Drugs List

Therapeutic Indications

Uses

Allergic reaction caused by peanut

Treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy in conjunction with a peanut-avoidant diet.

In patients aged 18 and older only the continuation of previously initiated treatment is recommended.

Contraindications

Children under 4 years
Within 60 days of life-threatening anaphylaxis
Dysphagia
Eosinophilic gastrointestinal disease
Eosinophilic oesophagitis
Gastroesophageal reflux
History of eosinophilic oesophagitis
History of severe mast cell disorder
Pregnancy
Severe asthma
Severe mast cell disorder

Precautions and Warnings

Adults aged 18 years and above
Acute severe oral inflammation
Breastfeeding
Cardiac arrhythmias
Congenital heart disease
Cystic fibrosis
Greatly reduced lung function
Metabolic disorder
Recent myocardial infarction
Uncontrolled hypertension
Unstable angina

Postpone treatment if severe inflammation of the mouth or oesophagus occur
Therapy should not be initiated during exacerbation of asthma
Advise patient not to drive/operate machinery for 2 hours after dose
Advise patient to take at least 2 hours before bedtime
Advise patient to wash hands after use
Have adrenaline injection ready for use in case of anaphylaxis
Record name and batch number of administered product
Treatment to be administered under the supervision of a specialist
Monitor for signs and symptoms of allergic reaction
Observe patient for the first 60 minutes after each injection
Advise patient to report if allergic reaction occurs
Consider eosinophilic oesophagitis if gastrointestinal symptoms occur
Discontinue if serious allergic or anaphylactic reaction occurs
Interrupt or reduce dose if significant gastrointestinal disturbances occur
Avoid alcohol 2 hours before and after administration
Advise patient to seek medical advice if delayed adverse event(s) occurs
Avoid exercise prior to and after 3 hours of treatment
Avoid hot showers or baths prior to and after 3 hours of treatment

Initial dose increase and the administration of the first dose of each up-dosing phase should be conducted in a healthcare setting that can manage potential severe allergic reactions.

The doses from each dose level in the up-dosing phase should come from the same batch to prevent variance in potency range.

A dose level is considered tolerated if only transient symptoms are observed with minimal or no medical intervention. Discontinue treatment if symptoms requiring medical intervention (e.g. use of adrenaline) occur during initial dose escalation.

Prior to initiation, 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.

Patients may be more likely to experience allergy symptoms following treatment in the presence of medical events such as intercurrent illness, 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). Consider dose reduction or interruption if these co-factors are unavoidable.

Signs of hypermetabolic state after exercise (e.g. flushing, sweating, rapid breathing, rapid heart rate) must have subsided before taking a dose.

Discontinue treatment and consider eosinophilic oesophagitis if patient experiences severe gastrointestinal symptoms such as dysphagia, gastroesophageal reflux, chest pain, or abdominal pain.

As there is no safety and efficacy data for the initiation of the treatment in patients aged over 17 years only the continuation of previously initiated treatment in those patient is recommended.

Chronic urticaria could have negative impact on the proper assessment of the treatment.

Pregnancy and Lactation

Pregnancy

Peanut protein is contraindicated during pregnancy.

The manufacturer advises that treatment with peanut protein can cause anaphylaxis to pregnant women. As the effects of oral immunotherapy (OIT) on the immune system of the mother and foetus is unknown, the benefits of using OIT and retaining desensitisation should be weighed against the risk of an anaphylactic reaction.

Lactation

Use peanut protein with caution during breastfeeding.

The manufacturer advises that the benefits of the mother taking the treatment should be weighed against the potential risk for the breastfed child from peanut protein. Peanut allergens have been found in human milk after consumption of peanuts.

Side Effects

Abdominal discomfort
Abdominal pain
Anaphylactic reaction
Cough
Dyspnoea
Eosinophilic oesophagitis
Lip pruritus
Nausea
Oral paraesthesia
Oral pruritus
Pruritus
Sneezing
Throat irritation
Throat tightness
Upper abdominal pain
Urticaria
Vomiting
Wheezing

Drugs List

Therapeutic Indications

Uses

Allergic reaction caused by peanut

Treatment of patients aged 4 to 17 years with a confirmed diagnosis of peanut allergy in conjunction with a peanut-avoidant diet.

In patients aged 18 and older only the continuation of previously initiated treatment is recommended.

