Giapreza 2.5 mg/mL
angiotensin II · INJECTION · La Jolla Pharmaceutical Company
Giapreza is a injection containing angiotensin ii at 2.5 mg/mL, taken intravenous. Manufactured by La Jolla Pharmaceutical Company.
Key Facts
- Brand Name
- Giapreza
- Generic Name
- angiotensin II
- NDC Code (Product)
68547-501- Manufacturer
- La Jolla Pharmaceutical Company
- Strength
- 2.5 mg/mL
- Dosage Form
- INJECTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- NDA209360
- Drug Class
- Vasoconstrictor [EPC]
- Marketing Start
- 02/05/2018
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1. INDICATIONS AND USAGE GIAPREZA increases blood pressure in adults with septic or other distributive shock [see Clinical Studies (14)] . GIAPREZA is a vasoconstrictor to increase blood pressure in adults with septic or other distributive shock. ( 1 )
Dosage & Administration
2. 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. Doses as low as 1.25 ng/kg/min may be used.( 2.2 ) 2.1. Preparation Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. GIAPREZA must be administered as an intravenous infusion. GIAPREZA must be diluted in 0.9% sodium chloride prior to use. Dilute the appropriate amount of GIAPREZA in a normal saline (0.9% sodium chloride) infusion bag to achieve the desired final concentration of 5,000 ng/mL or 10,000 ng/mL. Discard vial and any unused portion of the drug …
Contraindications
4. CONTRAINDICATIONS None. None (4.1)
Drug Interactions
7. 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 ) 7.1. Angiotensin Converting Enzyme (ACE) Inhibitors Concomitant use of angiotensin converting enzyme (ACE) inhibitors may increase the response to GIAPREZA. 7.2. Angiotensin II Receptor Blockers (ARB) Concomitant use of angiotensin II receptor blockers (ARBs) may decrease the response to GIAPREZA.
Adverse Reactions
6. ADVERSE REACTIONS The most common adverse reactions reported in greater than 10% of 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 . 6.1. 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. ATHOS-3 The safety of GIAPREZA was evaluated in ATHOS-3 [see Warnings and Precautions(5.1) ] . 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 1 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 1: Adverse Reactions Occurring in ≥ 4% of Patients Treated with GIAPREZA and ≥ 1.5% More Often than in Placebo-treated Patients in ATHOS-3 Adverse Event GIAPREZA N=163 Place…
Frequently Asked Questions
What is Giapreza used for?
Giapreza contains angiotensin II. It is a injection taken intravenous. Consult your doctor for specific uses.
Is Giapreza a controlled substance?
Giapreza is not classified as a controlled substance by the DEA.
What is the generic name for Giapreza?
The generic name for Giapreza is angiotensin II. There are 1 other brand versions of angiotensin II.
What is the NDC code for Giapreza 2.5 mg/mL?
The NDC (National Drug Code) for Giapreza 2.5 mg/mL is 68547-501, listed by La Jolla Pharmaceutical Company.