One place for your practice and patients, every step of the way

Personalized education and customized treatment support through a single point of engagement

Prescribe and connect your patients to myAgios® Patient Support Services

Prescribe online

Having trouble? Download the form instead.

You can also get started by calling us at 1-877-77-AGIOS (1-877-772-4467), Mon-Fri, 8 AM to 8 PM ET.

Starting AQVESME

All-in-one enrollment into myAgios and support for your patients

myAgios offers centralized support for your office staff when seeking care for your patients living with thalassemia. AQVESME has a Risk Evaluation and Mitigation Strategy (REMS) to help ensure safe use, regulatory compliance, and coordinated care for patients. Below, you'll find information and resources on how to get your patients started with AQVESME.

Personalized Patient Education

Every patient's treatment experience is unique. Our Agios Clinical Educators (ACEs) will share information that is tailored to each patient's individual needs, providing education and support pre- and post-prescription.

Support Through
Enrollment

A one-time AQVESME REMS certification is required for prescribers (AQVESMEREMS.com).

Before treatment initiation:

  1. Counsel the patient
  2. Obtain liver tests to establish a baseline
  3. Complete 2 forms

Access and Assistance

Patient Support Managers (PSMs) partner with your patients and your practice to facilitate access to AQVESME. They will help coordinate insurance and delivery through the exclusive REMS-certified Specialty Pharmacy.

Customized Treatment
Support and
Adherence

Through their ACE or PSM, patients can get help preparing for appointments, receive friendly reminders for monthly liver monitoring, and have their questions about AQVESME answered by text or phone.

Have your patients sign both the AQVESME REMS Patient Enrollment Form and the AQVESME Start Form while in the office, once counseled.

Your patients have a dedicated team at myAgios

Agios Clinical Educators (ACEs) and Patient Support Managers (PSMs) are here to help guide your patients living with thalassemia along every step of their journey.

What's an ACE?

An Agios Clinical Educator (ACE) is there from the start to offer personalized guidance to people living with thalassemia, with or without a prescription.

ACEs help your patients:

Learn about their disease, set goals for living with their condition, and discuss treatment and monthly liver monitoring requirements.

Get introduced to their PSM to learn more about health insurance coverage and access to AQVESME.

Build connections through webinars, community events, advocacy groups, and Facebook and Instagram pages.

What's a PSM?

A Patient Support Manager (PSM) guides patients in helping get their AQVESME prescription filled, qualify for financial assistance, get personalized support, and more.

PSMs help your patients:

  • Connect to ACEs to learn about their condition and treatment considerations
  • Understand financial assistance and eligibility criteria
  • Get their AQVESME prescription filled
  • Provide support through ongoing adherence

PSMs help you and your office:

  • Ensure all forms are received and completed
  • Navigate the patient's insurance coverage
  • Address prior authorization and appeals requirements
  • Coordinate all fulfillment and delivery with the exclusive REMS-certified Specialty Pharmacy

ACEs and PSMs do not provide medical advice. For medical advice or treatment-related questions, patients are instructed to talk to their healthcare team.

Is your patient not a native English speaker? No problem.

We have translation services available in the following languages: 简体中文 (Chinese), يبرع (Arabic), Tiếng Việt (Vietnamese), ودرا (Urdu), हिंदी (Hindi), and many more.

Start AQVESME in 3 simple steps

Once you and your patient have reviewed AQVESME clinical and REMS information and decided AQVESME is right for them, these are the steps to start treatment promptly:

Complete the AQVESME Start Form and your one-time HCP AQVESME REMS certification

After you and your patient sign and submit the AQVESME Start Form, the patient will be enrolled in myAgios® Patient Support Services. The myAgios team can assist you and your patient in determining insurance coverage and exploring financial assistance options.

Ensure your patient's pre-treatment liver test is completed

The pre-treatment liver test (blood test) must be completed within 4 weeks of the first prescription being filled. The myAgios team will work with you and your patient to determine the ideal timing to complete the required pre-treatment liver test based on the status of insurance determination.

Enroll your patient in AQVESME REMS

To enroll, you and your patient must complete and sign the AQVESME REMS Patient Enrollment Form, including documentation of the patient’s pre-treatment liver test and confirmation that the patient is appropriate for AQVESME.

Patient monitoring requirements include a pre-treatment liver test before initiating therapy and monitoring liver function every 4 weeks during the first 24 weeks of treatment and as clinically indicated thereafter.

*AQVESME is one pill taken twice daily, supplied as a 28-day pack.

The myAgios team will help ensure AQVESME is delivered directly to your patient's home through an exclusive REMS-certified Specialty Pharmacy.

For any questions regarding REMS, visit www.AQVESMEREMS
.com
or call
1-800-625-9951.

