Source: Medicines & Healthcare Products Regulatory Agency (GB) Revision Year: 2017 Publisher: Merck Sharp & Dohme Limited, Hertford Road, Hoddesdon, Hertfordshire, EN119BU, UK
Pharmacotherapeutic group: gonadotrophins
ATC code: G03GA01
Pregnyl is a preparation of human chorionic gonadotrophin obtained from the urine of pregnant women. It stimulates the steroidogenesis in the gonads by virtue of a biological effect similar to that of LH (Luteinizing hormone, which is the same as interstitial cell stimulating hormone). In the male it promotes the production of testosterone and in the female the production of estrogens and particularly of progesterone after ovulation. In certain cases, this preparation is used in combination with human menopausal gonadotrophin (HMG).
Because HCG is of human origin, no antibody formation is to be expected.
In a study performed in healthy male subjects, maximal hCG plasma levels were reached after a single IM or SC injection of hCG at approximately six and sixteen hours respectively; in addition, maximum concentrations and areas under the concentration curves were higher after the IM than after the SC injection. However, these differences did not translate into significant differences in terms of testicular steroidogenic response.
In a study performed in female subjects under oral contraceptives, IM and SC administration of hCG were found to be bioequivalent regarding the extent of absorption and the apparent elimination half-lives of approximately 33 hours; maximal hCG plasma levels were reached after approximately 20 hours regardless of the route of administration. Although high intersubject variability was observed, the difference related to gender after IM injection may be caused by gluteal fat thickness in women which exceeds that in men. In another study performed in female patients in the early follicular phase of their menstrual cycle, the bioavailability of a single dose of hCG was higher with the IM route than with the SC route and lower in obese women than in non-obese women.
HCG is approximately 80 per cent metabolized, predominantly in the kidneys.
On basis of the recommended dose regimens and elimination half-life, accumulation is not expected to occur.
There are no preclinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
