and ARTEMIS. Both studies recruited subjects with 

a documented history of peanut allergy. Subjects with a severe or life-threatening anaphylaxis event 

within 60 days of study entry and those with severe or uncontrolled asthma were excluded from the 

studies. After an initial dose escalation ranging from 0.5 mg to 6 mg on day 1 and confirmation of 

tolerability of the 3 mg dose on day 2, subjects underwent up-dosing for 20 to 40 weeks starting at 

3 mg until the 300 mg dose was reached. The Up-Dosing period varied for each subject depending on 

doses tolerated. Subjects then underwent 6 months (PALISADE) or 3 months (ARTEMIS) of 

maintenance immunotherapy with 300 mg PALFORZIA or placebo until the end of the study when 

subjects completed an exit DBPCFC to assess desensitisation to peanut. 

 

PALISADE recruited subjects aged 4 to 55 years in Europe and North America. A total of 

750 subjects aged 4 to 17 years were screened and 499 were randomly assigned (3:1) to study 

treatment (374 to PALFORZIA and 125 to placebo). The primary efficacy analysis population 

consisted of 496 subjects aged 4 to 17 years who received at least one dose of study treatment. In this 

study, eligible subjects were those sensitive to ≤ 100 mg of peanut protein at the screening DBPCFC. 

Of the subjects treated with PALFORZIA in the primary analysis population, 72% had a medical 

history of allergic rhinitis, 66% reported multiple food allergies, 63% had a medical history of atopic 

dermatitis, and 53% had a present or previous diagnosis of asthma. The median age of subjects was 

9 years. More than half of the subjects were male (56%) and most subjects were white (78%).  

 

ARTEMIS recruited subjects aged 4 to 17 years of age in Europe. A total of 175 subjects aged 

4 to 17 years were randomly assigned (3:1) to study treatment (132 to PALFORZIA and 43 to 

placebo). The primary efficacy analysis population consisted of 175 subjects aged 4 to 17 years who 

received at least one dose of study treatment. In this study, eligible subjects were those sensitive to 

≤ 300 mg of peanut protein at the screening DBPCFC. Of the subjects treated with PALFORZIA in 

the primary analysis group, 61% reported multiple food allergies, 59% had a medical history of atopic 

dermatitis, 48% had a medical history of allergic rhinitis, and 42% had a present or previous diagnosis 

of asthma. The median age of subjects was 8.0 years. More than half of the subjects were male (52%) 

and most subjects were white (82%).  

 

Efficacy data 

 

The primary efficacy endpoint in both PALISADE and ARTEMIS was the proportion of subjects aged 

4 to 17 years who tolerated a single highest dose of at least 1,000 mg peanut protein with no more than 

mild allergic symptoms at the exit DBPCFC (desensitisation response rate). Key secondary endpoints 

in this age group included determination of the desensitisation response rates after single doses of 

300 mg and 600 mg peanut protein and the maximum severity of symptoms at the exit DBPCFC. 

 

Desensitisation response rates 

 

The summary of desensitisation response rates for primary and secondary efficacy endpoints for the 

intention to treat (ITT) population in both PALISADE and ARTEMIS are provided in Table 9. 

Subjects without an exit DBPCFC were counted as non-responders. 

 



 

15 

Table 9:  PALISADE and ARTEMIS: Summary of desensitisation response rates for primary 

and key secondary efficacy endpoints (ITT population, 4-17 years) 

Endpoint 

PALISADE ARTEMIS 

PALFORZIA 

N = 372 

Placebo 

N = 124 

PALFORZIA 

N = 132 

Placebo 

N = 43 

Primary efficacy endpoint 

Response rate: proportion of subjects 

who tolerated 1,000 mg peanut 

protein (95% CI) [1] 

50.3%  

(45.2, 55.3) 

2.4%  

(0.8, 6.9) 

58.3%  

(49.4, 66.8) 

2.3%  

(0.1, 12.3) 

P-value [2] < 0.0001 < 0.0001 

Key secondary efficacy endpoints 

Response rate: proportion of subjects 

who tolerated 600 mg peanut protein 

(95% CI) [1] 

67.2%  

(62.3, 71.8) 

4.0%  

(1.7, 9.1) 

68.2%  

(59.5, 76.0) 

9.3%  

(2.6, 22.1) 

P-value [2] < 0.0001 < 0.0001 

Response rate: proportion of subjects 

who tolerated 300 mg peanut protein 

(95% CI) [1] 

76.6%  

(72.1, 80.6) 

8.1%  

(4.4, 14.2) 

73.5%  

(65.1, 80.8) 

16.3%  

(6.8, 30.7) 

P-value [2] < 0.0001 < 0.0001 

[1] PALISADE: Based on Wilson (score) confidence limits, ARTEMIS: Based on exact Clopper-

Pearson interval. 

[2] PALISADE: Based on the Farrington-Manning confidence limits. ARTEMIS: Based on exact 

unconditional confidence limits using the score statistic; p-values were based on Fisher's exact 

test. 

CI, confidence interval. 

 

Response rates in subjects who turned 18 years during therapy 

 

The response rate of PALFORZIA treated subjects who turned 18 years whilst participating in a study 

and tolerated a single highest dose of at least 1,000 mg peanut protein with no more than mild allergic 

symptoms at the exit DBPCFC (15/27, 55.6%) was consistent with the overall primary efficacy of the 

subjects aged 4 to 17 years. 

 

Sustained efficacy 

 

Sustained efficacy has been demonstrated in 104 subjects and 26 subjects who completed 12 and 

18 months of PALFORZIA maintenance treatment with the ongoing therapeutic dose (300 mg daily) 

through participation in both PALISADE and the open-label, follow-on ARC004 study. A comparison 

of response rates after longer-term maintenance therapy with PALFORZIA can be made by comparing 

the response rates for the 12-month and 18-month maintenance cohorts in ARC004 with those who 

completed PALISADE (see Table 10). 

 



 

16 

Table 10:  Percentage of challenge doses tolerated following continued maintenance during exit 

DBPCFC (PALISADE and ARC004 completer populations, 4-17 years) 

 PALISADE  ARC004  

 6-month maintenance 

(N = 296) 

12-month maintenance 

(N = 104) 

18-month maintenance 

(N = 26) 

Subjects who tolerated a single dose of peanut protein (response rate) [95% CI] 

2,000 mg  na [1] 50 (48.1%)  

[38.2%, 58.1%] 

21 (80.8%) 

[60.6%, 93.4%] 

1,000 mg  187 (63.2%) 

[57.5%, 68.5%] 

83 (79.8%) 

[70.8%, 87.0%] 

25 (96.2%) 

[80.4%, 99.9%] 

600 mg  250 (84.5%) 

[79.9%, 88.1%] 

93 (89.4%) 

[81.9%, 94.6%] 

25 (96.2%) 

[80.4%, 99.9%] 

300 mg  285 (96.3%) 

[93.5%, 97.9%] 

102 (98.1%) 

[93.2%, 99.8%] 

26 (100%) 

[86.8%, 100.0%] 

[1] 1,000 mg was the highest challenge dose of peanut protein in PALISADE. 

