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CONTACT INFORMATION

THANK YOU FOR YOUR INTEREST IN PALFORZIA. IN ORDER TO HELP YOU GET THE RIGHT ANSWERS, HERE ARE A FEW RESOURCES TO GUIDE YOUR PATH:

A caregiver carrying a child

Caregivers and Patients

  • For PALFORZIA treatment questions or inquiries, please call 1-844-PALFORZ.

  • To find a provider and learn more about PALFORZIA, please visit the Find A Provider locator tool. In order for a prescriber to prescribe PALFORZIA, they must become certified in the Risk Evaluation and Mitigation Strategy (REMS) program. If your child's allergist is not already certified, they can do so by going to PALFORZIAREMS.com.

  • For information on insurance coverage, financial assistance options, and other access resources, please call 1-844-PALFORZ. To determine if you are eligible for the PALFORZIA Pathway™ Co-Pay Savings Program, please visit the PALFORZIA Co-Pay website.

  • PALFORZIA is only administered to patients who are enrolled in the Risk Evaluation and Mitigation Strategy (REMS) Program. Your child's allergist will enroll your child in the PALFORZIA REMS Program and counsel you in what you need to do to enroll. Visit the PALFORZIA REMS website to learn more.

  • To report side effects or product complaints, please call Aimmune at 1-833-AIM2KNO (1-833-246-2566) or the FDA at 1-800-FDA-1088 or visit http://www.fda.gov/medwatch.

Specialty Pharmacies

IMPORTANT SAFETY INFORMATION

PALFORZIA can cause severe allergic reactions called anaphylaxis that may be life-threatening.

  • You will receive your first dose in a healthcare setting under the observation of trained healthcare staff.

  • You will receive the first dose of all dose increases in a healthcare setting.

  • In the healthcare setting, you will be observed for at least 1 hour for signs and symptoms of a severe allergic reaction.

  • If you have a severe reaction during treatment, you will need to receive an injection of epinephrine immediately and get emergency medical help right away.

  • You will return to the healthcare setting for any trouble tolerating your home doses.

Stop taking PALFORZIA and get emergency medical treatment right away if you have any of the following symptoms after taking PALFORZIA:

  • Trouble breathing or wheezing

  • Chest discomfort or tightness

  • Throat tightness

  • Trouble swallowing or speaking

  • Swelling of your face, lips, eyes, or tongue

  • Dizziness or fainting

  • Severe stomach cramps or pain, vomiting, or diarrhea

  • Hives (itchy, raised bumps on skin)

  • Severe flushing of the skin

WHAT IS PALFORZIA?

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 4 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.

You must maintain a strict peanut-free diet while 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:

  • You are unwilling or unable to receive (or self-administer) injectable epinephrine.

  • You have a condition or are taking a medication that reduces the ability to survive a severe allergic reaction.

What are the possible side effects of PALFORZIA?

The most commonly reported side effects of PALFORZIA 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:

  • Trouble swallowing

  • Food stuck in throat

  • Burning in chest, mouth, or throat

  • Vomiting

  • Regurgitation of undigested food

  • Feeling sick

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 full Prescribing Information and Medication Guide, including an Important Warning about anaphylaxis.

WHAT IS PALFORZIA?

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 4 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.

You must maintain a strict peanut-free diet while taking PALFORZIA.