Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following adverse reactions are discussed elsewhere: 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 reactions, injection site reactions, lipodystrophy, pruritus, rash, edema, and weight gain.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in clinical trials of a drug cannot be directly compared to rates in the clinical trial of another drug and may not reflect the rates observed in practice.
The data in Table 1 reflect the exposure of 2327 patients with type 1 diabetes to insulin glargine or NPH in Studies A, B, C, and D [see Clinical Studies ( 14.2 )] .
The type 1 diabetes population had the following characteristics: Mean age was 39 years.
Fifty-four percent were male, 97% were Caucasian, 2% were Black or African American and 3% were Hispanic.
5 WARNINGS AND PRECAUTIONS Never share a REZVOGLAR KwikPen prefilled pen 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 dosage, concomitant drugs, meal pattern, physical activity;
and in patients with renal or hepatic impairment and hypoglycemia unawareness.
Like all medications, Rezvoglar Kwikpen can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: