HIGHLIGHTS OF PRESCRIBING INFORMATION

 

These highlights do not include all the information needed to use GIAPREZA™ safely and effectively. See full prescribing information for GIAPREZA. 

 

GIAPREZA (angiotensin II) Injection for Intravenous Infusion 

Initial U.S. Approval: 2017 

 

INDICATIONS AND USAGE 

 

GIAPREZA is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. (1) 

DOSAGE AND ADMINISTRATION 

 

Dilute GIAPREZA in 0.9% sodium chloride prior to use. See Full Prescribing Information for instructions on preparation and administration of injection. Diluted solution may be stored at room temperature or under refrigeration and should be discarded after 24 hours. GIAPREZA must be administered as an intravenous infusion. (2.1) 

Start GIAPREZA intravenously at 20 nanograms (ng)/kg/min. Titrate as frequently as every 5 minutes by increments of up to 15 ng/kg/min as needed. During the first 3 hours, the maximum dose should not exceed 80 ng/kg/min. Maintenance dose should not exceed 40 ng/kg/min. (2.2)

 

DOSAGE FORMS AND STRENGTHS 

 

Injection: 2.5 mg/mL and 5mg/ mL (2.5 mg/mL) in a vial. (3)

 

CONTRAINDICATIONS 

None (4.1) (4)

 

WARNINGS AND PRECAUTIONS 

 

There is a potential for venous and arterial thrombotic and thromboembolic events in patients who receive GIAPREZA. Use concurrent venous thromboembolism (VTE) prophylaxis. (5.1, 6.1)

 

ADVERSE REACTIONS 

 

The most common adverse reactions reported in greater than 10% in GIAPREZA treated patients were thromboembolic events. (6.1) 

 

To report SUSPECTED ADVERSE REACTIONS, contact La Jolla Pharmaceutical Company at 1-800-651-3861 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 

 

DRUG INTERACTIONS 

 

Angiotensin converting enzyme (ACE) inhibitors

ACE inhibitors may increase response to GIAPREZA. (7.1)

Angiotensin II Receptor Blockers (ARB)

ARBs may reduce response to GIAPREZA. (7.2)

 

Revised: 1/2018

 

FULL PRESCRIBING INFORMATION: CONTENTS*

1. INDICATIONS AND USAGE 

 

2. DOSAGE AND ADMINISTRATION 

 

2.1. Preparation 

 

2.2. Administration 

 

3. DOSAGE FORMS AND STRENGTHS 

 

4. CONTRAINDICATIONS 

 

5. WARNINGS AND PRECAUTIONS 

 

5.1 Risk for Thrombosis 

 

6. ADVERSE REACTIONS 

 

6.1. Clinical Trials Experience 

 

7. DRUG INTERACTIONS 

 

7.1. Angiotensin Converting Enzyme (ACE) Inhibitors 

 

7.2. Angiotensin II Receptor Blockers (ARB) 

 

8. USE IN SPECIFIC POPULATIONS 

 

8.1. Pregnancy 

 

8.2. Lactation 

 

8.4. Pediatric Use 

 

8.5. Geriatric Use 

 

10. OVERDOSAGE 

 

11. DESCRIPTION 

 

12. CLINICAL PHARMACOLOGY 

 

12.1. Mechanism of Action