For: Diabetes Type 2
Soliqua 100/33 (insulin glargine and lixisenatide) is fixed-ratio combination of the long-acting human insulin analog insulin glargine (Lantus) and the glucagon-like peptide-1 (GLP-1) receptor agonist lixisenatide (Adlyxin), indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. 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
RECENT MAJOR CHANGES
Indications and Usage (1) 02/2019
Dosage and Administration (2.1, 2.2, 2.3, 2.5) 02/2019
Dosage and Administration (2.5) 11/2019
Warnings and Precautions (5.4) 11/2019
INDICATIONS AND USAGE
SOLIQUA 100/33 is a combination of a long-acting human insulin analog with 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 within the same region from one injection to the next to reduce risk of lipodystrophy and localized cutaneous amyloidosis. (2.5)
Do not administer intravenously, intramuscularly, or by an infusion pump. (2.5)
Do not dilute or mix with any other insulin products or solutions. (2.5)
DOSAGE FORMS AND STRENGTHS
Injection: 100 units of insulin glargine per mL and 33 mcg of lixisenatide per mL in a 3 mL single-patient-use pen. (3)
CONTRAINDICATIONS
During episodes of hypoglycemia. (4)
Hypersensitivity to SOLIQUA 100/33 either of the active drug substances (insulin glargine or lixisenatide), or any of its excipients. Hypersensitivity reactions including anaphylaxis have occurred with both lixisenatide and insulin glargine. (4)
WARNINGS AND PRECAUTIONS
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. (5.1)
Pancreatitis: Discontinue promptly if pancreatitis is suspected. Do not restart if pancreatitis is confirmed. (5.2)
Never share a SOLIQUA 100/33 prefilled pen between patients, even if the needle is changed. (5.3)
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. (5.4)
Overdose due to medication errors: SOLIQUA 100/33 contains two drugs. Instruct patients to always check the label before each injection since accidental mix-ups with insulin-containing products can occur. Do not exceed the maximum dose or use with other GLP-1 receptor agonists. (5.5)
Hypoglycemia: May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin dosage, coadministered glucose lowering medications, meal pattern, physical activity; and in patients with renal or hepatic impairment and hypoglycemia unawareness. (5.6)
Acute kidney injury: Monitor renal function in patients with renal impairment and in patients with severe GI adverse reactions. Use is not recommended in patients with end-stage renal disease. (5.7)
Immunogenicity: Patients may develop antibodies to insulin glargine and lixisenatide. If there is worsening glycemic control or failure to achieve targeted glycemic control, significant injection-site reactions or allergic reactions, alternative antidiabetic therapy should be considered. (5.8)
Hypokalemia: May be life-threatening. Monitor potassium levels in patients at risk of hypokalemia and treat if indicated. (5.9)
Fluid retention and heart failure with use of thiazolidinediones (TZDs): Observe for signs and symptoms of heart failure; consider dosage reduction or discontinuation if heart failure occurs. (5.10)
Macrovascular outcomes: Clinical studies have not shown macrovascular risk reduction with SOLIQUA 100/33. (5.11)
ADVERSE REACTIONS
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. (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact sanofi-aventis at 1-800-633-1610 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Drugs that affect glucose metabolism: Adjustment of SOLIQUA 100/33 dosage may be needed; closely monitor blood glucose. (7.1)
Antiadrenergic Drugs (e.g., beta-blockers, clonidine, guanethidine, and reserpine): Hypoglycemia signs and symptoms may be reduced. (7.1)
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. (7.2)
USE IN SPECIFIC POPULATIONS
Pregnancy: SOLIQUA 100/33 should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. (8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 11/2019
