Gonal-F

Gonal-F

follitropin alfa

Manufacturer:

Merck

Distributor:

Zuellig Pharma
Concise Prescribing Info
Contents
Follitropin α
Indications/Uses
Anovulation including polycystic ovarian syndrome 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 intra-fallopian transfer (GIFT) & zygote intra-fallopian transfer (ZIFT).
Dosage/Direction for Use
SC Women w/ anovulation (including polycystic ovarian syndrome) Commence w/in the 1st 7 days of menstrual cycle at 75-150 IU FSH daily & increased preferably by 37.5 or 75 IU at 7- or 14-day intervals. Max daily dose: 225 IU FSH. Ovarian stimulation for multiple follicular development prior to IVF or other ART 150-225 IU daily commencing on days 2 or 3 of the cycle. Dose adjustment should not exceed 450 IU daily.
Contraindications
Hypersensitivity to follitropin α, FSH. Ovarian enlargement or cyst not due to polycystic ovarian syndrome; gynaecological haemorrhages of unknown aetiology; ovarian, uterine or mammary carcinoma; hypothalamus & pituitary gland tumours. When an effective response cannot be obtained eg, primary ovarian failure, sexual organ malformation & uterine fibroid tumours incompatible w/ pregnancy. Pregnancy & lactation.
Special Precautions
Porphyria; thromboembolic events. Evaluate patients for hypothyroidism, adrenocortical deficiency, hyperprolactinemia & pituitary or hypothalamic tumours prior to therapy. Monitor therapy carefully to minimize incidence of ovarian enlargement or ovarian hyperstimulation syndrome (OHSS), multiple & ectopic pregnancy, pregnancy loss, reproductive system neoplasms, congenital malformation.
Adverse Reactions
Ovarian cysts; headache; local inj site reactions (pain, erythema, haematoma, swelling &/or irritation). Abdominal pain, distention & discomfort, nausea, vomiting, diarrhoea; mild to moderate OHSS.
Drug Interactions
Potentiated follicular response w/ other ovulation stimulating agents (eg, hCG, clomiphene citrate). Increased dosage of Gonal-F needed to elicit an adequate ovarian response w/ concurrent use of GnRH agonist-induced pituitary desensitisation.
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 powd for inj 450 IU/0.75 mL
Packing/Price
(multi-dose vial) 1's
Form
Gonal-F powd for inj 75 IU/mL
Packing/Price
1's
Form
Gonal-F pre-filled pen 300 IU/0.5 mL
Packing/Price
1's
Form
Gonal-F pre-filled pen 450 IU/0.75 mL
Packing/Price
1's
Form
Gonal-F pre-filled pen 900 IU/1.5 mL
Packing/Price
1's
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