DBPCFC, double-blind, placebo-controlled food challenge; CI confidence interval; na, not applicable. 

 

5.2 Pharmacokinetic properties 

 

No clinical studies investigating the pharmacokinetic profile and metabolism of PALFORZIA have 

been conducted. PALFORZIA contains naturally occurring allergenic peanut proteins. After oral 

administration, the proteins are hydrolysed to amino acids and small polypeptides in the lumen of the 

gastrointestinal tract. 

 

5.3 Preclinical safety data 

 

Non-clinical studies with defatted powder of Arachis hypogaea L., semen (peanuts) have not been 

conducted. 

 

 

6. PHARMACEUTICAL PARTICULARS 

 

6.1 List of excipients 

 

PALFORZIA 0.5 mg, 1 mg, 10 mg, 20 mg oral powder in capsules for opening 

 

Microcrystalline cellulose  

Partially pre-gelatinised maize starch  

Colloidal anhydrous silica 

Magnesium stearate 

 

PALFORZIA 100 mg oral powder in capsules for opening and PALFORZIA 300 mg oral powder in 

sachet 

 

Microcrystalline cellulose 

Colloidal anhydrous silica 

Magnesium stearate 

 

Capsules for opening contain hydroxypropyl methylcellulose (HPMC). 

 

Capsule shells 

 

0.5 mg capsule (white) 

 

Hydroxypropyl methylcellulose, Titanium dioxide (E171), Grey SW 5014 (ink) 

 



 

17 

1 mg capsule (red) 

 

Hydroxypropyl methylcellulose, Red iron oxide (E172), Titanium dioxide (E171), White TEK SW 

0012 (ink) 

 

10 mg capsule (blue) 

 

Hydroxypropyl methylcellulose, FD&C Blue #1 (E133), Red iron oxide (E172), Black iron oxide 

(E172), Titanium dioxide (E171), White SW 0012 (ink) 

 

20 mg capsule (white) 

 

Hydroxypropyl methylcellulose, Titanium dioxide (E171), Grey TEK SW 5014 (ink) 

 

100 mg capsule (red) 

 

Hydroxypropyl methylcellulose, Red iron oxide (E172), Titanium dioxide (E171), White SW 0012 

(ink) 

 

6.2 Incompatibilities 

 

In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 

products.  

 

6.3 Shelf life 

 

2 years 

 

After mixing a daily dose of PALFORZIA with age-appropriate soft-food, the entire volume of the 

prepared mixture should be consumed promptly, but if necessary, can be refrigerated for up to 8 hours. 

 

6.4 Special precautions for storage 

 

Store below 25°C. 

 

6.5 Nature and contents of container 

 

Initial dose escalation phase (see section 4.2) 

 

Initial dose escalation pack 

 

PVC:PCTFE/Aluminium blister containing 13 capsules (2 x 0.5 mg + 11 x 1 mg) in 5 single-dose 

blisters. 

 

Up-dosing phase (see section 4.2) 

 

Each 2-week pack contains additional doses in case of need. 

 

Name/Capsule or Sachet strength Pack contents by dose level (daily dose)  

PALFORZIA 1 mg 

oral powder in capsules for opening 

Level 1 (3 mg daily): 

48 capsules in PVC:PCTFE/Aluminium blisters in a carton 

Each blister-well contains three 1 mg capsules 

 

Level 2 (6 mg daily): 

96 capsules in PVC:PCTFE/Aluminium blisters in a carton 

Each blister-well contains six 1 mg capsules 

 



 

18 

Name/Capsule or Sachet strength Pack contents by dose level (daily dose)  

PALFORZIA 10 mg 

PALFORZIA 1 mg 

oral powder in capsules for opening 

Level 3 (12 mg daily): 

48 capsules in PVC:PCTFE/Aluminium blisters in a carton  

Each blister-well contains one 10 mg capsule and two 1 mg 

capsules 

 

PALFORZIA 20 mg 

oral powder in capsules for opening 

Level 4 (20 mg daily): 

16 capsules in PVC:PCTFE/Aluminium blisters in a carton 

Each blister-well contains one 20 mg capsule 

 

Level 5 (40 mg daily): 

32 capsules in PVC:PCTFE/Aluminium blisters in a carton 

Each blister-well contains two 20 mg capsules 

 

Level 6 (80 mg daily): 

64 capsules in PVC:PCTFE/Aluminium blisters in a carton 

Each blister-well contains four 20 mg capsules 

 

PALFORZIA 100 mg 

oral powder in capsules for opening 

Level 9 (200 mg daily): 

32 capsules in PVC:PCTFE/Aluminium blisters in a carton 

Each blister-well contains two 100 mg capsules 

 

PALFORZIA 100 mg 

PALFORZIA 20 mg 

oral powder in capsules for opening 

Level 7 (120 mg daily): 

32 capsules in PVC:PCTFE/Aluminium blisters in a carton 

Each blister-well contains one 100 mg capsule and one 

20 mg capsule 

 

Level 8 (160 mg daily): 

64 capsules in PVC:PCTFE/Aluminium blisters in a carton 

Each blister-well contains one 100 mg capsule and three 

20 mg capsules 

 

Level 10 (240 mg daily): 

64 capsules in PVC:PCTFE/Aluminium blisters in a carton 

Each blister-well contains two 100 mg capsules and two 

20 mg capsules 

 

PALFORZIA 300 mg 

oral powder in sachet 

Level 11 (300 mg daily): 

15 PET/Aluminium/mLLDPE foil sachets in a carton 

 

 

Maintenance phase (see section 4.2) 

 

Maintenance pack: 

 

Each pack of PALFORZIA 300 mg oral powder contains 30 PET/Aluminium/mLLDPE foil sachets in 

a carton. 

 



 

19 

6.6 Special precautions for disposal 

 

Disposal 

 

Any unused medicinal product or waste material should be disposed of in accordance with local 

requirements. 

 

Unused medicinal product or waste material includes opened capsule(s) (i.e., empty or contained 

powder that was not used) or sachet(s), and prepared mixtures not consumed within 8 hours. 

 

 

7. MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

Block B 

The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Ireland 

 

 

8. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/20/1495/001  

EU/1/20/1495/002  

EU/1/20/1495/003  

EU/1/20/1495/004  

EU/1/20/1495/005  

EU/1/20/1495/006  

EU/1/20/1495/007  

EU/1/20/1495/008  

EU/1/20/1495/009  

EU/1/20/1495/010  

EU/1/20/1495/011  

EU/1/20/1495/012  

EU/1/20/1495/013  

 

 

9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 

 

Date of first authorisation:  

 

 

10. DATE OF REVISION OF THE TEXT 

 

Detailed information on this medicinal product is available on the website of the European Medicines 

Agency http://www.ema.europa.eu    



 

20 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX II 

 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 

SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR 

BATCH RELEASE 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 

 

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 

MARKETING AUTHORISATION 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 

PRODUCT 

 

 



 

21 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 

MANUFACTURER RESPONSIBLE FOR BATCH RELEASE 

 

Name and address of the manufacturer of the biological active substance 

 

Golden Peanut Company, LLC 

(also known as Golden Peanut and Tree Nuts) 

Specialty Products Division 

3886 Martin Luther King Jr. Boulevard 

Blakely, Georgia 39823 

United States 

 

Name and address of the manufacturer responsible for batch release 

 

Millmount Health Limited 

Block 7, City North Business Campus 

Stamullen 

Co Meath 

Ireland 

 

 

B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  

 

Medicinal product subject to medical prescription. 

