Safety
Well-tolerated vs.
standard of care
Safety and tolerability vs.
placebo and standard of care (SOC) in athos-31
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| GIAPREZA + SOC (n=163) | Placebo + SOC (n=158) | |
|---|---|---|
| Adverse event of any grade, % (n) | 87.1% (142) | 91.8% (145) |
| Adverse event leading to discontinuation, % (n) | 14.1% (23) | 21.5% (34) |
| Any serious adverse event with frequency ≥1% in either study group, % (n) | 60.7% (99) | 67.1% (106) |
Adverse reactions occurring in ≥4% of patients treated with GIAPREZA and ≥1.5% more often than in placebo‑treated patients included thromboembolic events, including arterial and venous thrombosis events (12.9% vs. 5.1%), deep vein thrombosis (4.3% vs. 0.0%), thrombocytopenia (9.8% vs. 7.0%), tachycardia (8.6% vs. 5.7%), fungal infection (6.1% vs. 1.3%), delirium (5.5% vs. 0.6%), acidosis (5.5% vs. 0.6%), hyperglycemia (4.3% vs. 2.5%), and peripheral ischemia (4.3% vs. 2.5%).
Thromboembolic
events
- In ATHOS-3, serious adverse events (SAEs) were reported. The Prescribing Information grouped SAEs and adverse events, including thromboembolic events, as presented under a single category1
- The incidence of patients with a Grade 3 or 4 (severe or life-threatening) thromboembolic event was 9 (5.5%) events in the GIAPREZA group vs. 5 (3.2%) in the placebo group2
- In the GIAPREZA group, 12/25 (48%) thromboembolic events occurred within 5 days of randomization in comparison to 7/8 (87.5%) events in the placebo arm2
Use concurrent venous thromboembolism (VTE) prophylaxis
Fewer GIAPREZA-treated patients discontinued treatment vs. placebo due to adverse events1
Fewer GIAPREZA-treated patients experienced adverse events and serious adverse events vs. placebo1
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References:
- Khanna A, English SW, Wang XS, et al. Angiotensin II for the Treatment of Vasodilatory Shock. N Engl J Med. 2017;377(5):419-430. doi: 10.1056/NEJMoa1704154
- Data on File. Innoviva Specialty Therapeutics; 2023.
Important Safety Information
Indication
GIAPREZA® (angiotensin II) increases blood pressure in adults with septic or other distributive shock.
Contraindications
None.
Warnings and Precautions
The safety of GIAPREZA was evaluated in 321 adults with septic or other distributive shock in a randomized, double-blind, placebo-controlled study, ATHOS-3. There was a higher incidence of arterial and venous thrombotic and thromboembolic events in patients who received GIAPREZA compared to placebo-treated patients in the ATHOS-3 study (13% vs. 5%). The major imbalance was in deep venous thromboses. Use concurrent venous thromboembolism (VTE) prophylaxis.
Adverse Reactions
The most common adverse reactions reported in greater than 10% of GIAPREZA-treated patients were thromboembolic events. Adverse reactions occurring in ≥4% of patients treated with GIAPREZA and ≥1.5% more often than placebo‑treated patients in the ATHOS-3 study were thromboembolic events (including deep vein thrombosis), thrombocytopenia, tachycardia, fungal infection, delirium, acidosis, hyperglycemia, and peripheral ischemia.
Drug Interactions
Angiotensin converting enzyme (ACE) inhibitors may increase response to GIAPREZA. Angiotensin II receptor blockers (ARBs) may reduce response to GIAPREZA.
You are encouraged to report negative side effects of prescription drugs to the FDA.
To report SUSPECTED ADVERSE REACTIONS, please contact:
Before administering, please see the Full Prescribing Information for GIAPREZA.