FREQUENTLY
ASKED QUESTIONS
About
PALFORZIA
What is PALFORZIA?
PALFORZIA is a prescription medicine derived from peanuts. It 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 with a confirmed diagnosis of peanut allergy.
If your child turns 18 years of age while on PALFORZIA treatment, your child should continue taking PALFORZIA unless otherwise instructed by your child's allergist.
PALFORZIA is intended to gradually decrease your child's sensitivity to small amounts of peanuts that may be hidden in foods.
PALFORZIA is a medication that must be taken daily to maintain the treatment effect.
PALFORZIA is only intended to treat children with peanut allergy—it is not effective against other food allergies your child may have.
PALFORZIA does NOT treat allergic reactions and should not be given during an allergic reaction.
Your child must maintain a strict peanut-free diet while taking PALFORZIA.
What is the most important information I should know about PALFORZIA?
PALFORZIA can cause severe allergic reactions that may be life-threatening.
Your child will receive their first dose in a healthcare setting under the observation of trained healthcare staff.
Your child will receive the first dose of all dose increases in a healthcare setting.
In the healthcare setting, your child will be observed for at least one hour for signs and symptoms of a severe allergic reaction.
If your child has a severe reaction during treatment, your child will need to receive an injection of epinephrine immediately and get emergency medical help right away.
Your child will return to the healthcare setting for any trouble tolerating home doses.
Stop taking PALFORZIA and get emergency medical treatment right away if your child has any of the following symptoms after taking PALFORZIA:
Trouble breathing or wheezing
Chest discomfort or tightness
Throat tightness
Trouble swallowing or speaking
Swelling of the 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
For home administration of PALFORZIA, your child’s allergist will prescribe injectable epinephrine, a medicine you must inject if your child is having a severe allergic reaction after taking PALFORZIA. Your child’s allergist will train and instruct on the proper use of injectable epinephrine.
Talk to your child's allergist and read the epinephrine patient information if you have any questions about the use of injectable epinephrine.
What is PALFORZIA REMS?
PALFORZIA is only available through a restricted program called the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) Program. Before your child can receive PALFORZIA, you must:
Enroll your child in this program.
Receive education about the risk of a severe allergic reaction (anaphylaxis) from an allergist who practices in a setting that is certified through the REMS program.
Understand that your child will be monitored in a healthcare setting during and after the Initial Dose Escalation and for the first dose of each Up-Dosing level
(See details on Dosing & Starting Treatment below).
Receive education about how to maintain a strict peanut-free diet. You must attest that your child will continue to avoid peanuts at all times.
Fill the prescription your child's allergist gives you for the injectable epinephrine. You must attest that epinephrine will be available to your child at all times.
Talk to your child's allergist for more information about the PALFORZIA REMS program and how to enroll.
What are the possible side effects of PALFORZIA?
The most commonly reported side effects 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 that may be life-threatening. Symptoms of allergic reactions to PALFORZIA can include:
Trouble breathing or wheezing
Chest discomfort or tightness
Throat tightness or swelling
Trouble swallowing or speaking
Swelling of the face, lips, eyes, or tongue
Dizziness or fainting
Severe stomach cramps or pain, vomiting, or diarrhea
Skin rash, itching, or raised bumps on skin
Severe flushing of the skin
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 may report side effects to the U.S. Food and Drug Administration (FDA) at 1-800-FDA-1088 or www.fda.gov/medwatch.
How does PALFORZIA work?
PALFORZIA is intended to help your child gradually decrease their sensitivity to peanuts over time through a process called oral immunotherapy or OIT.
Who should not use PALFORZIA?
Your child should NOT take PALFORZIA if:
Your child has uncontrolled asthma.
Your child ever had eosinophilic esophagitis (EoE) or other eosinophilic gastrointestinal disease.
What should I tell my child's allergist before using PALFORZIA?
