Peanut protein oral
- Drugs List
- Therapeutic Indications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
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.
(Consult product literature)
Children aged 4 to 18 years
Treatment is divided into three phases: Initial dose escalation, up-dosing, and maintenance.
Initial dose escalation phase
The following doses are administered in a single day, no dose level should be omitted:
Dose number 1: 0.5mg
Dose number 2: 1mg
Dose number 3: 1.5mg
Dose number 4: 3mg
Dose number 5: 6mg
Observe patients for 20 to 30 minutes between each dose, patients should be observed for at least 60 minutes after the last dose.
Patients that can tolerate at least the 3mg single dose during initial dose escalation must return to healthcare setting for initiation of up-dosing.
Up-dosing phase should occur the day after initial dose escalation, if patient is unable to begin up-dosing phase within 4 days of initiation, then initial dose escalation phase should be repeated.
Patients that tolerate the first dose of an increase dose level can continue that dose at home. Each dose level is administered for a 2-week interval, no dose level should be omitted.
Dose level 1: 3mg
Dose level 2: 6mg
Dose level 3: 12mg
Dose level 4: 20mg
Dose level 5: 40mg
Dose level 6: 80mg
Dose level 7: 120mg
Dose level 8: 160mg
Dose level 9: 200mg
Dose level 10: 240mg
Dose level 11: 300mg
Consult product literature during up-dosing phase.
Additional Dosage Information
Missed 1 to 2 days: resume treatment at the same dose level at home.
Missed 3 to 4 days: resume treatment at the same dose level under medical supervision in a healthcare setting.
Missed 5 to 14 days: resume up-dosing under medical supervision in a healthcare setting at 50% or less of the last tolerated dose.
Missed greater than 14 days: re-start up-dosing at 3mg under medical supervision in a healthcare setting or discontinue treatment.
Children under 4 years
Within 60 days of life-threatening anaphylaxis
Eosinophilic gastrointestinal disease
History of eosinophilic oesophagitis
History of severe mast cell disorder
Severe mast cell disorder
Precautions and Warnings
Adults aged 18 years and above
Acute severe oral inflammation
Congenital heart disease
Greatly reduced lung function
Recent myocardial infarction
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
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.
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.
Upper abdominal pain
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 ).
Last Full Review Date: September 2022
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
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Medscape UK | Univadis prescription drug monographs & interactions are based on FDB Multilex Content
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