Patient Education

THE THREE PHASES

Of Treatment

Before you get started, it is important to understand the entire treatment process. In the three steps below, you will find detailed information for each phase of treatment, so you and your family know what to expect.
Initial Dose Escalation ~ 4 Hours

The first step will be your child’s Initial Dose Escalation (IDE) appointment. This appointment will last about 4 hours and your allergist will give your child five doses of PALFORZIA, with each dose containing a little more peanut allergen than the previous dose. After each dose, your allergist will observe your child for any allergic reactions and respond accordingly. Think of this appointment as your launchpad: This is where you get your child’s treatment off the ground and on its way.

1
Up-Dosing ~ 6 Months
In this phase, your child will move through 11 different dosing levels of PALFORZIA over approximately six months. Each visit will typically take two hours. Whenever your child starts a higher level, they will visit their allergist’s office for their first dose and your allergist will observe your child for about 60 minutes for any allergic reaction. Afterward, they will continue taking that same daily dose at home for a period of two weeks. Assuming everything has gone well, they will move on to the next dosing level—Up-Dosing with their allergist. If IDE was your launchpad for treatment, Up-Dosing is like climbing a staircase. Each step means a little bit more peanut allergen—bringing you a little bit closer to the Maintenance Dose.
2
Maintenance ~ Ongoing
Congratulations on reaching the Maintenance Phase! Your child won’t need to try any higher doses from now on, but you’ll still be giving them a daily dose at home. If IDE was your launchpad and Up-Dosing was your staircase, the Maintenance Phase is a consistent path for your family to follow into the future. With time, your child’s PALFORZIA dose will eventually become a routine part of your family’s life.
3

Initial Dose Escalation
~ 4 Hours

The first step will be your child’s Initial Dose Escalation (IDE) appointment. This appointment will last about 4 hours and your allergist will give your child five doses of PALFORZIA, with each dose containing a little more peanut allergen than the previous dose. After each dose, your allergist will observe your child for any allergic reactions and respond accordingly. Think of this appointment as your launchpad: This is where you get your child’s treatment off the ground and on its way.

Up-Dosing
~ 6 Months

In this phase, your child will move through 11 different dosing levels of PALFORZIA over approximately six months. Each visit will typically take two hours. Whenever your child starts a higher level, they will visit their allergist’s office for their first dose and your allergist will observe your child for about 60 minutes for any allergic reaction. Afterward, they will continue taking that same daily dose at home for a period of two weeks. Assuming everything has gone well, they will move on to the next dosing level—Up-Dosing with their allergist. If IDE was your launchpad for treatment, Up-Dosing is like climbing a staircase. Each step means a little bit more peanut allergen—bringing you a little bit closer to the Maintenance Dose.

Maintenance
~ Ongoing

Congratulations on reaching the Maintenance Phase! Your child won’t need to try any higher doses from now on, but you’ll still be giving them a daily dose at home. If IDE was your launchpad and Up-Dosing was your staircase, the Maintenance Phase is a consistent path for your family to follow into the future. With time, your child’s PALFORZIA dose will eventually become a routine part of your family’s life.

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REMS Program

& Requirements

Welcome to the PALFORZIA REMS (Risk Evaluation and Mitigation Strategy) Program

The PALFORZIA REMS (Risk Evaluation and Mitigation Strategy) Program is a safety program that manages the risk of anaphylaxis associated with PALFORZIA. The PALFORZIA REMS is required by the Food and Drug Administration (FDA) to ensure the potential benefits of PALFORZIA outweigh its risks. Every patient prescribed PALFORZIA is required to be enrolled in the PALFORZIA REMS. Talk to your health care provider for details on how to enroll in the REMS program.

REMS Patient Information

PALFORZIA is available only through the PALFORZIA REMS Program. For a patient to receive PALFORZIA the prescriber must enroll the patient in the PALFORZIA REMS Program. Your allergist will review these REMS Program requirements for Patients and Caregivers:

You must have injectable epinephrine available at all times

You must avoid peanuts or peanut containing foods in the diet

You know the signs and symptoms of severe allergic reaction (anaphylaxis) and to tell your doctor if you have any of these signs or symptoms

You will need to receive certain doses at your doctor’s office

You will need to be monitored after doses received at your doctor’s office for at least 60 minutes