REMS PROGRAMS
Risk Evaluation and Mitigation Strategy
What is REMS?
A rare metabolic disorder
What is PKU?
1. Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies
2. Train all relevant staff involved in distributing on the REMS Program requirements.
3. Distribute only to certified pharmacies and maintain records of all distributions
4. Comply with audits carried out by BioMarin or a third party acting on behalf of Biomarin to ensure that all processes and procedures are in place and are being followed.
What is a wholesaler
855.758.7367
What is the REMS program call center phone number?
Pharmacy recertification
If a new authorized representative is designated by completing and submitting the pharmacy enrollment form.
To ensure the benefits of a drug continue to outweigh its risks.
What is REMS objective?
Indicated to reduce blood phenylalanine concentrations.
What is PALYNZIQ?
1. Review the drug's prescribing information
2. Review: Prescriber Guide & REMS Program Overview
3. Successfully complete the Prescriber Knowledge Assessment
4. Enroll in the REMS by completing the prescriber enrollment form.
What is prescriber certification?
A validated, secure database of all REMS participants who are enrolled and/or certified in the PALYNZIQ REMS.
Where is stakeholder information kept?
Sixty
The number of active REMS programs
Anaphylaxis
What is the most important risk of PALYNZIQ?
What is an authorized representative?
Two business days
Time period to notify prescribers, patients and pharmacies that they have become certified in the REMS program.
Show this to all of your doctors or emergency responders involved in your medical treatment, even if it is not for your PKU.
What is the patient wallet card?
To mitigate the risk of anaphylaxis associated with PALYNZIQ
What is the goal of the PALYNZIQ REMS?
One of the essential amino acids, essential for life, but our bodies cannot make.
What is phenylalanine?
Prescribing information, REMS program overview, prescriber guide, prescriber knowledge assessment and prescriber enrollment form.
What are prescriber materials?
Fainting, dizziness, sudden confusion, trouble breathing, chest discomfort, swelling of face, flushed skin, rash, itching, nausea, vomiting.
What are symptoms of anaphylaxis?
The government agency overseeing REMS programs
What is the FDA?
Missing or deficient enzyme
What is phenylalanine hydroxylase (PAH)?
1. Review the Patient Guide, Safety Video and Wallet Card
2. Enroll in the REMS by completing the Patient Enrollment Form with the prescriber.
3. Receive counseling from the prescriber on how to recognize and respond to signs and symptoms of anaphylaxis, and having auto-injectable epinephrine with you at all times using the Patient Guide, Safety Video and Wallet Card.
4. Adhere to the safe use conditions including obtaining auto-injectable epinephrine.
What is a PALYNZIQ patient?
866.713.8421
What is the Palynziq REMS fax number?
An adult who can be present with the patient during and at least one hour after PALYNZIQ injection and is able to recognize signs and symptoms of anaphylaxis, call for medical support and administer auto-injectable epinephrine as required.
What is an observer?