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Fixed-dose combination

Doxecitine and Doxribtimine

Also known as doxecitine, doxribtimine
Available on requestOrphanRare diseases and enzyme replacement
Presentations
1
Brands
1
Manufacturers
1
Available from stock
0

Doxecitine and Doxribtimine is a fixed-dose combination medicine indicated for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years. MedsAcross supplies Doxecitine and Doxribtimine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.

Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review

Key facts

ATC classification
A16AX29 Doxecitine and Doxribtimine · Metabolic disease treatments, including enzyme replacement, subgroup A16A, subgroup A16AX
US FDA first approval
3 November 2025
EU status
Authorised
Orphan designation
Yes
WHO essential medicine
Not recorded
India (CDSCO)
Not yet confirmed against CDSCO approval lists
Routes
Oral
Dosage forms
Powder for oral solution
Fixed-dose combination of
Doxecitine, Doxribtimine

Clinical information

From the regulator-approved product information. Each section names its source.

Uses

KYGEVVI is indicated for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years. KYGEVVI is a combination of doxecitine and doxribtimine, both pyrimidine nucleosides, indicated for the treatment of thymidine kinase 2 deficiency (TK2d) in adults and pediatric patients with an age of symptom onset on or before 12 years.

Source: US FDA prescribing information

How it works

Administration of KYGEVVI is intended to incorporate the pyrimidine nucleosides, deoxycytidine and deoxythymidine, into skeletal muscle mitochondrial deoxyribonucleic acid (DNA). This action restores mitochondrial DNA copy number in TK2d mutant mice.

Source: US FDA prescribing information

Dosing overview

Obtain baseline transaminase (alanine aminotransferase [ALT] and aspartate aminotransferase [AST]) levels in all patients prior to treatment initiation. Recommended dosage: KYGEVVI Dosage Level KYGEVVI Dosage (mg/kg/day) Starting 260 mg/kg/day (consisting of 130 mg doxecitine and 130 mg doxribtimine) Intermediate 520 mg/kg/day (consisting of 260 mg doxecitine and 260 mg doxribtimine) Maintenance 800 mg/kg/day (consisting of 400 mg doxecitine and 400 mg doxribtimine) Titrate to the next dosage level based on tolerability after a minimum of 2 weeks at the current dosage level. Administer KYGEVVI orally in 3 equally divided doses with food. See full prescribing information for dosage and administration modifications, monitoring, and preparation and administration instructions. Use KYGEVVI only with ZX2000 administration kit.

Source: US FDA prescribing information

Warnings and precautions

Elevated Liver Transaminase Levels: Obtain baseline liver transaminase (ALT, AST) and total bilirubin levels prior to treatment initiation with KYGEVVI. If signs or symptoms consistent with liver injury are observed, interrupt treatment. Consider permanently discontinuing KYGEVVI if signs/symptoms consistent with liver injury persist or worsen. Monitor patients yearly and as clinically indicated. Gastrointestinal Adverse Reactions: Reduce KYGEVVI dosage or interrupt treatment based on severity of diarrhea and/or vomiting. If persistent severe diarrhea and/or vomiting occurs, consider discontinuing KYGEVVI permanently.

Source: US FDA prescribing information

Side effects

The following clinically significant adverse reactions are described elsewhere in the labeling: Elevated Liver Transaminase Levels Gastrointestinal Adverse Reactions Most common adverse reactions (incidence ≥5%) are diarrhea, abdominal pain (including abdominal pain upper), vomiting, alanine aminotransferase increased (ALT), and aspartate aminotransferase increased (AST).

Source: US FDA prescribing information

Storage

Store KYGEVVI packets at 20°C to 25°C (68°F to 77°F), excursion permitted between 15°C to 30°C (59°F to 86°F). Store reconstituted KYGEVVI solution at controlled room temperature or in the refrigerator.

Source: US FDA prescribing information

For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.

All presentations

1 presentations of Doxecitine and Doxribtimine, sorted by availability.

MedicineActive ingredientManufacturerRegisterAvailability
Kygevvi 2 g/2 g powder for oral solutionOralDoxecitine and DoxribtimineUCBUS FDAAvailable on request

Brands by market

1 brand names across 1 markets.

Brand names by country

United States

Manufacturers

Regulatory status

Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.

RegisterStatusSource
US FDAFirst approved 3 November 2025Drugs@FDA
EU (EMA)AuthorisedEMA medicines data
India (CDSCO)Not yet confirmed against CDSCO approval lists—
AustriaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BelgiumRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
BulgariaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CroatiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CyprusRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
CzechiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
DenmarkRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
EstoniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FinlandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
FranceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GermanyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
GreeceRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
HungaryRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IcelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
IrelandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
ItalyRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LatviaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LiechtensteinRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LithuaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
LuxembourgRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
MaltaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NetherlandsRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
NorwayRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PolandRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
PortugalRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
RomaniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SlovakiaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SloveniaRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SpainRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
SwedenRegisteredEuropean Medicines Agency (central authorisation)Checked 12 November 2026
United StatesRegisteredUS FDA (NDC directory, openFDA)Checked 12 November 2026

Questions and answers

Is Doxecitine and Doxribtimine available for export from India?

Yes, on request. MedsAcross lists 1 presentations of Doxecitine and Doxribtimine and sources them for licensed hospitals, importers and physicians against valid import documents.

What brand names does Doxecitine and Doxribtimine have?

The catalogue lists 1 brand names for Doxecitine and Doxribtimine, including Kygevvi.

Is Doxecitine and Doxribtimine approved by the US FDA?

Yes. The US FDA first approved Doxecitine and Doxribtimine on 3 November 2025, according to Drugs@FDA.

Is Doxecitine and Doxribtimine authorised in the European Union?

Yes. Doxecitine and Doxribtimine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.

Does Doxecitine and Doxribtimine need cold chain shipping?

No listed presentation of Doxecitine and Doxribtimine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.

Which ATC class is Doxecitine and Doxribtimine in?

Doxecitine and Doxribtimine is classified under ATC code A16AX29 (Doxecitine and Doxribtimine).

References

  1. KYGEVVI prescribing information (UCB). U.S. National Library of Medicine, DailyMed. Retrieved 16 October 2026
  2. Kygevvi: European public assessment report (EPAR). European Medicines Agency. Retrieved 22 October 2026

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