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Septic Shock

is Common, Frequently Fatal, and Expensive to Treat1-9

Distributive shock is the clinical expression of circulatory failure due to vasodilation that results in an insufficient transport of oxygen-carrying blood to meet the metabolic demand of the tissue cells.1

Septic shock is the most common form of distributive shock. Septic shock is characterized by a dysregulated immune response to infection in the host that leads to systemic cytokine release and results in vasodilation, organ dysfunction, and leakage of fluid from capillaries.1

Septic shock has been found to account for more than 62% of the shock that presents within the hospital setting and it has been reported that more than 1 in 4 patients who present with shock in the Emergency Department have septic shock.2,3 Septic shock is a frequently fatal condition, with as many deaths annually as those from acute myocardial infarction.4,5

A recent government study revealed that the annual cost for treating sepsis in U.S. hospitals is nearly $24 billion, making it the most expensive condition to treat in the entire U.S. healthcare system.6

There remains an unmet need4,7-8

Each year, a significant number of distributive shock patients fail to respond to 2nd line and 3rd line vasopressor therapy, after adequate fluid resuscitation.9

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Important Safety Information See more

Warnings and Precautions The safety of GIAPREZA was evaluated in 321 adults with septic or other distributive shock in the randomized, double-blind, placebo-controlled ATHOS-3 study. 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% (21/163 patients) vs. 5% (8/158 patients)]. The major imbalance was in deep venous thromboses. Use concurrent venous thromboembolism prophylaxis.

IndicationGIAPREZA™ (angiotensin II) increases blood pressure in adults with septic or other distributive shock.

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 the randomized, double-blind, placebo-controlled ATHOS-3 study. 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% (21/163 patients) vs. 5% (8/158 patients)]. The major imbalance was in deep venous thromboses. Use concurrent venous thromboembolism 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 inhibitors may increase response to GIAPREZA.

Angiotensin II receptor blockers may reduce response to GIAPREZA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For additional Important Safety Information, please see the full Prescribing Information.

References: 1. Elbers P, Ince C. Crit Care. 2006;10:221-229. 2. De Backer D et al. N Engl J Med. 2010;362:779-789. 3. Holler JG et al. Shock. 2019;51(1): 60–67. 4. Martin GS. Expert Rev Anti Infect Ther. 2012;10(6):701–706. 5. Torio CM, Moore BJ. AHRQ; 2016; May. 6. Sepsis Alliance Newsletter. July 2016. SepsisAlliance.com. https://www.sepsis.org/newsletter/sepsis-alliance-newsletter-july-2016/. July 2016. Accessed April 5 2019. 7. Khanna A et al. N Engl J Med. 2017;377:419-430. 8. Rhodes A et al. Intensive Care Med. 2017;43:304-377, 9. Data on File.

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