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Aqvesme
mitapivat
Black Box Warnings .
Appropriate Use
restricted distribution program, Aqvesme REMS, due to risk of hepatocellular injury; prescribers, pharmacies, and patients must enroll at 1-800-625-9951 or www.aqvesmerems.com
Hepatocellular Injury
can occur within 6mo of tx; measure LFTs, including ALT, AST, alk phos, and total bilirubin with fractionation, at baseline and q4wk x24wk, then as clinically indicated; avoid tx in patients with cirrhosis; D/C tx if hepatic injury suspected
Adult Dosing .
Dosage forms: TAB: 100 mg
Restricted Distribution in US
- [1-800-625-9951 or www.aqvesmerems.com for more info]
anemia, alpha- or beta-thalassemia-associated
- [100 mg PO bid]
- Info: do not cut/crush/chew/dissolve tab; see pkg insert for dose adjustments based on toxicities
renal dosing
- [see below]
- eGFR >60: no adjustment; eGFR <60: not defined
- HD/PD: not defined
hepatic dosing
- [see below]
- Child-Pugh Class B or C without cirrhosis: not defined, caution advised; Child-Pugh Class A, B, or C with cirrhosis: avoid use
Peds Dosing .
Peds dosing is currently unavailable or not applicable for this drug.