Dosages
Side effects in children
Warnings & precautions in children
Contra-indications in children

Interactions
PK
Renal impairment
References

Octreotide

Generic name
Octreotide
Brand name
ATC Code
H01CB02

Pharmacokinetics in children

Pharmacokinetic studies in children are lacking.

In adults, the following PK parameter apply [SmPC Siroctid, SmPC Sandsotatine, SmPC Sandostatine LAR]:

  • Tmax after subcutaneous administration: 30 minutes.
  • Tmax after intramuscular administration: within 1 hour, followed by a progressive decrease to non-detectable values within 24 hours. After 7 days levels gradually rise to a therapeutic plateau concentration around day 14, which subsequently remains fairly stable during 3-4 weeks
  • Css is reached after 3 injections with intervals of 4 weeks of the injection fluid with prolonged action
  • Vd: 0.27 L/kg body weight.
  • Cl: 160 ml/min
  • T1/2 after subcutaneous administration: 100 minutes.
  • T1/2 after intravenous administration: biphasic: 10 and 90 minutes

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

No information is present at this moment.

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Available formulations

No information is present at this moment.

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Dosages

Hyperinsulinism
  • Subcutaneous
    • 0 years up to 18 years
      [3] [4] [5] [6] [7]
      • 5 - 25 microg./kg/day in 3 - 4 doses. Max: 40 microg./kg/day.

      • Alternative administration via continuous infusion.
        Administer the maximum dose in 3 doses.
Hypersecretion of growth hormone
Gastrointestinal bleeding
  • Intravenous
    • 0 years up to 18 years
      [2] [4] [5] [6] [7]
      • Initial dose: 1 - 2 microg./kg/dose, once only.
      • Maintenance dose: 1 - 2 microg./kg/hour, continuous infusion.
Chylothorax
  • Intravenous
    • 1 month up to 18 years
      • Initial dose: 1 microg./kg/hour, continuous infusion.
      • Maintenance dose: if needed increase the starting dose in increments of 1 microg/kg/h every day to max. 10 microg./kg/hour, continuous infusion.
        • In severe cases a higher starting dose (up to 4 microg/kg/h) can be considered.
        • In exceptional cases maintenance doses up to 20 microg/kg/h have been described.
        • Congenital chylothorax tends to require higher doses compared to acquired chylothorax.
    • Preterm and Term neonate
      • Initial dose: 1 microg./kg/hour, continuous infusion.
      • Maintenance dose: if needed increase the starting dose in increments of 1 microg/kg/h every day to max. 10 microg./kg/hour, continuous infusion.
        • In severe cases a higher starting dose (up to 4 microg/kg/h) can be considered.
        • In exceptional cases maintenance doses up to 20 microg/kg/h have been described.
        • Congenital chylothorax tends to require higher doses compared to acquired chylothorax.

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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.

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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

Gallstones and biliary sludge [Hosokawa 2017, Demirbilek 2014], malabsorption [Thornton 1993], glucose intolerance, transient elevation of liver enzymes [Cao 2020, Demirbilek 2014, Karlekar 2021, Van der Steen 2018], gastrointestinal symptoms such as vomiting and diarrhea and abdominal discomfort [Hosokawa 2017, Demirbilek 2014], pulmonary hypertension [Bellini 2018].

A mild decrease in growth is seen when used for the indication hyperinsulinism [van der Steen 2018, Thornton 1993]

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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

There is little experience with octreotide in children.

Monitoring of growth 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][Roehr 2006].

Monitoring blood glucose and thyroid parameters is advisable [Roehr 2006].

Neonates should be closely monitored for signs of necrotizing enterocolitis (significant abdominal distension, vomiting and feeding intolerance), particularly preterm and IUGR neonates [Pan 2015]. Long-acting intramuscular octreotide is not recommended in neonates since a risk of necrotizing enterocolitis may require the octreotide to be stopped abruptly [Van der Steen 2018, Le Quan Sang 2012]

Long-acting intramuscular octreotide is not recommended in neonates since a risk of necrotizing enterocolitis may require the octreotide to be stopped abruptly [Van der Steen 2018, Le Quan Sang 2012].

 

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Interactions

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

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Gonadotropin-releasing hormones
H01CA01
Somatostatin and analogues
H01CB03

