Quest for the right Drug
גונאל-אף GONAL-F (FOLLITROPIN ALFA)
תרופה במרשם
תרופה בסל
נרקוטיקה
ציטוטוקסיקה
צורת מתן:
תת-עורי : S.C
צורת מינון:
תמיסה להזרקה : SOLUTION FOR INJECTION
עלון לרופא
מינוניםPosology התוויות
Indications תופעות לוואי
Adverse reactions התוויות נגד
Contraindications אינטראקציות
Interactions מינון יתר
Overdose הריון/הנקה
Pregnancy & Lactation אוכלוסיות מיוחדות
Special populations תכונות פרמקולוגיות
Pharmacological properties מידע רוקחי
Pharmaceutical particulars אזהרת שימוש
Special Warning עלון לרופא
Physicians Leaflet
Pharmacological properties : תכונות פרמקולוגיות
Pharmacodynamic Properties
5.1 Pharmacodynamic properties Pharmacotherapeutic group: Sex hormones and modulators of the genital systems, gonadotropins, ATC code: G03GA05. Mechanism of action Follicle stimulating hormone (FSH) and luteinising hormone (LH) are secreted from the anterior pituitary gland in response to GnRH and play a complementary role in follicle development and ovulation. FSH stimulates the development of ovarian follicles, while LH action is involved in follicle development, steroidogenesis and maturation. Pharmacodynamic effects Inhibin and estradiol (E2) levels are raised after administration of r-hFSH, with subsequent induction of follicular development. Inhibin serum level increase is rapid and can be observed as early as the third day of r-hFSH administration, while E2 levels take more time, and an increase is observed only from the fourth day of treatment. Total follicular volume starts to increase after 4 to 5 days of r-hFSH daily dosing, and, depending on patient response, the maximum effect is reached after about 10 days from the start of r-hFSH administration. Clinical efficacy and safety in women 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 clinical studies comparing r-hFSH (follitropin alfa) and urinary FSH in ART (see table below) and in ovulation induction, GONAL-f was more potent than urinary FSH in terms of a lower total dose and a shorter treatment period needed to trigger follicular maturation. In ART, GONAL-f at a lower total dose and shorter treatment period than urinary FSH, resulted in a higher number of oocytes retrieved when compared to urinary FSH. Table: Results of study GF 8407 (randomised parallel group study comparing efficacy and safety of GONAL-f with urinary FSH in assisted reproduction technologies) GONAL-f urinary FSH (n = 130) (n = 116) Number of oocytes retrieved 11.0 ± 5.9 8.8 ± 4.8 Days of FSH stimulation required 11.7 ± 1.9 14.5 ± 3.3 Total dose of FSH required (number 27.6 ± 10.2 40.7 ± 13.6 of FSH 75 IU ampoules) Need to increase the dose (%) 56.2 85.3 Differences between the 2 groups were statistically significant (p< 0.05) for all criteria listed. Clinical efficacy and safety in men In men deficient in FSH, GONAL-f administered concomitantly with hCG for at least 4 months induces spermatogenesis.
Pharmacokinetic Properties
5.2 Pharmacokinetic properties There is no pharmacokinetic interaction between follitropin alfa and lutropin alfa when administered simultaneously. Distribution Following intravenous administration, follitropin alfa is distributed to the extracellular fluid space with an initial half-life of around 2 hours and eliminated from the body with a terminal half-life of 14 to 17 hours. The steady state volume of distribution is in the range of 9 to 11 L. Following subcutaneous administration, the absolute bioavailability is 66% and the apparent terminal half-life is in the range of 24 to 59 hours. Dose proportionality after subcutaneous administration was demonstrated up to 900 IU. Following repeated administration, follitropin alfa accumulates 3-fold achieving a steady-state within 3 to 4 days. Elimination Total clearance is 0.6 L/h and about 12% of the follitropin alfa dose is excreted in the urine.
שימוש לפי פנקס קופ''ח כללית 1994
לא צוין
תאריך הכללה מקורי בסל
01/03/2002
הגבלות
תרופה מוגבלת לרישום ע'י רופא מומחה או הגבלה אחרת
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