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GIAPREZA increased MAP in critically ill, adult hypotensive patients with septic or other distributive shock1,2

Clinical data Significantly more patients treated with GIAPREZA reached the primary endpoint of achieving target MAP at Hour 3 versus patients treated with SoC plus placebo1

  • Target MAP is defined as ≥75 mmHg or an increase from baseline of ≥10 mmHg without an increase in baseline vasopressor therapy1
  • From Hour 3 to Hour 48, GIAPREZA or placebo was titrated to maintain MAP between 65 and 70 mmHg while reducing doses of other vasopressors1

Achievement of target MAP at Hour 31,a

Abbreviation: MAP, mean arterial pressure SoC, standard of care. aModified intent-to-treat (mITT) population: patients randomized and treated with study drug in any quantity included in the primary efficacy analysis.2

Trial Design

ATHOS-3: an international, multicenter, randomized, double-blind, placebo-controlled trial1,2

GIAPREZA was tested in adults with septic or other distributive shock who remained hypotensive despite fluid resuscitation and standard of care vasopressor therapy. GIAPREZA was tested against placebo; both were in addition to background standard of care vasopressors.1,a

ATHOS-3 Trial Design1,2

Adults with septic or other distributive shock who remained hypotensive despite fluid resuscitation and SoC vasopressor therapy were randomized to GIAPREZA or placebo1,2,a

aGIAPREZA and placebo were studied in conjunction with SoC vasopressors, including norepinephrine, epinephrine, dopamine, phenylephrine, and vasopressin.
SoC in the ATHOS-3 trial was defined as > 0.2 mcg of norepinephrine per kilogram of body weight per minute or the equivalent dose of another vasopressor.
bTreatment allowed up to Day 7. Day 28 (+/- 2 days) follow-up determined safety events that occurred between Day 7 and Day 28.

Baseline Characteristics

ATHOS-3: key baseline characteristics1

GIAPREZA was tested in adults with septic or other distributive shock who remained hypotensive despite fluid resuscitation and standard of care vasopressor therapy. GIAPREZA was tested against placebo; both were in addition to background standard of care vasopressors.1,a

Patient demographics:

Median age was 64 years (range: 22-89 years)1

  • 91% of trial participants had septic shock, while the remaining participants had other forms of distributive shock1
    • Patients with cardiogenic shock were excluded1
  • Over two-thirds of patients were enrolled in North American study centers1

Baseline vasopressor treatment details:

  • 83% of subjects had received 2 or more vasopressors prior to study drug administration1
  • 97% of patients were receiving norepinephrine and 67% were receiving vasopressin at the time of study drug administration1
Baseline vasopressor dose in patients in ATHOS-3 (n=321)2

aVasopressor doses are norepinephrine-equivalent doses.2

Rapid Response

Every minute matters and GIAPREZA rapidly increases MAP1

Rapid response: the median response time for GIAPREZA responders was approximately 5 minutes1,a

  • Monitor blood pressure closely after GIAPREZA initiation1

Short half-life: the plasma half-life of IV-administered GIAPREZA is less than 1 minute, which allows for individualized dose adjustment1

  • Titrate GIAPREZA to effect in each patient1
    • – Titrate every 5 minutes by increments of up to 15 ng/kg/min

aResponse was defined as achievement of target MAP ≥75 mmHg or increase of ≥10 mmHg from baseline without an increase in baseline vasopressor therapy.1

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. GIAPREZA™ (angiotensin II) [prescribing information]. San Diego, CA: La Jolla Pharmaceutical Company; 2017. 2. Khanna et al. N Engl J Med 2017;377(5):419-430.

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