Gonal-f

Gonal-f

follitropin alfa

Manufacturer:

Merck

Distributor:

Apex Pharma Marketing
Concise Prescribing Info
Contents
Follitropin α
Indications/Uses
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].
Dosage/Direction for Use
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. Dose adjustment according to patient's response, usually not >450 IU daily.
Contraindications
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.
Special Precautions
Closely monitor patients w/ existing or family history of porphyria during treatment. 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. Contains Na <1 mmol. Renal & hepatic impairment. Not indicated during pregnancy & lactation. No relevant use in paed population & elderly.
Adverse Reactions
Headache; ovarian cysts; inj site reactions (eg, pain, erythema, haematoma, swelling &/or inj site irritation). Abdominal pain, distension & discomfort, nausea, vomiting, diarrhoea; mild or moderate OHSS (including associated symptomatology).
Drug Interactions
May potentiate follicular response when concomitantly used 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.
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
G03GA05 - follitropin alfa ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Presentation/Packing
Form
Gonal-f soln for inj 150 IU/0.25 mL
Packing/Price
0.25 mL x 1's
Form
Gonal-f soln for inj 300 IU/0.5 mL
Packing/Price
0.5 mL x 1's
Form
Gonal-f soln for inj 450 IU/0.75 mL
Packing/Price
0.75 mL x 1's
Form
Gonal-f soln for inj 900 IU/1.5 mL
Packing/Price
1.5 mL x 1's
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