GLYPRESSIN solution for injection, 1 mg/8.5 ml

FERRING PHARMACEUTICALS PRIVATE LIMITED

FERRING PHARMACEUTICALS PRIVATE LIMITED

Therapeutic

Prescription Only

INJECTION, SOLUTION

**4.2. Posology and method of administration** **Bleeding Oesophageal Varices (BOV)** Posology Adults: Initially an i.v. injection of 2 ampoules of GLYPRESSIN® solution for injection (2 mg terlipressin acetate, equivalent to 1.7 mg terlipressin) is given every 4 hours. The treatment should be maintained until bleeding has been controlled for 24 hours, but up to a maximum of 48 hours. After the initial dose, the dose can be adjusted to 1 ampoule of GLYPRESSIN® solution for injection (1 mg terlipressin acetate, equivalent to 0.85 mg terlipressin) i.v. every 4 hours in patients with body weight < 50 kg or if adverse effects occur. Method of Administration i.v. injection **Hepatorenal Syndrome (HRS)** Posology 1 ampoule of GLYPRESSIN® solution for injection (1 mg terlipressin acetate, equivalent to 0.85 mg terlipressin) every 6 to 12 hours by slow intravenous bolus injection for 7 to 14 days (administered in association with albumin 20% 100 mL IV twice daily for 7 to 14 days). If serum creatinine (SCr) has not decreased by at least 30% from the baseline value after 3 days, the dose can be increased to a maximum of 2 ampoules of GLYPRESSIN® solution for injection (2 mg terlipressin acetate, equivalent to 1.7 mg terlipressin) every 6 hours. It is however recommended that the dose not be increased in patients with severe pre-existing cardiovascular disease or in the presence of an ongoing significant adverse event e.g., pulmonary oedema, ischaemia. Treatment should be continued until about 2 days after the patient achieves HRS reversal (SCr less than or equal to 132.6 micromole/L), or be discontinued if the patient undergoes dialysis or liver transplant or if SCr remains at or above baseline after 7 days of treatment. Management of suspected adverse drug reactions may require temporary interruption and/or dose reduction. When the patient’s symptoms resolve, GLYPRESSIN® may be re-commenced at a lower dose or at a less frequent dosing interval (e.g., every 8 – 12 hours). The lowest doses used in the clinical studies ranged from 1.7 to 2.55 mg terlipressin/day. The maximum dose studied (TAHRS Study\*) was 1.7 mg terlipressin every 4 hours. \*The study of Martín–Llahí et al. (2008), also known as the TAHRS study, was a supportive open-label, comparative multicentre study in 46 patients who were randomised in a 1:1 ratio to receive either intravenous terlipressin (0.85 – 1.7 mg (as 1 to 2 mg terlipressin acetate) every 4 hours) plus 20% albumin or 20% albumin alone, for a maximum of 15 days. The majority of patients had HRS type 1 (35/46) and the remainder, HRS type 2 (11/46). Method of Administration i.v. injection