Pharmacokinetics in children

Insulin glargine:
Children showed similar patterns in plasma concentrations to adults and there was no evidence of accumulation of insulin glargine or its metabolites with sustained administration. [SmPC Abasaglar]

A population pharmacokinetic analysis was performed based on the concentration data of its major metabolite M1 using data from 75 paediatric patients (6 to < 18 years) with type 1 diabetes. Body weight has a non-linear effect on clearance. As a result, exposure (AUC) is slightly lower in paediatric patients compared to adult patients when they receive the appropriate body weight-adjusted dose. [SmPC Toujeo]

Insulin degludec:
The pharmacokinetic properties of insulin degludec in children (1 - 11 years) and adolescents (12 - 18 years) at steady state were comparable to those observed in adults with type 1 diabetes mellitus. However, the overall exposure after the application of a single dose of insulin degludec was higher in children and adolescents than in adults with type 1 diabetes mellitus [SmPC Tresiba].

Insulin detemir:
No clinically relevant differences were found in pharmacokinetic properties between infants, children, adolescents and adults. [SmPC Levemir]

dose recommendation of formulary compared to licensed use (on-label versus off-label)

No information is present at this moment.

Available formulations

No information is present at this moment.

Dosages

Renal impaiment in children > 3 months

The insulin requirement may be decreased in cases of reduced renal function. The dosage is adjusted depending on the blood glucose measurements in this case.

The complete list of all undesirable drug reactions can be found in the national Summary of Product Characteristics (SmPC) – click here

Side effects in children

Insulin degludec/Insulin detemir
The frequency, type and severity of side effects in children and adolescents do not indicate differences from the experience in the general population with diabetes.
[SmPC Levemir, SmPC Tresiba]

Insulin glargine
In general, the safety profile in children and adolescents (≤ 18 years) is similar to that in adults.
Adverse event reports received after the market launch in children and adolescents (≤ 18 years) were relatively more frequent for injection site reactions (pain and local reaction at the injection site) and skin reactions (rash, urticaria) than in adults.
No safety data from clinical trials are available for children under 2 years of age.
[SmPC Absasaglar, SmPC Semglee]

The complete list of all contra-indications can be found in the national Summary of Product Characteristics (SmPC) – click here

Contra-indications

No information available on specific contra indications in children.

The complete list of all warnings and precautions can be found in the national Summary of Product Characteristics (SmPC) – click here

Warnings & precautions in children

In children, care should be taken to ensure that the insulin dose (especially with basal-bolus therapy) is coordinated with food intake and physical activity in order to minimise the risk of hypoglycaemia. [SmPC Tresiba, SmPC Levemir]

Interactions

The complete list of all interactions can be found in the national Summary of Product Characteristics (SmPC) – click here

• ALIMENTARY TRACT AND METABOLISM

DRUGS USED IN DIABETES

This pages provides a list of drugs from the same ATC class for comparison. This does not necessarily mean that these drugs are interchangeable.

References

1. NovoNordisk A/S, SmPC Tresiba (EU/1/12/807/001-5) 16-11-2017, www.ema.europa.eu
2. Novo Nordisk A/S, SPC Levemir (EU/1/04/278/001-003) 17-05-2016, www.geneesmiddeleninformatiebank.nl
3. Sanofi-Aventis Deutschland GmbH, SPC Lantus (EU/1/00/134/001-004 en 012) 22-02-2016, www.geneesmiddeleninformatiebank.nl
4. Eli Lilly Regional Operations GmbH, SmPC Abasaglar (EU/1/14/944/001-004; 009) 01-06-2016, www.geneesmiddeleninformatiebank.nl

Changes

Therapeutic Drug Monitoring

Overdose