 

 

C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 

 

• Periodic safety update reports (PSURs) 

 

The requirements for submission of PSURs for this medicinal product are set out in the list of 

Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC 

and any subsequent updates published on the European medicines web-portal. 

 

The marketing authorisation holder (MAH) shall submit the first PSUR for this product within 

6 months following authorisation.  

 

 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT   

 

• Risk management plan (RMP) 

 

The marketing authorisation holder (MAH) shall perform the required pharmacovigilance 

activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the 

marketing authorisation and any agreed subsequent updates of the RMP. 

 

An updated RMP should be submitted: 

• At the request of the European Medicines Agency; 

• Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result of 

an important (pharmacovigilance or risk minimisation) milestone being reached. 

 



 

22 

• Additional risk minimisation measures 

 

Key messages of the additional risk minimisation measures 

 

Healthcare professional educational materials: 

 

- The Summary of Product Characteristics 

- Healthcare professional educational materials: 

 

These materials consist of print and on-line materials and video resources including an instruction 

manual. The instruction manual is a reference document which details the appropriate use of 

PALFORZIA and will include the following information: 

• Treatment overview  

o Summary of relevant background information and overview of the three dosing phases 

(initial dose escalation, up-dosing and maintenance) 

o Explanation of dose preparation and administration 

o When to consider dose modifications and management of missed doses 

• Safety overview 

o Summary of risks of anaphylaxis and eosinophilic oesophagitis with focus on the 

identification of symptoms, management, and mitigation of known risks (including - 

co-factors which may precipitate systemic allergic reactions) 

o Summary of common side effects with focus on severity, frequency, and management 

o Explanation of requisite treatment adherence with focus on daily dosing, peanut 

avoidance, and appropriate prescription and use of emergency adrenaline 

o Appropriate referral to SmPC for additional information 

o Country-specific guidance on how and when to report adverse events 

 

Patient and parent/caregiver educational materials: 

 

- Package leaflet 

- Patient and parent/caregiver educational materials: 

 

These consist of a collection of print and on-line materials and video resources that will be developed 

in lay terms to an appropriate reading age for the following audiences: patients aged 4–6, 7–11, and 

12-17 years old, and parents/caregivers. Materials will include the following information: 

• Treatment overview  

o Brief explanation as to what PALFORZIA is used for, which patients are suitable to 

be treated with PALFORZIA, and who should not take the medicine 

o Summary of relevant background information and overview of the three dosing phases 

(initial dose escalation, up-dosing, and maintenance) 

o How to safely prepare, administer, and (if necessary) store doses and dispose of 

unused doses 

• Safety overview 

o Summary of risks of anaphylaxis and eosinophilic oesophagitis with focus on the 

identification of symptoms, management, and mitigation of known risks (including 

co-factors which may precipitate systemic allergic reactions) 

o Summary of common side effects with focus on severity, frequency, and management  

o Explanation of requisite treatment adherence with focus on daily dosing, peanut 

avoidance, and appropriate use of emergency adrenaline 

o Appropriate referral to package leaflet for additional information  

o Description of how and when to report side effects to a healthcare professional 

 

Patient card 

• To be given to a patient by the prescribing physician when PALFORZIA treatment is initiated 

• Patients will be instructed to carry the card on their person at all times 

• Warning for healthcare professionals treating the patient at any time, including in emergency 

situations, that the patient is peanut-allergic and that they are using PALFORZIA 



 

23 

• Warning that if anaphylaxis is suspected to administer a dose of adrenaline and to contact 

emergency services 

• Description of the symptoms of anaphylaxis and when to contact a healthcare professional 

• Emergency contact details for the patient 

• Contact details of the PALFORZIA prescriber 

 



 

24 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

ANNEX III 

 

LABELLING AND PACKAGE LEAFLET 

 

  



 

25 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

A. LABELLING 

  



 

26 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

OUTER CARTON FOR INITIAL DOSE ESCALATION (PHYSICIAN / CLINIC USE ONLY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 0.5 mg oral powder in capsules for opening 

Palforzia 1 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each 0.5 mg capsule contains 0.5 mg peanut protein as defatted powder of Arachis hypogaea L., 

semen (peanuts). 

 

Each 1 mg capsule contains 1 mg peanut as defatted powder of Arachis hypogaea L., semen (peanuts). 

 

Each 1.5 mg dose comprises 1 × 1 mg capsule + 1 × 0.5 mg capsule. 

 

Each 3 mg dose comprises 3 × 1 mg capsules. 

 

Each 6 mg dose comprises 6 × 1 mg capsules. 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Oral powder in capsules for opening 

 

Each pack of 13 capsules for initial dose escalation contains 2 capsules of 0.5 mg and 11 capsules 

of 1 mg  

5 doses 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. Mix capsule contents with soft food before administration. 

Do not ingest capsules.  

 

Initial dose escalation 

Physician use only 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 



 

27 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP   

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

Dublin D09 C6X8 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/20/1495/001 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Justification for not including Braille accepted. 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC 



 

28 

SN 

NN  



 

29 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

5-DOSE BLISTER STRIP 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 0.5 mg oral powder in capsules for opening 

Palforzia 1 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

 

 

3. EXPIRY DATE 

 

EXP   

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

0.5 mg → 1 mg → 1.5 mg → 3 mg → 6 mg  



 

30 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

OUTER CARTON (LEVEL 1 - 3 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 1 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each capsule contains 1 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

Each 3 mg dose comprises 3 × 1 mg capsules 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Oral powder in capsules for opening 

 

48 capsules  

16 doses 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. Mix capsule contents with soft food before administration. 

Do not ingest capsules.  

 

Level 1 (3 mg daily) 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP   

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 



 

31 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

Dublin D09 C6X8 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S)  

 

EU/1/20/1495/002 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Palforzia level 1 (3 mg daily) 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

SN 

NN   



 

32 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

BLISTER STRIPS (LEVEL 1 - 3 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 1 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

 

 

3. EXPIRY DATE 

 

EXP   

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

Level 1 (3 mg daily)  



 

33 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

OUTER CARTON (LEVEL 2 - 6 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 1 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each capsule contains 1 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

Each 6 mg dose comprises 6 × 1 mg capsules. 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Oral powder in capsules for opening 

 

96 capsules (96 capsules of 1 mg) 

16 doses 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. Mix capsule contents with soft food before administration. 

