Insulin glargine and Lixisenatide

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. 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. Limitations of Use: Concomitant use in combination with any other product containing a GLP-1 receptor agonist is not recommended. Not recommended for the treatment of diabetic ketoacidosis. Has not been studied in combination with prandial insulin. Limitations of Use: SOLIQUA 100/33 contains lixisenatide. Coadministration with any other product containing lixisenatide or another glucagon-like peptide-1 (GLP-1) receptor agonist is not recommended.

SOLIQUA 100/33 SOLIQUA 100/33 is a combination of insulin glargine, a basal insulin analog, and lixisenatide, a GLP-1 receptor agonist. Insulin glargine The primary activity of insulin, including insulin glargine, is regulation of glucose metabolism. Insulin and its analogs lower blood glucose by stimulating peripheral glucose uptake, especially by skeletal muscle and fat, and by inhibiting hepatic glucose production. Insulin inhibits lipolysis and proteolysis and enhances protein synthesis. Lixisenatide Lixisenatide is a GLP-1 receptor agonist that increases glucose-dependent insulin release, decreases glucagon secretion, and slows gastric emptying.

Inject subcutaneously once a day within the hour prior to the first meal of the day. SOLIQUA 100/33 pen delivers 15 units to 60 units per injection. Maximum daily dosage is 60 units (60 units of insulin glargine and 20 mcg of lixisenatide). Discontinue basal insulin or GLP-1 receptor agonist prior to initiation. 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. In patients inadequately controlled on 30 to 60 units of basal insulin, the starting dosage is 30 units subcutaneously once daily. See Full Prescribing Information for titration recommendations.

SOLIQUA 100/33 is contraindicated: During episodes of hypoglycemia. In patients with serious hypersensitivity to insulin glargine, lixisenatide, or any of the excipients in SOLIQUA 100/33. Hypersensitivity reactions including anaphylaxis have occurred with both lixisenatide and insulin glargine. During episodes of hypoglycemia. Serious hypersensitivity to insulin glargine, lixisenatide, or any of the excipients in SOLIQUA 100/33

Anaphylaxis and Serious Hypersensitivity Reactions: Severe, life-threatening, and generalized allergic reactions can occur. Instruct patients to discontinue use if a reaction occurs and promptly seek medical attention. Acute Pancreatitis: Has been observed in patients treated with GLP-1 receptor agonists, including SOLIQUA 100/33. Discontinue if pancreatitis is suspected. Never share a SOLIQUA 100/33 prefilled pen between patients, even if the needle is changed. Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen: Make changes to a patient's insulin regimen (e.g., insulin strength, manufacturer, type, injection site or method of administration) under close medical supervision with increased frequency of blood glucose monitoring. Overdose Due to Medication Errors: SOLIQUA 100/33 contains two drugs.

The following adverse reactions are discussed elsewhere: Anaphylaxis and Serious Hypersensitivity Reactions Acute Pancreatitis Hypoglycemia Acute Kidney Injury Due to Volume Depletion Severe Gastrointestinal Adverse Reactions Hypokalemia Acute Gallbladder Disease Pulmonary Aspiration During General Anesthesia or Deep Sedation The most common adverse reactions, reported in ≥5% of patients treated with SOLIQUA 100/33 include hypoglycemia, nausea, nasopharyngitis, diarrhea, upper respiratory tract infection, and headache.

Drugs that affect glucose metabolism: Adjustment of SOLIQUA 100/33 dosage may be needed, closely monitor blood glucose. Antiadrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Hypoglycemia signs and symptoms may be reduced. Effects of delayed gastric emptying on oral medications: Lixisenatide delays gastric emptying which may impact absorption of concomitantly administered oral medications. Oral contraceptives and other medications such as antibiotics and acetaminophen should be taken at least 1 hour prior to SOLIQUA 100/33 administration or 11 hours after.

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. After first use, store at room temperature up to 77°F (25°C). Protect from light. Replace the pen cap after each use to protect from light. Remove the needle after each injection and store the SOLIQUA 100/33 pen without a needle attached.