Tell your child's allergist if your child is not feeling well prior to starting treatment with PALFORZIA. Your child's allergist may decide to delay treatment until your child is feeling better. Also tell your child's allergist about any medical conditions your child has. You should tell your child's allergist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription and herbal supplements. Keep a list of them and show it to your child's allergist and pharmacist each time your child gets a new supply of PALFORZIA.
Tell your child's allergist if your child is pregnant, planning to become pregnant, or breastfeeding.
Your child's allergist may decide that PALFORZIA is not the best treatment if:
You or your child are unwilling or unable to receive (or self-administer) injectable epinephrine.
Your child has a condition or is taking a medication that reduces the ability to survive a severe allergic reaction.
What are the benefits of PALFORZIA?
PALFORZIA is the first and only FDA-approved treatment to help reduce the severity of allergic reactions to peanuts, including anaphylaxis, in children aged 4 through 17 years old with a confirmed diagnosis of peanut allergy. Treatment with PALFORZIA is designed for consistency, so at each dosing level, every dose is exactly the same. This provides a gradual and controlled exposure to increasing doses of peanut allergens over time.
The effectiveness of PALFORZIA has been proven in the largest randomized, double-blind, placebo-controlled clinical trial of an oral peanut allergy treatment. Learn more about the PALISADE clinical trial.
How much does PALFORZIA treatment cost?
Out-of-pocket costs may vary. You must speak to your pharmacist or insurance provider to determine your out-of-pocket cost. Eligible, commercially insured patients may qualify for the PALFORZIA Pathway™ Co-Pay Savings Program and may pay as little as $20 per month for PALFORZIA, with a maximum benefit of $6,200 per calendar year. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state healthcare programs. Please see Program Terms, Conditions, and Eligibility Criteria. After the annual maximum benefit is reached, the patient or legal guardian will be responsible for all PALFORZIA out-of-pocket costs.
The co-pay assistance from the program may be applied only to PALFORZIA drug out-of-pocket costs, including plan deductibles, co-payments, or co-insurance; co-pay assistance from the program cannot be applied toward physician office visits or other medical expenses.
Our PALFORZIA Pathway customer representatives can assist eligible patients in enrolling in the PALFORZIA Pathway program that's right for them.
Ask your child's allergist how to get started in our program.
Who developed PALFORZIA?
PALFORZIA was developed by Aimmune Therapeutics, Inc. Learn more about Aimmune and our story.
DOSING &
STARTING TREATMENT
Can my child take PALFORZIA with other medication they are taking?
Your child’s allergist will tell you if your child can take other medicines with PALFORZIA, such as other allergy treatments, medicines for your child’s stomach, or medicines for any other conditions that your child has.
Your child’s allergist may decide that PALFORZIA is not the best treatment if:
You or your child are unwilling or unable to receive (or self-administer) injectable epinephrine.
Your child has a condition or is taking a medication that reduces the ability to survive a severe allergic reaction.
Tell your allergist about any medical conditions your child has. Also tell your child’s allergist if your child is taking or has recently taken any other medicines, including medicines obtained without a prescription and herbal supplements. Keep a list of them and show it to your child’s allergist and pharmacist each time your child gets a new supply of PALFORZIA.
What is a specialty pharmacy?
In order for your family member to receive PALFORZIA in a timely manner, the prescription must be fulfilled by a specialty pharmacy. Specialty pharmacies have expertise in dispensing medications like PALFORZIA and are different from your usual pharmacy. After receiving the prescription, the specialty pharmacy ships the drug to your preferred location.
Note: Your child, your child's allergist, and your child's allergist’s practice must be enrolled in the PALFORZIA REMS Program before getting your child's prescription.
How should my child take PALFORZIA?
Prepare and take PALFORZIA exactly as instructed by your child's allergist.
PALFORZIA is an oral powder that is mixed with refrigerated or room-temperature soft foods such as applesauce, yogurt, or pudding.
PALFORZIA is provided as either capsules or sachets.
PALFORZIA oral powder should be completely emptied from the capsules or sachets into the food before mixing.
Do not swallow the capsules.
Do not breathe in the powder. This could cause breathing problems (worsening of asthma) or cause an allergic reaction.
