BRYNOVIN 25 mg/mL
Sitagliptin Hydrochloride Oral · SOLUTION · Azurity Pharmaceuticals, Inc.
BRYNOVIN is a solution containing sitagliptin hydrochloride oral at 25 mg/mL, taken oral. Manufactured by Azurity Pharmaceuticals, Inc..
Key Facts
- Brand Name
- BRYNOVIN
- Generic Name
- Sitagliptin Hydrochloride Oral
- NDC Code (Product)
24338-017- Manufacturer
- Azurity Pharmaceuticals, Inc.
- Strength
- 25 mg/mL
- Dosage Form
- SOLUTION
- Route
- ORAL
- Marketing Status
- Application #
- NDA219122
- Drug Class
- Dipeptidyl Peptidase 4 Inhibitor [EPC]
- Marketing Start
- 04/01/2025
Recall History
No Recall HistoryFull Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE BRYNOVIN is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use BRYNOVIN is not recommended in patients with type 1 diabetes. BRYNOVIN has not been studied in patients with a history of pancreatitis. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using BRYNOVIN. [see Warnings and Precautions ( 5.1 )] . BRYNOVIN is a dipeptidyl peptidase-4 (DPP-4) inhibitor indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. ( 1 ) Limitations of Use: • BRYNOVIN is not recommended in patients with type 1 diabetes. ( 1 ) • BRYNOVIN has not been studied in patients with a history of pancreatitis. ( 1 )
Dosage & Administration
2 DOSAGE & ADMINISTRATION The recommended dose of BRYNOVIN is 100 mg orally once daily (4 mL). BRYNOVIN can be taken with or without food. ( 2.1 ) Dosage adjustment is recommended for patients with eGFR less than 45 mL/min/1.73 m 2 . ( 2.2 ) Dosage Adjustment in Patients with Renal Impairment ( 2.2 ) eGFR greater than or equal to 30 mL/min/1.73 m 2 to less than 45 mL/min/1.73 m 2 eGFR less than 30 mL/min/1.73 m 2 (including patients with end stage renal disease [ESRD] on dialysis) 50 mg once daily (2 mL) 25 mg once daily (1 mL) 2.1 Recommended Dosage and Administration Measure the BRYNOVIN dose using a calibrated oral syringe or oral dosing cup scored using metric units of measurements (i.e., mL). The recommended dosage of BRYNOVIN is 100 mg (4 mL) taken orally once daily. BRYNOVIN can be taken with or without food [see Clinical Pharmacology ( 12.3 )] . 2.2 Recommendations for Use in Renal Impairment Assess renal function prior to initiation of BRYNOVIN and periodically thereafter [see Use in Specific Populations ( 8.6 )] . For patients with an estimated glomerular filtration rate (eGFR) greater than or equal to 45 mL/min/1.73 m 2 to less than 90 mL/min/1.73 m 2 , no dosage adjustm…
Contraindications
4 CONTRAINDICATIONS BRYNOVIN is contraindicated in patients with a history of a serious hypersensitivity reaction to sitagliptin or any of the excipients in BRYNOVIN. Serious hypersensitivity reactions, including anaphylaxis and angioedema have been reported [see Warnings and Precautions ( 5.5 ) and Adverse Reactions ( 6.2 )]. History of a serious hypersensitivity reaction to sitagliptin or any of the excipients in BRYNOVIN, such as anaphylaxis or angioedema. ( 4 )
Drug Interactions
7 DRUG INTERACTIONS 7.1 Concomitant Use with Insulin or Insulin Secretagogues BRYNOVIN lowers blood glucose in patients with type 2 diabetes mellitus. Coadministration of BRYNOVIN with insulin or an insulin secretagogue (e.g., sulfonylurea) or insulin may require lower dosages of the insulin secretagogue or insulin to reduce the risk of hypoglycemia. [See Warnings and Precautions ( 5.4 )].
Adverse Reactions
6 ADVERSE REACTIONS The following adverse reactions are also discussed elsewhere in the labeling: • Pancreatitis [ see Warnings and Precautions ( 5.1 ) ] • Heart Failure [ see Warnings and Precautions ( 5.2 ) ] • Acute Renal Failure [ see Warnings and Precautions ( 5.3 ) ] • Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues [ see Warnings and Precautions ( 5.4 ) ] • Hypersensitivity Reactions [ see Warnings and Precautions ( 5.5 ) ] • Severe and Disabling Arthralgia [ see Warnings and Precautions ( 5.6 ) ] • Bullous Pemphigoid [ see Warnings and Precautions ( 5.7 ) ] Most common adverse reactions (incidence ≥5%) are: upper respiratory tract infection, nasopharyngitis and headache. In the add-on to sulfonylurea and add-on to insulin trials, hypoglycemia was also more commonly reported in patients treated with sitagliptin compared to placebo. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Azurity Pharmaceuticals, Inc., at 1-800-461-7449 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 cann…
Frequently Asked Questions
What is BRYNOVIN used for?
BRYNOVIN contains Sitagliptin Hydrochloride Oral. It is a solution taken oral. Consult your doctor for specific uses.
Is BRYNOVIN a controlled substance?
BRYNOVIN is not classified as a controlled substance by the DEA.
What is the generic name for BRYNOVIN?
The generic name for BRYNOVIN is Sitagliptin Hydrochloride Oral. There are no other listed brand versions of Sitagliptin Hydrochloride Oral.
What is the NDC code for BRYNOVIN 25 mg/mL?
The NDC (National Drug Code) for BRYNOVIN 25 mg/mL is 24338-017, listed by Azurity Pharmaceuticals, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)