Giapreza

Giapreza should be prescribed by a physician experienced in the treatment of shock and is intended for use in an acute and hospital setting. Posology The recommended starting dose of Giapreza is 20 nanograms (ng)/kg per minute via continuous intravenous infusion.

When initiating, it is important to closely monitor blood pressure response and adjust dose accordingly. 4). Once an infusion has been established, the dose may be titrated as frequently as every 5 minutes in steps of up to 15 ng/kg per minute, as needed, depending on the patient’s condition and target mean arterial pressure.

8), thus needing dose down-titration. For critically ill patients, the usual target mean arterial pressure is 65 – 75 mmHg. Do 3 not exceed 80 ng/kg per minute during the first 3 hours of treatment. Maintenance doses should not exceed 40 ng/kg per minute.

25 ng/kg per minute may be used. 4). 5 to 168 hours). In order to minimise the risk of adverse events derived from prolonged vasoconstriction, treatment with Giapreza should be withdrawn once underlying shock is sufficiently improved.

4). Special populations Elderly There are limited efficacy and safety data of Giapreza in patients > 75 years. No special dose adjustment is required in patients over 75 years. As for other age groups, it is important to closely monitor blood pressure response and adjust dose accordingly.

2). As for other patient populations, it is important to closely monitor blood pressure response and adjust dose accordingly. Paediatric population The safety and efficacy of Giapreza in children less than 18 years old has not yet been established.

No data are available. Method of administration Giapreza should only be administered by continuous intravenous infusion under close monitoring of haemodynamics and end-organ perfusion. For intravenous use only after dilution. Giapreza is recommended to be administered via a central venous line.

6.

Summary of the safety profile The adverse reactions described in this section were identified in the pivotal clinical trial (N = 163 treated with Giapreza). 9%) respectively. Tabulated list of adverse reactions Table 1 lists the adverse reactions recorded in clinical trials in the total safety population treated with Giapreza by MedDRA system organ class and frequency.

Frequency categories are defined as: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000), and very rare (< 1/10 000).

Table 1:

Frequency of adverse reactions MedDRA System organ class Very common Common Cardiac disorders Tachycardia Vascular disorders Thromboembolic eventsa Transient hypertensionb Peripheral ischaemia a Grouped term to include arterial and venous thrombotic events b Defined as an increase in mean arterial pressure > 100 mmHg Description of selected adverse reactions Transient hypertension A total of 37 patients (23%) experienced transient hypertension with the angiotensin II 20 ng/kg/min starting dose.

2). 1%]). 1%] vs 0 [0%] respectively). Of these, 7 cases corresponded to deep vein thrombosis. 2%) patients in the Giapreza arm experienced a fatal thromboembolic event compared with no patients in the placebo arm. 4). 5%]). 9%) cases in the placebo arm were considered serious.

One patient in each arm discontinued treatment as a result. Peripheral ischaemia may be a consequence of the mechanism of action of Giapreza. It is important to administer Giapreza at the lowest compatible dose to achieve or maintain adequate mean arterial pressure and tissue perfusion.

4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.

The clinical experience with Giapreza is limited to septic or other distributive shock. g. 1). Thromboembolic events Thromboembolic events have been reported with the use of angiotensin II in clinical trials. 8). Concurrent venous thromboembolism (VTE) prophylaxis should be used unless contraindicated during treatment with Giapreza.

Non-pharmacologic VTE prophylaxis may be considered where pharmacologic prophylaxis is contraindicated. 8). It is important to administer Giapreza at the lowest compatible dose to achieve or maintain adequate mean arterial pressure and tissue perfusion.

2). 5 mg/ml, that is to say essentially ‘sodium-free’.

1.