Mitapivat

Mitapivat Uses, Dosage, Side Effects, Food Interaction and all others data.

Mitapivat is under investigation in clinical trial NCT03548220 (A Study to Evaluate Efficacy and Safety of AG-348 in Not Regularly Transfused Adult Participants With Pyruvate Kinase Deficiency (PKD)).

Trade Name	Mitapivat
Availability	Prescription only
Generic	Mitapivat
Mitapivat Other Names	Mitapivat, Pkr-in-1
Type
Formula	C₂₄H₂₆N₄O₃S
Weight	Average: 450.56 Monoisotopic: 450.172561887
Groups	Investigational
Therapeutic Class
Manufacturer
Available Country
Last Updated:	September 19, 2023 at 7:00 am

Food Interaction

[Major] GENERALLY AVOID: Theoretically, the coadministration with grapefruit juice may increase the plasma concentrations of mitapivat.

The proposed mechanism is inhibition of CYP450 3A4-mediated first-pass metabolism in the gut wall by certain compounds present in grapefruits.

The extent and clinical significance are unknown.

In general, the effect of grapefruit juice is concentration,-, dose- and preparation-dependent, and can vary widely among brands.

Certain preparations of grapefruit juice (e.g., high dose, double strength) have sometimes demonstrated potent inhibition of CYP450 3A4, while other preparations (e.g., low dose, single strength) have typically demonstrated moderate inhibition.

Moreover, pharmacokinetic alterations associated with interactions involving grapefruit juice are often subject to a high degree of interpatient variability.

MANAGEMENT: Although clinical data are lacking, it may be advisable to avoid or limit consumption of grapefruit or grapefruit juice during therapy with mitapivat if possible.

If concomitant use is unavoidable, close monitoring of hemoglobin levels and for the development of adverse effects such as atrial fibrillation, gastroenteritis, rib fracture, musculoskeletal pain, arthralgia, increased urate levels, and in males, for decreased estrone and estradiol levels, is recommended.

The product labeling should be consulted for dose adjustments of mitapivat in the event of the development of adverse reaction or hemoglobin levels above normal.