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

Interactions
PK
Renal impairment
References

Triptorelin

Generic name
Triptorelin
Brand name
ATC Code
L02AE04

Pharmacokinetics in children

In children with pubertas praecox was tmax 4 (2-8) hours and Cmax (0-169 days) was 39.9 (19.1 to 107.0) ng/ml.
No accumulation of triptorelin was observed during the 12-month treatment. [SmPC Pamorelin LA 22.5 mg]

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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

Central precocious puberty
  • Subcutaneous
    • < 20 kg
      • In boys aged < 10 years:
        In girls aged  <  8 years: 1.875         mg/dose once every 4 weeks. If the suppression is insufficient, every 3 weeks..
      • Duration of treatment:

        The treatment must be stopped when a bone age of greater than 12 years is reached in girls or 13 years in boys.

        • If suppression is insufficient, the dosefrequency may be increased to every 3 weeks.
        • Only on prescription  from physician with knowledge of disease profile and treatment
    • 20 up to 30 kg
      • In boys aged < 10 years:
        In girls aged <  8 years: 2.5         mg/dose every 4 weeks. If the suppression is insufficient, every 3 weeks..
        ALTERNATIVE DOSING REGIMENS, INTRAMUSCULAR
        • 11,25 mg/dosis 1 x per 3 maanden
        • 22,5 mg/dosis 1 x per 6 maanden
        .
      • Duration of treatment:

        The treatment must be stopped when a bone age of greater than 12 years is reached in girls or 13 years in boys.

      • If suppression is insuffient, the dose can be administerd every 3 weeks.
        Only on prescription from physician with knowledge of disease profile and treatment.

    • ≥ 30 kg
      • In boys aged < 10 years:
        In girls aged < 8 years: 3.75         mg/dose every 4 weeks. If the suppression is insufficient, every 3 weeks..
        ALTERNATIVE DOSING REGIMENS, INTRAMUSCULAR
        • 11,25 mg/dosis 1 x per 3 maanden
        • 22,5 mg/dosis 1 x per 6 maanden
        .
      • Duration of treatment:

        The treatment must be stopped when a bone age of greater than 12 years is reached in girls or 13 years in boys.

      • If suppression is insuffient, the dose can be administerd every 3 weeks.
        Only on prescription from physician with knowledge of disease profile and treatment.

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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

Very common (≥ 10%): mild to moderate vaginal bleeding, including withdrawal bleeding (in the first month).

Common (1-10%): abdominal pain. Reaction at the injection site (erythema, inflammation, pain). Hypersensitivity. Weight gain. Headache. Mood swings, depression. Acne. Hot flushes.

Uncommon (0.1-1%): anaphylactic reaction. Visual disturbances. Nausea, vomiting, constipation. Malaise. Obesity. Neck pain. Chest pain. Epistaxis. Itching, rash, urticaria.

Also reported: myalgia. Idiopathic intracranial hypertension. Convulsions. Nervousness, (affective) lability. Angioneurotic oedema, alopecia, erythema. Epiphysiolysis capitis femoris, muscle weakness. Genital bleeding. Hypertension, increase in prolactin in blood.

 

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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

Before treatment, exclude pseudoprecocious puberty (gonadal tumour, adrenal tumour or hyperplasia) and gonadotropin-independent precocious puberty (testicular toxicosis, familial Leydig cell hyperplasia).

Use in children with progressive brain tumours should be carefully considered.

In girls, vaginal bleeding of mild or moderate intensity may occur during the first month. Future reproductive function and fertility do not appear to be affected by treatment with GnRH agonists, but sufficient data are not yet available. In most girls, regular menstruation occurs on average 1 year after discontinuation of treatment.

Idiopathic intracranial hypertension (IIH) has been reported. Warn the patient about symptoms of IIH, including severe or recurrent headaches, visual disturbances and tinnitus. Consider discontinuing triptorelin if IIH occurs.

Peak bone mass in late adolescence does not appear to be affected by treatment.

After discontinuation of treatment, femoral epiphysis displacement may be observed.

 

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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 hormone analogues
L02AE01
L02AE02

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References

  1. Ferring BV, SmPC Decapeptyl (RVG 12450) 17-12-2019, www.geneesmiddeleninformatiebank.nl
  2. Noordam, C, NVK werkboek Kinderendocrinologie, 2010
  3. Ferring Pharma, SmPC Decapeptyl N 3,75mg Pulver und Lösungsmittel zur Herstellung einer Injektionssuspension (51973.00.00), 01/2015
  4. Ipsen, SmPC Pamorelin LA 11,25mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension (55394.00.00), 03/2018
  5. Ipsen, SmPC Pamorelin LA 3,75mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension (59220.00.00), 06/2017
  6. Ipsen, SmPC Pamorelin LA 22,5mg Pulver und Lösungsmittel zur Herstellung einer Depot-Injektionssuspension (73771.00.00), 03/2018
  7. Bereket, A, A critical appraisal of the effect of gonadotropin-releasing hormon analog treatment on adult height of girls with central precocious puberty, J Clin Res Pediatr Endocrinol, 2017, 30;9(Suppl 2), 33-48
  8. Carel, JC, et al, Consensus statement on the use of GnRH analogs in children, Pediatrics, 2009, 12(4), 752-62
  9. IPSEN Farmaceutica B.V., SmPC Pamorelin 22,5 mg (RVG 103585) 17-04-2019, www.geneesmiddeleninformatiebank.nl

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Changes

Changes