A peanut allergy is one of the most common food allergies in children under the age of 18. However, strict avoidance of peanuts is not always possible due to potential inconsistent food labeling, cross contamination and accidental ingestion or exposure. While there is no cure for peanut allergy, one treatment is helping parents feel more confident about managing the risk of accidental exposure with peanut allergy, hear their story.
INDICATION
PALFORZIA is an oral immunotherapy indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. PALFORZIA is approved for use in patients with a confirmed diagnosis of peanut allergy. PALFORZIA may be started in patients aged 1 through 17 years old. If you turn 18 years of age while on PALFORZIA treatment you should continue taking PALFORZIA unless otherwise instructed by your doctor. PALFORZIA does NOT treat allergic reactions and should not be given during an allergic reaction, including anaphylaxis. You must maintain a strict peanut-free diet while taking PALFORZIA.
IMPORTANT SAFETY INFORMATION
PALFORZIA can cause severe allergic reactions called anaphylaxis that may be life-threatening.
Stop taking PALFORZIA and get emergency medical treatment right away if you have any of the following symptoms after taking PALFORZIA:
Because of the risk of severe allergic reactions, PALFORZIA is only available through a restricted program called the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) Program. Talk to your healthcare provider for more information about the PALFORZIA REMS program and how to enroll.
You should NOT take PALFORZIA if you have uncontrolled asthma, or if you ever had eosinophilic esophagitis (EoE) or other eosinophilic gastrointestinal disease.
Tell your doctor if you are not feeling well prior to starting treatment with PALFORZIA. Your doctor may decide to delay treatment until you are feeling better. Also tell your doctor about any medical conditions you have and if you are taking or have recently taken any other medicines, including medicines obtained without a prescription and herbal supplements.
Your doctor may decide that PALFORZIA is not the best treatment if:
What are the possible side effects of PALFORZIA?
The most commonly reported side effects of PALFORZIA in ages 1 through 3 years were: cough, sneezing, runny nose, nasal congestion, throat irritation, wheezing, stomach pain, vomiting, diarrhea, itchy mouth, pain in the throat, hives, rash, itchy skin, and/or inflammation of the skin around the mouth.
The most commonly reported side effects of PALFORZIA in ages 4 through 17 years were: stomach pain, vomiting, feeling sick, itching or burning in the mouth, throat irritation, cough, runny nose, sneezing, throat tightness, wheezing, shortness of breath, itchy skin, hives, and/or itchy ears.
PALFORZIA can cause severe allergic reactions called anaphylaxis that may be life-threatening.
PALFORZIA can cause stomach or gut symptoms including inflammation of the esophagus (called eosinophilic esophagitis). Symptoms of eosinophilic esophagitis can include:
For additional information on the possible side effects of PALFORZIA, talk with your doctor or pharmacist.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please see Medication Guide, including an Important Warning about anaphylaxis.
