6.5.1. Hypothalamic and anterior pituitary hormones and anti-oestrogens
Restrictions:
Restricted to specialist use for the indications listed in the Prescribing Notes section below:
Prescribing Notes:
In adult women for:
- anovulation (including polycystic ovarian syndrome) in women who have been unresponsive to treatment with clomiphene citrate.
- stimulation of multi-follicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intrafallopian transfer and zygote intra-fallopian transfer.
- in association with a luteinising hormone (LH) preparation for the stimulation of follicular development in women with severe LH and follicle-stimulating hormone (FSH) deficiency. In clinical trials these patients were defined by an endogenous serum LH level <1.2 units/L.
In adult men for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hCG) therapy.
The BNF recommends that is is good practice to prescribe biosimilars by brand name.
Restrictions:
Restricted to specialist use only for the treatment of adults with acromegaly who have had an inadequate response to surgery and/or radiation therapy and in whom an appropriate medical treatment with somatostatin analogues did not normalise IGF-1 (insulin-like growth factor 1) concentrations or was not tolerated.
Restrictions:
Somatropin for use in adults with growth hormone deficiency is restricted to initiation by consultant endocrinologists. The treatment of growth disturbance in short children born small for gestational age and who have failed to show catch-up growth by 4 years of age or later is restricted to initiation and monitoring by a paediatrician with expertise in managing childhood growth disorders and growth hormone therapy.