Dosage

Adults

Children

Additional Dosage Information

Contraindications

Children under 4 years
Within 60 days of life-threatening anaphylaxis
Dysphagia
Eosinophilic gastrointestinal disease
Eosinophilic oesophagitis
Gastroesophageal reflux
History of eosinophilic oesophagitis
History of severe mast cell disorder
Pregnancy
Severe asthma
Severe mast cell disorder

Precautions and Warnings

Adults aged 18 years and above
Acute severe oral inflammation
Breastfeeding
Cardiac arrhythmias
Congenital heart disease
Cystic fibrosis
Greatly reduced lung function
Metabolic disorder
Recent myocardial infarction
Uncontrolled hypertension
Unstable angina

Postpone treatment if severe inflammation of the mouth or oesophagus occur
Therapy should not be initiated during exacerbation of asthma
Advise patient not to drive/operate machinery for 2 hours after dose
Advise patient to take at least 2 hours before bedtime
Advise patient to wash hands after use
Have adrenaline injection ready for use in case of anaphylaxis
Record name and batch number of administered product
Treatment to be administered under the supervision of a specialist
Monitor for signs and symptoms of allergic reaction
Observe patient for the first 60 minutes after each injection
Advise patient to report if allergic reaction occurs
Consider eosinophilic oesophagitis if gastrointestinal symptoms occur
Discontinue if serious allergic or anaphylactic reaction occurs
Interrupt or reduce dose if significant gastrointestinal disturbances occur
Avoid alcohol 2 hours before and after administration
Advise patient to seek medical advice if delayed adverse event(s) occurs
Avoid exercise prior to and after 3 hours of treatment
Avoid hot showers or baths prior to and after 3 hours of treatment

Initial dose increase and the administration of the first dose of each up-dosing phase should be conducted in a healthcare setting that can manage potential severe allergic reactions.

The doses from each dose level in the up-dosing phase should come from the same batch to prevent variance in potency range.

A dose level is considered tolerated if only transient symptoms are observed with minimal or no medical intervention. Discontinue treatment if symptoms requiring medical intervention (e.g. use of adrenaline) occur during initial dose escalation.

Prior to initiation, 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.

Patients may be more likely to experience allergy symptoms following treatment in the presence of medical events such as intercurrent illness, 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). Consider dose reduction or interruption if these co-factors are unavoidable.

Signs of hypermetabolic state after exercise (e.g. flushing, sweating, rapid breathing, rapid heart rate) must have subsided before taking a dose.

Discontinue treatment and consider eosinophilic oesophagitis if patient experiences severe gastrointestinal symptoms such as dysphagia, gastroesophageal reflux, chest pain, or abdominal pain.

As there is no safety and efficacy data for the initiation of the treatment in patients aged over 17 years only the continuation of previously initiated treatment in those patient is recommended.

Chronic urticaria could have negative impact on the proper assessment of the treatment.

Pregnancy and Lactation

Pregnancy

Peanut protein is contraindicated during pregnancy.

The manufacturer advises that treatment with peanut protein can cause anaphylaxis to pregnant women. As the effects of oral immunotherapy (OIT) on the immune system of the mother and foetus is unknown, the benefits of using OIT and retaining desensitisation should be weighed against the risk of an anaphylactic reaction.

Lactation

Use peanut protein with caution during breastfeeding.

The manufacturer advises that the benefits of the mother taking the treatment should be weighed against the potential risk for the breastfed child from peanut protein. Peanut allergens have been found in human milk after consumption of peanuts.

Side Effects

Abdominal discomfort
Abdominal pain
Anaphylactic reaction
Cough
Dyspnoea
Eosinophilic oesophagitis
Lip pruritus
Nausea
Oral paraesthesia
Oral pruritus
Pruritus
Sneezing
Throat irritation
Throat tightness
Upper abdominal pain
Urticaria
Vomiting
Wheezing

Overdosage

It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

The following number will direct the caller to the relevant local centre (0844) 892 0111

Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).

Further Information

Last Full Review Date: September 2022

Reference Sources

Summary of product characteristics: Palforzia 0.5, 1, 10, 20, 100, 300mg oral powder in capsules for opening. Aimmune Therapeutics UK Limited. Revised November 2021.

NICE Evidence Services Available at: www.nice.org.uk Last accessed: 22 September 2022