brynovin
Pharmaranks rates Brynovin 3.5/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Brynovin (Sitagliptin Hydrochloride) is a dipeptidyl peptidase 4 inhibitor used to treat Type 2 Diabetes Mellitus.
Sitagliptin Hydrochloride · by Azurity
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Sitagliptin Hydrochloride
- Drug class
- Dipeptidyl Peptidase 4 Inhibitor
- Form
- Solution
- Strength
- Sitagliptin Hydrochloride EQ 25MG BASE/ML
- Type
- Prescription (Rx)
- Brand or generic
- Brand-name
- May treat
- type 2 diabetes mellitus
- Manufacturer
- Azurity
- Half-life
- about 12.4 hours (apparent terminal half-life after a single 100 mg oral dose in healthy volunteers) (how long it stays in your system)
- What the pharmacy pays
- ~$110.51 for 30 — not your price
- FDA application
- NDA219122
What is Brynovin?
From the FDA label:BRYNOVIN (sitagliptin) oral solution contains sitagliptin hydrochloride (HCl), an orally-active inhibitor of the DPP-4 enzyme. Sitagliptin HCl is described chemically as ((3R)-3-Amino-1-(3-(trifluoromethy1)-5,6-dihydro-[1,2,4]triazolo[4,3-a]pyrazin-7(8H)-y1)-4-(2,4,5-trifluorophenyl)butan-l-one HCl monohydrate. The empirical formula is C 16 H 15 F 6 N 5 O•HCl.H 2 O and the molecular weight is 461.79. The structural formula is: Sitagliptin HCl is a white to off-white, crystalline, non-hygroscopic powder. It is soluble in water; very slightly soluble in ethanol; and practically insoluble in n-Heptane. BRYNOVIN oral solution is a clear, colorless to nearly colorless oral solution. Each mL contains 27.24 mg of sitagliptin HCl, equivalent to 25 mg of sitagliptin. BRYNOVIN contains the following inactive ingredients: butylated hydroxyanisole, citric acid anhydrous, edetate disodium, hydroxyethyl cellulose, methylparaben sodium, polysorbate 80, purified water, sodium citrate dihydrate, and sweetener/flavoring agent. Structure
How to use
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 adjustment for BRYNOVIN is required. For patients with moderate renal impairment (eGFR greater than or equal to 30 mL/min/1.73 m 2 to less than 45 mL/min/1.73 m 2 ), the dosage of BRYNOVIN is 50 mg (2 mL) once daily. For patients…
Side effects
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 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 BRYNOVIN has been established for glycemic control in patients with type 2…
Warnings
Important safety information
Pancreatitis : There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis. If pancreatitis is suspected, promptly discontinue BRYNOVIN. ( 5.1 ) • Heart failure : Heart failure has been observed with two other members of the DPP-4 inhibitor class. Consider risks and benefits of BRYNOVIN in patients who have known risk factors for heart failure. Monitor patients for signs and symptoms. ( 5.2 ) • Acute Renal Failure : Has been reported postmarketing, sometimes requiring dialysis. Assessment of renal function is recommended prior to initiating BRYNOVIN and periodically thereafter. ( 5.3 ) • Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues : Increased risk of hypoglycemia when used in combination with insulin or an insulin secretagogue. Lower dose of insulin or insulin secretagogue may be required. ( 5.4 ) • Hypersensitivity Reactions : There have been postmarketing reports of serious allergic and hypersensitivity reactions in patients treated with sitagliptin such as anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Promptly stop BRYNOVIN, assess for other potential causes, institute appropriate monitoring and treatment. ( 5.5 ) • Severe and Disabling Arthralgia : Has been reported in patients taking DPP-4 inhibitors. Consider as a possible cause for severe joint pain and discontinue drug if appropriate. ( 5.6 ) • Bullous Pemphigoid : There have been postmarketing reports requiring hospitalization in patients taking DPP-4 inhibitors. Tell patients to report development of blisters or erosions. If bullous pemphigoid is suspected, discontinue BRYNOVIN. ( 5.7 ) 5.1 Pancreatitis There have been postmarketing reports of acute pancreatitis, including fatal and non-fatal hemorrhagic or necrotizing pancreatitis, in patients taking sitagliptin. After initiation of BRYNOVIN, patients should be observed carefully for signs and symptoms of pancreatitis. If pancreatitis is suspected, BRYNOVIN should promptly be discontinued and appropriate management should be initiated. It is unknown whether patients with a history of pancreatitis are at increased risk for the development of pancreatitis while using BRYNOVIN. 