Data from FDA - Curated by EPG Health - Last updated 11 June 2018

Indication(s)

1 INDICATIONS AND USAGE STARLIX is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Limitations of Use: STARLIX should not be used in patients with type 1 diabetes mellitus or for the treatment of diabetic ketoacidosis. STARLIX (nateglinide) is a glinide indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. (1) Limitations of Use: Not for treating type 1 diabetes mellitus or diabetes ketoacidosis (1)

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Advisory information

contraindications
4 CONTRAINDICATIONS STARLIX is contraindicated in patients with a history of hypersensitivity to STARLIX or its inactive ingredients. History of hypersensitivity to nateglinide or its inactive ingredients (4)
Adverse reactions
6 ADVERSE REACTIONS The following serious adverse reaction is also described elsewhere in the labeling: Hypoglycemia [see Warnings and Precautions (5.1)] Common adverse reactions associated with STARLIX (3% or greater incidence) were upper respiratory tract infection, back pain, flu symptoms, dizziness, arthropathy, diarrhea. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Novartis at 1-888-669-6682 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 the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In clinical trials, approximately 2,600 patients with type 2 diabetes mellitus were treated with STARLIX. Of these, approximately 1,335 patients were treated for 6 months or longer and approximately 190 patients for one year or longer. Table 1 shows the most common adverse reactions associated with STARLIX. Table 1: Adverse Reactions other than Hypoglycemia (%) occurring Greater than or Equal to 2% in STARLIX-Treated Patients from Pool of 12 to 64 week Placebo Controlled Trials Placebo N = 458 STARLIX N = 1441 Preferred Term Upper Respiratory Infection 8.1 10.5 Back Pain 3.7 4.0 Flu Symptoms 2.6 3.6 Dizziness 2.2 3.6 Arthropathy 2.2 3.3 Diarrhea 3.1 3.2 Accidental Trauma 1.7 2.9 Bronchitis 2.6 2.7 Coughing 2.2 2.4 Hypoglycemia Episodes of severe hypoglycemia (plasma glucose less than 36 mg/dL) were reported in two patients treated with STARLIX. Non-severe hypoglycemia occurred in 2.4 % of STARLIX treated patients and 0.4 % of placebo-treated patients [see Warnings and Precautions (5.1)]. Weight Gain Patients treated with STARLIX had statistically significant mean increases in weight compared to placebo. In clinical trials, the mean weight increases with STARLIX 60 mg (3 times daily) and STARLIX 120 mg (3 times daily) compared to placebo were 1.0 kg and 1.6 kg respectively. Laboratory Test Increases in Uric Acid: There were increases in mean uric acid levels for patients treated with STARLIX alone, STARLIX in combination with metformin, metformin alone, and glyburide alone. The respective differences from placebo were 0.29 mg/dL, 0.45 mg/dL, 0.28 mg/dL, and 0.19 mg/dL. 6.2 Postmarketing Experience The following adverse reactions have been identified during post-approval use of STARLIX. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Hypersensitivity Reactions: Rash, itching, and urticaria Hepatobiliary Disorders: Jaundice, cholestatic hepatitis, and elevated liver enzymes

Usage information

Dosing and administration
2 DOSAGE AND ADMINISTRATION The recommended dose of STARLIX is 120 mg orally three times daily before meals. The recommended dose of STARLIX is 60 mg orally three times daily before meals in patients who are near glycemic goal when treatment is initiated. Instruct patients to take STARLIX 1 to 30 minutes before meals. In patients who skip meals, instruct patients to skip the scheduled dose of STARLIX to reduce the risk of hypoglycemia [see Warnings and Precautions (5.1)]. Recommended dose is 120 mg three times daily (2) In patients who are near glycemic goal when treatment is initiated, 60 mg three times daily may be administered. (2) Administer 1 to 30 minutes before meals (2) If a meal is skipped, skip the scheduled dose to reduce the risk of hypoglycemia. (2, 5.1)
Use in special populations
8 USE IN SPECIFIC POPULATIONS Nursing Mothers: Discontinue STARLIX or nursing (8.3) 8.1 Pregnancy 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). 8.3 Nursing Mothers 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. 8.4 Pediatric Use The safety and effectiveness of STARLIX have not been established in pediatric patients. 8.5 Geriatric Use 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. 8.6 Renal Impairment No dosage adjustment is recommended in patients with mild to severe renal impairment [see Clinical Pharmacology (12.3)]. 8.7 Hepatic Impairment 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 (12.3)].

Interactions

7 DRUG INTERACTIONS Table 2 includes a list of drugs with clinically important drug interactions when concomitantly administered or withdrawn with STARLIX and instructions for managing or preventing them. Table 2: Clinically Significant Drug Interactions with STARLIX Drugs That May Increase the Blood-Glucose-Lowering Effect of STARLIX and Susceptibility to Hypoglycemia Drugs: Nonsteroidal anti-inflammatory drugs (NSAIDs), salicylates, monoamine oxidase inhibitors, non-selective beta-adrenergic-blocking agents, anabolic hormones (e.g., methandrostenolone), guanethidine, gymnema sylvestre, glucomannan, thioctic acid, and inhibitors of CYP2C9 (e.g., amiodarone, fluconazole, voriconazole, sulfinpyrazone) or in patients known to be poor metabolizers of CYP2C9 substrates, alcohol. Intervention: Dose reductions and increased frequency of glucose monitoring may be required when STARLIX is coadministered with these drugs. Drugs and Herbals That May Reduce the Blood-Glucose-Lowering Effect of STARLIX and Increase Susceptibility to Hyperglycemia Drugs: Thiazides, corticosteroids, thyroid products, sympathomimetics, somatropin, somatostatin analogues (e.g., lanreotide, octreotide), and CYP inducers (e.g., rifampin, phenytoin and St John’s Wort). Intervention: Dose increases and increased frequency of glucose monitoring may be required when STARLIX is coadministered with these drugs. Drugs That May Blunt Signs and Symptoms of Hypoglycemia Drugs: beta-blockers, clonidine, guanethidine, and reserpine Intervention: Increased frequency of glucose monitoring may be required when STARLIX is coadministered with these drugs. Drugs That May Increase the Potential for Hypoglycemia: STARLIX dose reductions and increased frequency of glucose monitoring may be required when co-administered (7) Drugs That May Increase the Potential for Hyperglycemia: STARLIX dose increases and increased frequency of glucose monitoring may be required when co-administered (7) Drugs That May Blunt Signs and Symptoms of Hypoglycemia: Increased frequency of glucose monitoring may be required when co-administered (7)

More information

Category Value
Authorisation number NDA021204
Agency product number 41X3PWK4O2
Orphan designation No
Product NDC 0078-0352,0078-0351
Date Last Revised 10-05-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 284529
Marketing authorisation holder Novartis Pharmaceuticals Corporation