Gonal-f

Anovulation (including PCOS) in women unresponsive to treatment w/ clomiphene citrate. Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) [eg, in vitro fertilisation (IVF), gamete & zygote intra-fallopian transfer].

SC Anovulation (including PCOS) Initially 75-150 IU daily, may be increased by 37.5 IU or 75 IU at 7- or 14-day intervals if necessary. Max daily dose: 225 IU. Ovarian stimulation for multiple follicular development prior to IVF or other ART 150-225 IU daily commencing on day 2 or 3 of the cycle. Adjust dose according to patient's response, usually not >450 IU daily.

Hypersensitivity to follitropin-α or FSH. Hypothalamic & pituitary gland tumours. Ovarian enlargement or cyst not due to PCOS. Gynaecological haemorrhages of unknown aetiology. Ovarian, uterine or mammary carcinoma. Not to be used when an effective response cannot be obtained eg, primary ovarian failure; sexual organ malformations or fibroid uterine tumours incompatible w/ pregnancy.

Closely monitor patients w/ existing or family history of porphyria during treatment; treatment cessation may be required at deterioration or a 1st appearance of porphyria. Assess couple's infertility & evaluate putative CI for pregnancy before starting treatment; evaluate for hypothyroidism, adrenocortical deficiency, hyperprolactinemia & appropriate specific treatment given. Ovarian hyperstimulation syndrome (OHSS); monitor stimulation cycles by ultrasound scans & oestradiol measurements; discontinue use if severe OHSS occurs. Increased incidence of multiple pregnancy & pregnancy loss by miscarriage or abortion in patients undergoing ovulation induction or ART. Carefully monitor ovarian response. Risk of ectopic pregnancy in women w/ history of tubal disease. Possible ovarian & other reproductive system neoplasms in women undergoing multiple treatment regimens for infertility. Congenital malformation. Risk of thromboembolic events; women w/ recent or ongoing thromboembolic disease or generally recognised risk factors for thromboembolic events (eg, personal or family history, treatment w/ gonadotropins) may further increase risk for aggravation or occurrence of such events. Contains Na <1 mmol. Renal & hepatic impairment. Not indicated during pregnancy & lactation. No relevant use in paed population & elderly.

Headache; ovarian cysts; inj site reactions (eg, pain, erythema, haematoma, inj site swelling &/or irritation). Abdominal pain, distension & discomfort, nausea, vomiting, diarrhoea; mild or moderate OHSS (including associated symptomatology).

May potentiate follicular response when used concomitantly w/ other ovulation-stimulating medicinal products (eg, HCG, clomiphene citrate). May increase dose needed to elicit adequate ovarian response when used concurrently w/ GnRH agonist or antagonist.

Trophic Hormones & Related Synthetic Drugs

G03GA05 - follitropin alfa ; Belongs to the class of gonadotropins. Used as ovulation stimulants.

POM