Leaflet KYGEVVI 2g/2 g powder for oral solution

Product code:
W72211001
Indicated for:
genetically confirmed thymidine kinase 2 (TK2) deficiency with symptom onset at or before 12 years of age, in children a
Route of administration:
oral
Substance:
doxecitine + doxribtimine (pyrimidine nucleoside substrate replacement therapy)
ATC
A16AX29 — Alimentary tract and metabolism | Other alimentary tract and metabolism products | Other alimentary tract and metabolism products | Various alimentary tract and metabolism products
Doxecitine + doxribtimine treats children and adults with genetically confirmed thymidine kinase 2 deficiency whose symptoms began at or before 12 years of age. The disease impairs energy production in muscles. These medicines provide mitochondrial DNA precursors and may improve motor function, although their mechanism in humans is not fully confirmed.

Dissolve the powder in water and take it orally in three equal daily doses with food. A specialist calculates the dose by body weight and increases it gradually according to tolerability. Use the recommended measuring devices, not household spoons. Administration through a feeding tube requires specific instructions.

Important side effects are diarrhoea, vomiting, abdominal pain and increased liver enzymes. Digestive fluid losses can cause dehydration and electrolyte imbalance, especially in children. Liver tests are needed before treatment and during follow-up; the doctor may reduce the dose or temporarily interrupt treatment.

Contact the doctor urgently for severe diarrhoea, repeated vomiting, reduced urination, unusual sleepiness, jaundice or dark urine. Report pregnancy, breastfeeding and kidney disease. Treatment does not cure the genetic defect or replace breathing support, nutritional care and rehabilitation. Benefit is assessed through changes in strength and movement.

General data about KYGEVVI 2g/2 g

Substance:
doxecitine + doxribtimine
Product code:
W72211001
Concentration:
2g / 2g
Pharmaceutical form:
powder for oral solution
Product type:
Generic medicine
Prescription status:
S — Medicines dispensed with a restricted medical prescription, reserved for use in certain specialized fields.

Precautions:

Take with food

Take this medicine with food.

General warning

Read the package leaflet before use.

Colitis / severe diarrhea

Seek medical advice if severe or persistent diarrhea occurs.

Hepatotoxicity

This medicine may affect the liver.

Additional monitoring

This medicine is subject to additional monitoring.

Requires periodic laboratory tests

Periodic laboratory tests may be required during treatment.

Breastfeeding warning

Use during breastfeeding only on medical advice.

Pregnancy warning

Use during pregnancy only on medical advice.

Pediatric warning

Use in children only as recommended in the leaflet or by a doctor.

Electrolyte disturbances

This medicine may change blood electrolyte levels.