Do not ingest capsules.  

 

Level 2 (6 mg daily) 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP   

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 



 

34 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

Dublin D09 C6X8 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/20/1495/003 

 

 

13. BATCH NUMBER<, DONATION AND PRODUCT CODES> 

 

Lot   

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Palforzia level 2 (6 mg daily) 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC  

SN  

NN   



 

35 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

BLISTER STRIPS (LEVEL 2 - 6 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 1 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

 

 

3. EXPIRY DATE 

 

EXP   

 

 

4. BATCH NUMBER 

 

Lot  

 

 

5. OTHER 

 

Level 2 (6 mg daily)  



 

36 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

OUTER CARTON (LEVEL 3 - 12 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 10 mg oral powder in capsules for opening 

Palforzia 1 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each 10 mg capsule contains 10 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

Each 1 mg capsule contains 1 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

Each 12 mg dose comprises 1 × 10 mg capsule + 2 × 1 mg capsules 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Oral powder in capsules for opening 

 

48 capsules (16 capsules of 10 mg, 32 capsules of 1 mg)   

16 doses 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. Mix capsule contents with soft food before administration. 

Do not ingest capsules.  

 

Level 3 (12 mg daily) 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP   

 



 

37 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

Dublin D09 C6X8 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/20/1495/004  

 

 

13. BATCH NUMBER 

 

Lot   

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Palforzia level 3 (12 mg daily) 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC 

SN 

NN   



 

38 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

BLISTER STRIPS (LEVEL 3 - 12 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 10 mg oral powder in capsules for opening 

Palforzia 1 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

 

 

3. EXPIRY DATE 

 

EXP   

 

 

4. BATCH NUMBER 

 

Lot  

 

 

5. OTHER 

 

Level 3 (12 mg daily)  



 

39 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

OUTER CARTON (LEVEL 4 – 20 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 20 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each capsule contains 20 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

Each 20 mg dose comprises 1 × 20 mg capsule 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Oral powder in capsules for opening 

 

16 capsules  

16 doses 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. Mix capsule contents with soft food before administration. 

Do not ingest capsules.  

 

Level 4 (20 mg daily) 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP   

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 



 

40 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

Dublin D09 C6X8 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/20/1495/005  

 

 

13. BATCH NUMBER 

 

Lot   

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Palforzia level 4 (20 mg daily) 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC  

SN  

NN   



 

41 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

BLISTER STRIPS (LEVEL 4 - 20 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 20 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

 

 

3. EXPIRY DATE 

 

EXP   

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

Level 4 (20 mg daily)  



 

42 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

OUTER CARTON (LEVEL 5 - 40 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 20 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each capsule contains 20 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

Each 40 mg dose comprises 2 × 20 mg capsules 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Oral powder in capsules for opening 

 

32 capsules  

16 doses 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. Mix capsule contents with soft food before administration 

Do not ingest capsules.  

 

Level 5 (40 mg daily) 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP   

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 



 

43 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

Dublin D09 C6X8 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/20/1495/006 

 

 

13. BATCH NUMBER 

 

Lot   

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Palforzia level 5 (40 mg daily) 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC  

SN  

NN   



 

44 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

BLISTER STRIPS (LEVEL 5 – 40 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 20 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

 

 

3. EXPIRY DATE 

 

EXP   

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. OTHER 

 

Level 5 (40 mg daily)  



 

45 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

OUTER CARTON (LEVEL 6 - 80 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 20 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each capsule contains 20 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

Each 80 mg dose comprises 4 × 20 mg capsules 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Oral powder in capsules for opening 

 

64 capsules  

16 doses 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. Mix capsule contents with soft food before administration. 

Do not ingest capsules.  

 

Level 6 (80 mg daily) 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP   

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 



 

46 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

Dublin D09 C6X8 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/20/1495/007  

 

 

13. BATCH NUMBER 

 

Lot   

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Palforzia level 6 (80 mg daily) 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC  

SN   

NN   



 

47 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

BLISTER STRIPS (LEVEL 6 - 80 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 20 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

 

 

3. EXPIRY DATE 

 

EXP   

 

 

4. BATCH NUMBER 

 

Lot  

 

 

5. OTHER 

 

Level 6 (80 mg daily)  



 

48 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

OUTER CARTON (LEVEL 7 - 120 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 100 mg oral powder in capsules for opening 

Palforzia 20 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each 100 mg capsule contains 100 mg peanut protein as defatted powder of Arachis hypogaea L., 

semen (peanuts). 

 

Each 20 mg capsule contains 20 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

Each 120 mg dose comprises 1 × 100 mg capsule + 1 × 20 mg capsule 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Oral powder in capsules for opening 

 

32 capsules (16 capsules of 100 mg, 16 capsules of 20 mg)   

16 doses 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. Mix capsule contents with soft food before administration. 

Do not ingest capsules.  

 

Level 7 (120 mg daily) 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP   

 



 

49 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

Dublin D09 C6X8 

Ireland  

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/20/1495/008  

 

 

13. BATCH NUMBER 

 

Lot   

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Palforzia level 7 (120 mg daily) 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC  

SN  

NN   



 

50 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

BLISTER STRIPS (LEVEL 7 - 120 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 100 mg oral powder in capsules for opening 

Palforzia 20 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

 

 

3. EXPIRY DATE 

 

EXP  

 

 

4. BATCH NUMBER 

 

Lot  

 

 

5. OTHER 

 

Level 7 (120 mg daily)  



 

51 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

OUTER CARTON (LEVEL 8 - 160 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 100 mg oral powder in capsules for opening 

Palforzia 20 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each 100 mg capsule contains 100 mg peanut protein as defatted powder of Arachis hypogaea L., 

semen (peanuts). 

 

Each 20 mg capsule contains 20 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

Each 160 mg dose comprises 1 × 100 mg capsule + 3 × 20 mg capsules 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Oral powder in capsules for opening 

 

64 capsules (16 capsules of 100 mg, 48 capsules of 20 mg)   

16 doses 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. Mix capsule contents with soft food before administration. 

Do not ingest capsules.  

 

Level 8 (160 mg daily) 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP   

 



 

52 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

Dublin D09 C6X8 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/20/1495/009  

 

 

13. BATCH NUMBER 

 

Lot   

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Palforzia level 8 (160 mg daily) 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC  

SN  

NN   



 

53 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

BLISTER STRIPS (LEVEL 8 - 160 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 100 mg oral powder in capsules for opening 

Palforzia 20 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

 

 

3. EXPIRY DATE 

 

EXP   

 

 

4. BATCH NUMBER 

 

Lot   

 

 

5. OTHER 

 

Level 8 (160 mg daily)  



 

54 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

OUTER CARTON (LEVEL 9 - 200 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 100 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each capsule contains 100 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

Each dose comprises 2 × 100 mg capsules 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Oral powder in capsules for opening 

 

32 capsules  

16 doses 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. Mix capsule contents with soft food before administration. 

