STARLIX- nateglinide tablet
Novartis Pharmaceuticals Corporation
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.
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)].
- 60 mg tablets: pink, round, beveled edge film-coated tablet with “STARLIX” debossed on one side and “60” on the other
- 120 mg tablets: yellow, ovaloid film-coated tablet with “STARLIX” debossed on one side and “120” on the other
STARLIX is contraindicated in patients with a history of hypersensitivity to STARLIX or its inactive ingredients.
All glinides, including STARLIX, can cause hypoglycemia [see Adverse Reactions (6.1) ]. 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 (7)] , 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 (7)], 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 (8.6, 8.7), Clinical Pharmacology (12.3)].
Patients should take STARLIX before meals and be instructed to skip the dose of STARLIX if a meal is skipped [see Dosage and Administration (2)]. 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.
The following serious adverse reaction is also described elsewhere in the labeling:
- Hypoglycemia [see Warnings and Precautions (5.1)]
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.
|Placebo N = 458||STARLIX N = 1441|
|Upper Respiratory Infection||8.1||10.5|
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)].
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.
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.
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
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.
|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.|
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