5.2 Heart Failure An association between dipeptidyl peptidase-4 (DPP-4) inhibitor treatment and heart failure has been observed in cardiovascular outcomes trials for two other members of the DPP-4 inhibitor class. These trials evaluated patients with type 2 diabetes mellitus and atherosclerotic cardiovascular disease. Consider the risks and benefits of BRYNOVIN prior to initiating treatment in patients at risk for heart failure, such as those with a prior history of heart failure and a history of renal impairment, and observe these patients for signs and symptoms of heart failure during therapy. Advise patients of the characteristic symptoms of heart failure and to immediately report such symptoms. If heart failure develops, evaluate and manage according to current standards of care and consider discontinuation of BRYNOVIN. 5.3 Acute Renal Failure There have been postmarketing reports of worsening renal function, including acute renal failure, sometimes requiring dialysis with sitagliptin. A subset of these reports involved patients with renal impairment, some of whom were prescribed inappropriate dosages of sitagliptin. A return to baseline levels of renal impairment has been observed with supportive treatment and discontinuation of potentially causative agents. Consideration can be given to cautiously reinitiating BRYNOVIN if another etiology is deemed likely to have precipitated the acute worsening of renal function. Assessment of renal function is recommended prior to initiating BRYNOVIN and periodically thereafter. A dosage adjustment is recommended in patients with moderate or severe renal impairment and in patients with ESRD requiring hemodialysis or peritoneal dialysis. [see Dosage and Administration ( 2.2 ) and Use in Specific Populations ( 8.6 )]. 5.4 Hypoglycemia with Concomitant Use with Insulin or Insulin Secretagogues When BRYNOVIN was used in combination with insulin or insulin secretagogues (e.g., sulfonylurea), medications known to cause hypoglycemia, the incidence of hypoglycemia was increased over that of placebo [see Adverse Reactions ( 6.1 )] . Therefore, a lower dosage of insulin or sulfonylurea may be required to reduce the risk of hypoglycemia when used in combination with BRYNOVIN. [see Drug Interactions ( 7.1 )] . Inform patients using these concomitant medications of the risk of hypoglycemia and educate them on the signs and symptoms of hypoglycemia. 5.5 Hypersensitivity Reactions There have been postmarketing reports of serious hypersensitivity reactions in patients treated with sitagliptin. These reactions include anaphylaxis, angioedema, and exfoliative skin conditions including Stevens-Johnson syndrome. Onset of these reactions occurred within the first 3 months after initiation of treatment with sitagliptin, with some reports occurring after the first dose. If a hypersensitivity reaction is suspected, discontinue BRYNOVIN, assess for other potential causes for the event, and institute alternative treatment for diabetes. [see Adverse Reactions ( 6.2 )] . Angioedema has also been reported with other DPP-4 inhibitors. Use caution in a patient with a history of angioedema with another DPP-4 inhibitor because it is unknown whether such patients will be predisposed to angioedema with BRYNOVIN. 5.6 Severe and Disabling Arthralgia There have been postmarketing reports of severe and disabling arthralgia in patients taking DPP-4 inhibitors. The time to onset of symptoms following initiation of drug therapy varied from one day to years. Patients experienced relief of symptoms upon discontinuation of the medication. A subset of patients experienced a recurrence of symptoms when restarting the same drug or a different DPP-4 inhibitor. Consider DPP-4 inhibitors as a possible cause for severe joint pain and discontinue the drug if appropriate. 5.7 Bullous Pemphigoid Postmarketing cases of bullous pemphigoid requiring hospitalization have been reported with DPP- 4 inhibitor use. In reported cases, patients typically recovered with topical or systemic immunosuppressive treatment and discontinuation of the DPP-4 inhibitor. Tell patients to report development of blisters or erosions while receiving BRYNOVIN. If bullous pemphigoid is suspected, BRYNOVIN should be discontinued and referral to a dermatologist should be considered for diagnosis and appropriate treatment.
Who should not take Brynovin
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 )
Overdose — what happens if you take too much
In the event of an overdose with BRYNOVIN, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. Employ the usual supportive measures dictated by the patient’s clinical status. Sitagliptin is modestly dialyzable. In clinical trials, approximately 13.5% of the dose was removed over a 3- to 4-hour hemodialysis session. Prolonged hemodialysis may be considered if clinically appropriate. It is not known if sitagliptin is dialyzable by peritoneal dialysis.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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 )].
How long does Sitagliptin Hydrochloride stay in your body?
