Vabrinty 22.5 mg/.375mL
Leuprolide acetate · INJECTION, SUSPENSION, EXTENDED RELEASE · URONOVA PHARMACEUTICALS, INC.
Vabrinty is a injection, suspension, extended release containing leuprolide acetate at 22.5 mg/.375mL, taken subcutaneous. Manufactured by URONOVA PHARMACEUTICALS, INC..
Key Facts
- Brand Name
- Vabrinty
- Generic Name
- Leuprolide acetate
- NDC Code (Product)
85043-025- Manufacturer
- URONOVA PHARMACEUTICALS, INC.
- Strength
- 22.5 mg/.375mL
- Dosage Form
- INJECTION, SUSPENSION, EXTENDED RELEASE
- Route
- SUBCUTANEOUS
- Marketing Status
- Application #
- NDA021379
- Marketing Start
- 08/04/2025
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 VABRINTY is indicated for the treatment of advanced prostate cancer. VABRINTY is a gonadotropin releasing hormone (GnRH) agonist indicated for the treatment of advanced prostate cancer. ( 1 )
Dosage & Administration
2 DOSAGE AND ADMINISTRATION VABRINTY is administered subcutaneously based on the following recommended dose and schedule: 7.5 mg subcutaneously every month ( 2.1 ) 22.5 mg subcutaneously every 3 months ( 2.1 ) 30 mg subcutaneously every 4 months ( 2.1 ) 45 mg subcutaneously every 6 months ( 2.1 ) See Full Prescribing Information for preparation and administration instructions. ( 2.2 , 2.3 ) 2.1 Recommended Dosage VABRINTY is administered subcutaneously and provides continuous release of leuprolide acetate over a one-, three-, four-, or six-month treatment period (Table 1). VABRINTY must be administered by a healthcare provider. The injection delivers the dose of leuprolide acetate incorporated in a polymer formulation. Table 1. VABRINTY Recommended Dosing Dosage 7.5 mg 22.5 mg 30 mg 45 mg Recommended dose 1 injection every month 1 injection every 3 months 1 injection every 4 months 1 injection every 6 months As with other drugs administered by subcutaneous injection, the injection site should vary periodically. The specific injection location should be an area with sufficient soft or loose subcutaneous tissue. In clinical trials, the injections were administered in the upper- or mi…
Contraindications
4 CONTRAINDICATIONS Hypersensitivity VABRINTY is contraindicated in patients with hypersensitivity to GnRH, GnRH agonist analogs or any of the components of VABRINTY. Anaphylactic reactions to synthetic GnRH or GnRH agonist analogs have been reported in the literature. Known hypersensitivity to GnRH, GnRH agonist analogs or any of the components of VABRINTY ( 4 )
Adverse Reactions
6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in the labeling: Tumor Flare [see Warnings and Precautions ( 5.1 )] Hyperglycemia and Diabetes [see Warnings and Precautions ( 5.2 )] Cardiovascular Disease [see Warnings and Precautions ( 5.3 )] Effect on QT/QTc Interval [see Warnings and Precautions ( 5.4 )] Convulsions [see Warnings and Precautions ( 5.5 )] Severe Cutaneous Adverse Reactions [see Warnings and Precautions ( 5. 6 )] Most common adverse reactions in clinical studies (incidence ≥ 5%): Malaise, fatigue, hot flashes/sweats, and testicular atrophy. ( 6.1 ) As with other GnRH agonists, other adverse reactions, including decreased bone density and rare cases of pituitary apoplexy have been reported. ( 6.1 , 6.2 ) To report SUSPECTED ADVERSE REACTIONS, contact Uronova Pharmaceuticals, Inc. at 877-712-4575 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial 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 obs…
Frequently Asked Questions
What is Vabrinty used for?
Vabrinty contains Leuprolide acetate. It is a injection, suspension, extended release taken subcutaneous. Consult your doctor for specific uses.
Is Vabrinty a controlled substance?
Vabrinty is not classified as a controlled substance by the DEA.
What is the generic name for Vabrinty?
The generic name for Vabrinty is Leuprolide acetate. There are 9 other brand versions of Leuprolide acetate.
What is the NDC code for Vabrinty 22.5 mg/.375mL?
The NDC (National Drug Code) for Vabrinty 22.5 mg/.375mL is 85043-025, listed by URONOVA PHARMACEUTICALS, INC..