Palforzia
Authorised
This medicine is authorised for use in the European Union
defatted powder of Arachis hypogaea L., semen (peanuts)
MedicineHumanAuthorised
Overview
Palforzia is a medicine for treating peanut allergy in children from 4 to 17 years of age and patients who become adults whilst on treatment. While taking this medicine, patients continue avoiding peanuts.
Palforzia contains peanut powder.
Palforzia is available as a powder in capsules or sachets. The patient opens the capsules or sachets and mixes the powder with a small amount of soft food (such as like fruit puree, yogurt and rice pudding).
In the first phase of treatment, which takes place in the clinic, the patient receives increasing doses of Palforzia over several hours on a single day under observation of the doctor. For the second phase, the doctor prescribes increasing doses each of which the patient should take daily for two weeks if they can tolerate it. This phase of increasing doses under supervision lasts at least 22 weeks. If the patient continues to tolerate treatment, in the third phase they will then be prescribed a daily dose to maintain the effects of the medicine.
Palforzia can only be obtained with a prescription. Treatment should be started by a healthcare professional qualified to treat allergic diseases. Because this medicine can cause serious allergic reactions in some patients, for the first phase of treatment, facilities must be on hand for treating such reactions. The patients should also have self-injectable adrenaline with them at all times.
For more information about using Palforzia, see the package leaflet or contact your doctor or pharmacist.
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. It is not effective against other nut or food allergies.
Palforzia does not treat the symptoms of peanut allergy and must not be taken during an allergic reaction.
Two main studies involving 671 patients have shown that Palforzia can help some patients tolerate a small amount of peanuts with only mild symptoms.
In one of the studies, 50% of the patients aged 4 to 17 who took Palforzia could tolerate 1000 mg of peanut protein with only mild symptoms, compared with 2% of those who received placebo (a dummy treatment). In the second study, 58% of 4- to 17-year-olds could tolerate the same dose of peanut protein with only mild symptoms compared with 2% of those who took placebo.
The most common side effects with Palforzia (which may affect more than 1 in 5 people) are abdominal (belly) pain and discomfort, irritation in the throat and mouth, itchy skin, nausea, vomiting and urticaria (itchy rash).
Palforzia should not be taken by patients with severe or uncontrolled asthma or those who have ever had problems with swallowing or stomach acid or severe mast cell disorder (a condition that causes allergic-like reactions). It should also not be taken by patients who have had a severe allergic reaction in the past two months.
For the full list of restrictions and side effects of Palforzia, see the package leaflet.
Studies show that Palforzia can help young patients (aged 4 to 17) with peanut allergy to tolerate peanut protein with only mild symptoms. Although there are insufficient data from patients who become adults while on treatment, these patients should be able to decide with their doctor whether or not to continue treatment.
The side effects of Palforzia, including allergic reactions, can be managed by following advice for patients and healthcare professionals in the product information. The European Medicines Agency therefore concluded that Palforzia’s benefits are greater than its risks and that it can be authorised for use in the EU.
The company that markets Palforzia will provide patients, healthcare professionals and caregivers with information about how to take the medicine and manage its risks. Patients will also receive a patient card which they should carry at all times.
Recommendations and precautions for the safe and effective use of Palforzia have also been included in the summary of product characteristics and the package leaflet.
As for all medicines, data on the use of Palforzia are continuously monitored. Side effects reported with Palforzia are carefully evaluated and any necessary action taken to protect patients.
Palforzia received a marketing authorisation valid throughout the EU on 17 December 2020.
Product information
Latest procedure affecting product information: N/0011
19/09/2022
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Palforzia
- Active substance
- defatted powder of Arachis hypogaea L., semen (peanuts)
- International non-proprietary name (INN) or common name
- defatted powder of Arachis hypogaea L., semen (peanuts)
- Therapeutic area (MeSH)
- Peanut Hypersensitivity
- Anatomical therapeutic chemical (ATC) code
- V01
Pharmacotherapeutic group
AllergensTherapeutic indication
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.
News on Palforzia
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