myAgios Patient Support Managers (PSMs): Patient Support for Patients With Pyruvate Kinase (PK) Deficiency

Who are the PSMs and what is their role? PSMs:

Have over 20 years of collective experience with rare diseases

Tailor support for patients and their caregivers based upon their unique needs in living with PK deficiency

Can direct patients to educational resources about PYRUKYND® and PK deficiency, including community connections

Help patients navigate financial assistance questions and eligibility criteria

Can be supportive resources and provide adherence assistance through

Regular phone calls (cadence is approximately monthly)

Email communications

Social support via patient webinars with other patients with PK deficiency

How do the PSMs work together with physicians and eligible patients?

Prescription Submission, Benefits, and Coverage

HCP

Completes the PYRUKYND Commercial Enrollment Form and faxes it to myAgios Patient Support Services at 1-800-951-7814

PATIENT

Becomes enrolled in myAgios when Enrollment Form is received and patient's HIPAA release authorization is obtained

PSM

Connects with physician's office to confirm prescription has been received

Conducts a welcome call with patient to provide information about PK deficiency, PYRUKYND, and insurance coverage

Calls specialty pharmacy to help coordinate initial dispense and subsequent refills

Connects with physician to discuss patient’s plan, prior authorization requirements, or questions insurance company might have while determining patient’s coverage

Can screen for Patient Assistance Program (PAP) eligibility if patients are uninsured or underinsured, or if the PYRUKYND prescription is rejected due to multiple properly completed authorization denials. On-label prescriptions only

Treatment Access

HCP

Office completes paperwork needed for myAgios support program

PATIENT

Discusses copay/coinsurance options with PSM as needed, to determine what financial assistance might be available

PSM

Assists with the coordination of the initial dispense and subsequent refills with the specialty pharmacy

Provides treatment and product education to support patient adherence to the medication

INDICATION

PYRUKYND is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency.

IMPORTANT SAFETY INFORMATION

Acute Hemolysis: Acute hemolysis with subsequent anemia has been observed following abrupt interruption or discontinuation of PYRUKYND in a dose-ranging study. Avoid abruptly discontinuing PYRUKYND. Gradually taper the dose of PYRUKYND to discontinue treatment if possible. When discontinuing treatment, monitor patients for signs of acute hemolysis and anemia including jaundice, scleral icterus, dark urine, dizziness, confusion, fatigue, or shortness of breath.

Adverse Reactions: Serious adverse reactions occurred in 10% of patients receiving PYRUKYND in the ACTIVATE trial, including atrial fibrillation, gastroenteritis, rib fracture, and musculoskeletal pain, each of which occurred in 1 patient. In the ACTIVATE trial, the most common adverse reactions including laboratory abnormalities (≥10%) in patients with PK deficiency were estrone decreased (males), increased urate, back pain, estradiol decreased (males), and arthralgia.

Drug Interactions:

  • Strong CYP3A Inhibitors and Inducers: Avoid concomitant use.
  • Moderate CYP3A Inhibitors: Do not titrate PYRUKYND beyond 20 mg twice daily.
  • Moderate CYP3A Inducers: Consider alternatives that are not moderate inducers. If there are no alternatives, adjust PYRUKYND dosage.
  • Sensitive CYP3A, CYP2B6, CYP2C Substrates Including Hormonal Contraceptives: Avoid concomitant use with substrates that have narrow therapeutic index.
  • UGT1A1 Substrates: Avoid concomitant use with substrates that have narrow therapeutic index.
  • P-gp Substrates: Avoid concomitant use with substrates that have narrow therapeutic index.

Hepatic Impairment: Avoid use of PYRUKYND in patients with moderate and severe hepatic impairment.

Please see full Prescribing Information for PYRUKYND.