Finished product reference
Lutropin Alfa
Injection, Powder, for Solution · Parenteral · 75 IU
- List code
- 10786
- Pharmacologic class
- Gonadotrophin: recombinant human luteinising hormone (r-hLH)
What it is and how it works
Lutropin alfa is recombinant human LH produced in Chinese hamster ovary cells. In the ovary it stimulates theca cells to produce androgens, which are converted by FSH-stimulated granulosa cells to oestradiol, supporting FSH-induced follicular development.
Indications
In combination with FSH, stimulation of follicular development in adult women with severe LH and FSH deficiency (hypogonadotrophic hypogonadism, typically serum LH below 1.2 IU/L).
Dosage and administration (summary)
75 IU by subcutaneous injection once daily together with FSH (usually 75–150 IU), adjusted according to ovarian response monitored by ultrasound and oestradiol levels, under specialist supervision.
Contraindications
Carcinoma of the ovary, uterus or breast; active untreated tumours of the hypothalamus or pituitary; ovarian enlargement or cyst not due to polycystic ovary disease; gynaecological haemorrhage of unknown cause; hypersensitivity to gonadotrophins.
Warnings and precautions
Ovarian hyperstimulation syndrome and multiple pregnancy may occur; careful monitoring of ovarian response is required. Increased risk of ectopic pregnancy, miscarriage and thromboembolic events in predisposed women. Thyroid, adrenal and prolactin disorders should be excluded or treated before therapy.
Pregnancy
Not indicated during pregnancy.
Storage and supply
Store below 25 °C in the original package, protected from light; do not freeze.
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.
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