Mitapivat
Generic Name: mitapivat
Brand Names:
Pyrukynd
11 DESCRIPTION The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is: The molecular formula is (C 24 H 26 N 4 SO 3 ) 2 • H 2 SO 4 • 3H 2 O, and the molecular weight is 1053.23 for mitapivat sulfate.
Overview
11 DESCRIPTION The active ingredient of PYRUKYND is mitapivat, a pyruvate kinase activator, present as mitapivat sulfate. The chemical name of mitapivat sulfate is 8-quinolinesulfonamide, N-[4-[[4- (cyclopropylmethyl)-1-piperazinyl]carbonyl]phenyl]-, sulfate, hydrate (2:1:3). The chemical structure of mitapivat sulfate is: The molecular formula is (C 24 H 26 N 4 SO 3 ) 2 • H 2 SO 4 • 3H 2 O, and the molecular weight is 1053.23 for mitapivat sulfate.
Uses
1 INDICATIONS AND USAGE PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency. PYRUKYND is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency. ( 1 )
Dosage
2 DOSAGE AND ADMINISTRATION PYRUKYND is taken orally with or without food. The tablets should be swallowed whole. Do not split, crush, chew, or dissolve the tablets. Starting dosage: 5 mg orally twice daily with or without food. ( 2.1 ) See Full Prescribing Information for dose titration and taper schedule. ( 2.1 , 2.3 ) The tablet should be swallowed whole. ( 2.1 ) 2.1 Recommended Dose PYRUKYND is taken with or without food and swallowed whole. Do not split, crush, chew, or dissolve the tablets. The starting dosage for PYRUKYND is 5 mg orally twice daily. To gradually increase hemoglobin (Hb), titrate PYRUKYND from 5 mg twice daily to 20 mg twice daily, and then to the maximum recommended dose of 50 mg twice daily, with these dose increases occurring every 4 weeks (see Table 1).
Side Effects
6 ADVERSE REACTIONS The following clinically significant adverse reaction is described elsewhere in labeling: Acute Hemolysis with Abrupt Treatment Discontinuation [see Warn ings and Preca utions (5.1) ]. Hepatocellular Injury in Another Condition [see Warnings and Precautions (5.2) ] . 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Agios Pharmaceuticals at 1-833-228-8474 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Interactions
7 DRUG INTERACTIONS Strong CYP3A Inhibitors and Inducers: Avoid concomitant use. ( 7.1 ) Moderate CYP3A Inhibitors: Do not titrate PYRUKYND beyond 20 mg twice daily. ( 7.1 ) Moderate CYP3A Inducers: Consider alternatives that are not moderate inducers. If there are no alternatives, adjust PYRUKYND dosage. ( 7.1 ) Sensitive CYP3A, CYP2B6, CYP2C substrates including hormonal contraceptives: Avoid concomitant use with substrates that have narrow therapeutic index. ( 7.2 ) UGT1A1 Substrates: Avoid concomitant use with substrates that have narrow therapeutic index. ( 7.2 ) P-gp Substrates: Avoid concomitant use with substrates that have narrow therapeutic index.
Warnings
5 WARNINGS AND PRECAUTIONS Acute Hemolysis: Avoid abrupt interruption or abrupt discontinuation of PYRUKYND to minimize the risk of acute hemolysis. A gradual reduction in dosing rather than abrupt cessation is recommended when possible. ( 5.1 ) Hepatocellular Injury in Another Condition: Obtain liver tests prior to the initiation of PYRUKYND and monthly thereafter for the first 6 months and as clinically indicated. Interrupt PYRUKYND if clinically significant increases in liver tests are observed or alanine aminotransferase is >5 times the upper limit of normal (ULN). Discontinue PYRUKYND if hepatic injury due to PYRUKYND is suspected. 4 CONTRAINDICATIONS None None ( 4 )
Pregnancy
8.1 Pregnancy Risk Summary Available data from clinical trials of PYRUKYND are insufficient to evaluate for a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, mitapivat orally administered twice daily to pregnant rats and rabbits during organogenesis was not teratogenic at doses up to 13 and 3 times the maximum recommended human dose (MRHD) of 50 mg twice daily, respectively.
Storage
16 HOW SUPPLIED/STORAE AND HANDLING How Supplied 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 C...
Frequently Asked Questions
What is Mitapivat used for?▼
1 INDICATIONS AND USAGE PYRUKYND is indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency. PYRUKYND is a pyruvate kinase activator indicated for the treatment of hemolytic anemia in adults with pyruvate kinase (PK) deficiency. ( 1 )
What are the side effects of Mitapivat?▼
6 ADVERSE REACTIONS The following clinically significant adverse reaction is described elsewhere in labeling: Acute Hemolysis with Abrupt Treatment Discontinuation [see Warn ings and Preca utions (5.1) ]. Hepatocellular Injury in Another Condition [see Warnings and Precautions (5.2) ] . 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. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Agios Pharmaceuticals at 1-833-228-8474 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Can I take Mitapivat during pregnancy?▼
8.1 Pregnancy Risk Summary Available data from clinical trials of PYRUKYND are insufficient to evaluate for a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. In animal reproduction studies, mitapivat orally administered twice daily to pregnant rats and rabbits during organogenesis was not teratogenic at doses up to 13 and 3 times the maximum recommended human dose (MRHD) of 50 mg twice daily, respectively.
What are the important warnings for Mitapivat?▼
5 WARNINGS AND PRECAUTIONS Acute Hemolysis: Avoid abrupt interruption or abrupt discontinuation of PYRUKYND to minimize the risk of acute hemolysis. A gradual reduction in dosing rather than abrupt cessation is recommended when possible. ( 5.1 ) Hepatocellular Injury in Another Condition: Obtain liver tests prior to the initiation of PYRUKYND and monthly thereafter for the first 6 months and as clinically indicated. Interrupt PYRUKYND if clinically significant increases in liver tests are observed or alanine aminotransferase is >5 times the upper limit of normal (ULN). Discontinue PYRUKYND if hepatic injury due to PYRUKYND is suspected. 4 CONTRAINDICATIONS None None ( 4 )
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Medical Disclaimer
This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.