PALFORZIA should be taken at approximately the same time each day with a meal.
What is the treatment process?
There are three different phases of dosing with PALFORZIA: Initial Dose Escalation, Up-Dosing, and Maintenance Dosing.
Initial Dose Escalation:
The first five doses (Initial Dose Escalation) of PALFORZIA will be administered on a single day in your child's allergist's office. If your child does not tolerate the Initial Dose Escalation, your child's allergist may not continue your child's treatment with PALFORZIA.
Up-Dosing:
If your child tolerates the Initial Dose Escalation phase, you will return to your child's allergist's office the next day to start the Up-Dosing phase. There are 11 different dose levels of Up-Dosing, starting with PALFORZIA 3 mg (Level 1) and finishing with PALFORZIA 300 mg (Level 11). The first dose of each Up-Dosing level is given in your child's allergist's office. If your child tolerates the first dose of a new dose level, your child's allergist will ask your child to continue to take that dose level every day at home. PALFORZIA should be taken at approximately the same time each day.
During Up-Dosing, your child will return to your child’s allergist’s office approximately every two weeks to be assessed for a new Up-Dosing level. Dose levels cannot be skipped.
Maintenance Dosing:
If your child tolerates all dose levels of the Up-Dosing phase, your child's allergist will ask your child to continue taking PALFORZIA at a 300 mg dose every day as Maintenance therapy.
PALFORZIA must be taken every day for it to be effective.
Your child's allergist will tell you if your child can take other medicines with PALFORZIA, such as other allergy treatments, medicines for your child's stomach, or medicines for any other conditions that your child has.
How am I supposed to prepare a dose of PALFORZIA for my child?
Open the daily dose of PALFORZIA capsule(s) or sachet and empty the full dose of PALFORZIA oral powder onto refrigerated or room-temperature soft foods like applesauce, yogurt, or pudding. Do not use liquid (e.g., milk, water, juice) to prepare. Mix well.
The amount of food for mixing must enable your child to take the full dose of PALFORZIA in a few spoonfuls.
Your child should take PALFORZIA immediately after mixing.
You and your child should wash your hands immediately after handling PALFORZIA capsules or sachets.
PALFORZIA must be stored in a refrigerator.
What happens if my child misses a dose?
If your child misses taking a dose of PALFORZIA, contact your child's allergist. Do not take additional doses on the same day to make up for missed doses.
Can my child continue normal activities after taking PALFORZIA?
Your child should not exercise or have a hot bath or shower within three hours after taking PALFORZIA.
If your child has been exercising or has taken a hot bath or shower and feels hot, or your child is sweating and your child’s heart is beating fast, do not let your child take PALFORZIA until your child has cooled down and has a normal heartbeat.
Certain conditions may increase the likelihood of an allergic reaction. These include:
Having an illness, such as a viral infection
Being very tired or missing sleep
Being stressed
Having a menstrual period
Exercising
Taking certain pain medications, such as aspirin or ibuprofen
Drinking alcohol
How should I store PALFORZIA?
Refrigerate PALFORZIA at 2°C to 8°C (36°F to 46°F). Do not freeze. Store in the original packaging until use to protect from moisture.
Keep PALFORZIA out of the reach of children.
Throw away any unused PALFORZIA after the expiration date.
Where do I get PALFORZIA?
PALFORZIA is only available through a restricted program called the PALFORZIA Risk Evaluation and Mitigation Strategy (REMS) Program.
Once you and your child’s allergist have made the decision to start PALFORZIA, your child’s allergist will write your child a prescription, which can either be shipped directly to your home or to your child’s allergist’s office by the pharmacy.
PALFORZIA prescriptions are filled by a specialty pharmacy, which has expertise in dispensing medications like PALFORZIA and is different from your usual pharmacy. Specialty pharmacies that dispense PALFORZIA must also be certified in the PALFORZIA REMS Program.
SUPPORT
Who do I call if I have more questions?
Call 1-844-PALFORZ [1-844-725-3679] with any questions about PALFORZIA.