This site is intended for a healthcare professional audience in the United States.

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.

  • Drug Interactions Angiotensin converting enzyme inhibitors may increase response to GIAPREZA.
    Angiotensin II receptor blockers may reduce response to GIAPREZA.

87% of patients treated with GIAPREZA experienced AEs versus 92% of patients treated with placebo2,a

  • 14.1% of patients discontinued GIAPREZA due to AEs versus 21.5% of patients who discontinued placebo2,a
  • Use concurrent venous thromboembolism prophylaxis in patients treated with GIAPREZA1

Abbreviation: AE, adverse event.
aNo significant difference.2 bIncluding arterial and venous thrombotic events.1

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.

Reference: GIAPREZA™ (angiotensin II) [prescribing information]. San Diego, CA: La Jolla Pharmaceutical Company; 2017.

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

IndicationGIAPREZA™ (angiotensin II) increases blood pressure in adults with septic or other distributive shock. ContraindicationsNone. Warnings and PrecautionsThe 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 ReactionsThe 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 InteractionsAngiotensin 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. Smith N and Silberman M. NCBI Bookshelf: National Institutes of Health. StatPearls (2019); Jan. 2. De Backer D, et al. NEJM (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 and Moore BJ. AHRQ (2016); May. 6. SepsisAlliance.com. (2016) Jun. Accessed at: https://www.sepsis.org/sepsis-alliance-news/new-u-s-government-report-reveals-annualcost-of-hospital-treatment-of-sepsis-has-grown-by-3-4-billion/. 7. Khanna A, et al. NEJM. 2017;377(5):419-430. 8. Rhodes A, et al. Intensive Care Med. (2017);43:304–377. 9. Data on File.

Are you a healthcare professional in the United States?