IVF-M HP

Highly purified menotrophin

Female infertility in anovulation including WHO group II in women who have been unresponsive to treatment w/ clomiphene citrate, & women undergoing controlled ovarian hyperstimulation for multiple follicular development for assisted reproductive technologies (ART).

SC Anovulation including WHO group II in women who have been unresponsive to treatment w/ clomiphene citrate Start treatment w/in initial 7 days of menstrual cycle. 75 IU for 7 days to max 12 days until adequate response is achieved based on serum estradiol level 1.1-2.9 nMol/L = 300-800 pg/mL & maturation of follicles (diameter ≤18 mm). Dose may be increased to 150 IU daily if ovaries do not respond, considering treatment w/ previous dose was repeated at least twice. Give single inj of 5,000-10,000 IU HCG 1 day after last IVF-M HP inj. Women undergoing controlled ovarian hyperstimulation for multiple follicular development for ART Initially 225 IU daily using down-regulation w/ gonadotrophin-releasing hormone agonist or antagonist on day 2 or 3 of menstrual cycle w/ 150-300 IU daily until adequate maturation of follicles is obtained. Treatment period: Approx 5-20 days. Max dose adjustment: Not exceeding 150 IU per adjustment. Max daily dose: 450 IU not beyond 20 days in treatment cycle. Administer 5,000-10,000 IU HCG when adequate response is obtained 24-48 hr after last IVF-M HP inj. Repeat previous treatment cycle for at least twice before increasing dose if there is evidence of ovulation but not pregnant.

Hypersensitivity. Ovarian cysts or enlarged ovaries not due to PCOS; gynaecological haemorrhage of unknown aetiology; ovarian, uterine or mammary carcinoma; ovarian hyperstimulation syndrome (OHSS). VTE or arterial thromboembolism or medical history of this disease. Infertile except for anovulation unless undergoing in vitro fertilization; high FSH level indicating primary ovarian failure. Tumours of pituitary gland or hypothalamus. Galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption. Pregnancy & lactation.

Hypersensitive/anaphylaxis reaction. Withhold treatment & HCG in case of high estrogen level & excessive follicular development & refrain from coitus or use barrier methods for at least 4 days. Withhold HCG if OHSS may be developing prior to HCG administration. Not to be administered w/ HCG if abnormal ovarian enlargement occurs on the last day of IVF-M HP treatment. Discontinue treatment if severe OHSS occurs. Not for use in treatment of amenorrhea. Incidence of multiple births. Risk of ectopic pregnancy in patients w/ history of tubal disease. Miscarriage or abortion. Severe pelvic pain, nausea, vomiting & wt gain. Pulmonary & vascular complications. Increased risk of adverse maternal & perinatal outcomes. Benign & malignant ovarian & other reproductive system neoplasms. Patients w/ PCOS; risk factors for thromboembolic events eg, personal or family history, severe obesity (BMI ≥30 kg/m²) or thrombophilia. Evaluate patients for hypothyroidism, adrenocortical deficiency, hyperprolactinemia, or pituitary tumour; anatomical abnormality of reproductive system (primary ovarian failure) or other hormonal disorders (thyroid, adrenal, diabetes); partner's semen analysis before treatment initiation. Monitor patients for mild to moderate adverse reaction. Carefully monitor ovarian response to avoid mild to moderate ovarian enlargement; follicular maturation & development, & determine the timing of HCG administration. Assess intake & output of body fluid, wt, hematocrit, serum & urinary electrolytes, urine specific gravity, BUN & creatinine, & abdominal girth daily if hemoconcentration associated w/ fluid loss occurs. Avoid pelvic exam. Prohibit intercourse in case of significant ovarian enlargement after ovulation, due to risk of hemoperitoneum caused by rupture of ovarian cyst. Avoid use of diuretics except in late phase of convalescence. Not to be given during pregnancy & lactation. Congenital malformations after ART.

Inj site local reaction (pain, itchiness, swelling or redness), rash, anaphylaxis shock, acne; urticaria, facial & angioneurotic edema, dyspnea from laryngeal edema; OHSS, multiple pregnancy, ovarian enlargement, cyst, & torsion, breast pain; cerebral thrombosis, thromboembolism, hypotension, hemoconcentration, tachycardia; hydrothorax, dyspnea, tachypnea; nausea, vomiting, diarrhea, abdominal cramps, distension, pain, & discomfort; dizziness, headache, malaise; abortion, pyrexia, pelvic & musculoskeletal pain, arthralgia, lower abdominal pain, ascites, oliguria, occasional pain after treatment, excessive increase of serum estradiol levels, hemoperitoneum, fatigue, facial blush (hot flush), visual disorders.

Excessive ovarian reaction eg, Meigs syndrome accompanied by ovarian enlargement, rupture of the enlarged ovary, ascites, & hydrothorax in concomitant or subsequent use w/ ovarian stimulating hormone.

Trophic Hormones & Related Synthetic Drugs

G03GA02 - human menopausal gonadotrophin ; Belongs to the class of gonadotropins. Used as ovulation stimulants.

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