The information in this webpage is intended for US residents 18 years and over only, and is not intended to provide medical advice.
The information in this webpage is intended for US residents 18 years and over only, and is not intended to provide medical advice.
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PALFORZIA can cause severe allergic reactions called anaphylaxis that may be life-threatening and can occur at any time during PALFORZIA therapy.
PALFORZIA is a treatment for people who are allergic to peanuts. PALFORZIA can help reduce the severity of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. 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.
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. PALFORZIA is a prescription only medication. 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 PALFORZIA and/or the possible side effects, talk with your doctor or pharmacist.
Please see full Prescribing Information, including Boxed WARNING and Medication Guide.
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.