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Kygevvi
doxecitine/ doxribtimine
Adult Dosing .
Dosage forms: PWDR: 2 g/2 g per pkt
Special Note
- [strength clarification]
- Info: doses expressed as total doxecitine + doxribtimine amt; 260 mg doxecitine/doxribtimine contains 130 mg doxecitine + 130 mg doxribtimine; 520 mg doxecitine/doxribtimine contains 260 mg doxecitine + 260 mg doxribtimine; 800 mg doxecitine/doxribtimine contains 400 mg doxecitine + 400 mg doxribtimine
thymidine kinase 2 deficiency
- [800 mg/kg/day PO or via feeding tube divided tid]
- Start: 260 mg/kg/day PO or via feeding tube divided tid for at least 2wk, then 520 mg/kg/day PO or via feeding tube divided tid for at least 2wk; Info: for patients w/ age of onset <12 yo; give doses approx. 6h apart and w/ food; use w/ ZX2000 administration kit; see pkg insert for dose adjustments and interruptions based on AST/ALT/total bilirubin, diarrhea, or vomiting
renal dosing
- [see below]
- CrCl 60-89: not defined; CrCl <60: not defined, caution advised
- HD/PD: not defined
hepatic dosing
- [not defined]
Peds Dosing .
- Dosage forms: PWDR: 2 g/2 g per pkt
Special Note
- [strength clarification]
- Info: doses expressed as total doxecitine + doxribtimine amt; 260 mg doxecitine/doxribtimine contains 130 mg doxecitine + 130 mg doxribtimine; 520 mg doxecitine/doxribtimine contains 260 mg doxecitine + 260 mg doxribtimine; 800 mg doxecitine/doxribtimine contains 400 mg doxecitine + 400 mg doxribtimine
thymidine kinase 2 deficiency
- [800 mg/kg/day PO or via feeding tube divided tid]
- Start: 260 mg/kg/day PO or via feeding tube divided tid for at least 2wk, then 520 mg/kg/day PO or via feeding tube divided tid for at least 2wk; Info: for patients w/ age of onset <12 yo; give doses approx. 6h apart and w/ food; use w/ ZX2000 administration kit; see pkg insert for dose adjustments and interruptions based on AST/ALT/total bilirubin, diarrhea, or vomiting
renal dosing
- [see below]
- CrCl 60-89: not defined; CrCl <60: not defined, caution advised
- HD/PD: not defined
hepatic dosing
- [not defined]
Contraindications / Cautions .
- hypersensitivity to drug or ingredient
Drug Interactions .
Overview
doxecitine
pyrimidine nucleoside
-
None
doxribtimine
pyrimidine nucleoside
-
None
No significant interactions known or found for this drug. Caution always advised with multiple medications.
Adverse Reactions .
Serious Reactions
- diarrhea, severe
Common Reactions
- diarrhea
- abdominal pain
- vomiting
- ALT or AST incr.
Safety/Monitoring .
Monitoring Parameters
ALT/AST, total bilirubin at baseline, then q12mo; electrolytes if persistent nausea or vomiting
Pregnancy/Lactation .
Pregnancy
Clinical Summary
weigh risk/benefit during pregnancy; no human data available, though likely to cross placenta based on data w/ endogenous pyrimidine nucleosides; risk of fetal toxicity based on conflicting animal data at 1233x and 811x MRHD for doxecitine and doxribtimine respectively
Lactation
Clinical Summary
weigh risk/benefit while breastfeeding; no human data available to assess risk of infant harm or effects on milk production
Pharmacology .
Metabolism: for doxecitine, doxribtimine: catabolism; CYP450: unknown
Excretion: for doxecitine: urine (<1%); Half-life: 1h; for doxribtimine: urine (<1%); Half-life: 5h
Subclass: Mitochondrial Diseases, Neurologic
Mechanism of Action
incorporates pyrimidine nucleosides, deoxycytidine and deoxythymidine, into skeletal muscle mitochondrial DNA, which may restore mitochondrial function
Formulary .
No Formulary Selected
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