Glypressin

/ Ferring Pharmaceuticals

In bleeding oesophageal varices: Unless otherwise prescribed, initially 1-2 mg terlipressin acetate, equivalent to 1-2 vials of Glypressin 1 mg, are slowly administered intravenously in adults. The maintenance dose is 1 mg terlipressin acetate each, equivalent to 1 vial Glypressin 1 mg, after 4-6 hours. The standard value for the maximum daily dose of Glypressin is 120-150 g/kg body weight. For an adult person of 70 kg body weight, this corresponds to a dose of 8-9 vials per day, to be administered in 4-hour intervals.
In type 1 hepatorenal syndrome: 3 to 4 mg every 24 hours as 3 or 4 administrations. In the absence of any reduction of the serum creatinine after 3 days of treatment, cessation of Glypressin treatment is advised. In the other cases, Glypressin treatment is to be pursued until the obtaining either of a serum creatinine less than 130 mol/litre or of a drop of at least 30% in the serum creatinine with respect to the value measured at the time of diagnosis of hepatorenal syndrome. The standard average duration of treatment is 10 days.
For full details see prescribing information.

Bleeding esophageal varices; hepatorenal syndrome (HRS).

Hypersensitivity to terlipressin or any other excipient of the product.
Contraindicated in pregnancy.

Blood pressure, heart rate and fluid balance should be monitored during treatment.
Caution should be exercised in treating patients with hypertension, recognised heart disease, renal dysfunction, cerebral or peripheral vascular disease, asthma or respiratory failure.
To avoid local necrosis at the injection site, the injection must be administered intravenously.
In patients with septic shock with a low cardiac output terlipressin should not be used.
Prior to use of terlipressin for hepatorenal syndrome, it must be ascertained that the patient has an acute functional renal failure and this functional renal failure does not respond to a suitable plasma expansion therapy.
Children and the elderly: Particular caution should be exercised in the treatment of children and elderly patients, as experience is limited in these groups.
There is no data available regarding dosage recommendation in these special patient categories.

The most commonly reported undesired effects in clinical trials (frequency 1-10%) are paleness, increased blood pressure, abdominal pain, nausea, diarrhoea, and headache.
See prescribing information for full details.

The hypotensive effect of non-selective beta-blockers on the portal vein is increased with terlipressin. Concomitant treatment with medicinal products with a known bradycardiac effect (e.g. propofol, sufentanil) may lower the heart rate and cardiac output. These effects are due to reflexogenic inhibition of the cardiac activity via the vagus nerve due to the elevated blood pressure.

Pregnancy: Treatment with GLYPRESSIN during pregnancy is contraindicated. GLYPRESSIN has been shown to cause uterine contractions and increased intrauterine pressure in early pregnancy and may decrease uterine blood flow. GLYPRESSIN may have harmful effects on pregnancy and foetus.
Spontaneous abortion and malformation have been shown in rabbits after treatment with GLYPRESSIN.
Lactation: It is not known whether GLYPRESSIN is excreted in human breast milk. The excretion of GLYPRESSIN in milk has not been studied in animals. A risk to the suckling child cannot be excluded. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with GLYPRESSIN should be made taking into account the benefit of breast-feeding to the child and the benefit of GLYPRESSIN therapy to the woman.

The recommended dose (2 mg/4 hours) should not be exceeded as the risk of severe circulatory adverse effects is dose-dependent.
Elevated blood pressure in patients with hypertension can be controlled with clonidine 150 µg IV. Severe bradycardia should be treated with atropine.