Pharmacokinetics in children

Pharmacokinetic studies in children are lacking.

In adults, the following PK parameter apply [SmPC Mytolac, SmPC Somatuline AutoSolution]:

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

GFR ≥10 ml/min/1.73m2: Dose adjustment not required.

GFR <10 ml/min/1.73m2: A general recommendation on dose adjustment cannot be provided.

Clinical consequences

Patients with severe renal impairment show an approximately twofold decrease in total serum clearance of lanreotide, with a consistent increase in half-life and AUC. However, it is not necessary to adjust the starting dose in patients with renal impairment as serum lanreotide concentrations in these populations are expected to be well within the range of by healthy volunteers.

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

A mild decrease in growth and elevated liver enzymes are seen [van der Steen 2018]

Gallstones [Cuff 2022]

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

Monitoring of growth and thyroid parameters at least 6-monthly is recommended [van der Steen 2018]

Monitor liver enzymes every 4–6 weeks and repeat abdominal ultrasound every 3–6 months [Van der Steen 2018].

Because of its long half-life and the potential risk of necrotizing enterocolitis, lanreotide use is not recommended in the neonatal period [Corda 2017, van der Steen 2018]

Interactions

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

• SYSTEMIC HORMONAL PREPARATIONS, EXCL. SEX HORMONES AND INSULINS
• PITUITARY AND HYPOTHALAMIC HORMONES AND ANALOGUES

HYPOTHALAMIC HORMONES

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. Modan-Moses D, et al., Treatment of congenital hyperinsulinism with lanreotide acetate (Somatuline Autogel)., J Clin Endocrinol Metab, 2011, 96(8), 2312-7
2. Souabni SA, et al., Congenital hyperinsulinemic hypoglycemia (HH) requiring treatment as the presenting feature of Kabuki syndrome., Clin Case Rep, 2023, 11(6), e7336
3. Cuff H, et al., The Use of Lanreotide in the Treatment of Congenital Hyperinsulinism., J Clin Endocrinol Metab., 2022, 107(8), e3115-e20
4. van der Steen I, et al., A Multicenter Experience with Long-Acting Somatostatin Analogues in Patients with Congenital Hyperinsulinism. , Horm Res Paediatr., 2018, 89(2), 82-9
5. Kühnen P, et al., Long-term lanreotide treatment in six patients with congenital hyperinsulinism., Horm Res Paediatr., 2012, 78(2), 106-12
6. Dastamani A, et al., The Use of a Long-Acting Somatostatin Analogue (Lanreotide) in Three Children with Focal Forms of Congenital Hyperinsulinaemic Hypoglycaemia., Horm Res Paediatr., 2019, 91(1), 56-61
7. Corda H, et al., Treatment with long-acting lanreotide autogel in early infancy in patients with severe neonatal hyperinsulinism., Orphanet J Rare Dis, 2017, 12(1), 108
8. Shah P, et al., Use of Long-Acting Somatostatin Analogue (Lanreotide) in an Adolescent with Diazoxide-Responsive Congenital Hyperinsulinism and Its Psychological Impact., Horm Res Paediatr., 2015, 84(5), 355-60
9. Kiff S, et al., Partial diazoxide responsiveness in a neonate with hyperinsulinism due to homozygous ABCC8 mutation., Endocrinol Diabetes Metab Case Re, 2019, p. 2019
10. Uppal S, et al., Hepatoblastoma and Wilms' tumour in an infant with Beckwith-Wiedemann syndrome and diazoxide resistant congenital hyperinsulinism., Endocrinol Diabetes Metab Case Rep, 2019
11. Takasawa K, et al., Clinical management of diazoxide-unresponsive congenital hyperinsulinism: A single-center experience., Clin Pediatr Endocrinol., 2024, 33(3), 187-94
12. van der Steen I, et al., A Multicenter Experience with Long-Acting Somatostatin Analogues in Patients with Congenital Hyperinsulinism., Horm Res Paediatr., 2018, 89(2), 82-9

Changes

Therapeutic Drug Monitoring

Overdose