Adult: Dosage should be individualised and adjusted according to the patient’s metabolic needs, blood glucose monitoring results, and goal in glycaemic control. Must be used in regimens with intermediate- or long-acting insulin or basal insulin analogue, and can be given with oral hypoglycaemics. Via SC inj: Inject within 15 minutes before a meal or within 20 minutes after starting a meal into the abdominal wall, thigh or upper arm. Via continuous SC insulin infusion (CSII) or insulin pump: Administer into the abdominal wall or region recommended in the instructions of pump manufacturer. Change insulin glulisine infusion set and reservoir at least every 48 hours. In case of pump system failure, patients must have available alternative insulin delivery system. Via IV infusion: Give only under medical supervision with close blood glucose and K level monitoring. Dose adjustments may be necessary when switching from other insulin, with changes in physical activity, meal patterns, renal or hepatic functions, or during acute illness. Treatment guidelines may vary among countries (refer to specific product guidelines). Child: ≥6 years Dosage should be individualised and adjusted according to the patient’s metabolic needs, blood glucose monitoring results, and goal in glycaemic control. Treatment guidelines may vary among countries (refer to specific product guidelines).
Renal Impairment
Dose reduction may be needed.
Hepatic Impairment
Dose reduction may be needed.
Administration
Should be taken with food. Administer w/in 15 min before a meal or w/in 20 min after starting a meal.
Reconstitution
IV infusion: Dilute a concentration of 1 unit/mL insulin glulisine in infusion systems with 0.9% NaCl solution for infusion (with or without 40 mmol/L K chloride); use coextruded polyolefin/polyamide or polyvinyl chloride (PVC) plastic infusion bags with a dedicated infusion line.
Incompatibility
SC inj: Not to be mixed with other insulin preparations other than neutral protamine Hagedorn (NPH) human insulin. CSII (insulin pump): Avoid mixing with diluents or any other types of insulin. IV: Incompatible with glucose 5% solution and Ringer’s solution; do not mix with any other insulin.
Contraindications
Hypersensitivity. Episodes of hypoglycaemia.
Special Precautions
Patient with risk factors for hypoglycaemia, including changes in meal pattern, level of physical activity, insulin regimen, concurrent illness, emotional distress and medications used; conditions that may make hypoglycaemia symptom awareness less pronounced (e.g. long-standing diabetes, recurrent hypoglycaemia, diabetic nerve disease, intensified insulin treatment, use of β-blockers); cardiac disease, risk factors for developing heart failure and hypokalaemia (e.g. taking loop diuretics). Renal and hepatic impairment. Children. Pregnancy and lactation.
Adverse Reactions
Significant: Hypoglycaemia, hypokalaemia; inj site reactions (e.g. lipodystrophy, localised cutaneous amyloidosis); hyperglycaemia, ketosis and diabetic ketoacidosis (if handling errors or pump system failure occur via CSII). Immune system disorders: Local hypersensitivity reactions at the inj site (e.g. redness, pain, itching, swelling). Infections and infestations: Influenza. Investigations: Weight gain. Metabolism and nutrition disorders: Peripheral oedema. Musculoskeletal and connective tissue disorders: Arthralgia. Nervous system disorders: Headache, hypoglycaemic seizure. Respiratory, thoracic and mediastinal disorders: Nasopharyngitis, upper respiratory tract infection. Vascular disorders: Hypertension. Potentially Fatal: Hypersensitivity reactions, including anaphylaxis; severe and prolonged hypoglycaemia episodes resulting in unconsciousness, convulsion, or brain damage (temporary or permanent); untreated hypokalaemia leading to respiratory paralysis and ventricular arrhythmia.
This drug may impair the patient’s ability to concentrate and react due to hypoglycaemia; if affected, do not drive or operate machinery. SC: Continuously rotate inj site within the same region to the next to prevent long-term site reactions.
Monitoring Parameters
Monitor blood glucose (usually before meals and snacks, and at night, then as required); electrolytes; HbA1c (at least twice yearly in patients with stable glycaemic control; quarterly in patients not meeting treatment goals or with treatment change); renal and hepatic function; weight. When administered via IV, closely monitor blood glucose and serum K.
