Recombinent Human Luteinising Hormone (Lutropin alpha)
Indications
Recombinent Human Luteinising Hormone (Lutropin alpha) is used for:
Female infertility, (LH) and FSH deficiency
Adult Dose
Treatment should be tailored to the individual patient's response as assessed by measuring follicle size by ultrasound and estrogen response.
A recommended regimen commences at lutropinalpha 75 IU (ie, 1 vial of Luveris) daily with FSH 75-150 IU.
If an FSH, dose increase is deemed appropriate; dose adaptation should preferably be after 7- to 14-day intervals and preferably by 37.5-75 IU increments. It may be acceptable to extend the duration of stimulation in any 1 cycle to up to 5 weeks.
When an optimal response is obtained, a single injection of 5000-10,000 IU hCG should be administered 24-48 hrs after the last Luveris and FSH injections. The patient is recommended to have coitus on the day of, and on the day following, hCG administration.
Child Dose
Renal Dose
Administration
Contra Indications
Hypersensitivity to gonadotropins or to any of the excipients of Luveris.
Ovarian, uterine or mammary carcinoma; active, untreated tumors of the hypothalamus and pituitary gland; ovarian enlargement or cyst not due to polycystic ovarian disease; gynecological hemorrhages of unknown origin.
Use in pregnancy & lactationThis should not be administered during pregnancy and lactation.
Precautions
Before starting treatment, the couple's infertility should be assessed as appropriate and putative contraindications for pregnancy evaluated.
It should not be used when an effective response cannot be obtained eg, ovarian failure, malformation of the sexual organs incompatible with pregnancy or fibroid tumors of the uterus incompatible with pregnancy.
In addition, patients should be evaluated for hypothyroidism, adrenocortical deficiency and hyperprolactinemia and, pituitary or hypothalmic tumors, and appropriate specific treatment given.
Patients undergoing follicular growth stimulation are at increased risk of developing hyperstimulation in view of possible excessive oestrogen response and multiple follicular development.
Ovarian hyperstimulation syndrome can become a serious medical event characterised by large ovarian cysts which are prone to rupture. Excessive ovarian response seldom gives rise to significant hyperstimulation unless hCG is administered to induce ovulation. It is therefore prudent to withhold hCG in such cases and advise the patient to refrain from coitus or use barrier methods for at least 4 days.
Careful monitoring of ovarian response, based on ultrasound is recommended prior to and during stimulation therapy, especially in patients with polycystic ovaries.
In patients undergoing induction of ovulation, the incidence of multiple pregnancies and births is increased compared with natural conception.
Pregnancy-Lactation
Interactions
Lutropin alpha should not be administered as a mixture with other medicinal products, in the same injection, except follitropin for which studies have shown that co-administration does not significantly alter the activity, stability, pharmacokinetic nor pharmacodynamic properties of the active substances.
Adverse Effects
Side effects of Recombinent Human Luteinising Hormone (Lutropin alpha) :
General Description: Lutropin alpha is used for the stimulation of follicular development in association with follitropin alpha. In this context, it is difficult to attribute adverse reactions to any one of the substances used.
There is considerable post-marketing safety experience with human luteinizing hormone (hLH)-containing medicinal products of urinary origin. The safety profile of Luveris is expected to be very similar to that of urine-derived hLH, with the exception of hypersensitivity reactions and application site disorders.
In a clinical trial, mild and moderate injection site reactions (bruising, pain, redness, itching or swelling) were reported in 7.4% and 0.9% of the injections, respectively. No severe injection site reactions were reported. To date, no systemic allergic reactions have been reported following Luveris administration.
Ovarian hyperstimulation syndrome was observed in <6% of patients treated with Luveris. No severe OHSS was reported.
Ectopic pregnancy may also occur, especially in women with a history of prior tubal disease.
Mechanism of Action
Luteinizing hormone binds to a receptor shared with the human chorionic gonadotropin hormone (hCG) on the ovarian theca (and granulosa) cells and testicular Leydig cells. This LH/CG transmembrane receptor is a member of the super-family of G protein-coupled receptors. Adenylate cyclase then activates many other pathways leading to steroid hormone production and other follicle maturation processes.