Insulin Glulisine

Insulin glulisine is a prescription medicine used to treat the symptoms of type 1 and 2 diabetes mellitus.

• Insulin glulisine is available under the following different brand names: Apidra, Apidra Solostar

Adult and pediatric dosage

Injectable solution (as 10 mL vial and 3 mL cartridge for OptiClick SC device)

• 100 units/mL
• Prefilled 3 mL pen (Solostar)
  • 100 units/mL

Diabetes Mellitus Type I or II

Adult dosage

• Total daily insulin requirement may vary and is usually between 0.5-1 unit/kg/day

Type 1 Diabetes Mellitus

Pediatric dosage

• Children below 4 years: Safety and efficacy not established
• Children 4 to 17 years: May require 0.8-1.2 units/kg/day SC during growth spurts; otherwise use adult dosing (0.5-1 unit/kg/day)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

Common side effects of Insulin glulisine include:

• low blood sugar,
• itching,
• mild skin rash, and
• thickening or hollowing of the skin where the medicine was injected.

Serious side effects of Insulin glulisine include:

• hives,
• difficulty breathing,
• swelling of the face, lips, tongue, or throat,
• redness or swelling at the injection site,
• itchy skin rash,
• fast heartbeats,
• lightheadedness,
• weight gain,
• swelling in the hands or feet,
• shortness of breath,
• leg cramps,
• constipation,
• irregular heartbeats,
• fluttering in the chest,
• increased thirst,
• increased urination,
• numbness or tingling,
• muscle weakness, and
• limp feeling.

Rare side effects of Insulin glulisine include:

• none 

This is not a complete list of side effects and other serious side effects or health problems that may occur as a result of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Insulin glulisine has severe interactions with the following drug:
  • pramlintide
• Insulin glulisine has serious interactions with the following drugs:
  • ethanol
  • macimorelin
• Insulin glulisine has moderate interactions with at least 125 other drugs.
• Insulin glulisine has minor interactions with at least 76 other drugs. 

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns.

Contraindications

• During episodes of hypoglycemia
• Documented hypersensitivity

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Insulin glulisine?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Insulin glulisine?”

Cautions

• Adjust dosage and monitoring when medically warranted
• Decreased insulin requirements: Diarrhea, nausea/vomiting, malabsorption, hypothyroidism, renal impairment, hepatic impairment
• Increased insulin requirements: fever, hyperthyroidism, trauma, infection, surgery
• Hypoglycemia is the most common adverse reaction
• May cause a shift in potassium from extracellular to intracellular space, possibly leading to hypokalemia; caution when coadministered with potassium-lowing drugs or conditions that may decrease potassium
• Frequent glucose monitoring and insulin dose reduction may be required with renal or hepatic impairment
• Thiazolidinediones are peroxisome proliferator-activated receptor (PPAR)-gamma agonists and can cause dose-related fluid retention, particularly when used in combination with insulin; fluid retention may lead to or exacerbate heart failure, monitor for signs and symptoms of heart failure and treat accordingly and consider discontinuing thiazolidinediones
• Never share a pen between patients even if the needle is changed
• Patients using vials must never share needles or syringes with another person
• Accidental mix-ups between insulin products reported; to avoid medication errors between APIDRA and other insulins, instruct patients to always check insulin labels before each injection
• If hypersensitivity reactions occur, discontinue therapy; treat per standard of care and monitor until symptoms and signs resolve; the drug is contraindicated in patients who have had a hypersensitivity reaction to it or any of its excipients
• Do not mix SC injection with insulin preparations other than NPH insulin
• Hyperglycemia or hypoglycemia with changes in insulin regimen
  • Changes in insulin, insulin strength, manufacturer, type, or method of administration may affect glycemic control and predispose to hypoglycemia or hyperglycemia
  • Changes should be made cautiously and only under close medical supervision and the frequency of blood glucose monitoring should be increased
  • Repeated insulin injections into areas of lipodystrophy or localized cutaneous amyloidosis reported to result in hyperglycemia; a sudden change in the injection site (to the unaffected area) has been reported to result in hypoglycemia
  • Make any changes to a patient’s insulin regimen under close medical supervision with increased frequency of blood glucose monitoring
  • Advise patients who have repeatedly injected into areas of lipodystrophy or localized cutaneous amyloidosis to change injection site to unaffected areas and closely monitor for hypoglycemia
  • For patients with type 2 diabetes, dosage adjustments in concomitant oral antidiabetic treatment may be needed
• SC insulin infusion
  • Do not dilute or mix with any other insulin
  • Insulin in the reservoir must be changed at least every 48 hours
  • Do not expose to temperatures above 98.6 F (37 C)
  • Malfunction of the insulin pump or infusion set, or handling errors or insulin degradation can rapidly lead to hyperglycemia, ketosis, and diabetic ketoacidosis; prompt identification and correction of the cause of hyperglycemia or ketosis necessary; patients using continuous subcutaneous insulin infusion pump therapy must be trained to administer insulin by injection and have alternate insulin therapy available in case of pump failure

Pregnancy and Lactation

• Available pharmacovigilance data have not established an association with insulin glulisine use during pregnancy and major birth defects, miscarriage, or adverse maternal or fetal outcomes; there are risks to mother and fetus associated with poorly controlled diabetes in pregnancy
• Poorly controlled diabetes in pregnancy increases the maternal risk for diabetic ketoacidosis, preeclampsia, spontaneous abortions, preterm delivery, and delivery complications; poorly controlled diabetes increases the fetal risk for major birth defects, stillbirth, and macrosomia related morbidity
• Lactation
  • Available data from published literature suggest that human insulin products are transferred into human milk; there are no adverse reactions reported in breastfed infants in literature; there are no data on effects of exogenous human insulin products, on milk production; developmental and health benefits of breastfeeding should be considered along with mother’s clinical need for therapy and any potential adverse effects on the breastfed infant or from the underlying maternal condition