Finished product reference
Follitropin Beta
Injection, Solution · Parenteral · 833 IU/1mL · 1.08 mL
- List code
- 50823
- Pharmacologic class
- Gonadotrophin; recombinant human follicle-stimulating hormone (FSH)
What it is and how it works
Follitropin beta is recombinant FSH produced in Chinese hamster ovary cells. In women it stimulates recruitment, growth and maturation of ovarian follicles and oestradiol production; in men with hypogonadotrophic hypogonadism, given with hCG, it stimulates spermatogenesis.
Indications
Anovulation (including polycystic ovary syndrome) unresponsive to clomifene; controlled ovarian hyperstimulation to induce multiple follicles in assisted reproduction (e.g. IVF, ICSI); deficient spermatogenesis due to hypogonadotrophic hypogonadism in men.
Dosage and administration (summary)
Subcutaneous (or intramuscular, depending on presentation) injection, with dose and duration individualised by the fertility specialist according to ovarian response monitored by ultrasound and oestradiol levels; in men, given with hCG over several months.
Contraindications
Tumours of the ovary, breast, uterus, testis, pituitary or hypothalamus, undiagnosed vaginal bleeding, ovarian cysts or enlargement not due to polycystic ovary syndrome, primary ovarian or testicular failure, and malformations of the reproductive organs or fibroids incompatible with pregnancy.
Warnings and precautions
Ovarian hyperstimulation syndrome, multiple pregnancy, ectopic pregnancy, miscarriage and thromboembolism may occur; ovarian response must be monitored closely. Endocrine disorders (thyroid, adrenal, pituitary) should be excluded or treated before therapy.
Pregnancy
Not indicated during pregnancy.
Storage and supply
Store refrigerated at 2–8 °C; do not freeze; protect from light (patients may store at up to 25 °C for a limited period as stated by the manufacturer).
Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.
Other presentations of the same active ingredient
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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