Out.qxp 5/10/07 09:56 Page 16
Recombinant Technology
Evidence from another study in both healthy volunteers and patients
suggests that the granulosa cells of women with a specific genotype are SAFETY INFORMATION on Follistim
®
AQ Cartridge and
more resistant to FSH action than those of other women.
28
Follistim
®
AQ Vial
• Follistim
®
AQ Cartridge/Vial, like all gonadotropins, is a potent
Other researchers have put forward a polygenic hypothesis for clinical substance capable of causing mild to severe side effects including
outcome of COS involving FSHR, estrogen receptor 1 (ESR1), ESR2, and ovarian hyperstimulation syndrome (OHSS), with or without
the cytochrome P450 aromatase gene (CYP19). The presence of a pulmonary or vascular complications.
trigenic haplotype, detected using different multilocus approaches, was • Follistim
®
AQ Cartridge/Vial should be prescribed only by
over-represented in poor responders in the heterozygous state, physicians who are experienced in infertility treatment, who
suggesting that a discrete set of genes is controlling the ovarian response should advise their patients of treatment risks, including OHSS
to FSH in humans.
29
and multiple births.
Conclusion SAFETY INFORMATION on Follistim
®
AQ Cartridge
In conclusion, the development of the rFSH follitropin beta using rDNA • Follistim
®
AQ Cartridge administered with Follistim Pen
®
delivers
technology has made it possible for Organon to provide safe, effective, on average 18% more follitropin beta compared with lyophilized
patient-friendly treatment options to the field of reproductive medicine. preparations administered with a conventional syringe and
Research is ongoing in the field of fertility to focus on a patient-centered needle. A lower dose should be considered when using Follistim
®
approach of administration and to include the evaluation of AQ Cartridge.
pharmacogenetics to tailor drug therapy to an individual’s genetic profile.
This can potentially maximize a therapy’s value. ■
1. Gordon K, Prins M, Schuller K, Commentary one million and 12. Lunenfeld B, Development of gonadotrophins for clinical use, 21. Silverberg KM, Ormand RA, Hansard LJ, Vaughn TC, Recombinant
counting, Reprod Biomed Online, 2006;13(3):313–14. Reprod Biomed Online, 2002;4(Suppl. 1):11–17. FSH provides more efficient, cost-effective stimulation for
2. Lunenfeld B, Historical perspectives in gonadotrophin therapy, Hum 13. Porchet HC, Le Cotonnec JY, Canali S, Zanolo G, Ovulation Induction/Intrauterine Insemination (OI/IUI) cycles than
Reprod Update, 2004;10:453–67. Pharmacokinetics of recombinant follicle stimulating hormone highly purified urinary FSH, Fertil Steril, 2001:75(Suppl. 1):
3. Smith PE, Hastening of development of female genital system by after intravenous, intramuscular, and subcutaneous S15–S16
daily hemoplastic pituitary transplants, Proc Soc Exp Biol Med, administration in monkeys, and comparison with intravenous 22. Al-Inany H, Afnan M, Models of cost-effectiveness of recombinant
1926;24;311–26. administration of urinary follicle stimulating hormone, Drug FSH versus urinary FSH, Hum Reprod, 2002;17:1671–4.
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Gynakol, 1926;90:327. 14. Keene JL, Matzuk MM, Otani T, et al., Expression of biologically immunological and physico-chemical comparison of the current
5. Zondek B, Ueber die Hormone des Hypophysenvorderlappens, Klin active human follitropin in Chinese hamster ovary cells, J Biol clinical batches of the recombinant FSH preparations Gonal-F and
Wochenschrift, 1930;9:245–8. Chem, 1989;264:4769–75. Puregon, Hum Reprod, 2000;15:1898–1902.
6. Fevold SL, Hisaw FL, Leonard SL, The Gonad-stimulating and the 15. Galway AB, Hsueh AJ, Keene JL, et al., In vitro and in vivo 24. van de Weijer B, Mulders J, Bos E, et al., Compositional
Luteinizing hormones of the anterior lobe of the hypophysis, Am J bioactivity of recombinant human follicle stimulating hormone and analyses of a human menopausal gonadotrophin preparation
Physiol, 1931;9:291–301. partially deglycosylated variants secreted by transfected eukaryotic extracted from urine (menotropin). Identification of some of its
7. Gemzell CA, Diczfalusy E, Tillinger G, Clinical effect of human cell lines, Endocrinology, 1990;127:93–100. major impurities, Reprod Biomed Online, 2003;7(5):547–57.
pituitary follicule stimulating hormone (FSH), J Clin Endocrinol 16. Hard K, Mekking A, Damm JB, et al., Isolation and structure 25. Lispi M, Bassett R, Crisci C, et al., Comparative assessment of the
Metab, 1958;18:1333. determination of the intact sialylated N-linked carbohydrate chains consistency and quality of a highly purified FSH extracted from
8. Out HJ, Mannaerts BM, Driessen SG, et al., A prospective, of recombinant human follitropin expressed in Chinese hamster human urine (urofollitropin) and a recombinant human FSH
randomized, assessor-blind, multicentre study comparing ovary cells, Eur J Biochem, 1990;193:263–71. (follitropin alpha), Reprod Biomed Online, 2006;13(2):179–93.
recombinant and urinary follicle stimulating hormone (Puregon vs 17. Out HJ, Mannaerts B, Driessen, et al., Recombinant follicle 26. Gordon K, New developments in gonadotrophin pharmacology,
Metrodin) in in-vitro fertilization, Hum Reprod, 1995;10:2534–40. stimulating hormone (rFSH; Puregon) in assisted reproduction: Reprod Biomed Online, 2002;5(3):259–64.
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Successful in vitro fertilisation and embryo transfer after treatment studies, Hum Reprod Update, 1996;2(2):162–71. to follicle-stimulating hormone (FSH) stimulation depends on the
with recombinant human FSH, Lancet, 1992;339:1170–71. 18. Organon USA Inc., Data on file, IMS-National Sales Perspective, FSH receptor genotype, J Endocrinol Metab, 2000;85:3365–9.
10. Olijve W, de Boer W, Mulders JW, et al., Molecular biology and August 2005 – July 2006. 28. Greb RR, Behre HM, Simoni M, Pharmacogenetics in ovarian
biochemistry of human recombinant follicle stimulating hormone 19. Out HJ, Recombinant follicle stimulating hormone: Gold standard stimulation – current concepts and future options, Reprod Biomed
(Puregon), Mol Hum Reprod, 1996;1:1–12. or not?, RBM Online, 2005;11:536–9. Online, 2005;11(5):589–600.
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1998;4:260–83. clinician’s perspective, J Assist Reprod Genet, 2001;18:45–55. 2005;6(6):629–637.
16 FERTILITY TREATMENT REVIEW
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