Palforzia

Pronunciation: pall-for-zee-ah
Generic name: peanut allergen extract
Dosage form: capsule, sachet
Drug class: Allergenics

Medically reviewed by Carmen Pope, BPharm. Last updated on Jul 31, 2024.

What is Palforzia?

Palforzia is an oral immunotherapy treatment that may be used to help reduce the severity of an allergic reaction (including anaphylaxis) in people aged 1 year and older with a confirmed peanut allergy who are accidentally exposed to peanuts.

Treatment can be initiated in children aged 1 through 17 years. If a child turns 18 while on Palforzia treatment, it should be continued. Palforzia should not be started in a patient 18 years or older.
Palforzia is used at the same time as a peanut-avoidance diet.
This medicine will not treat an allergic reaction that has already begun.
Palforzia does not work for allergic reactions due to other foods.
Always seek emergency medical attention if you have an allergic reaction.
Palforzia is not a cure for peanut allergy, but it can help make childrens reaction to accidental peanut exposure less severe.

Palforzia contains peanut protein (peanut [Arachis hypogaea] allergen powder-dnfp) contained in a capsule or sachet, and the Palforzia treatment program consists of 3 stages: an initial dose escalation stage, an up-dosing stage, and a maintenance stage. Palforzia works to reduce the severity of peanut allergies by slowly building a tolerance in the child to peanut protein so that they can get to the stage of eating small amounts of real-world peanuts every day. But Palforzia is not suitable for everyone.

Palforzia is available only under a special program, called the Palforzia REMS Program. You must be registered in the program and understand the risks and benefits of this medicine, and have injectable epinephrine available on hand to use at all times, in case of anaphylaxis.

Palforzia gained FDA approval on January 31, 2020.

Palforzia side effects

Common Palforzia side effects may include:

itching or burning in your mouth
cough, wheezing, trouble breathing
tightness or irritation in your throat
rash, itchy skin
itching in or around your ear
runny nose, sneezing
stomach pain, nausea, vomiting.

Severe side effects and warnings

Palforzia carries a Boxed Warning for anaphylaxis.

Palforzia can cause severe or life-threatening allergic reactions, including anaphylaxis. Your doctor will prescribe an epinephrine injection for you to keep on hand, in case you have an allergic reaction, and will observe you for 1 hour following your initial dose of Palforzia and for any dose escalations. People with uncontrolled asthma should not take Palforzia. Call your doctor or get emergency medical help if you have an allergic reaction, even if you have used epinephrine to treat it. Symptoms of an allergic reaction to Palforzia include:

chest discomfort, wheezing, or trouble breathing
tightness in your throat
trouble speaking or swallowing
swelling of your face, lips, eyes, or tongue
itchy, raised bumps on your skin
flushing (sudden warmth, redness, or tingly feeling)
severe stomach pain, vomiting, or diarrhea
a light-headed feeling, like you might pass out.

Other serious side effects include inflammation in your stomach or esophagus. Call your healthcare provider at once if you have the following symptoms:

vomiting undigested food
trouble swallowing (food getting stuck in your throat)
feeling sick
a burning in your mouth, throat, or chest.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking this medicine

You should not take Palforzia if you have:

untreated or uncontrolled asthma
problems with your esophagus or digestive tract caused by higher than normal levels of eosinophils (a type of white blood cell).

You may not be able to use Palforzia if:

you are unable to give yourself an epinephrine injection in the case of an allergic reaction
an allergic reaction would be life-threatening to you because of a medical condition you have or a medicine you use.

To make sure Palforzia is safe for you, tell your doctor if you have:

asthma; or
any disease related to increased eosinophils.

Tell your doctor if you are pregnant or breastfeeding.

How should I take Palforzia?

Take Palforzia exactly as your doctor prescribed. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

When you start using Palforzia (and any time your dose is increased) you will receive your first dose in a hospital or clinic setting.
Your breathing, blood pressure, oxygen levels, and other vital signs will be watched closely for at least 60 minutes after your dose.

Your dose may need to be postponed if you are not feeling well before starting this treatment.

Do not swallow a Palforzia capsule whole or inhale the powder medicine.

Open the capsule or powder packet and sprinkle the medicine onto a spoonful of refrigerated or room-temperature semi-solid food, such as applesauce, yogurt, or pudding (do not mix with liquid).
Stir well and swallow the mixture right away without chewing. Do not save it for later use.

Once your dose has reached a certain point, you may need to open up to 6 capsules to get the correct dose. Follow your doctor's dosing instructions very carefully.

Wash your hands after handling a capsule or powder packet.

Monitor yourself or your child carefully You may be more likely to have an allergic reaction:

if you have uncontrolled asthma
if you are sick with a virus
during your menstrual period
during vigorous exercise or exposure to hot water
if you are not getting enough sleep
if you are not getting enough to eat
if you are taking an NSAID (nonsteroidal anti-inflammatory drug).

The timing of your doses may need to be adjusted to avoid using Palforzia while any of the above conditions exist.

