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The information in this webpage is intended for US healthcare professionals only.
Preparing to prescribe PALFORZIA®
The patient images are AI generated and are not real patients treated with PALFORZIA.
Individual results will vary with each patient.
The PALFORZIA REMS Program is an FDA-required drug safety program that manages the risk of anaphylaxis associated with prescription medications, such as PALFORZIA, to ensure the potential benefits outweigh the risks. The goal of the program is to help mitigate the possibility of anaphylaxis associated with peanut allergy.
The healthcare provider who prescribes PALFORZIA
The practice that administers PALFORZIA
Prescribers must also enroll their patients in PALFORZIA REMS before treatment can begin
For prescribers and the healthcare setting, it is a one-time enrollment process. Each new patient, for which PALFORZIA is prescribed, must be REMS enrolled prior to beginning treatment. Learn more about the REMS program at PalforziaREMS.com or download the REMS Overview Brochure.
For more information about ordering, call 1-844-PALFORZ (1-844-725-3679).
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There are important things to consider when
determining whether PALFORZIA is the appropriate
treatment for your individual patients, including:
Consider discussing options to start PALFORZIA during your next touch point with your patient and their caregiver.
Click the button below to review hypothetical
example patient profiles.
Models for illustrative purposes only.
After your patient is enrolled in the REMS Program, you can prescribe PALFORZIA by submitting the patient Prescription Enrollment electronically through our QuickEnroll Portal. Or by downloading, completing, and faxing the Prescription Enrollment Form to the PALFORZIA Pathway™ Patient Hub.
Walgreens, the exclusive REMS Certified specialty pharmacy for PALFORZIA, will work with you and your patients to dispense the medication.
Walgreens Specialty Pharmacies
Models for illustrative purposes only.
Once the patient’s prescription has been processed by the Patient Hub and triaged to Walgreens Specialty Pharmacy, the pharmacy will ship the Initial Dose Escalation card to the prescriber’s healthcare setting upon confirming the patient’s IDE appointment.
Upon moving on to the Up-Dosing phase of the treatment protocol, the prescriber will initiate the first dose of each new Up-Dose level in the healthcare setting using the Office Dose Kit (ODK) or the Daily Dose Pack.
Find the treatment request form here.
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Models for illustrative purposes only.
Find information and downloadable resources to support you
and your practice as you are treating patients. Learn more
about PALFORZIA Pathway™.
Models for illustrative purposes only.
WARNING: ANAPHYLAXIS
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. Initial Dose Escalation may be administered to patients aged 1 through 17 years. Up-Dosing and Maintenance may be continued in patients 1 years of age and older.
PALFORZIA is to be used in conjunction with a peanut-avoidant diet.
Limitation of Use: Not indicated for the emergency treatment of allergic reactions, including anaphylaxis.
CONTRAINDICATIONS
PALFORZIA is contraindicated in patients with uncontrolled asthma, or with a history of eosinophilic esophagitis and other eosinophilic gastrointestinal disease.
WARNINGS AND PRECAUTIONS
ANAPHYLAXIS
PALFORZIA can cause anaphylaxis, which may be life-threatening. PALFORZIA is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the PALFORZIA REMS because of the risk of anaphylaxis. Only prescribers, healthcare settings, pharmacies, and patients certified and enrolled in the REMS Program can prescribe, receive, dispense or administer PALFORZIA.
Anaphylaxis has been reported during all phases of PALFORZIA dosing, including Maintenance and in subjects who have undergone recommended Up-Dosing and dose modification procedures.
Do not initiate PALFORZIA treatment in a patient who has had severe or life-threatening anaphylaxis within the previous 60 days. PALFORZIA may not be suitable for patients with certain medical conditions that may reduce the ability to survive anaphylaxis, including but not limited to markedly compromised lung function, severe mast cell disorder, or cardiovascular disease. In addition, PALFORZIA may not be suitable for patients taking medications that can inhibit or potentiate the effects of epinephrine.
All Initial Dose Escalation doses and the first dose of each Up-Dosing level must be administered under observation in a certified health care setting.
Patients may be more likely to experience allergic reactions following PALFORZIA administration in the presence of cofactors such as exercise, hot water exposure, intercurrent illness (e.g., viral infection), or fasting. Other potential cofactors may include menstruation, sleep deprivation, nonsteroidal anti-inflammatory drug use, or uncontrolled asthma. Patients should be proactively counseled about the potential for the increased risk of anaphylaxis in the presence of these cofactors. If possible, adjust the time of dosing to avoid these cofactors. If it is not possible to avoid these cofactors, consider withholding PALFORZIA temporarily.
ASTHMA
Uncontrolled asthma is a risk factor for a serious outcome, including death, in anaphylaxis. Ensure patients with asthma have their asthma under control prior to initiation of PALFORZIA.
PALFORZIA should be temporarily withheld if the patient is experiencing an acute asthma exacerbation. Following resolution of the exacerbation, resumption of PALFORZIA should be undertaken cautiously. Re-evaluate patients who have recurrent asthma exacerbations and consider discontinuation of PALFORZIA.
EOSINOPHILIC GASTROINTESTINAL DISEASE
Discontinue PALFORZIA and consider a diagnosis of eosinophilic esophagitis in patients who experience severe or persistent gastrointestinal symptoms, including dysphagia, vomiting, nausea, gastroesophageal reflux, chest pain, or abdominal pain.
GASTROINTESTINAL ADVERSE REACTIONS
Gastrointestinal adverse reactions were commonly reported in PALFORZIA-treated subjects, and dose modification should be considered for patients who report these reactions. For severe or persistent gastrointestinal symptoms consider a diagnosis of eosinophilic esophagitis.
ADVERSE REACTIONS
The most common adverse reactions reported in subjects ages 1 through 3 years treated with PALFORZIA (incidence ≥5%) are cough, sneezing, rhinitis, nasal congestion, throat irritation, wheezing, abdominal pain, vomiting, diarrhea, oral pruritus, oropharyngeal pain, urticaria, rash, pruritus, and perioral dermatitis.
The most common adverse events reported in subjects ages 4 through 17 years treated with PALFORZIA (incidence ≥ 5% and at least 5% greater than placebo) are abdominal pain, vomiting, nausea, oral pruritus, oral paresthesia, throat irritation, cough, rhinorrhea, sneezing, throat tightness, wheezing, dyspnea, pruritus, urticaria, anaphylactic reaction, and ear pruritus.
Please see full Prescribing Information, including Boxed WARNING and Medication Guide.