The elimination half-life of sitagliptin hydrochloride is about 12.4 hours (apparent terminal half-life after a single 100 mg oral dose in healthy volunteers) — the time it takes the body to clear about half of it. As a rule of thumb, a medicine is mostly gone after roughly 4 to 5 half-lives, though this varies from person to person with age and kidney or liver function. This is the apparent terminal (elimination) half-life the label reports; it does not describe a separate distribution phase. Sitagliptin is not a prodrug and has no active metabolite that outlasts it — metabolism is a minor pathway (about 16% of the dose), and the label states that the six metabolites detected were at trace levels and are not expected to contribute to DPP-4 inhibition. About 79% of the drug is excreted unchanged in the urine, so the kidneys drive elimination: the label reports an approximately 2-fold higher sitagliptin AUC in moderate renal impairment (eGFR 30 to under 45 mL/min/1.73 m2) and an approximately 4-fold higher AUC in severe impairment and end-stage renal disease on hemodialysis, versus healthy controls — the label quantifies these as exposure (AUC) increases rather than restating a longer half-life. Older adults (65 to 80 years) had about 19% higher plasma concentrations than younger subjects, and the label says that once the effect of age on renal function is accounted for, age alone has no clinically meaningful impact on sitagliptin pharmacokinetics. Moderate hepatic impairment (Child-Pugh 7 to 9) raised AUC by only about 21% and Cmax by about 13%, which the label calls not clinically meaningful; there is no clinical experience in severe hepatic impairment (Child-Pugh over 9).
This is general information, not medical advice. It doesn’t tell you when a drug test would read negative (tests detect substances for different, often longer, windows) or when it’s safe to take another dose — ask your pharmacist or prescriber. Source: JANUVIA (sitagliptin) tablet, film coated — Merck Sharp & Dohme LLC, DailyMed SPL, §12.3 Pharmacokinetics.
Drug class
How this class works, per Dipeptidyl Peptidase IV (DPP IV) Inhibitors - StatPearls - NCBI Bookshelf.
May treat (source: NIH RxClass)
See how Brynovin ranks — best-rated dipeptidyl peptidase 4 inhibitor for:
Dosage forms
Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
Ways to save
Ask for the generic
Same active ingredient, far cheaper. Is there a generic? →
Request a 90-day supply
Bulk fills usually lower the per-dose price vs monthly refills.
Use copay cards
Manufacturer copay cards & patient-assistance programs — especially for brand drugs.
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Frequently asked questions
- What does Brynovin treat?
- Brynovin (Sitagliptin Hydrochloride) may be used to treat type 2 diabetes mellitus, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How does Brynovin work?
- Brynovin is a dipeptidyl peptidase 4 inhibitor. DPP-4 inhibitors block the enzyme that quickly destroys the body's own gut hormones (incretins like GLP-1). With these hormones lasting longer, the pancreas releases more insulin and less glucagon after meals, which lowers blood sugar.
- How is Brynovin rated?
- pharmaranks gives Brynovin a composite score of 3.5 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- How much does Brynovin cost?
- Nobody can tell you what you will pay — your price is set by your insurer's formulary, your deductible and the pharmacy's markup, and none of those are published. What IS published is what the pharmacy paid to acquire it: about $110.51 for 30, per the CMS NADAC survey. Treat that as the floor, not the quote — ask the pharmacist for the cash price as well as your copay, because for cheap generics the cash price often wins.
- Is there a coupon or discount for Brynovin?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Brynovin. To pay less, ask your prescriber or pharmacist whether a generic equivalent exists, check the manufacturer's copay/savings card and patient-assistance program, and compare a pharmacy discount card against your insurance copay. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Brynovin?
- Brynovin is marketed by Azurity. You can see Azurity's full profile, rating, and other products on pharmaranks.
- Is Brynovin a brand-name or generic drug?
- Brynovin is a brand-name product with the active ingredient Sitagliptin Hydrochloride.
- Is Brynovin available over the counter?
- No. Brynovin is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Brynovin come in?
- Brynovin is currently marketed as solution, per the FDA's National Drug Code Directory.
- What class of drug is Brynovin?
- Brynovin is classified as dipeptidyl peptidase 4 inhibitor, per the FDA's Established Pharmacologic Class.
- Is Brynovin FDA-registered?
- Brynovin is on record with the U.S. FDA under application number NDA219122. You can verify this on its official FDA label.
- Has Brynovin been recalled by the FDA?
- Brynovin has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Brynovin safe?
- There's no single safe-or-not verdict. pharmaranks gives Brynovin a recall-safety score of 70/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Brynovin?
- Brynovin's side effects are taken directly from its FDA label. From the label: 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 Insul… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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brynovin
70/100