You must keep injectable epinephrine with you at all times while you are using Palforzia. Read and carefully follow any Instructions for Use provided with your epinephrine. Ask your doctor or pharmacist if you don't understand all the instructions.

Palforzia dosing

Palforzia initial dosing for ages 1 through 3 years

Initial dose escalation. Palforzia is supplied as a single card consisting of 4 blisters containing a total of 7 capsules. Each blister is marked A, B, C, or D.

Each dose is administered on a single day (so A to D below is administered on one day) separated by an observation period of 20 to 30 minutes.

Blister A. One 0.5 mg capsule
Blister B. One 1 mg capsule
Blister C. One 0.5 mg capsule and one 1 mg capsule
Blister D. Three 1 mg capsules.

The 4 doses should be followed by an observation period of at least 60 minutes after the last dose, before you are allowed to go home.

Patients aged 1 through 3 years who tolerate all doses (A to D) during initial dose escalation must return to the healthcare setting for initiation of up-dosing. If possible, begin up-dosing the day after the initial dose-escalation.

Up-dosing consists of 12 dosing levels and is initiated at a 1 mg dose and up-dosed to level 11. See the up-dosing table below.

If a patient does not begin up-dosing within 4 days then repeat the initial dose escalation.

Palforzia initial dosing for ages 4 through 17 years

Initial dose escalation. Palforzia is supplied as a single card consisting of 5 blisters containing a total of 13 capsules. Each blister is marked A, B, C, D, or E.

Each dose is administered on a single day (so A to E below is administered on one day) separated by an observation period of 20 to 30 minutes.

Blister A. One 0.5 mg capsule
Blister B. One 1 mg capsule
Blister C. One 0.5 mg capsule and one 1 mg capsule
Blister D. Three 1 mg capsules.
Blister E. Six 1 mg capsules.

The 5 doses should be followed by an observation period of at least 60 minutes after the last dose before you are allowed to go home.

Patients aged 4 through 17 years who tolerate at least the 3 mg single-dose (Level D) ll doses during initial dose escalation must return to the healthcare setting for initiation of up-dosing. If possible, begin up-dosing the day after the initial dose-escalation.

Up-dosing consists of 11 dosing levels and is initiated at a 3 mg dose and up-dosed to level 11. See the up-dosing table below.

If a patient does not begin up-dosing within 4 days then repeat the initial dose escalation.

Up-dosing table of Palforzia for patients aged 1 through 17 years

Each dose level is given daily for 2 weeks.

The first dose of each new dosing level should be administered under healthcare supervision; observe the patient for at least 60 minutes after dose until suitable for discharge.
If the first dose of each dose level is tolerated, the patient may continue that dose level at home.
Doses should be consumed with a meal at approximately the same time each day, preferably in the evening.
Administer dose levels in sequential order; do not omit dose levels or progress more rapidly.
Consider dose modification or discontinuation for patients who do not tolerate up-dosing.

Total Daily Dose	Daily Dose Configuration	Dose Duration (weeks)	Patient Age (years)
1 mg	One 1 mg capsule	2	1-3
3 mg	Three 1 mg capsules	2	1-17
6 mg	Six 1 mg capsules	2	1-17
12 mg	Two 1 mg capsules, one 10 mg capsule	2	1-17
20 mg	One 20 mg capsule	2	1-17
40 mg	Two 20 mg capsules	2	1-17
80 mg	Four 20 mg capsules	2	1-17
120 mg	One 20 mg capsule, one 100 mg capsule	2	1-17
160 mg	Three 20 mg capsules, one 100 mg capsule	2	1-17
200 mg	Two 100 mg capsules	2	1-17
240 mg	Two 20 mg capsules, two 100 mg capsules	2	1-17
300 mg	One 300 mg sachet	2	1-17

Maintenance dose of Palforzia for patients aged 1 through 17 years

Complete all dose levels of up-dosing before starting maintenance.

Palforzia maintenance dosage for ages 1 year and older: One 300 mg sachet orally daily
This dose must be given daily to maintain the effect.
Tell your healthcare provider immediately if you are not tolerating Palforzia.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include trouble swallowing, trouble breathing, changes in your voice, or a feeling of fullness in your throat.

What should I avoid while taking Palforzia?

In addition to taking this medicine, you should avoid eating peanuts or peanut butter in your diet.

What other drugs will affect Palforzia?

Other drugs may interact with peanut allergen extract, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Palforzia ingredients

Active: Peanut protein 0.5 mg, 1 mg, 10 mg, 20 mg, 100 mg or 300 mg

Inactive (depends on the dose level): microcrystalline cellulose, partially pregelatinized maize starch (0.5 mg, 1 mg, 10 mg, 20 mg capsule presentations only), magnesium stearate, and colloidal silicon dioxide.

Available in capsules containing 0.5 mg, 1 mg, 10 mg, 20 mg, and 100 mg peanut protein, and a sachet containing 300 mg peanut protein.