Insulin glulisine

FDA label

Read the full label on DailyMed ↗

Renal Increased risk of hypoglycemia - may require more frequent dose adjustment and more frequent blood glucose monitoring.

Hepatic Increased risk of hypoglycemia - may require more frequent dose adjustment and more frequent blood glucose monitoring.

Dosage differs by route (SC injection / pump / IV). Pump reservoir must be changed at least every 48 hours.

Instructions

• Inject SC into the abdominal wall, thigh or upper arm within 15 minutes before a meal or within 20 minutes after starting a meal; rotate sites within the same region and do not inject into areas of lipodystrophy or localized cutaneous amyloidosis.
• Generally use in a regimen with an intermediate- or long-acting insulin when given by SC injection.
• For SC injection, do not mix with any insulin other than NPH - draw the insulin glulisine into the syringe first and inject immediately after mixing.
• Pump: do not dilute or mix; change the reservoir at least every 48 hours (or per pump manual, whichever is shorter); change infusion sets and the insertion site per the manufacturer's manual; do not expose the reservoir to temperatures above 98.6 F (37 C).
• Train pump users to give insulin by injection and keep alternate insulin available in case of pump failure.
• IV use only under medical supervision with close blood glucose and potassium monitoring; diluted drug is stable at room temperature for 48 hours in 0.9% sodium chloride only - it is NOT compatible with dextrose or Ringer's solutions.
• Always check the insulin label before administration; use only if clear and colorless.
• The SoloStar prefilled pen dials in 1-unit increments - use with caution in visual impairment where the patient relies on audible clicks.
• Increase the frequency of blood glucose monitoring during any change to the insulin regimen.

Contraindications

• During episodes of hypoglycemia

Cautions

• Never share a SoloStar pen, syringe or needle between patients, even if the needle is changed.
• Hyperglycemia or hypoglycemia with changes in insulin regimen (strength, manufacturer, type, injection site or route) - change only under close supervision with more frequent glucose monitoring.
• Hypoglycemia may be life-threatening; risk rises with dosage changes, other glucose-lowering drugs, meal or activity changes, renal or hepatic impairment, and hypoglycemia unawareness.
• Hypoglycemia due to medication errors - accidental mix-ups between insulin products; check labels before every injection.
• Hypokalemia - insulin shifts potassium intracellularly; monitor and treat in patients at risk.
• Severe, life-threatening generalized allergy including anaphylaxis; systemic allergic reactions have occurred - discontinue, monitor and treat.
• Fluid retention and heart failure with concomitant PPAR-gamma agonists (thiazolidinediones).
• Hyperglycemia and ketoacidosis from insulin pump device malfunction.

Adverse reactions

• Hypoglycemia (most common); higher rate of severe symptomatic hypoglycemia in pediatric than adult type 1 diabetes
• Allergic reactions, including systemic allergy
• Injection or infusion site reactions
• Lipodystrophy and localized cutaneous amyloidosis
• Pruritus, rash
• Weight gain
• Hypokalemia

Pregnancy Pharmacovigilance data have not established an association with major birth defects, miscarriage or adverse maternal/fetal outcomes; poorly controlled diabetes in pregnancy itself carries substantial maternal and fetal risk.

Lactation Human insulin products including insulin glulisine are transferred into human milk with no reported adverse reactions in breastfed infants; no data on milk production.