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References

  1. Rademaker C.M.A. et al, Geneesmiddelen-Formularium voor Kinderen, 2007
  2. Kneepkens CMF et al, Werkboek Kindergastroenterologie, VU Uitgeverij, 2002, 2e druk
  3. Noordam C et al, Werkboek Kinderendocrinologie, digitale publicatie op www.nvk.nl (alleen leden), 2010
  4. Sun Pharmaceuticals Germany GmbH, Octreotid SUN 0,05; 0,1; 0,5; 0,2 mg/ml Injektionslösung (84088.00.00), 06/17
  5. Bendalis GmbH, Octreotid Bendalis 0,05; 0,1; 0,5; 0,2 mg/ml Injektionslösung (73244.00.00), 10/10
  6. Novartis Pharma GmbH, SmPC, Sandostatin® LAR®-Monatsdepot 10 mg/- 20 mg/- 30 mg Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension (43320.00.00), 02/18
  7. Novartis Pharma GmbH, SmPC, Sandostatin® 50 μg, -100 μg, -500 μg, -1000 μg Injektionslösung/Infusionslösung (29423.00.00), 02/18
  8. Uptodate: UpToDate®, Pediatric Drug information: Octreotide Topic 9714 Lexicomp® Version 210.0, accessed 01/19
  9. McMahon AW, et al., Octreotide use and safety in infants with hyperinsulinism., Pharmacoepidemiol Drug Saf., 2017, 26(1), 26-31
  10. Hosokawa Y, et al., Efficacy and safety of octreotide for the treatment of congenital hyperinsulinism: a prospective, open-label clinical trial and an observational study in Japan using a nationwide registry., Endocr J, 2017, 64(9), 867-80
  11. Yorifuji T, et al., Efficacy and safety of long-term, continuous subcutaneous octreotide infusion for patients with different subtypes of KATP-channel hyperinsulinism., Clin Endocrinol (Oxf), 2013, 78(6), 891-7
  12. Thornton PS, et al., Short- and long-term use of octreotide in the treatment of congenital hyperinsulinism., J Pediatr, 1993, 123(4), 637-43
  13. Noordam C, et al., Treatment of tall stature in boys with somatostatin analogue 201-995: effect on final height, Eur J Endocrinol., 2006, 154(2), 253-7
  14. Hindmarsh PC, et al., The effect of a continuous infusion of a somatostatin analogue (octreotide) for two years on growth hormone secretion and height prediction in tall children., Clin Endocrinol (Oxf)., 1995, 42(5), 509-15
  15. Das A, Shah PS., Octreotide for the treatment of chylothorax in neonates, Cochrane Database Syst Rev, 2010, (9), Cd006388
  16. Helin RD, et al, Octreotide therapy for chylothorax in infants and children: A brief review., Pediatr Crit Care Med, 2006, 7(6), 576-9
  17. 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
  18. Pan S, et al., Experience of Octreotide Therapy for Hyperinsulinemic Hypoglycemia in Neonates Born Small for Gestational Age: A Case Series., Horm Res Paediatr., 2015, 84(6), 383-7
  19. Le Quan Sang KH, et al., Successful treatment of congenital hyperinsulinism with long-acting release octreotide., Eur J Endocrinol., 2012, 166(2), 333-9
  20. Jenkinson AC, et al., Octreotide for Acquired Chylothorax in Pediatric Patients Post-Cardiothoracic Surgery for Congenital Heart Disease: A Systematic Review., Pediatr Cardiol., 2023, 44(2), 297-305
  21. Alhasoon MA., The use of high dose octreotide in management of neonatal chylothorax: Review., J Neonatal Perinatal Med., 2021, 14(4), 457-61
  22. Karlekar MP, et al., Octreotide-LAR is a Useful Alternative for the Management of Diazoxide-Responsive Congenital Hyperinsulinism., Horm Metab Res., 2021, 53(11), 723-9
  23. Resch B, et al., Congenital Chylothorax of the Newborn: A Systematic Analysis of Published Cases between 1990 and 2018., Respiration, 2022, 101(1), 84-96
  24. Bellini C, et al., Octreotide for congenital and acquired chylothorax in newborns: A systematic review., J Paediatr Child Health, 2018, 54(8), 840-7
  25. Roehr CC, et al., Somatostatin or octreotide as treatment options for chylothorax in young children: a systematic review., Intensive Care Med., 2006, 32(5), 650-7
  26. Cao B, et al., Efficacy and safety of octreotide treatment for diazoxide-unresponsive congenital hyperinsulinism in China., Pediatr Investig., 2020, 4(1), 29-36
  27. Demirbilek H, et al., Long-term follow-up of children with congenital hyperinsulinism on octreotide therapy., J Clin Endocrinol Metab, 2014, 99(10), 3660-7
  28. Tauber MT, et al., Effect of the long-acting somatostatin analogue SMS 201-995 on growth rate and reduction of predicted adult height in ten tall adolescents., Acta Paediatr Scand., 1990, 79(2), 176-81
  29. Hindmarsh PC, et al., A preliminary report on the role of somatostatin analogue (SMS 201-995) in the management of children with tall stature., Clin Endocrinol (Oxf)., 1990, 32(1), 83-91
  30. Siafakas C, et al, Use of octreotide for the treatment of severe gastrointestinal bleeding in children., J Pediatr Gastroenterol Nutr., 1998, 26(3), 356-9
  31. Mas E, et al., Drugs in Focus: Octreotide Use in Children With Gastrointestinal Disorders., J Pediatr Gastroenterol Nutr., 2022, 74(1), 1-6

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Changes

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