- Dosages
- Side effects in children
- Warnings & precautions in children
- Contra-indications in children
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Interactions - PK
- Renal impairment
- References
Pharmacokinetics in children
After four weeks, the leuprorelin plasma level (1.22 ng/ml) is higher in children than in adults treated with the same dose. There is no other data known about the pharmacokinetic properties in children.
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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
| Idiopathic central precocious puberty GIRLS |
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| Idiopathic central precocious puberty BOYS |
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| Diagnosis pubertas praecox (lucrin test) |
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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
Common (1–10%): vaginal and other infections, (Abnormal) weight gain, Retarded growth, moodchanges, depression, emotional lability, Emotional lability, headache, Vasodilatation, Nausea, vomiting, abdominal pain. (maculopapular) skin rash, Acne, abnormal body odour., erythema multiforme, striae. Gynecomastia, increased breast size, vaginal bleeding, 'spotting', vaginal discharge, vaginitis, injection site reaction.
Sometimes (0,1-1%): Rhinitis, influenza, pharyngitis, sinusitis. Cervical neoplasm. Hypersensitivity. Enlargement of the thyroid. Increased appetite. Nervousness. Sleepiness, syncope,hyperkinesia. Bradycardia. Hypertension. Peripheral vascular disease. Epistaxis, asthma, dysphagia, gingivitis, dyspepsia, constipation. Alopecia, hair disease, hirsutism, nail disease, skin hypertrophy, purpura, leukoderma. Conditions of the joints, muscle pain, myopathy, artrialgia. Urinary incontinence. Breast hypertrophia, painfull breast, menstrual disease, dysmenorrhoea, cervix diseases, feminization. Peripheral oedema, fever. presence of antinuclear antibodies, increased sedimentation rate, hot flashes.
Rare (< 0,01%): Anaphylaxis, systemic allergic reactions.
seizures, apoplexy of the pituitary gland [SmPC Enantone, Trenantone, Klebrocid]
[SmpC Leuproreline Abbvie]
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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 in children
Children with a disease or treatment that may affect the growth and/or activity of the pituitary-gonadal axis. Bone maturation of more than 12 years in girls or 13 years in boys. Intraarterial injection.
In Girls: Vaginal bleeding of unknown cause [SmPC Enantone, Trenantone, Klebrocid]
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
A significant increase in body size in central precocious puberty (CPP) is only to be expected if diagnosis / treatment starts at an age of <6 years (girls) and if (untreated) course is progressive. Treatment should be considered for all boys with onset of progressive CPP before 9 years of age who have compromised height potential [Bereket 2017, Carel et al. 2009.]. At the start of treatment, the chronological age should be less than 9 years for girls and less than 10 years for boys. Exclude pseudo-precocious puberty (gonadal or adrenal tumour or hyperplasia) and gonadotropin-independent precocious puberty (testotoxicosis, familial Leydig cell hyperplasia). The effects on fertility and adult bone density and the long-term safety are not yet known. During treatment of precocious puberty with GnRH analogues, a decrease in bone density can occur. After the end of the treatment, remineralization usually takes place again, so that the bone mass in late adolescence does not seem to be affected by the treatment. During the early phase of treatment, an increase in complaints and symptoms may occur due to a temporary increase in sex hormones. Inadequate dosing may lead to insufficient control of the process of adolescence. There is no experience with leuprorelin implants in children aged < 18 years. If sterile abscesses occur at the injection site (reported frequently with intramuscular injection of an improperly high dose), the absorption of leuprorelin acetate may be reduced. In this case, the hormonal parameters (testosterone, estradiol) should be monitored every 2 weeks. After the first injection, girls may experience hormone withdrawal symptoms in the form of vaginal bleeding, spotting and discharge. The cause of vaginal bleeding that persists for the first two months of treatment must be clarified. Epiphysiolysis of the femoral head may occur after treatment has ended. In patients with progressive brain tumors, a careful benefit/risk assessment should be performed before starting treatment. [SmPC Enantone, Trenantone, Klebrocid]
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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 | ||
| L02AE04 | ||
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References
- Abbot BV, SPC Lucrin (RVG 14351), www.cbg-meb.nl, accessed 21 Dec 2011, http://db.cbg-meb.nl/IB-teksten/h14351.pdf
- Noordam C et al. ., Werkboek Kinderendocrinologie, digitale publicatie op www.nvk.nl (alleen leden), 2010
- Kim YJ et al, Multicenter clinical trial of leuprolide acetate depot (Luphere deport 3,75 mg) for efficacy and safety in girls with central precocious puberty., Ann Pediatr Endocrinol Metab, 2013, 18(4), 173-8
- AbbVie BV, SmPC Lucrin PDS depot 1 month (RVG 30197) 15-05-2018, www.geneesmiddeleninformatiebank.nl
- ErasmusMC, Lucrintest (vroege pubertijdsontwikkeling) bij kinderen (Versie 3)
- ErasmusMC, Lucrintest (vroege pubertijdsontwikkeling) bij kinderen (Versie 3)
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Changes
Changes
