No black box warning on record for Insulin Glargine

As of the latest FDA labeling reviewed, Insulin Glargine (insulin glargine) does not carry a black box warning. Standard warnings and precautions still apply — see the full Insulin Glargine medicine page for the complete safety profile.

Other warnings & precautions

NEVER Use IV: Insulin glargine must only be administered subcutaneously. IV administration would cause severe hypoglycemia due to rapid systemic exposure. The 300 units/mL Toujeo concentration should never be administered IV.
Do Not Mix: Insulin glargine cannot be mixed with any other insulin or solution in the same syringe — the acidic pH of glargine (which creates its depot effect) is altered by mixing, changing its pharmacokinetics unpredictably. This includes not mixing with regular insulin.
Hypoglycemia: The most significant adverse effect. Risk factors: excessive dose, missed meals, increased physical activity, alcohol use, renal/hepatic impairment, concomitant antidiabetic medicines. Train patients to recognize and treat hypoglycemia and to carry fast-acting glucose.
Toujeo vs Lantus Are NOT Interchangeable: Toujeo contains 300 units/mL vs Lantus 100 units/mL. They have different pharmacodynamics and are not dose-equivalent on a unit-per-unit basis when switching — the same unit dose of Toujeo provides less effect than Lantus. Switching requires dose adjustment.
Lantus vs Biosimilar Basaglar: Basaglar is an approved biosimilar of Lantus and can be substituted, but it is not identical to Lantus. Switching should be done with monitoring.

No black box warning on record for Insulin Glargine

Other warnings & precautions

NEVER Use IV: Insulin glargine must only be administered subcutaneously. IV administration would cause severe hypoglycemia due to rapid systemic exposure. The 300 units/mL Toujeo concentration should never be administered IV.
Do Not Mix: Insulin glargine cannot be mixed with any other insulin or solution in the same syringe — the acidic pH of glargine (which creates its depot effect) is altered by mixing, changing its pharmacokinetics unpredictably. This includes not mixing with regular insulin.
Hypoglycemia: The most significant adverse effect. Risk factors: excessive dose, missed meals, increased physical activity, alcohol use, renal/hepatic impairment, concomitant antidiabetic medicines. Train patients to recognize and treat hypoglycemia and to carry fast-acting glucose.
Toujeo vs Lantus Are NOT Interchangeable: Toujeo contains 300 units/mL vs Lantus 100 units/mL. They have different pharmacodynamics and are not dose-equivalent on a unit-per-unit basis when switching — the same unit dose of Toujeo provides less effect than Lantus. Switching requires dose adjustment.
Lantus vs Biosimilar Basaglar: Basaglar is an approved biosimilar of Lantus and can be substituted, but it is not identical to Lantus. Switching should be done with monitoring.

Insulin Glargine Black Box Warning

No black box warning on record for Insulin Glargine

Other warnings & precautions

Insulin Glargine Black Box Warning

No black box warning on record for Insulin Glargine

Other warnings & precautions