Medical Editor: John P. Cunha, DO, FACOEP
- blood clots,
- low platelet count (thrombocytopenia),
- fast heart rate,
- fungal infection,
- high levels of acid on the blood (acidosis),
- high blood sugar (hyperglycemia), and
- lack of blood flow to extremities
The starting dose of Giapreza is 20 nanograms (ng)/kg/min administered intravenously. The dose is adjusted as frequently as every 5 minutes by increments of up to 15 ng/kg/min as needed. Giapreza may interact with angiotensin converting enzyme (ACE) inhibitors and angiotensin II blockers (ARBs). Tell your doctor all medications and supplements you use. Tell your doctor if you are pregnant or plan to become pregnant before using Giapreza; it is unknown if it would affect a fetus. It is unknown if Giapreza passes into breast milk. Consult your doctor before breastfeeding.
Our Giapreza (angiotensin II) Injection for Intravenous Infusion Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
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.
The safety of GIAPREZA was evaluated in ATHOS-3 [see WARNINGS AND PRECAUTIONS]. Patients in ATHOS-3 were receiving other vasopressors in addition to GIAPREZA 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 GIAPREZA and with a rate of at least 1.5% higher with GIAPREZA than with placebo.
Table 2: Adverse Reactions Occurring in ≥
4% of Patients Treated with GIAPREZA and ≥ 1.5% More Often than in
Placebo-treated Patients in ATHOS-3
|Thromboembolic eventsa||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|
Read the entire FDA prescribing information for Giapreza (Angiotensin II Injection for Infusion)