Pergoveris

Pergoveris

Manufacturer:

Merck

Distributor:

Apex Pharma Marketing
Concise Prescribing Info
Contents
Follitropin α, lutropin α
Indications/Uses
Follicular development stimulation in adult women w/ severe LH & FSH deficiency.
Dosage/Direction for Use
SC Individualized dosage. Recommended initial dose: 150 IU r-hFSH/75 IU r-hLH daily. If FSH dose increase is necessary, dose adaptation should be after 7-14 day intervals & preferably by 37.5-75 IU increments. Duration of stimulation in any 1 cycle may be extended up to 5 wk. Administer single inj of 250 mcg r-hCG or 5,000-10,000 IU hCG 24-48 hr after last Pergoveris inj when optimal response is obtained.
Contraindications
Hypersensitivity. Hypothalamus & pituitary gland tumours. Ovarian enlargement or cyst unrelated to polycystic ovarian disease. Gynaecological haemorrhages of unknown origin. Ovarian, uterine or mammary carcinoma. Not to be used when an effective response cannot be obtained eg, primary ovarian failure; sexual organ malformations & uterine fibroid tumours incompatible w/ pregnancy.
Special Precautions
Assess couple's infertility as appropriate & evaluate putative CI for pregnancy before starting treatment. Evaluate patients for hypothyroidism, adrenocortical deficiency, hyperprolactinemia & give appropriate specific treatment. Regularly monitor ovarian response w/ ultrasound, alone or in combination w/ serum oestradiol level measurement. Closely monitor patients w/ existing or family history of porphyria. W/hold hCG & advise patient to refrain from coitus or to use barrier contraceptive methods for at least 4 days if signs of ovarian hyperstimulation syndrome (OHSS) occur. Consider treatment discontinuation when risk of OHSS & multiple pregnancies is assumed. Possible ovarian torsion. Incidence of pregnancy loss by miscarriage or abortion is higher in patients undergoing follicular growth stimulation for ovulation induction. Risk of ectopic pregnancy in women w/ history of tubal disease. Possible ovarian & other reproductive system neoplasms in women who have undergone multiple regimens for infertility treatment. Possible congenital malformations. May increase risk in women w/ recent or ongoing thromboembolic disease or w/ generally recognized risk factors for thromboembolic events [eg, personal or family history, thrombophilia or severe obesity (BMI >30 kg/m2). Contains Na <1 mmol. Renal & hepatic impairment. Not indicated for use during pregnancy & breast-feeding. No relevant use in paed population. Elderly.
Adverse Reactions
Headache; ovarian cysts; mild to severe inj site reactions (eg, pain, erythema, haematoma, bruising, swelling &/or inj site irritation). Abdominal pain, distension & discomfort, nausea, vomiting, diarrhoea; breast & pelvic pain, mild to moderate OHSS.
Drug Interactions
Not to be administered as mixt w/ other medicinal products in the same inj. May be administered concomitantly w/ licensed follitropin α prep as separate inj.
MIMS Class
Trophic Hormones & Related Synthetic Drugs
ATC Classification
G03GA30 - combinations ; Belongs to the class of gonadotropins. Used as ovulation stimulants.
Presentation/Packing
Form
Pergoveris soln for inj 300 IU + 150 IU
Packing/Price
0.48 mL x 1's
Form
Pergoveris soln for inj 900 IU + 450 IU
Packing/Price
1.44 mL x 1's
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