HuMog Special Precautions

The following conditions should be properly treated and excluded as the cause of infertility before menotrophin therapy is initiated: Dysfunction of the thyroid gland and cortex of the suprarenal gland; Hyperprolactinaemia; Tumours in the pituitary or hypothalamic glands.
In the treatment of female infertility, ovarian activity should be checked (by ultrasound and plasma 17 beta-oestradiol measurement) prior to HuMoG administration. During treatment, these tests and urinary oestrogen measurement should be carried out at regular intervals, until stimulation occurs. Close supervision is imperative during treatment. See Dosage & Administration for optimum response levels of urinary oestrogens and plasma 17 beta-oestradiol.
Values below these ranges may indicate inadequate follicular development. If urinary oestrogen levels exceed 540 nmol (150 micrograms)/24 hours, or if plasma 17 beta-oestradiol levels exceed 3,000 pmol/L (800 picograms/ml), or if there is any steep rise in values, there is an increased risk of hyperstimulation and HuMoG treatment should be immediately discontinued, and human chorionic gonadotrophin withheld. Ultrasound will reveal any excessive follicular development and unintentional hyperstimulation. In the event of hyperstimulation, the patient should refrain from sexual intercourse until they are no longer at risk.
If during ultrasound, several mature follicles are visualised, human chorionic gonadotrophin should not be given as there is a risk of multiple ovulation and the occurrence of hyperstimulation syndrome.
Patients undergoing superovulation may be at an increased risk of developing hyperstimulation in view of the excessive oestrogen response and multiple follicular development. Aspiration of all follicles, prior to ovulation, may reduce the incidence of hyperstimulation syndrome.
The severe form of hyperstimulation syndrome may be life-threatening and is characterised by large ovarian cysts (prone to rupture), acute abdominal pain, ascites, very often hydrothorax and occasionally thromboembolic phenomena.
Prior to treatment with HuMoG, primary ovarian failure should be excluded by the determination of gonadotrophin levels.
There have been reports of ectopic pregnancy in women receiving menotrophin who have undergone assisted conception. One predisposing factor for ectopic pregnancy is tubal disease/occlusion, which women undergoing assisted conception may have. No causal relationship between ectopic pregnancy and the use of menotrophin has been established.
Special precautions for the physician: HCG should not be administered to induce ovulation in females whose ovaries have unintentionally been hyperstimulated.
When treating sterile women, ovarian activity should be checked (ultrasound and estradiol levels in serum resp.) prior to HMG administration. During treatment, these tests should be carried out every one to two days until stimulation occurs. Ovarian reaction can also be measured using a cervix index.
Close supervision is imperative during treatment. Treatment should be immediately discontinued if unintentional hyperstimulation occurs.
Effects on ability to drive and use machine: No studies on the effects on the ability to drive and use machines have been performed. However, HuMoG is unlikely to have influence on the patient's ability to drive and use machines.