Peanut allergen powder

Peanut (Arachis hypogaea) Allergen Powder, sold under the brand name Palforzia, is an oral medication for the treatment of allergic reactions, including anaphylaxis, in children typically aged between four and 17 years of age who have confirmed cases of peanut allergy. It is taken by mouth.

Peanut allergen powder is a powder that is manufactured from peanuts and packaged in pull-apart color-coded capsules for dose escalation and up-dosing, and in a sachet for maintenance treatment. The powder is emptied from the capsules or sachet and mixed with a small amount of semisolid food, such as applesauce, yogurt, or pudding for consumption.

The most common side effects of peanut allergen powder are abdominal pain, vomiting, nausea, tingling in the mouth, itching (including in the mouth and ears), cough, runny nose, throat irritation and tightness, hives, wheezing and shortness of breath and anaphylaxis. Peanut allergen powder should not be administered to those with uncontrolled asthma.

To mitigate the risk of anaphylaxis associated with peanut allergen powder, the U.S. Food and Drug Administration (FDA) requires a Risk Evaluation and Mitigation Strategy (REMS). Peanut allergen powder is only available through specially certified healthcare providers, health care settings, and pharmacies to those who are enrolled in the REMS program. The FDA is requiring that healthcare providers who prescribe peanut allergen powder - and healthcare settings that dispense and administer peanut allergen powder - are educated on the risk of anaphylaxis associated with its use. In addition, the Initial Dose Escalation phase and first dose of each Up-Dosing level must only be administered to patients in a certified healthcare setting equipped to monitor patients and to identify and manage anaphylaxis. Patients or their parents or caregivers must also be counseled on the need for the patients to have injectable epinephrine available for immediate use at all times, the need for continued dietary peanut avoidance, and how to recognize the signs and symptoms of anaphylaxis.

In January 2020, the FDA approved the drug to Aimmune Therapeutics for mitigating "allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanuts." It is the first drug approved for peanut allergies. It will not make allergic people able to eat normal amounts of peanuts, but will prevent allergies due to accidental eating.