BRYNOVIN - sitagliptin hydrochloride oral solution
Azurity Pharmaceuticals, Inc.
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Medication Guide BRYNOVINTM (bri-know-vin) (sitagliptin) oral solution |
| What is the most important information I should know about BRYNOVIN? BRYNOVIN can cause serious side effects, including: • Inflammation of the pancreas (pancreatitis) which may be severe and lead to death. Certain medical problems make you more likely to get pancreatitis. Before you start taking BRYNOVIN, tell your healthcare provider if you have ever had: • Pancreatitis • stones in your gallbladder (gallstones) • a history of alcoholism • high blood triglyceride levels • kidney problems Stop taking BRYNOVIN and call your healthcare provider right away if you have pain in your stomach area (abdomen) that is severe and will not go away. The pain may be felt going from your abdomen through to your back. The pain may happen with or without vomiting. These may be symptoms of pancreatitis. • Heart failure. Heart failure means your heart does not pump blood well enough. Before you start taking BRYNOVIN, tell your healthcare provider if you have ever had heart failure or have problems with your kidneys. Contact your healthcare provider right away if you have any of the following symptoms:• increasing shortness of breath or trouble breathing, especially when you lie down • swelling or fluid retention, especially in the feet, ankles or legs • an unusually fast increase in weight • unusual tiredness These may be symptoms of heart failure. |
| What is BRYNOVIN? • BRYNOVIN is a prescription medicine used along with diet and exercise to lower blood sugar in adults with type 2 diabetes. • BRYNOVIN is not for people with type 1 diabetes. • If you have had pancreatitis (inflammation of the pancreas) in the past, it is not known if you have a higher chance of getting pancreatitis while you take BRYNOVIN. • It is not known if BRYNOVIN is safe and effective in children. |
| Who should not take BRYNOVIN? Do not take BRYNOVIN if: • you are allergic to sitagliptin or any of the ingredients in BRYNOVIN. See the end of this Medication Guide for a complete list of ingredients in BRYNOVIN. Symptoms of a serious allergic reaction to BRYNOVIN may include rash, raised red patches on your skin (hives), or swelling of the face, lips, tongue, and throat that may cause difficulty in breathing or swallowing. |
| What should I tell my healthcare provider before taking BRYNOVIN? Before you take BRYNOVIN, tell your healthcare provider about all of your medical conditions, including if you: • have or have had inflammation of your pancreas (pancreatitis). • have kidney problems. • have heart failure. • are pregnant or plan to become pregnant. It is not known if BRYNOVIN will harm your unborn baby. If you are pregnant, talk with your healthcare provider about the best way to control your blood sugar while you are pregnant. • are breastfeeding or plan to breastfeed. It is not known if BRYNOVIN will pass into your breast milk. Talk with your healthcare provider about the best way to feed your baby if you are taking BRYNOVIN. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of your medicines and show it to your healthcare provider and pharmacist when you get a new medicine. |
| How should I take BRYNOVIN?
• Use an oral dosing syringe or oral dosing cup to correctly measure your dose of BRYNOVIN. Ask your pharmacist for an oral dosing syringe or oral dosing cup if you do not have one. • Take BRYNOVIN 1 time each day exactly as your healthcare provider tells you. • You can take BRYNOVIN with or without food. • Your healthcare provider will do blood tests to check how well your kidneys are working before and during your treatment with BRYNOVIN. • Your healthcare provider may tell you to take BRYNOVIN along with other diabetes medicines. Low blood sugar can happen more often when BRYNOVIN is taken with certain other diabetes medicines. See “What are the possible side effects of BRYNOVIN?”. • If you take too much BRYNOVIN, call your healthcare provider or the Poison Help line at 1-800-222-1222 or go to the nearest hospital emergency room right away. |
| What are the possible side effects of BRYNOVIN?
BRYNOVIN can cause serious side effects, including: • See "What is the most important information I should know about BRYNOVIN?” • Kidney problems, sometimes requiring dialysis. • Low blood sugar (hypoglycemia). If you take BRYNOVIN with another medicine that can cause low blood sugar, such as a sulfonylurea or insulin, your risk of getting low blood sugar is higher. The dose of your sulfonylurea medicine or insulin may need to be lowered while you use BRYNOVIN. Signs and symptoms of low blood sugar may include: • headache • irritability • dizziness • sweating • weakness • drowsiness • hunger • confusion • feeling jittery • fast heartbeat • Serious allergic reactions. If you have any symptoms of a serious allergic reaction, stop taking BRYNOVIN and call your healthcare provider right away or get emergency medical help. See “Who should not take BRYNOVIN?”. Your healthcare provider may give you a medicine for your allergic reaction and prescribe a different medicine for your diabetes. • Joint pain. Some people who take BRYNOVIN, may develop joint pain that can be severe. Call your healthcare provider if you have severe joint pain.• Skin reaction. Some people who take BRYNOVIN may develop a skin reaction called bullous pemphigoid that can require treatment in a hospital. Tell your healthcare provider right away if you develop blisters or the breakdown of the outer layer of your skin (erosion). Your healthcare provider may tell you to stop taking BRYNOVIN. The most common side effects of BRYNOVIN include upper respiratory infection, stuffy or runny nose and sore throat, and headache. These are not all the possible side effects of BRYNOVIN. For more information, ask your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or does not go away. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Azurity Pharmaceuticals, Inc., at 1-800-461-7449 or www.fda.gov/medwatch. |
| How should I store BRYNOVIN? • Store BRYNOVIN in the refrigerator, between 36°F to 46°F (2°C to 8°C). • Protect BRYNOVIN from light. • Avoid excessive heat. • Avoid freezing BRYNOVIN. • Throw away BRYNOVIN if not used within 90 days after you first open the bottle. Keep BRYNOVIN and all medicines out of the reach of children. |
| General information about the safe and effective use of BRYNOVIN. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use BRYNOVIN for a condition for which it was not prescribed. Do not give BRYNOVIN to other people, even if they have the same symptoms you have. It may harm them. This Medication Guide summarizes the most important information about BRYNOVIN. If you would like to know more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about BRYNOVIN that is written for health professionals. |
| What are the ingredients in BRYNOVIN? Active ingredient: sitagliptin Inactive ingredients: butylated hydroxyanisole, citric acid anhydrous, edetate disodium, hydroxyethyl cellulose, methylparaben sodium, polysorbate 80, purified water, sodium citrate dihydrate, and sweetener/flavoring agent. |
| Manufactured for: Azurity Pharmaceuticals, Inc. Woburn, MA 01801 BRYNOVIN is a registered trademark of Azurity Pharmaceuticals, Inc. For patent information: https://azurity.com/patents. This medication guide may have been updated. For current medication guide, please visit www.BRYNOVIN.com |
This Medication Guide has been approved by the U.S. Food and Drug Administration. Issued: 01/2025