Financial support for your patients

myAgios can connect patients to financial assistance and coverage support programs to help with access to AQVESME.

Here are 3 ways our myAgios team helps your patients get, afford, and continue on AQVESME:

$0 responsibility for commercially insured patients, regardless of how much they make

This program lowers costs for eligible patients to $0 per prescription, if their prescription copay exceeds that amount. Support is available for those who qualify. Patients who have government insurance are not eligible for this program.

Please see full Terms and Conditions for more information.

We’re ready to help!

If you and your practice have any questions about patient eligibility, find your PSM for answers or call us at 1-877-77-AGIOS (1-877-772-4467).

Prescribe and connect your patients

The AQVESME Start Form is a single form that connects your patients to myAgios to get all the support they need.

Explore more

Find out more about efficacy, safety, and dosing for AQVESME.

We’re ready to help

If you and your practice have any questions about patient eligibility, find your PSM for answers.

Or call us at 1-877-77-AGIOS (1-877-772-4467).

IMPORTANT SAFETY
INFORMATION

BOXED WARNING: HEPATOCELLULAR INJURYAQVESME can cause serious hepatocellular injury. Measure liver laboratory tests (ALT, AST, alkaline phosphatase and total bilirubin with fractionation) at baseline and every 4 weeks for 24 weeks and then as clinically indicated. Avoid use of AQVESME in patients with cirrhosis. Discontinue AQVESME if hepatic injury is suspected.
Because of the risk of hepatocellular injury, AQVESME is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the AQVESME REMS.

WARNINGS AND PRECAUTIONS

Hepatocellular Injury
AQVESME can cause hepatocellular injury. Avoid use of AQVESME in patients with cirrhosis. In patients with thalassemia treated with AQVESME, liver injury with and without jaundice has been observed within the first 6 months of exposure. Obtain liver tests (including ALT, AST, alkaline phosphatase, total bilirubin with fractionation) prior to the initiation of AQVESME, then every 4 weeks for the first 24 weeks, and as clinically indicated thereafter. Interrupt AQVESME if clinically significant increases in liver tests are observed or alanine aminotransferase is >5 times the upper limit of normal (ULN). Complete a comprehensive evaluation to rule out other causes of liver injury when drug-induced liver injury is suspected. Discontinue AQVESME if hepatocellular injury due to AQVESME is suspected.

Symptoms and signs of early liver injury may mimic those of thalassemia. Advise patients to report new or worsening symptoms of loss of appetite, nausea, right-upper-quadrant abdominal pain, vomiting, scleral icterus, jaundice, or dark urine while on AQVESME treatment.

During the double-blind period, 2 of 301 patients (0.66%) with thalassemia treated with AQVESME experienced adverse reactions suggestive of hepatocellular injury. Three additional patients experienced adverse reactions suggestive of hepatocellular injury during the open-label extension periods after switching from placebo to AQVESME. Of these 5 patients, 2 had serious liver injury requiring hospitalization, including 1 patient who developed jaundice (peak bilirubin 32 mg/dL). Another patient developed jaundice (peak bilirubin 4 mg/dL) without requiring hospitalization. These reactions were characterized by a time to onset within the first 6 months of treatment with peak elevations of alanine aminotransferase of >5×ULN with or without jaundice. All patients discontinued treatment with AQVESME, and these reactions improved upon treatment discontinuation.

AQVESME REMS
AQVESME is available only through a restricted program under a REMS called the AQVESME REMS because of the risk of hepatocellular injury.

ADVERSE REACTIONS
The most common adverse reactions among patients taking AQVESME were headache and insomnia.

DRUG INTERACTIONS

  • Strong CYP3A Inhibitors and Inducers: Avoid concomitant use.
  • Moderate CYP3A Inhibitors: Avoid concomitant use.
  • Moderate CYP3A Inducers: Consider alternatives that are not moderate inducers. If there are no alternatives, see full Prescribing Information for recommended dosage for drug interactions with moderate CYP3A inducers.
  • Sensitive CYP3A Substrates, including hormonal contraceptives: Avoid concomitant use with substrates that have narrow therapeutic index.
  • CYP2B6, CYP2C, and UGT1A1 Substrates: Monitor patients for efficacy of the substrates with narrow therapeutic index.
  • P-gp Substrates: Monitor patients for adverse reactions of the substrates with narrow therapeutic index.

HEPATIC IMPAIRMENT
Avoid use of AQVESME in patients with cirrhosis (Child-Pugh Class A, B, or C).

INDICATION

AQVESME is indicated for the treatment of anemia in adults with alpha- or beta-thalassemia.

Please see full Prescribing Information for AQVESME, including Boxed Warning.