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 serious adverse reaction is also described elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions (5.1) ] The most common adverse reactions (5% or greater incidence) among patients treated with repaglinide were: hypoglycemia, upper respiratory infection, headache, sinusitis, arthralgia, nausea, diarrhea, and back pain.
(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Rising Health, LLC at 1-833-395-6928 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 designs, the adverse reaction rates reported in one clinical trial may not be easily compared to those rates reported in another clinical trial, and may not reflect the rates actually observed in clinical practice.
Repaglinide has been administered to 2931 individuals during clinical trials.
Approximately 1500 of these individuals with type 2 diabetes have been treated for at least 3 months, 1000 for at least 6 months, and 800 for at least 1 year.
The majority of these individuals (1228) received repaglinide in one of five 1-year, active-controlled trials.
Over one year, 13% of repaglinide patients were discontinued due to adverse reactions.
The most common adverse reactions leading to withdrawal were hyperglycemia, hypoglycemia, and related symptoms.
Table 1 lists the common adverse reactions for repaglinide patients compared to placebo in trials 12 to 24 weeks duration.
Table 1: Adverse Reactions (%) occurring ≥ 2% in Repaglinide Treated Patients from Pool of 12 to 24 Week Placebo Controlled Trials* *See trial descriptions in Clinical Trials (14) Repaglinide N=352 Placebo N=108 Upper Respiratory Infection Headache Sinusitis Arthralgia Nausea Diarrhea Back Pain Rhinitis Constipation Vomiting Paresthesia Chest pain Bronchitis Dyspepsia Urinary tract infection Tooth disorder Allergy 16 11 6 6 5 5 5 3 3 3 3 3 2 2 2 2 2 8 10 2 3 5 2 4 3 2 3 3 1 1 2 1 0 0 Hypoglycemia In clinical trials with repaglinide, hypoglycemia is the most commonly observed adverse reaction.
5 WARNINGS AND PRECAUTIONS Hypoglycemia : Repaglinide may cause hypoglycemia.
Skip the scheduled dose of repaglinide if a meal is skipped to reduce the risk of hypoglycemia.
Reduce the dose of repaglinide if hypoglycemia occurs.
(5.1) Serious Cardiovascular Adverse Reactions with Concomitant NPH-insulin : Repaglinide is not indicated for use in combination with NPH-insulin.
(5.2) Macrovascular outcomes : There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with repaglinide.
Like all medications, Repaglinide 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: