Palforzia

Generic name: Peanut Allergen Extract
Drug class: Allergenics

Usage of Palforzia

Palforzia is used to help reduce the severity of an allergic Reaction (including anaphylaxis) when you are accidentally exposed to peanuts. This medicine will not treat an allergic reaction that has already begun.

Palforzia is for use in adults and children at least 4 years old who have been diagnosed with an actual peanut allergy. Palforzia will not affect allergic reactions to other foods. Always seek emergency medical attention if you have an allergic reaction.

Palforzia is available only under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Palforzia side effects

Palforzia can cause a severe or life-threatening allergic reaction. Stop using this medicine and get emergency medical help if you have signs of an allergic reaction to Palforzia:

chest discomfort, wheezing, 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; or

a light-headed feeling, like you might pass out.

Your doctor may prescribe Epinephrine injection to keep on hand in case you have an allergic reaction. Get emergency medical help if you have an allergic reaction, even if you have used epinephrine to treat it.

Also call your doctor at once if you have symptoms of inflammation in your stomach or esophagus:

vomiting undigested food;

trouble swallowing (food getting stuck in throat);

feeling sick; or

burning in your mouth, throat, or chest.

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; or

stomach pain, nausea, vomiting.

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 FDA at 1-800-FDA-1088.

Before taking Palforzia

You should not use Palforzia if you have:

untreated or uncontrolled asthma; or

problems with your esophagus or digestive tract that are 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; or

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.

Relate drugs

How to use Palforzia

Usual Pediatric Dose for Allergic Reaction:

4 to 17 years: Initial dose escalation: Single doses of 0.5 mg, then 1 mg, 1.5 mg, 3 mg, and 6 mg orally -Doses are administered on a single day under healthcare supervision. -Separate doses with observation periods of 20 to 30 minutes. -Do not omit any dose levels. -Observe patient for at least 60 minutes after last dose until suitable for discharge. -Discontinue if medical intervention is required after any dose. -Patients who tolerate at least the 3 mg single dose must return to the healthcare setting for Up-dosing initiation. -If possible, begin Up-dosing the day after initial dose escalation. -Repeat initial dose escalation if patient does not begin Up-dosing within 4 days. 4 to 17 years: Up-dosing: Dose level 1: 3 mg orally daily for 2 weeks Dose level 2: 6 mg orally daily for 2 weeks Dose level 3: 12 mg orally daily for 2 weeks Dose level 4: 20 mg orally daily for 2 weeks Dose level 5: 40 mg orally daily for 2 weeks Dose level 6: 80 mg orally daily for 2 weeks Dose level 7: 120 mg orally daily for 2 weeks Dose level 8: 160 mg orally daily for 2 weeks Dose level 9: 200 mg orally daily for 2 weeks Dose level 10: 240 mg orally daily for 2 weeks Dose level 11: 300 mg orally daily for 2 weeks -Complete initial dose escalation prior to Up-dosing. -The first dose of each new dosing level should be administered under healthcare supervision; observe patient for at least 60 minutes after dose until suitable for discharge. -If first dose of each dose level is tolerated, 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. 4 years and older: Maintenance dose: 300 mg orally daily -Daily maintenance is required to maintain effect -Assess patient at regular intervals for adverse effects. Comments: -Prior to initiation, verify that patient has injectable epinephrine and has been instructed on its appropriate use. -Use in conjunction with a peanut-avoidant diet. -Not indicated for emergency treatment of allergic reactions or anaphylaxis. Use: Mitigation of allergic reactions, including anaphylaxis, to accidental peanut exposure in patients with cOnfirmed peanut allergy.

Warnings

You should not use Palforzia if you have uncontrolled asthma, or problems with your esophagus or digestive tract due to increased eosinophils (a type of white blood cell).

Palforzia can cause a severe or life-threatening allergic reaction. Your doctor may prescribe epinephrine injection to keep on hand in case you have an allergic reaction.

Call your doctor or get emergency medical help if you have an allergic reaction, even if you have used epinephrine to treat it.

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.

Disclaimer

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