Do not ingest capsules.  

 

Level 9 (200 mg daily) 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP   

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 



 

55 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

Dublin D09 C6X8 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/20/1495/011 

 

 

13. BATCH NUMBER 

 

Lot  

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Palforzia level 9 (200 mg daily) 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 

 

PC  

SN  

NN    



 

56 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

BLISTER STRIPS (LEVEL 9 - 200 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 100 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

 

 

3. EXPIRY DATE 

 

EXP   

 

 

4. BATCH NUMBER 

 

Lot   

 

 

5. OTHER 

 

Level 9 (200 mg daily)  



 

57 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

OUTER CARTON (LEVEL 10 – 240 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 100 mg oral powder in capsules for opening 

Palforzia 20 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each 100 mg capsule contains 100 mg peanut protein as defatted powder of Arachis hypogaea L., 

semen (peanuts). 

 

Each 20 mg capsule contains 20 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

Each 240 mg dose comprises 2 × 100 mg capsules + 2 × 20 mg capsules. 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Oral powder in capsules for opening 

 

64 capsules (32 capsules of 100 mg, 32 capsules of 20 mg)   

16 doses 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. Mix capsule contents with soft food before administration. 

Do not ingest capsules.  

 

Level 10 (240 mg daily) 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP   

 



 

58 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

 

 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

Dublin D09 C6X8 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/20/1495/010  

 

 

13. BATCH NUMBER 

 

Lot   

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Palforzia level 10 (240 mg daily) 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC  

SN  

NN   



 

59 

MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS 

BLISTER STRIPS (LEVEL 10 - 240 MG DAILY) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 100 mg oral powder in capsules for opening 

Palforzia 20 mg oral powder in capsules for opening 

defatted powder of Arachis hypogaea L., semen (peanuts)  

 

 

2. NAME OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

 

 

3. EXPIRY DATE 

 

EXP   

 

 

4. BATCH NUMBER 

 

Lot  

 

 

5. OTHER 

 

Level 10 (240 mg daily)  



 

60 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 

OUTER CARTON (LEVEL 11 - 300 MG DAILY / Maintenance) 

 

 

1. NAME OF THE MEDICINAL PRODUCT 

 

Palforzia 300 mg oral powder in sachet 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

2. STATEMENT OF ACTIVE SUBSTANCE(S) 

 

Each sachet contains 300 mg peanut protein as defatted powder of Arachis hypogaea L., semen 

(peanuts). 

 

 

3. LIST OF EXCIPIENTS 

 

 

4. PHARMACEUTICAL FORM AND CONTENTS 

 

Oral powder in sachet 

 

15 sachets 

30 sachets 

 

 

5. METHOD AND ROUTE(S) OF ADMINISTRATION 

 

Read the package leaflet before use. 

Oral use. Mix sachet contents with soft food before administration. 

 

Level 11 (300 mg daily) 

Maintenance 

 

 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 

 

Keep out of the sight and reach of children. 

 

 

7. OTHER SPECIAL WARNING(S), IF NECESSARY 

 

 

8. EXPIRY DATE 

 

EXP   

 

 

9. SPECIAL STORAGE CONDITIONS 

 

Store below 25°C. 

 

 



 

61 

10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 

APPROPRIATE 

 

 

11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 

 

Aimmune Therapeutics Ireland Limited 

Dublin D09 C6X8 

Ireland 

 

 

12. MARKETING AUTHORISATION NUMBER(S) 

 

EU/1/20/1495/012 15 sachets 

EU/1/20/1495/013 30 sachets 

 

 

13. BATCH NUMBER 

 

Lot 

 

 

14. GENERAL CLASSIFICATION FOR SUPPLY 

 

 

15. INSTRUCTIONS ON USE 

 

 

16. INFORMATION IN BRAILLE 

 

Palforzia level 11 (300 mg) 

Palforzia 300 mg 

 

 

17. UNIQUE IDENTIFIER – 2D BARCODE 

 

2D barcode carrying the unique identifier included. 

 

 

18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 

 

PC 

SN 

NN  



 

62 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 

SACHETS (LEVEL 11 – 300 MG DAILY / Maintenance) 

 

 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 

 

Palforzia 300 mg oral powder in sachet 

defatted powder of Arachis hypogaea L., semen (peanuts) 

Oral use 

 

 

2. METHOD OF ADMINISTRATION 

 

Read the package leaflet before use. 

Mix contents of sachet with soft food before adminstration. 

 

 

3. EXPIRY DATE 

 

EXP   

 

 

4. BATCH NUMBER 

 

Lot 

 

 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 

 

300 mg 

 

 

6. OTHER 

 

  



 

63 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

B. PACKAGE LEAFLET 



 

64 

Package leaflet: Information for the patient 

 

PALFORZIA 0.5 mg oral powder in capsules for opening 

PALFORZIA 1 mg oral powder in capsules for opening 

PALFORZIA 10 mg oral powder in capsules for opening 

PALFORZIA 20 mg oral powder in capsules for opening 

PALFORZIA 100 mg oral powder in capsules for opening 

PALFORZIA 300 mg oral powder in sachet 

defatted powder of Arachis hypogaea L., semen (peanuts) 

 

 

This medicine is subject to additional monitoring. This will allow quick identification of new 

safety information. You can help by reporting any side effects you may get. See the end of section 4 

for how to report side effects. 

 

Read all of this leaflet carefully before you start taking this medicine because it contains 

important information for you. 

 

- Keep this leaflet. You may need to read it again. 

- If you have any further questions, ask your doctor. 

- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 

- If you get any side effects, talk to your doctor. This includes any possible side effects not listed 

in this leaflet. See section 4. 

 

What is in this leaflet 

 

1. What PALFORZIA is and what it is used for 

2. What you need to know before you take PALFORZIA 

3. How to take PALFORZIA 

4. Possible side effects 

5. How to store PALFORZIA  

6. Contents of the pack and other information 

 

 

1. What PALFORZIA is and what it is used for 

 

PALFORZIA contains peanut protein from defatted powder of peanut seed. It is a treatment for people 

who are allergic to peanuts (Arachis hypogaea L.).  

 

PALFORZIA is intended for children and young people aged from 4 to 17 years and those who 

become adults whilst on treatment. 

 

PALFORZIA works in people with peanut allergy by gradually increasing the body’s ability to 

tolerate small amounts of peanut (desensitisation). PALFORZIA can help reduce the severity of 

allergic reactions after coming into contact with peanut. 

 

PALFORZIA is not effective against any other nut or food allergies. 

 

You must continue to strictly avoid eating peanuts while taking PALFORZIA. 

 

 

2. What you need to know before you take PALFORZIA 

 

Do not take PALFORZIA 

- if you are allergic to any of the excipients (other ingredients) in this medicine (listed in 

section 6). 



 

65 

- if you have severe asthma or if your asthma is not under control (as assessed by a doctor). 

- if you have ever had a problem swallowing or long term problems with your digestive system. 

- if you have ever had a severe mast cell disorder (as assessed by a doctor). 

