Peanut allergen powder facts for kids

Palforzia is a special medicine given by mouth. It helps children and teenagers who are allergic to peanuts. This medicine is for those aged 4 to 17 years old who have a confirmed peanut allergy. It helps reduce the chance of a serious allergic reaction, like anaphylaxis, if they accidentally eat peanuts.

Palforzia is a powder made from peanuts. It comes in small capsules or sachets. You mix the powder with a little bit of soft food, like applesauce or yogurt, and then eat it.

Understanding Peanut Allergy Treatment

What is Palforzia?

Palforzia is a type of treatment called immunotherapy. It slowly introduces tiny amounts of peanut protein to your body. Over time, this helps your body get used to peanuts. The goal is to make your body less sensitive to peanuts. This way, if you accidentally eat a small amount of peanut, your reaction might be less severe.

It's important to know that Palforzia does not mean you can start eating peanuts freely. You still need to avoid peanuts in your diet. This medicine is for protection against accidental exposure.

How Palforzia is Used

Taking Palforzia involves a careful process. It starts with a very small dose, which is slowly increased over time. This is called "dose escalation" and "up-dosing." The first few doses are given in a special healthcare setting. This is because there's a risk of an allergic reaction, and doctors need to be ready to help if that happens.

Once you reach a certain dose, you continue taking it regularly at home. This is called "maintenance treatment." Your doctor will tell you exactly how to take it.

Important Safety Information

Like all medicines, Palforzia can have side effects. The most common ones include:

• Stomach pain
• Vomiting or feeling sick
• Tingling in the mouth
• Itching (in the mouth or ears)
• Cough or runny nose
• Throat irritation
• Hives (itchy red bumps on the skin)
• Wheezing or shortness of breath

The most serious side effect is anaphylaxis. This is a severe allergic reaction that can be life-threatening. Because of this risk, Palforzia is only available through a special safety program. This program makes sure that doctors and patients know how to manage the risks.

• If you have uncontrolled asthma, you should not take Palforzia.
• You must always carry an epinephrine auto-injector (like an EpiPen) with you. This is for immediate use if you have a serious allergic reaction.
• Your doctor or parents will teach you how to recognize the signs of anaphylaxis.

How Palforzia Was Approved

Research and Studies

Scientists studied Palforzia to see if it was safe and effective. One big study involved about 500 people with peanut allergies in the U.S., Canada, and Europe.

• In this study, some people received Palforzia, and others received a placebo (a fake medicine).
• After six months, the researchers checked how many people could eat a small amount of peanut protein without a bad reaction.
• The results showed that 67.2% of those who took Palforzia could tolerate the peanut protein. Only 4.0% of those who took the placebo could. This showed that Palforzia helped many people become less sensitive to peanuts.

The safety of Palforzia was also checked in other studies with about 700 people.

Approval Process

• In December 2018, the company Aimmune Therapeutics asked the U.S. Food and Drug Administration (FDA) to approve Palforzia.
• In September 2019, a group of experts at the FDA voted to recommend its approval.
• Finally, on January 31, 2020, the FDA officially approved Palforzia. It was the first medicine ever approved for peanut allergies in the U.S.
• Later, in December 2020, it was also approved for medical use in the European Union.