Country: United States
Language: English
Source: NLM (National Library of Medicine)
INSULIN GLARGINE (UNII: 2ZM8CX04RZ) (INSULIN GLARGINE - UNII:2ZM8CX04RZ), LIXISENATIDE (UNII: 74O62BB01U) (LIXISENATIDE - UNII:74O62BB01U)
sanofi-aventis U.S. LLC
insulin glargine
insulin glargine 100 U in 1 mL
SUBCUTANEOUS
PRESCRIPTION DRUG
SOLIQUA 100/33 is a combination of insulin glargine and lixisenatide and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use : - SOLIQUA 100/33 has not been studied in patients with a history of pancreatitis [see Warnings and Precautions (5.2)] . Consider other antidiabetic therapies in patients with a history of pancreatitis. - SOLIQUA 100/33 is not recommended for use in combination with any other product containing a GLP-1 receptor agonist [see Warnings and Precautions (5.5)] . - SOLIQUA 100/33 is not indicated for use in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. - SOLIQUA 100/33 has not been studied in patients with gastroparesis and is not recommended in patients with gastroparesis. - SOLIQUA 100/33 has not been studied in combination with prandial insulin. SOLIQUA 100/33 is contraindicated: - During episodes of hypoglycemia [see Warnings and Precautions (5.6)] . - In patients w
SOLIQUA 100/33 (insulin glargine and lixisenatide) injection is a clear, colorless to almost colorless solution in a 3 mL prefilled, disposable, single-patient-use pen: Needles are not included. Only use needles that are compatible for use with SOLIQUA 100/33 prefilled pen. Dispense in the original sealed carton with the enclosed Instructions for Use. Prior to first use, SOLIQUA 100/33 pen should be stored in a refrigerator, 36°F–46°F (2°C–8°C). Do not freeze. Discard SOLIQUA 100/33 if it has been frozen. Protect from light. After first use, store at room temperature up to 77°F (25°C). Replace the pen cap after each use to protect from light. Discard pen 28 days after first use. Remove the needle after each injection and store the SOLIQUA 100/33 pen without a needle attached.
Biologic Licensing Application
sanofi-aventis U.S. LLC ---------- This Medication Guide has been approved by the U.S. Food and Drug Administration. Revised: September 2023 Medication Guide SOLIQUA® 100/33 (So - lee - kwa) (insulin glargine and lixisenatide) injection, for subcutaneous use What is the most important information I should know about SOLIQUA 100/33? Do not share your SOLIQUA 100/33 pen with other people, even if the needle has been changed. You may give other people a serious infection or get a serious infection from them. SOLIQUA 100/33 can cause serious side effects including inflammation of the pancreas (pancreatitis), which may be severe and lead to death. Before using SOLIQUA 100/33, tell your healthcare provider if you have had: • pancreatitis • stones in your gallbladder (cholelithiasis) • a history of alcoholism These medical problems may make you more likely to get pancreatitis. Stop taking SOLIQUA 100/33 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. What is SOLIQUA 100/33? SOLIQUA 100/33 is an injectable prescription medicine that contains 2 diabetes medicines, insulin glargine and lixisenatide, which may improve blood sugar (glucose) control in adults with type 2 diabetes when used with diet and exercise. • SOLIQUA 100/33 has not been studied in people with a history of pancreatitis. • SOLIQUA 100/33 is not recommended for people who also take lixisenatide or other medicines called GLP-1 receptor agonists. • SOLIQUA 100/33 is not for use in people with type 1 diabetes or people with diabetic ketoacidosis. • SOLIQUA 100/33 has not been studied in people who have a stomach problem that causes slow emptying of the stomach (gastroparesis). SOLIQUA 100/33 is not for people with slow emptying of the stomach. • SOLIQUA 100/33 has not been studied in people who also take a short- Read the complete document
SOLIQUA 100/33- INSULIN GLARGINE AND LIXISENATIDE INJECTION, SOLUTION SANOFI-AVENTIS U.S. LLC ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE SOLIQUA 100/33 SAFELY AND EFFECTIVELY_ ._ SEE FULL PRESCRIBING INFORMATION FOR SOLIQUA 100/33. SOLIQUA 100/33 (INSULIN GLARGINE AND LIXISENATIDE) INJECTION, FOR SUBCUTANEOUS USE INITIAL U.S. APPROVAL: 2016 INDICATIONS AND USAGE SOLIQUA 100/33 is a combination of insulin glargine, an insulin analog, and lixisenatide, a glucagon-like peptide-1 (GLP-1) receptor agonist, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1) Limitations of Use (1): Has not been studied in patients with a history of pancreatitis. Consider other antidiabetic therapies in patients with a history of pancreatitis. Not recommended for use in combination with any other product containing a GLP-1 receptor agonist. Not for treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Not recommended for use in patients with gastroparesis. Has not been studied in combination with prandial insulin. DOSAGE AND ADMINISTRATION Inject subcutaneously once a day within the hour prior to the first meal of the day. (2.1) SOLIQUA 100/33 pen delivers 15 units to 60 units per injection. (2.1, 2.2) Maximum daily dosage is 60 units (60 units of insulin glargine and 20 mcg of lixisenatide). (2.1) Discontinue basal insulin or GLP-1 receptor agonist prior to initiation. (2.2) In patients naive to basal insulin or to a GLP-1 receptor agonist, currently on less than 30 units of basal insulin, or on a GLP-1 receptor agonist, the recommended starting dosage is 15 units subcutaneously once daily. (2.2) In patients inadequately controlled on 30 to 60 units of basal insulin, the starting dosage is 30 units subcutaneously once daily. (2.2) See Full Prescribing Information for titration recommendations. (2.3) Inject subcutaneously in abdominal area, thigh, or upper arm and rotate injection sites with Read the complete document