Share on Facebook
Share on Twitter
Share on LinkedIn
Share by Email
Print
Pyrukynd Generic Name & Formulations
Legal Class
Rx
General Description
Mitapivat 5mg, 20mg, 50mg; tabs.
Pharmacological Class
Pyruvate kinase activator.
How Supplied
Tabs—28; Blister wallet—7 (5mg); Blister wallet—14 (20mg×7 + 5mg×7); Blister wallet—14 (50mg×7 + 20mg×7)
Manufacturer
Generic Availability
NO
Pyrukynd Indications
Indications
Hemolytic anemia in adults with pyruvate kinase (PK) deficiency.
Pyrukynd Dosage and Administration
Adult
Swallow whole. Initially 5mg twice daily. Titrate by every 4 weeks to 20mg twice daily, then to max 50mg twice daily according to titration schedule. Assess hemoglobin (Hb) and transfusion requirement before increasing to the next dose level. Discontinue therapy if no benefit is observed by 24 weeks based on lab results and transfusion requirements. Concomitant moderate CYP3A inhibitors: do not titrate beyond 20mg twice daily. Concomitant moderate CYP3A inducers (if no alternatives): titrate beyond 50mg twice daily if needed; max 100mg twice daily. Dose titration schedule or modifications for adverse reactions: see full labeling.
Children
Not established.
Pyrukynd Contraindications
Not Applicable
Pyrukynd Boxed Warnings
Not Applicable
Pyrukynd Warnings/Precautions
Warnings/Precautions
Risk of acute hemolysis with subsequent anemia. Avoid abrupt interruption or abrupt discontinuation. Moderate or severe hepatic impairment: avoid. Pregnancy. Nursing mothers.
Pyrukynd Pharmacokinetics
See Literature
Pyrukynd Interactions
Interactions
Potentiated by strong CYP3A inhibitors (eg, itraconazole, ketoconazole); avoid. Potentiated by moderate CYP3A inhibitors (eg, fluconazole); monitor Hb, adverse reactions, and avoid titrating (see Adult). Antagonized by strong CYP3A inducers (eg, rifampin); avoid. Antagonized by moderate CYP3A inducers (eg, efavirenz); consider alternatives; if no alternative therapies, titrate dose (see Adult). Antagonizes sensitive CYP3A substrates, including hormonal contraceptives (eg, ethinyl estradiol, midazolam); monitor drugs with narrow therapeutic index. Advise to use an alternative non-hormonal contraceptive or add a barrier method of contraception during treatment. May antagonize sensitive substrates of CYP2B6, CYP2C, UGT1A1 or potentiate P-gp substrates; monitor these drugs with narrow therapeutic index.
Pyrukynd Adverse Reactions
Adverse Reactions
Decreased estrone (males), increased urate, back pain, decreased estradiol (males), arthralgia.
Pyrukynd Clinical Trials
See Literature
Pyrukynd Note
Not Applicable
Pyrukynd Patient Counseling
See Literature
