PYRUKYND

Generic Name/API: mitapivat

Manufacturer: Agios Pharmaceuticals, Inc.

Dosage Forms & Strength & Pack Size:
Tablets: 5 mg, 20 mg, and 50 mg.

PYRUKYND 28-Day Packs
Tablet
Strength Description Imprint NDC
5 mg Round, blue, film-coated tablets “M5” printed on one side 71334-205-05
20 mg Round, blue, film-coated tablets “M20” printed on one side 71334-210-20
50 mg Oblong, blue, film-coated tablets “M50” printed on one side 71334-215-50

PYRUKYND Taper Packs
Tablet strength(s) Blister Wallet Configuration Tablet Description Imprint NDC
5 mg • 5 mg blister wallet containing 7 tablets round, blue, film-coated tablets “M5” printed on one side 71334-220-11

20 mg and 5 mg • 20 mg blister wallet containing 7 tablets • 5 mg blister wallet containing 7 tablets round, blue, film-coated tablets round, blue, film-coated tablets “M20” printed on
one side “M5” printed on one side 71334-225-12
50 mg and 20 mg • 50 mg blister wallet containing 7 tablets • 20 mg blister wallet containing 7 tablets oblong, blue, film coated tablets round, blue, film-coated tablets
“M50” printed on one side “M20” printed on one side 71334-230-13

Storage:
Store at 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F
and 86°F) [see USP Controlled Room Temperature]. Store the blister wallets in the original
carton until use.

  • INDICATION
  • IMPORTANT SAFETY INFORMATION

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.

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