LANGLARA (insulin glargine-aldy) · SUNSHINE LAKE PHARMA CO LTD

AbsorptionAfter subcutaneous injection of insulin glargine in healthy subjects and in patients with diabetes, the insulin serum concentrations indicated a slower, more prolonged absorption and a relatively constant concentration/time profile over 24 hours with no pronounced peak in comparison to NPH insulin.

EliminationMetabolism A metabolism study in humans indicates that insulin glargine is partly metabolized at the carboxyl terminus of the B chain in the subcutaneous depot to form two activ...

14.1 Overview of Clinical Studies The safety and effectiveness of insulin glargine given once-daily at bedtime was compared to that of once-daily and twice-daily NPH insulin in open-label, randomized, active-controlled, parallel studies of 2,327 adult patients and 349 pediatric patients with type 1 diabetes mellitus and 1,563 adult patients with type 2 diabetes mellitus (see Tables 9 – 11 ). In general, the reduction in glycated hemoglobin (HbA1c) with insulin glargine was similar to that with NPH insulin. 14.2 Clinical Studies in Adult and Pediatric Patients with Type 1 Diabetes Adult Patient...

The following adverse reactions are discussed elsewhere: Hyperglycemia or Hypoglycemia with Changes in Insulin Regimen [see Warnings and Precautions (5.2) ] Hypoglycemia [see Warnings and Precautions (5.3) ] Hypoglycemia Due to Medication Errors [see Warnings and Precautions (5.4) ] Hypersensitivity Reactions [see Warnings and Precautions (5.5) ] Hypokalemia [see Warnings and Precautions (5.6) ] Adverse reactions commonly associated with insulin glargine products include hypoglycemia, allergic r...

LANGLARA is contraindicated: During episodes of hypoglycemia [see Warnings and Precautions (5.3) ] In patients with hypersensitivity to any insulin glargine product or any of the inactive ingredients of LANGLARA [see Warnings and Precautions (5.5) ] During episodes of hypoglycemia ( 4 ) Hypersensitivity to any insulin glargine product or any of the inactive ingredients of LANGLARA ( 4 )

Never share a LANGLARA prefilled pen or needle between patients, even if the needle is changed. ( 5.1 ) 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. ( 5.2 ) Hypoglycemia : May be life-threatening. Increase frequency of glucose monitoring with changes to: insulin...

7 DRUG INTERACTIONS Table 8 includes clinically significant drug interactions with LANGLARA.

Table 8Clinically Significant Drug Interactions with LANGLARA Drugs that May Increase the Risk of Hypoglycemia Drugs : Antidiabetic agents, ACE inhibitors, angiotensin II receptor blocking agents, disopyramide, fibrates, fluoxetine, monoamine oxidase inhibitors, pentoxifylline, pramlintide, salicylates, ...