4.2 Posology and method of administration
INCIVO is not recommended in patients with moderate to severe hepatic impairment (Child‑Pugh B or C, score ≥ 7) or decompensated liver disease (ascites, portal hypertensive bleeding, encephalopathy, and/or jaundice other than Gilbert’s Syndrome, see section 4.4). Dose modification of INCIVO is not required when administered to hepatitis C patients with mild hepatic impairment (Child‑Pugh A, score 5‑6).
4.4 Special warnings and precautions for use
Use in patients with advanced liver disease
Hypoalbuminaemia and low platelet counts have been identified as predictors of severe complications of liver disease as well as of interferon‑based therapies (e.g., hepatic decompensation, serious bacterial infections). Furthermore, high rates of anaemia have been seen when using INCIVO with peginterferon and ribavirin in patients with these characteristics. INCIVO in combination with peginterferon and ribavirin is not recommended in patients with platelets < 90,000/mm3 and/or albumin < 3.3 g/dl. When INCIVO is used in patients with advanced liver disease very close monitoring and early management of adverse events is recommended.
These are recommended baseline values for initiation of INCIVO combination treatment:
- Haemoglobin: ≥ 12 g/dl (females); ≥ 13 g/dl (males)
- Platelet count ≥ 90,000/mm3
- Absolute neutrophil counts ≥ 1,500/mm3
- Adequately controlled thyroid function (TSH)
- Calculated creatinine clearance ≥ 50 ml/min
- Potassium ≥ 3.5 mmol/l
- Albumin > 3.3 g/dl
INCIVO has not been studied in patients with severe hepatic impairment (Child‑Pugh C, score ≥ 10) or decompensated liver disease (ascites, portal hypertensive bleeding, encephalopathy, and/or jaundice other than Gilbert’s Syndrome) and is not recommended in these populations.
section 6.1 sulphate chnages to sulfate