Gonal-f

Gonal-f

follitropin alfa

Manufacturer:

Merck

Distributor:

Apex Pharma Marketing
Concise Prescribing Info
Contents
Follitropin α
Indications/Uses
Anovulation including polycystic ovarian syndrome (PCOS) in women unresponsive to treatment w/ clomiphene citrate. Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART).
Dosage/Direction for Use
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 should not exceed 450 IU daily.
Contraindications
Hypersensitivity. Hypothalamic & pituitary tumours; ovarian enlargement or cyst not due to polycystic ovarian disease; gynaecological haemorrhages of unknown aetiology; ovarian, uterine or mammary carcinoma; primary ovarian failure; malformations of sexual organs or fibroid uterine tumours incompatible w/ pregnancy.
Special Precautions
Existing or history of porphyria. Evaluate for hypothyroidism, adrenocortical deficiency & hyperprolactinemia before starting therapy. Ovarian hyperstimulation syndrome (OHSS); monitor stimulation cycles by ultrasound scans & oestradiol measurements; discontinue if severe OHSS occurs. Incidence of multiple pregnancy & pregnancy loss by miscarriage/abortion is increased in patients undergoing induction of ovulation. Careful monitoring of ovarian response is recommended. Patients w/ history of tubal disease are at risk for ectopic pregnancy. Congenital malformation. Thromboembolism. Pregnancy & lactation.
Adverse Reactions
Headache, ovarian cysts, local inj site reactions (eg pain, erythema, haematoma, swelling &/or irritation at the site of inj); abdominal pain, distension & discomfort, nausea, vomiting, diarrhoea; mild/moderate OHSS.
Drug Interactions
Other ovulation-stimulating agents eg HCG, clomiphene citrate; GnRH agonist/antagonist.
ATC Classification
G03GA05 - follitropin alfa ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Presentation/Packing
Form
Gonal-f inj 450 IU/0.75 mL
Packing/Price
(pre-filled pen) 0.75 mL x 1's
Form
Gonal-f inj 1050 IU/1.75 mL
Packing/Price
(vial) 1.75 mL x 1's
Form
Gonal-f inj 900 IU/1.5 mL
Packing/Price
(pre-filled pen) 1.5 mL x 1's
Form
Gonal-f inj 300 IU/0.5 mL
Packing/Price
(pre-filled pen) 0.5 mL x 1's
Form
Gonal-f inj 75 IU
Packing/Price
(vial) 1's
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