"Boehringer Ingelheim and Eli Lilly have filed a supplemental new drug application (sNDA) with the US Food and Drug Administration (FDA) based on cardiovascular risk reduction data from the landmark EMPA-REG OUTCOME trial for their SGLT2 inhibitor"...
All glinides, including STARLIX, can cause hypoglycemia [see ADVERSE REACTIONS]. Severe hypoglycemia can cause seizures, may be life-threatening, or cause death. Hypoglycemia can impair concentration ability and reaction time; this may place an individual and others at risk in situations where these abilities are important (e.g., driving or operating other machinery).
Hypoglycemia can happen suddenly and symptoms may differ in each individual and change over time in the same individual. Symptomatic awareness of hypoglycemia may be less pronounced in patients with longstanding diabetes, in patients with diabetic neuropathy (nerve disease), in patients using medications that block the sympathetic nervous system (e.g., beta-blockers) [see DRUG INTERACTIONS], or in patients who experience recurrent hypoglycemia.
Factors which may increase the risk of hypoglycemia include changes in meal pattern (e.g., macronutrient content), changes in level of physical activity, changes to coadministered medication [see DRUG INTERACTIONS], and concomitant use with other antidiabetic agents. Patients with renal or hepatic impairment may be at higher risk of hypoglycemia [see Use In Specific Populations].
Patients should take STARLIX before meals and be instructed to skip the dose of STARLIX if a meal is skipped [see DOSAGE AND ADMINISTRATION]. Patients and caregivers must be educated to recognize and manage hypoglycemia. Self-monitoring of blood glucose plays an essential role in the prevention and management of hypoglycemia. In patients at higher risk for hypoglycemia and patients who have reduced symptomatic awareness of hypoglycemia, increased frequency of blood glucose monitoring is recommended.
There have been no clinical studies establishing conclusive evidence of macrovascular risk reduction with STARLIX.
Carcinogenesis, Mutagenesis, Impairment Of Fertility
Nateglinide did not increase tumors in two year carcinogenicity studies conducted in mice and rats. Oral doses of Nateglinide up to 900 mg/kg in rats and 400 mg/kg in mice were tested, which produced exposures in rats approximately 30-40 times and in mice 10-30 times the human therapeutic exposure of nateglinide at a dose of 120 mg three times daily, based on AUC.
Impairment Of Fertility
Fertility was unaffected by administration of nateglinide to rats at doses up to 600 mg/kg (approximately 16 times the human therapeutic exposure with a recommended STARLIX dose of 120 mg three times daily before meals).
Use In Specific Populations
Pregnancy Category C
There are no adequate and well-controlled studies of nateglinide in pregnant women. It is unknown whether STARLIX can cause fetal harm when administered to a pregnant woman. STARLIX should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
In the rabbit, embryonic development was adversely affected and the incidence of gall bladder agenesis or small gallbladder was increased at a dose of 500 mg/kg (approximately 27 times the human therapeutic exposure of 120 mg three times daily, based on body surface area). Nateglinide was not teratogenic in rats at doses up to 1,000 mg/kg (approximately 27 times the human therapeutic exposure based on body surface area).
It is not known whether nateglinide is excreted in human milk. Nateglinide is excreted in rat milk. Offspring of rats exposed to 1,000 mg/kg nateglinide (approximately 27 times the human therapeutic exposure of 120 mg three times daily, based on body surface area) had lower body weight. Because the potential for hypoglycemia in nursing infants may exist, a decision should be made as to whether STARLIX should be discontinued in nursing mothers, or if mothers should discontinue nursing.
The safety and effectiveness of STARLIX have not been established in pediatric patients.
436 patients 65 years and older, and 80 patients 75 years and older were exposed to STARLIX in clinical studies. No differences were observed in safety or efficacy of STARLIX between patients age 65 and over, and those under age 65. However, greater sensitivity of some older individuals to STARLIX therapy cannot be ruled out.
No dosage adjustment is recommended in patients with mild to severe renal impairment [see CLINICAL PHARMACOLOGY].
No dose adjustment is recommended for patients with mild hepatic impairment. Use of STARLIX in patients with moderate-to-severe hepatic impairment has not been studied and therefore, should be used with caution in these patients [see CLINICAL PHARMACOLOGY].This monograph has been modified to include the generic and brand name in many instances.
Last reviewed on RxList: 4/11/2017
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