Insulina lispro

Regulatory sources consulted

• ema-epar-EMEA/H/C/006158
• aemps-cima-196007044
• RxNorm rxcui 86009 ↗

Approved indications

• For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance of normal glucose homeostasis. Also indicated for the initial stabilisation of diabetes mellitus.

Contraindications

Clinical warnings

• Major warning · Hypoglycaemia is the most frequent adverse reaction. The timing of its occurrence depends on the action profile of the insulin and may change when the treatment regimen is changed. — EMA SPC
• Major warning · Risk of medication errors: patients must be instructed to always check the insulin label before each injection to avoid accidental mix-ups between different insulins. — EMA SPC
• Transferring to another type or brand of insulin should be done under strict medical supervision. — EMA SPC

Drug interactions

• ModerateBeta-blockersC07

  Mechanism: May mask the symptoms of hypoglycaemia (e.g., tachycardia) and prolong recovery from it.

  Recommendation: Monitor glucose closely. Educate the patient about unmasked hypoglycaemia symptoms (e.g., sweating).

  EMA SPC

• ModerateSystemic corticosteroidsH02

  Mechanism: Induce hyperglycaemia by increasing insulin resistance and gluconeogenesis.

  Recommendation: An increase in insulin dose may be necessary. Monitor glucose closely, especially when starting, changing, or stopping the corticosteroid.

  EMA SPC

• HighAlcoholV03AB16

  Mechanism: May intensify or reduce the hypoglycaemic effect of insulin. Acute consumption inhibits gluconeogenesis, increasing the risk of delayed hypoglycaemia.

  Recommendation: Advise moderation. Consume with food to reduce the risk of hypoglycaemia. Monitor glucose.

  EMA SPC

Adverse events

Pregnancy and lactation

The use of insulin lispro may be considered during pregnancy, if clinically needed. Breast-feeding is not contraindicated.