Patient leaflet - Palforzia 100 mg oral powder in capsules for Opening
1. What PALFORZIA is and what it is used for
PALFORZIA contains peanut protein from defatted powder of peanut seed. It belongs to a class of medicines called food allergens. It is a treatment for people who are allergic to peanuts (Arachis hypogaea L.).
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
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
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
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:
go away or worsens
mouth to the stomach (oesophagus)
There are actions you should take to avoid some of these factors from affecting you. These factors
for advice on what to do about these.
allergic reactions during any of these.
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
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
and after at least 3 months of maintenance therapy and this continues to improve over time.
can lead to an increased risk of allergic reactions.
PALFORZIA treatment may not work in all patients.
Children and adolescents
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
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.
your doctor for advice before taking this medicine.
Driving and using machines
reactions have gone away before driving, cycling, or using machinery.
3. How to take PALFORZIA
sure.
How should I take PALFORZIA?
Dosing
maintenance. You must complete these treatment phases in the order that your doctor has prescribed.
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
If you tolerate the initial doseescalation phase, you will be asked to return to your doctor’s clinic on
increasing to PALFORZIA 300 mg (level 11).
Daily dose Dose level Presentation of dose
3 mg
o you by your doctor in a clinic. If you tolerate the
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.
thumb. Tap the ends of each half capsule to make sure that all the powder is emptied.
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
full dose.
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.
remaining capsules or sachets from that pack (see section 5) before starting on a new level. This
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.
about 1 hour afterwards for any symptoms of an allergic reaction.
Do not have a hot bath or shower just before or for 3 hours after taking PALFORZIA.
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.
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.
increase your risk of allergic reactions.
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.
Important side effects
following symptoms, stop taking PALFORZIA, treat the reaction according to any instructions previously provided by your doctor, and then contact a doctor immediately.
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:
If you have these symptoms persistently, contact a doctor.
Other side effects
Very common (may affect up to 1 in 10 people)
Common (may affect up to 1 in 100 people)
Allergic reactions may affect different parts of the body as follows:
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 Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.
5. How to store PALFORZIA
Keep this medicine out of the sight and reach of children.
date which is stated on the carton and the blister or sachet .
Store below
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 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
cellulose, colloidal anhydrous silica, magnesium stearate
PALFORZIA 300 mg oral powder in sachet
cellulose, colloidal anhydrous silica, magnesium stearate
What PALFORZIA looks like and contents of the pack
to beige oral powder in capsule for opening or sachet.
Initial dose escalation (see section 3)
Each carton contains 13
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):
Level 2 (6 mg daily):
PALFORZIA 10 mg
PALFORZIA 1 mg oral powder in capsules for opening
Level 3 (12 mg daily):
oral powder in capsules for opening
Level 4 (20 mg daily):
Level 5 (40 mg daily):
Level 6 (80 mg daily):
PALFORZIA 100 mg oral powder in capsules for opening
Level 9 (200 mg daily):
PALFORZIA 100 mg oral powder in capsules for opening
Level 7 (120 mg daily):
Level 8 (160 mg daily):
Level 10 (240 mg daily):
PALFORZIA 300 mg oral powder in sachet
Level 11 (300 mg daily):
15 sachets (300 mg sachet)
Each carton contains 30 sachets of 300 mg.
Marketing Authorisation Holder
STALLERGENES
6 rue Alexis de Tocqueville
92160 Antony
France
Manufacturer
For
Authorisation Holder:
STALLERGENES
Tel: +44 (0)800 0487 217