BD MediFollitropin Alfa + Lutropin Alfa
Drugs for Infertility
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📋 Indications & Uses⚠️ Contraindications🛡️ Warnings & Precautions🔬 Pharmacology & Mechanism
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📖 Official Clinical Monograph
DGDA Approved Prescribing GuidelinesThis injection is indicated for the stimulation of follicular development in adult women with severe LH and FSH deficiency. In clinical trials, these patients were defined by an endogenous serum LH level < 1.2 IU/L.
This injection is contraindicated in patients with:
hypersensitivity to the active substances or to any of the excipients
tumours of the hypothalamus and pituitary gland
ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin
gynaecological haemorrhages of unknown origin
ovarian, uterine or mammary carcinoma
This injection must not be used when an effective response cannot be obtained, such as:
primary ovarian failure
malformations of sexual organs incompatible with pregnancy
fibroid tumours of the uterus incompatible with pregnancy
This injection contains potent gonadotrophic substances capable of causing mild to severe adverse reactions, and should only be used by physicians who are thoroughly familiar with infertility problems and their management.
Gonadotrophin therapy requires a certain time commitment by physicians and supportive health care professionals, as well as the availability of appropriate monitoring facilities. In women, safe and effective use of this injection calls for monitoring of ovarian response with ultrasound, alone or preferably in combination with measurement of serum oestradiol levels, on a regular basis. There may be a degree of interpatient variability in response to FSH/LH administration, with a poor response to FSH/LH in some patients. The lowest effective dose in relation to the treatment objective should be used in women.
This injection is a preparation of recombinant human follicle stimulating hormone (follitropin alfa, r-hFSH) and recombinant human luteinising hormone (lutropin alfa, r-hLH) produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. In clinical trials the efficacy of the combination of follitropin alfa and lutropin alfa has been demonstrated in women with hypogonadotropic hypogonadism. In the stimulation of follicular development in anovulatory women deficient in LH and FSH, the primary effect resulting from administration of lutropin alfa is an increase in oestradiol secretion by the follicles, the growth of which is stimulated by FSH.
In clinical trials, patients with severe FSH and LH deficiency were defined by an endogenous serum LH level < 1.2 IU/L as measured in a central laboratory. However, it should be taken into account that there are variations between LH measurements performed in different laboratories. In these trials the ovulation rate per cycle was 70-75%.