Palforzia® [Peanut (Arachis hypogaea) Allergen Powder-dnfp]

Palforzia® [Peanut (Arachis hypogaea) Allergen Powder-dnfp] is a drug used to treat peanut allergies. It was the first drug approved by the U.S. Food and Drug Administration (FDA) to treat a food allergy.^1,2

Palforzia is an immunotherapy taken by mouth. It is approved for people as young as 4 years old. It is used along with food avoidance.^1,2

Peanut allergy is one of the most common food allergies. It tends to be a life-long allergy and affects more than 1.6 million children and teens in United States. Reactions can range from mild to severe. One out of every 5 people with a peanut allergy end up in an emergency room each year due to accidental exposure.^1,2

What are the ingredients in Palforzia?

The active ingredient in Palforzia is peanut (Arachis hypogaea) allergen powder-dnfp.^1,2

How does Palforzia work?

Palforzia is a type of immunotherapy that is eaten. People begin taking a small amount and gradually increase their dose over time. It comes in a capsule that contains a pre-measured amount of peanut powder. The capsule is opened, and its ingredients mixed with food.^1,2

The goal of taking it is to raise the threshold of food protein that may trigger an allergic reaction, including anaphylaxis. This helps to protect someone if they accidentally eat peanuts. It is not meant to allow peanut-allergic people to eat as many peanuts as they would like.^1,2

Palforzia is approved for use in children ages 4 to 17 with a confirmed diagnosis of peanut allergy. It must be started in this age group, but it may be continued in adulthood. It is not a cure for peanut allergy. Most people will need long-term treatment. It is taken in addition to avoiding peanuts. It is not an emergency treatment for a peanut allergy reaction.^1,2

What are the possible side effects?

The most common side effects of Palforzia include:^1,2

• Abdominal pain
• Vomiting and nausea
• Itchy mouth, nose, or ears
• Irritation or tightness in the throat
• Sneezing, wheezing, shortness of breath, or coughing

Palforzia has a boxed warning, the strictest warning from the FDA. It has this warning because of the risk of anaphylaxis, a potentially life-threatening allergic reaction. Your doctor should counsel you on the risk of anaphylaxis while taking Palforzia. Anaphylaxis can occur at any time during Palforzia treatment.^1,2

Things that increase the risk of reaction while taking Palforzia include:²

• Exercise
• Hot water or feeling hot
• Illness
• Fasting
• Menstruation
• Not getting enough sleep or being very tired
• Use of certain pain medicines like aspirin or ibuprofen
• Uncontrolled asthma
• Drinking alcohol

To take Palforzia, you must enroll in a special program called the Risk Evaluation and Mitigation Strategies (REMS). This program ensures the drug is used under controlled circumstances and helps monitor safety while using it.^1,2

These are not all the possible side effects of Palforzia. Talk to your doctor about what to expect when taking Palforzia. You also should call your doctor if you have any changes that concern you when taking Palforzia.

Other things to know

Palforzia should only be given under medical supervision. As part of the treatment, you and your doctor should monitor for symptoms of allergic reactions. People taking Palforzia should be observed for at least 60 minutes following initial or increased dosing levels. Dose modifications may be necessary following an anaphylactic reaction.¹

Do not exercise or take a hot bath immediately before or for 3 hours after taking Palforzia. Many give Palforzia with dinner when their child is less likely to be active. The exercise restrictions can make the drug less appealing to active teens and young adults.^1,2

Palforzia is not for people with uncontrolled asthma, eosinophilic esophagitis, and other eosinophilic gastrointestinal diseases.^1,2

Palforzia is not meant to treat other food allergies. Those with multiple food allergies may want to consider whether treatment for just peanut allergy is right for them.^1,2

People taking Palforzia must see their allergist every 2 weeks until they tolerate the drug. Then they can take the medicine at home.^1,2

Palforzia is taken to protect against accidental exposures with the goal of reducing severity of potential reactions. It does not give someone the ability to freely eat peanuts.^1,2

For more information, read the full prescribing information of Palforzia.