Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The most common adverse reactions reported in greater than 10% in Angiotensin II treated patients were thromboembolic events.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Gland Pharma at (609)-250‐7990 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 Angiotensin II was evaluated in ATHOS-3 [see Warnings and Precautions (5.1) ] .
Patients in ATHOS-3 were receiving other vasopressors in addition to Angiotensin II or placebo, which were titrated to effect on mean arterial pressure (MAP).
Table 2 summarizes adverse reactions with an incidence of at least 4% among patients treated with Angiotensin II and with a rate of at least 1.5% higher with Angiotensin II than with placebo.
Table 2: Adverse Reactions Occurring in ≥ 4% of Patients Treated with Angiotensin II and ≥ 1.5% More Often than in Placebo-treated Patients in ATHOS-3 A dverse Event Angiotensin II N= 163 Placebo N= 158 Thromboembolic events a 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%) a Including arterial and venous thrombotic events
5 WARNINGS AND PRECAUTIONS • There is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive Angiotensin II.
Use concurrent venous thromboembolism (VTE) prophylaxis.
( 5.1 , 6.1 ) 5.1 Risk for Thrombosis The safety of Angiotensin II was evaluated in 321 adults with septic or other distributive shock in a randomized, double-blind, placebo-controlled study, ATHOS-
There was a higher incidence of arterial and venous thrombotic and thromboembolic events in patients who received Angiotensin II compared to placebo-treated patients in the ATHOS-3 study (13% vs.
The major imbalance was in deep venous thromboses.
Like all medications, Angiotensin Ii can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: