GIAPREZA Solution for injection Ref.[9974] Active ingredients: Angiotensin II

2.1. Preparation

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

GIAPREZA must be administered as an intravenous infusion. GIAPREZA must be diluted in 0.9% sodium chloride prior to use. Dilute 1 mL of GIAPREZA in a normal saline (0.9% sodium chloride) infusion bag to achieve a final concentration of 5,000 ng/mL or 10,000 ng/mL (see Table 1).

Discard vial and any unused portion of the drug product after use.

Table 1: Preparation of Diluted Solution

Diluted solution may be stored at room temperature or under refrigeration. Discard prepared solution after 24 hours at room temperature or under refrigeration.

2.2. Administration

The recommended starting dosage of GIAPREZA is 20 nanograms (ng)/kg/min via continuous intravenous infusion. Administration through a central venous line is recommended.

Monitor blood pressure response and titrate GIAPREZA as frequently as every 5 minutes by increments of up to 15 ng/kg/min as needed to achieve or maintain target blood pressure. Do not exceed 80 ng/kg/min during the first 3 hours of treatment. Maintenance dose should not exceed 40 ng/kg/min. Doses as low as 1.25 ng/kg/min may be used.

Once the underlying shock has sufficiently improved, down-titrate every 5 to 15 minutes by increments of up to 15 ng/kg/min based on blood pressure.

Overdose of GIAPREZA would be expected to result in hypertension, necessitating close monitoring and supportive care. Effects are expected to be brief because the half-life of angiotensin II is less than one minute.

• GIAPREZA vials should be stored in the refrigerator (36-46°F, 2-8°C).
• Discard prepared diluted solution after 24 hours at room temperature or under refrigeration.