Insulina glargina

ATC code

A10AE04

Therapeutic class

Long-acting insulin analogue · Insulins and analogues for injection, long-acting

Forms

solution for injection in pre-filled pen, solution for injection in vial

Brand names

Abasaglar (ES) · Ondibta (EU) · Lantus (Global) · Toujeo (Global)

Overall confidence

high

Regulatory sources consulted

ema-epar-EMEA/H/C/006136
aemps-cima-114944012
RxNorm rxcui 274783 ↗

Approved indications

Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.

Contraindications

Absolute

Hypersensitivity to the active substance or to any of the excipients. Episode of hypoglycaemia.

Clinical warnings

Major warning · Risk of hypoglycaemia, which is the most frequent adverse effect. Patients must be instructed on symptoms and management. Risk of medication errors; always check the insulin label before each injection to avoid mix-ups with other insulins. — EMA SPC

Drug interactions

ModerateBeta-blockersC07
Mechanism: May mask the symptoms of hypoglycaemia (e.g., tachycardia) and enhance the hypoglycaemic effect of insulin.
Recommendation: Monitor blood glucose more closely. Warn the patient about the masking of hypoglycaemia symptoms.
EMA SPC
ModerateCorticosteroids (systemic)H02
Mechanism: Induce hyperglycaemia by increasing insulin resistance and gluconeogenesis.
Recommendation: Insulin dose may need to be increased. Monitor blood glucose.
EMA SPC

Adverse events

Common (≥1%)

hypoglycaemia · injection site reactions · lipohypertrophy

Rare but serious

severe hypoglycaemia · systemic hypersensitivity reactions · anaphylactic shock

Pregnancy and lactation

Use of insulin glargine may be considered during pregnancy, if clinically needed. No effects on the breastfed newborn/infant are anticipated. Dose adjustment may be necessary.