12.2. Pharmacodynamics 

 

12.3. Pharmacokinetics 

 

13. NONCLINICAL TOXICOLOGY 

 

13.1. Carcinogenesis, Mutagenesis, Impairment of Fertility 

 

13.2. Animal Toxicology and/or Pharmacology 

 

13.3. Safety Pharmacology 

 

14. CLINICAL STUDIES 

 

14.1. ATHOS-3 

 

16. HOW SUPPLIED/STORAGE AND HANDLING 

 

16.1. How Supplied 

 

16.2. Storage and Handling 

* Sections or subsections omitted from the full prescribing information are not listed. Close 

1. INDICATIONS AND USAGE

 

GIAPREZA increases blood pressure in adults with septic or other distributive shock.

 

2. DOSAGE AND ADMINISTRATION

 

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 the contents of one vial of GIAPREZA in 0.9% saline to achieve a final concentration of 5,000 ng/mL or 10,000 ng/mL.

 

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

 

Table 1: Preparation of Diluted Solution 

 

Fluid Restricted?

 

Vial Strength

 

Withdraw Amount (mL)

 

Infusion Bag Size (mL)

 

Final Concentration (ng/mL)

No 2.5 mg/mL 1 500 5,000 

Yes 2.5 mg/mL 1 250 10,000 

5 mg/2 mL 2 500 10,000 

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 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 doses 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.

 

3. DOSAGE FORMS AND STRENGTHS

 

Injection: 2.5 mg/mL angiotensin II and 5 mg/2 mL angiotensin II (2.5 mg/mL) in a vial.

 

GIAPREZA is a clear, aqueous solution.

 

4. CONTRAINDICATIONS

None.

 

5. WARNINGS AND PRECAUTIONS

 

5.1 Risk for Thrombosis