| TAH Drug Code | IGON4 |
|---|---|
| Indications | Female: - Induction of ovulation in women who are still unable to ovulate after treatment with Clomiphene Citrate (including polycystic ovary disease, PCOD). - Used together with lutein-stimulating hormone (LH) to stimulate the development of multiple follicles in patients with severe deficiencies of lutein-stimulating hormone and follicle-stimulating hormone. - For stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilization (IVF), gamete intra fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT). Male: Induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism for whom the cause of infertility is not due to primary testicular failure. |
| Dosing | Women with anovulation (including PCOD) 75-150 IU daily & increased by 37.5 or 75 IU at 7 or 14 day intervals. Maximum daily dose: 225 IU. When an optimal response is obtained a single injection of up to 5,000 IU, up to 10,000 IU hCG should be given 24-48 hr after the last Gonal-F injection. The patient is recommended to have coitus on the day of, & the day after hCG administration. Women undergoing ovarian stimulation for multiple follicular development prior to in vitro fertilization or other ART 150-225 IU of Gonal-F daily, commencing on day 2 or 3 of the cycle. When an optimal response is obtained a single injection of up to 5,000 IU, up to 10,000 IU hCG should be given 24-48 hour after the last Gonal-F injection. Dose adjustment should not exceed 450 IU daily. A single inj of up to 10,000 IU hCG is administered 24-48 hour after the last Gonal-f inj to induce final follicular maturation. Women with anovulation resulting from severe LH and FSH deficiency usually is starting as dose of GONAL-f 75-150 IU together with 75 IU of lutropin alfa, dose increased should be after 7-14 day intervals and preferablt by 37.5-75 IU. When an optimal response is obtained a single injection of up to 5,000 IU, up to 10,000 IU hCG should be given 24-48 hr after the last Gonal-F injection. Men with hypogonadotrophic hypogonadism should be given at a dose of 150 IU three times a week, together with hCG, for minimum of 4 months. |
| Hepatic Impairment | Dose adjustment not necessary |
| Renal Impairment | Dose adjustment not necessary |
| Contraindications | Pregnancy & lactation, ovarian enlargement or cyst not due to polycystic ovarian disease, gynaecological haemorrhages of unknown aetiology, ovarian, uterine or mammary carcinoma, case of tumours of the hypothalamus & pituitary gland, hypersensitivity to follitropin α, FSH or to any of the excipients. When an effective response cannot be obtained, such as primary ovarian failure, malformation of sexual organs incompatible with pregnancy, fibroid tumours of the uterus incompatible with pregnancy. |
| Adverse Effects | Local reactions at the inj site. Fever, arthralgia, pain in the lower abdominal region, nausea, vomiting, weight gain. |
| Pregnancy | Unknown |
| Lactation | Unknown |
| More Info | UpToDate |