- if you had severe or life-threatening anaphylaxis within 60 days before starting treatment. 

 

Warnings and precautions 

  

Talk to your doctor before taking PALFORZIA and tell your doctor about any medical conditions that 

you have. 

 

You must not take any peanut or peanut containing food in your diet whilst taking PALFORZIA. 

 

It is important to keep a record of the batch number of your PALFORZIA. So, every time you get a 

new package of PALFORZIA, note down the date and the batch number (which is on the packaging 

after “Lot”) and keep this information in a safe place. 

 

PALFORZIA does not treat the symptoms of peanut allergy and you must not take 

PALFORZIA during an allergic reaction. 

 

Your doctor will advise the best time to start treatment depending on any medical conditions that you 

have.  

 

PALFORZIA contains the substance that patients with peanut allergy react to. Allergic reactions to 

PALFORZIA may occur during treatment. These reactions mostly occur during the first two hours 

after taking a PALFORZIA dose and are usually mild or moderate but ocasionally can be severe. 

 

Stop taking PALFORZIA and get medical treatment straight away if you have any of the following 

symptoms: 

- Trouble breathing 

- Throat tightness or feeling of fulness in throat  

- Trouble swallowing 

- Change in voice  

- Dizziness or fainting or feeling of impending doom 

- Severe stomach cramps or pain, vomiting or diarrhoea 

- Severe flushing or itching of the skin 

- Worsening of asthma or of any other breathing condition 

- Heartburn, difficult swallowing, pain with swallowing, stomach pain or chest pain that does 

not go away or worsens 

 

Certain conditions or factors can increase the likelihood of an allergic reaction. These include: 

- Worsening of asthma 

- Having an open sore or other damage to the lining of the mouth or the passage leading from the 

mouth to the stomach (oesophagus) 

- Exercising 

- Having a hot bath or shower 

- Being very tired or missing sleep 

- For women, having your period  

- Taking certain pain medications such as aspirin or ibuprofen 

- Drinking alcohol 

- Being stressed 

- Taking PALFORZIA on an empty stomach 

 

There are actions you should take to avoid some of these factors from affecting you. These factors 

include: exercise, having a hot bath or shower, drinking alcohol, or taking this medicine on an empty 

stomach. See the sections on ‘PALFORZIA with food, drink and alcohol’ and ‘Dosing instructions’ 

for advice on what to do about these. 

 



 

66 

For all other conditions or factors listed above, contact your doctor for advice if you experience 

allergic reactions during any of these. 

 

Your doctor will prescribe adrenaline for you to self-inject, which you must have with you at all times 

in case you have a severe allergic reaction. Your doctor will tell you how to recognise an allergic 

reaction and teach you when and how to use the adrenaline. Talk to your doctor and read the 

adrenaline package leaflet if you have any questions about its use. 

 

If you use adrenaline, do not take any further doses of PALFORZIA and seek emergency medical care 

immediately afterwards. 

 

Desensitisation to peanut with PALFORZIA takes time. The ability to tolerate gradually increasing 

small amounts of peanut has been shown after completion of all up-dosing levels of PALFORZIA and 

after at least 3 months of maintenance therapy and this continues to improve over time. 

 

You must take PALFORZIA every day to maintain the desensitisation it provides. Missing any doses 

can lead to an increased risk of allergic reactions. 

 

PALFORZIA treatment may not work in all patients. 

 

Children and adolescents 

 

PALFORZIA is intended for children and young people aged 4 to 17 years and those who become 

adults whilst on treatment. 

 

Do not give this medicine to children aged less than 4 years because it is not known if PALFORZIA is 

safe and effective in this age group. 

 

Other medicines and PALFORZIA 

 

Tell your doctor if you are taking, have recently taken, or might take any other medicines. 

 

PALFORZIA with food, drink and alcohol 

 

PALFORZIA should not be mixed with liquid (e.g., water, milk, juice, soup, smoothie). 

 

Do not drink alcohol 2 hours before and 2 hours after taking PALFORZIA as this may increase the 

likelihood of an allergic reaction.  

 

Pregnancy, breast-feeding and fertility 

 

Do not start treatment with PALFORZIA if you are pregnant or planning to become pregnant. 

 

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask 

your doctor for advice before taking this medicine. 

 

Driving and using machines 

 

PALFORZIA may have a small effect on your ability to drive, cycle or operate machinery. Exercise 

caution for 2 hours after taking a dose of PALFORZIA in case you have an allergic reaction which 

affects your ability to drive, cycle, or use machinery. Wait until all symptoms of such allergic 

reactions have gone away before driving, cycling, or using machinery. 

 

 



 

67 

3. How to take PALFORZIA 

 

Always take this medicine exactly as your doctor has told you. Check with your doctor if you are not 

sure. 

 

PALFORZIA is prescribed by doctors who are experienced in the diagnosis and treatment of allergy 

and allergic reactions, including anaphylaxis. 

 

How should I take PALFORZIA? 

 

Dosing 

 

There are 3 phases of treatment with PALFORZIA: initial dose escalation, up-dosing, and 

maintenance. You must complete these treatment phases in the order that your doctor has prescribed. 

During the initial dose escalation and up-dosing phases, the dose of PALFORZIA is increased in a 

precise way. During the maintenance phase, you take the same dose of PALFORZIA each day. 

 

You should take PALFORZIA every day to maintain your level of desensitisation to peanuts. 

 

Tell your doctor on the day of each clinic visit if you are feeling unwell or if you feel your asthma is 

less controlled. 

 

Initial dose escalation 

 

You will be treated with the first doses (initial dose escalation) of PALFORZIA over about 4 to 

5 hours in your doctor’s clinic. On the first day you will be treated with 0.5 mg, 1 mg, 1.5 mg, 3 mg, 

and 6 mg of PALFORZIA. 

 

Up-dosing 

 

If you tolerate the initial dose-escalation phase, you will be asked to return to your doctor’s clinic on 

another day (usually 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 

increasing to PALFORZIA 300 mg (level 11). 

 

The up-dosing levels are shown in the table below: 

 

Daily dose Dose level Presentation of dose 

3 mg level 1 3 × 1 mg capsules (red) 

6 mg level 2 6 × 1 mg capsules (red) 

12 mg level 3 2 × 1 mg capsules (red) and  

1 × 10 mg capsule (blue) 

20 mg level 4 1 × 20 mg capsule (white) 

40 mg level 5 2 × 20 mg capsules (white) 

80 mg level 6 4 × 20 mg capsules (white) 

120 mg level 7 1 × 20 mg capsule (white) and  

1 × 100 mg capsule (red) 

160 mg level 8 3 × 20 mg capsules (white) and  

1 × 100 mg capsule (red) 

200 mg level 9 2 × 100 mg capsules (red) 

240 mg level 10 2 × 20 mg capsules (white) and  

2 × 100 mg capsules (red) 

300 mg level 11 1 × 300mg sachet 

 



 

68 

The first dose of each up-dosing level is given to you by your doctor in a clinic. If you tolerate the first 

dose of a new dose level, your doctor will ask you to continue to take that dose every day at home for 

about 2 weeks. 

