Giapreza
Generic: ANGIOTENSIN II
Basic Information
Manufacturer
La Jolla Pharmaceutical Company
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRAVENOUS
FDA Set ID
c265d69a-3efe-4107-9a9e-e6fd3d531c48
Indications & Usage
1.
INDICATIONS AND USAGE GIAPREZA increases blood pressure in adults with septic or other distributive shock [see Clinical Studies (14)] .
GIAPREZA is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock.
( 1 )
INDICATIONS AND USAGE GIAPREZA increases blood pressure in adults with septic or other distributive shock [see Clinical Studies (14)] .
GIAPREZA is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock.
( 1 )
Adverse Reactions
6.
ADVERSE REACTIONS The most common adverse reactions reported in greater than 10% of GIAPREZA treated patients were thromboembolic events.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact La Jolla Pharmaceutical Company at 1-800-651-3861 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1.
Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
ATHOS-3 The safety of GIAPREZA was evaluated in ATHOS-3 [see Warnings and Precautions(5.1) ] .
Patients in ATHOS-3 were receiving other vasopressors in addition to GIAPREZA or placebo, which were titrated to effect on mean arterial pressure (MAP).
Table 1 summarizes adverse reactions with an incidence of at least 4% among patients treated with GIAPREZA and with a rate of at least 1.5% higher with GIAPREZA than with placebo.
Table 1: Adverse Reactions Occurring in ≥ 4% of Patients Treated with GIAPREZA and ≥ 1.5% More Often than in Placebo-treated Patients in ATHOS-3 Adverse Event GIAPREZA N=163 Placebo N=158 Thromboembolic events Including arterial and venous thrombotic events 21 (12.9%) 8 (5.1%) Deep vein thrombosis 7 (4.3%) 0 (0.0%) Thrombocytopenia 16 (9.8%) 11 (7.0%) Tachycardia 14 (8.6%) 9 (5.7%) Fungal infection 10 (6.1%) 2 (1.3%) Delirium 9 (5.5%) 1 (0.6%) Acidosis 9 (5.5%) 1 (0.6%) Hyperglycemia 7 (4.3%) 4 (2.5%) Peripheral ischemia 7 (4.3%) 4 (2.5%)
ADVERSE REACTIONS The most common adverse reactions reported in greater than 10% of GIAPREZA treated patients were thromboembolic events.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact La Jolla Pharmaceutical Company at 1-800-651-3861 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1.
Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
ATHOS-3 The safety of GIAPREZA was evaluated in ATHOS-3 [see Warnings and Precautions(5.1) ] .
Patients in ATHOS-3 were receiving other vasopressors in addition to GIAPREZA or placebo, which were titrated to effect on mean arterial pressure (MAP).
Table 1 summarizes adverse reactions with an incidence of at least 4% among patients treated with GIAPREZA and with a rate of at least 1.5% higher with GIAPREZA than with placebo.
Table 1: Adverse Reactions Occurring in ≥ 4% of Patients Treated with GIAPREZA and ≥ 1.5% More Often than in Placebo-treated Patients in ATHOS-3 Adverse Event GIAPREZA N=163 Placebo N=158 Thromboembolic events Including arterial and venous thrombotic events 21 (12.9%) 8 (5.1%) Deep vein thrombosis 7 (4.3%) 0 (0.0%) Thrombocytopenia 16 (9.8%) 11 (7.0%) Tachycardia 14 (8.6%) 9 (5.7%) Fungal infection 10 (6.1%) 2 (1.3%) Delirium 9 (5.5%) 1 (0.6%) Acidosis 9 (5.5%) 1 (0.6%) Hyperglycemia 7 (4.3%) 4 (2.5%) Peripheral ischemia 7 (4.3%) 4 (2.5%)