Overdosage
Symptoms: Mild to severe hypoglycaemia. Management: For mild hypoglycaemic episodes, give oral glucose or sugary products. For severe hypoglycaemia where the patient becomes unconscious, administer SC or IM 0.5-1 mg glucagon, or IV glucose if the patient does not respond to glucagon within 10-15 minutes. Once consciousness is regained, give oral carbohydrates to prevent a relapse. Monitor patient to determine the reason for severe hypoglycaemia and prevent similar episodes.
Drug Interactions
May cause dose-related fluid retention and exacerbate heart failure with peroxisome proliferator-activated receptor (PPAR)-γ agonists, including thiazolidinediones (e.g. pioglitazone). May increase the risk of hypoglycaemia with other antidiabetic agents, ACE inhibitors, angiotensin II receptor blockers, MAOIs, fibrates, fluoxetine, pentoxifylline, salicylates, and sulfonamides. Hypoglycaemic effects of insulin glulisine may be decreased by glucagon, corticosteroids, diuretics, danazol, isoniazid, atypical antipsychotics (e.g. olanzapine), phenothiazine derivatives, sympathomimetic agents (e.g. salbutamol, epinephrine, terbutaline), protease inhibitors, estrogens, oral contraceptives, and thyroid hormones. May either enhance or reduce the risk of hypoglycaemia with β-blockers, lithium salts, and clonidine. Hypoglycaemic symptoms may be reduced or blunted by β-blockers, clonidine, guanethidine, and reserpine.
Food Interaction
May either enhance or reduce the risk of hypoglycaemia with alcohol.
Action
Description: Mechanism of Action: Insulin glulisine, a rapid-acting recombinant human insulin analogue, is equipotent to regular human insulin; however, it has a more rapid onset and a shorter duration of action than regular human insulin. It lowers blood glucose by stimulating peripheral glucose uptake and by inhibiting hepatic glucose production. Insulin glulisine also prevents lipolysis and proteolysis and enhances protein synthesis. Onset: 0.2-0.5 hours. Duration: 3-4 hours. Pharmacokinetics: Absorption: Bioavailability: Approx 70% (SC). Time to peak plasma concentration: SC: 60 minutes (range: 40-120 minutes). Distribution: Volume of distribution: 13 L (IV). Excretion: Via urine. Elimination half-life: 42 minutes (SC); 13 minutes (IV).
Chemical Structure
Insulin glulisine Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 16136701, Apidra. https://pubchem.ncbi.nlm.nih.gov/compound/Apidra. Accessed Aug. 26, 2021.
Storage
Unopened pen/cartridge/vial: Store between 2-8°C. Do not freeze. Protect from light. Opened (in-use) pen/cartridge: Store below 25°C for up to 28 days. Do not refrigerate. Protect from heat and light. Opened (in-use) vial: May be stored under refrigeration or below 25°C for up to 28 days. Protect from heat and light. Storage recommendations may vary among countries (refer to specific product guidelines).
A10AB06 - insulin glulisine ; Belongs to the class of fast-acting insulins and analogues. Used in the treatment of diabetes.
References
Anon. Insulin Glulisine. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 05/08/2021.Anon. Insulin Glulisine. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 05/08/2021.Apidra 100 Units/mL (PT. Aventis Pharma). MIMS Indonesia. http://www.mims.com/indonesia. Accessed 05/08/2021.Apidra 100 Units/mL Solution for Injection in a Cartridge (Aventis Pharma Limited, Trading as Sanofi). MHRA. https://products.mhra.gov.uk. Accessed 05/08/2021.Apidra 100 Units/mL Solution for Injection in a Vial (Aventis Pharma Limited, Trading as Sanofi). MHRA. https://products.mhra.gov.uk. Accessed 05/08/2021.Apidra and Apidra Solostar Injection Solution (Sanofi-aventis U.S. LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 05/08/2021.Apidra SoloStar 100 Units/mL Solution for Injection in a Pre-filled Pen (Aventis Pharma Limited, Trading as Sanofi). MHRA. https://products.mhra.gov.uk. Accessed 05/08/2021.Apidra Solostar 100 Units/mL Solution for Injection in a Pre-Filled Pen (Sanofi-Aventis [Malaysia] Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 05/08/2021.Buckingham R (ed). Insulin. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/08/2021.Joint Formulary Committee. Insulin Glulisine. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 05/08/2021.
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