 

During the up-dosing phase, your doctor will see you about every 2 weeks to assess you for a new up-

dosing level. 

 

You must have completed all 11 up-dosing levels before you can start maintenance treatment. It will 

take at least 22 weeks to complete all up-dosing levels. 

 

Maintenance dosing 

 

If you are able tolerate level 11 of the up-dosing phase, your doctor will ask you to continue taking 

PALFORZIA at a 300 mg dose every day as maintenance therapy. 

 

Preparation for use 

 

PALFORZIA is available either in capsules or sachets. Empty the powder from PALFORZIA capsules 

or sachets.  

 

Do not swallow PALFORZIA capsules. 

 

Open the daily dose of PALFORZIA. 

- To open a capsule gently pull the two ends of the capsule apart over a bowl with soft food and 

empty the powder into the bowl by rolling each half of the capsule between the finger and 

thumb. Tap the ends of each half capsule to make sure that all the powder is emptied. 

- To open a sachet carefully cut or tear along the top along the line indicated. Tip the sachet 

upside down over a bowl with soft food and tap the sachet to make sure that all the powder is 

emptied. 

 

Empty the full dose of PALFORZIA oral powder on to a small amount of soft food to which you are 

not allergic such as fruit puree, yogurt, or rice-pudding. Make sure you are not allergic to the food 

used for mixing. 

 

The food used for mixing should be cool and no warmer than room temperature. 

 

Mix well. 

 

Use just enough food to mix with PALFORZIA so you can eat it all in a few spoonfuls to take the full 

dose. 

 

Take PALFORZIA immediately after mixing. However, if needed, you can mix PALFORZIA with 

food and keep it in a refrigerator for up to 8 hours before taking. If it is not used within 8 hours, throw 

it away and prepare a new dose. 

 

Handling instructions 

 

Do not breathe in PALFORZIA powder as this could cause breathing problems (worsening of asthma) 

or cause an allergic reaction. 

 

Wash your hands immediately after handling PALFORZIA capsules or sachets. 

 

When your doctor has told you that an up-dosing level is complete, you must dispose of all remaining 

capsules or sachets from that pack (see section 5) before starting on a new level. This includes any 

extra doses that are provided in each pack, if not used. 

 



 

69 

Dosing instructions 

 

Take PALFORZIA at about the same time every day with food, preferably as part of your evening 

meal. Do not take this medicine on an empty stomach. 

 

Do not take PALFORZIA at home on the days that you visit your doctor for assessment as your doctor 

will give you PALFORZIA on these days. 

 

Children should be given each dose of PALFORZIA by an adult and they should be watched for about 

1 hour afterwards for any symptoms of an allergic reaction. 

 

Do not take within 2 hours of bedtime. 

 

Do not have a hot bath or shower just before or for 3 hours after taking PALFORZIA. 

 

Do not exercise just before or for 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 

rate (pulse) has returned to normal. 

 

Do not take more than your individual total daily dose according to your current dose level of 

PALFORZIA in a single day. 

 

If you take more PALFORZIA than you should 

 

Taking PALFORZIA at doses more than those recommended increases the risk of allergic reactions. 

 

In the case of severe reactions such as difficulty swallowing, difficulty breathing, changes in your 

voice, or a feeling of fullness in the throat, treat the reaction with adrenaline self-injector as instructed 

by your doctor and then contact a doctor immediately. 

 

If you forget to take PALFORZIA 

 

Do not take a double dose to make up for a forgotten dose. 

 

Missed doses of PALFORZIA may cause you to lose the peanut tolerance you have built up and 

increase your risk of allergic reactions. 

 

If you miss your dose of PALFORZIA for 1 to 2 days in a row, take the next dose at your normal 

scheduled time the next day. 

 

If you miss your dose of PALFORZIA for 3 days in a row or longer, stop taking PALFORZIA and 

contact your doctor for advice on how to start your treatment again. 

 

If you stop taking PALFORZIA 

 

Stopping PALFORZIA may cause you to lose the peanut tolerance you have built up and increase 

your risk of allergic reactions. 

 

If you have any further questions on the use of this medicine, ask your doctor. 

 

 

4. Possible side effects 

 

Like all medicines, this medicine can cause side effects, although not everybody gets them. 

 



 

70 

Important side effects 

 

PALFORZIA can cause severe allergic reactions that may be life-threatening. If you get any of the 

following symptoms, stop taking PALFORZIA, treat the reaction according to any instructions 

previously provided by your doctor, and then contact a doctor immediately. 

- Trouble breathing 

- Throat tightness or or feeling of fulness in throat  

- Trouble swallowing or speaking 

- Changes in voice  

- Dizziness or fainting 

- Severe stomach cramps or pain, vomiting, or diarrhoea 

- Severe flushing or itching of the skin 

 

PALFORZIA can cause problems with the stomach and digestive system including eosinophilic 

oesophagitis. This is a condition that affects the passage between the mouth and the stomach and 

affects up to 1 in 1,000 people. Symptoms of eosinophilic oesophagitis can include: 

- Trouble swallowing 

- Food stuck in throat 

- Burning in chest, mouth, or throat 

- Regurgitation 

 

If you have these symptoms persistently, contact a doctor. 

 

Other side effects 

 

Very common (may affect up to 1 in 10 people) 

- Throat tightness 

- Vomiting 

- Stomach discomfort or ache 

- Feeling sick 

- Allergic reactions (mild or moderate) 

- Cough 

- Sneezing 

- Throat irritation 

- Stomach pain 

- Tingling of mouth or itching in and around the mouth 

- Hives 

- Itchy skin 

 

Common (may affect up to 1 in 100 people) 

- Difficulty breathing 

- Allergic reactions (severe) 

- Wheezing 

 

Allergic reactions may affect different parts of the body as follows:  

- Skin related: hives, flushing or itching of the skin, face swelling, rash 

- Breathing related: difficulty breathing, wheezing, cough, throat tightness, runny nose, throat 

irritation 

- Stomach related: stomach pain, feeling sick, vomiting 

 

Reporting of side effects 

 

If you get any side effects, talk to your doctor or pharmacist or nurse. This includes any possible side 

effects not listed in this leaflet. You can also report side effects directly via the national reporting 

system listed in Appendix V. By reporting side effects, you can help provide more information on the 

safety of this medicine. 

 



 

71 

 

5. How to store PALFORZIA 

 

Keep this medicine out of the sight and reach of children. 

 

Do not use this medicine after the expiry date which is stated on the carton and the blister or sachet 

after EXP. The expiry date refers to the last day of that month. 

 

Store below 25°C. 

 

Do not use this medicine if you notice any hard lumps of powder that do not easily fall apart or if the 

powder is discoloured. 

 

Do not throw away any medicines via household waste. Ask your pharmacist how to throw away 

medicines you no longer use. These measures will help protect the environment. 

 

 

6. Contents of the pack and other information 

 

What PALFORZIA contains 

 

The active substance is peanut protein from defatted powder of peanut (Arachis hypogaea L.) seed. 

 

The other ingredients are: 

 

PALFORZIA 0.5 mg, 1 mg, 10 mg, 20 mg oral powder in capsules for opening 

Partially pregelatinised maize starch, microcrystalline cellulose, colloidal anhydrous silica, magnesium 

stearate 

 

PALFORZIA 100 mg oral powder in capsules for opening 

Microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate 

 

PALFORZIA 300 mg oral powder in sachet 

Microcrystalline cellulose, colloidal anhydrous silica, magnesium stearate 

 

What PALFORZIA looks like and contents of the pack 

 

White to beige oral powder in capsule for opening or sachet. 

 

Initial dose escalation (see section 3) 

 

Each carton contains 13 capsules in 5 single-dose blisters: 

- 0.5 mg (1 × 0.5 mg capsule) 

- 1 mg (1 × 1 mg capsule) 

- 1.5 mg (1 × 0.5 mg capsule and 1 × 1 mg capsule) 

- 3 mg (3 × 1 mg capsules) 

- 6 mg (6 × 1 mg capsules) 

 



 

72 

Up-dosing phase (see section 3) 

 

Name/Capsule or sachet strength Pack contents by dose level (daily dose) 

PALFORZIA 1 mg 

oral powder in capsules for opening 

Level 1 (3 mg daily): 

48 capsules in blisters 

16 doses (each blister-well contains 3 capsules of 1 mg)  

 

Level 2 (6 mg daily): 

96 capsules in blisters  

16 doses (each blister-well contains 6 capsules of 1 mg)  

 

PALFORZIA 10 mg 

PALFORZIA 1 mg 

oral powder in capsules for opening 

Level 3 (12 mg daily): 

48 capsules in blisters  

16 doses (each blister-well contains 1 capsule of 10 mg + 

2 capsules of 1 mg)  

 

PALFORZIA 20 mg 

oral powder in capsules for opening 

Level 4 (20 mg daily): 

16 capsules in blisters 

16 doses (each blister-well contains 1 capsule of 20 mg) 

 

Level 5 (40 mg daily): 

32 capsules in blisters  

16 doses (each blister-well contains 2 capsules of 20 mg)  

 

Level 6 (80 mg daily): 

64 capsules in blisters 

16 doses (each blister-well contains 4 capsules of 20 mg)  

 

PALFORZIA 100 mg 

oral powder in capsules for opening 

Level 9 (200 mg daily): 

32 capsules in blisters  

16 doses (each blister-well contains 2 capsules of 100 mg) 

 

PALFORZIA 100 mg 

PALFORZIA 20 mg 

oral powder in capsules for opening 

Level 7 (120 mg daily): 

32 capsules in blisters  

16 doses (each blister-well contains 1 capsule of 100 mg + 

1 capsule of 20 mg)  

 

Level 8 (160 mg daily): 

64 capsules in blisters 

16 doses (each blister-well contains 1 capsule of 100 mg + 

3 capsules of 20 mg) 

 

Level 10 (240 mg daily): 

64 capsules in blisters 

16 doses (each blister-well contains 2 capsules of 100 mg + 

2 capsules of 20 mg) 

 

PALFORZIA 300 mg 

oral powder in sachet 

 

Level 11 (300 mg daily): 

15 sachets (300 mg sachet) 

 

 

Maintenance dosing (see section 3) 

 

Each carton contains 30 sachets of 300 mg. 

 



 

73 

Marketing Authorisation Holder 

 

Aimmune Therapeutics Ireland Ltd 

Block B 

The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Ireland  

 

Manufacturer 

Millmount Healthcare Limited  

Block 7, City North Business Campus 

Stamullen 

Co Meath 

Ireland 

 

For any information about this medicine, please contact the local representative of the Marketing 

Authorisation Holder: 

 

België/Belgique/Belgien 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Irlande  

Tel: +353 (0)1 5827964 

 

Lietuva 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Airija 

Tel: +353 (0)1 5827964 

 

България 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Ирландия  

Teл.: +353 (0)1 5827964 

 

Luxembourg/Luxemburg 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Irlande/Irland 

Tél/Tel: +353 (0)1 5827964 

 

Česká republika 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Irsko  

Tel: +353 (0)1 5827964 

 

Magyarország 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Írország 

Tel.: +353 (0)1 5827964 

 

Danmark 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Irland 

Tlf: +353 (0)1 5827964 

 

Malta 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

L-Irlanda  

Tel: +353 (0)1 5827964 

 



 

74 

Deutschland 

Aimmune Therapeutics Germany GmbH 

Mies-van-der-Rohe-Straße 6 

80807 München 

Deutschland 

Tel: +49 (0)800 00 09 897 

 

Nederland 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Ierland 

Tel: +353 (0)1 5827964 

 

Eesti 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Iirimaa  

Tel: +353 (0)1 5827964 

 

Norge 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Irland  

Tlf: +353 (0)1 5827964 

 

Ελλάδα 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Ιρλανδία  

Τηλ: +353 (0)1 5827964 

 

Österreich 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Irland  

Tel: +353 (0)1 5827964 

 

España 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Irlanda  

Tel: +353 (0)1 5827964 

 

Polska 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Irlandia  

Tel.: +353 (0)1 5827964 

 

France 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Irlande  

Tél: +353 (0)1 5827964 

 

Portugal 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Irlanda  

Tel: +353 (0)1 5827964 

 

Hrvatska 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Irska  

Tel: +353 (0)1 5827964 

 

România 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Irlanda 

Tel: +353 (0)1 5827964 

 



 

75 

Ireland 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Ireland   

Tel: (+353) 1800 816563 

 

Slovenija 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Irska  

Tel: +353 (0)1 5827964 

 

Ísland 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Írland  

Sími: +353 (0)1 5827964 

 

Slovenská republika 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Írsko  

Tel: +353 (0)1 5827964 

 

Italia 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Irlanda  

Tel: +353 (0)1 5827964 

 

Suomi/Finland 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Irlanti  

Puh/Tel: +353 (0)1 5827964 

 

Κύπρος 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Ιρλανδία  

Τηλ: +353 (0)1 5827964 

 

Sverige 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Irland  

Tel: +353 (0)1 5827964 

 

Latvija 

Aimmune Therapeutics Ireland Ltd. 

Block B, The Crescent Building 

Northwood Crescent 

Northwood, Dublin 9 

D09 C6X8 

Īrija 

Tel: +353 (0)1 5827964 

 

United Kingdom 

Aimmune Therapeutics UK Ltd. 

10 Eastbourne Terrace  

London, W2 6LG 

United Kingdom   

Tel: +44 (0)800 0487 217  

 

 

This leaflet was last revised in . 

 

 

 

Other sources of information 

 

Detailed information on this medicine is available on the European Medicines Agency web site: 

http://www.ema.europa.eu 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET