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Meriofert® (menotrophin)

Prescribing Information
SmPC 75iu
SmPC 150iu
PIL

What is Meriofert®?

Meriofert® contains highly purified human menopausal gonadotrophin, containing follicle stimulating hormone (FSH) together with luteinising hormone (LH) activity, both obtained from natural human sources (not genetically engineered).1

This natural source means that the type of FSH contained in Meriofert® closely resembles the acidic FSH found in the early to mid-follicular phase of a woman's natural fertility cycle2,3. This type of FSH is important for optimal growth of the follicles containing the eggs4. The LH activity within Meriofert® is particularly important in the second half of the follicular phase as LH is the major factor responsible for growth and development of the follicles at this time.5,6

Meriofert® can be given by subcutaneous self-injection1.

What is the difference between Meriofert® and Menopur®(menotrophin)?

Clinically, in a long down-regulation stimulation protocol for IVF, Meriofert has been shown to produce two more mature oocytes than Menopur with a shorter period of stimulation.*7 In another study, a higher proportion of mature oocytes were obtained with significantly less gonadotrophin being administered during a shorter period of stimulation.#8

The LH activity in Meriofert is predominantly from placental hCG1,9 whereas Menopur's LH activity comes from pituitary hCG10,11,12. These two types of hCG are different in terms of half-life and the effect on the receptor13,14.

Meriofert® has a higher purity than Menopur®9

*This finding is from a prospective, controlled, randomised, multicentre, non-inferiority study which was designed in a way that daily gonadotrophin administration was continued until at least two follicles had a mean diameter greater than 16 mm, serum oestradiol levels greater than 400 pg/ml (or 1500 pmol/l), or both7. While in Menopur’s SPC, it is recommended there should be at least 3 follicles greater than 17mm in diameter with 17 beta-oestradiol levels of at least 3500 pmol/L (920 picograms/ml).10

#This finding is from a prospective, randomised, investigator-blind, controlled, clinical study which was designed in a way that daily gonadotrophin administration was continued until at least two follicles had a mean diameter greater than 16 mm and serum oestradiol levels were appropriate for the total number of developing follicles.8 While in Menupur's SPC, it is recommended there should be at least 3 follicles greater than 17 mm in diameter with 17 beta-oestradiol levels of at least 3500 pmol/L (920 picograms/ml).10

Adverse events should be reported. Reporting forms and information can be found at www.mhra.gov.uk/yellowcard. Adverse events should also be reported to Pharmasure.

Fostimon® (urofollitropin)

Prescribing Information
SmPC 75iu
SmPC 150iu
PIL

What is Fostimon®?

Fostimon® contains highly purified follicle stimulating hormone (FSH) obtained from natural human sources (not genetically engineered)15. This natural source means that the type of FSH contained in Fostimon® closely resembles the acidic FSH found in the early to mid-follicular phase of a woman’s natural fertility cycle2,3. This type of FSH is important for optimal growth of the follicles containing the eggs.4

Fostimon® can be given by subcutaneous self-injection.15

What is the difference between Fostimon and recombinant FSH (Follitropin alpha)?

Fostimon is derived from a natural human source, whereas recombinant FSH is derived from genetically engineered chinese hamster ovary cells.16

The FSH in Fostimon has a more acidic FSH isoform profile than follitropin alpha.17

There is a gentler oestradiol rise with acidic FSH isoforms than with less acidic FSH isoforms.19 A premature oestradiol rise can cause an early rise in progesterone levels, resulting in endometrial advancement and reduced likelihood of implantation.20

Clinically, Fostimon achieves more fertilised oocytes, more top-quality embryos for fresh transfer and cryopreservation and a higher fertilisation rate compared with the follitropin alpha group in PCOS patients.21

Lubion® (progesterone)

Prescribing Information
SmPC
PIL

What is Lubion®?

Lubion® is the only aqueous solution of progesterone.22

Progesterone is a natural hormone, which is important to help establish and maintain pregnancy.

Lubion® is the only progesterone solution which can be given by subcutaneous self-injection.22 A recent study has measured patients' opinions on comfort, ease of use, convenience, overall satisfaction, level of anxiety and pain associated with subcutaneous administration compared with their previous experience with the vaginal route of administration.  The results show that patients are significantly more in favour of the subcutaneous route compared with vaginal route of administration.23

  1. Meriofert SPC Apr 2017 revision.
  2. Andersen CY et al., Reproductive Biology Insights, 2011.  What is the Clinical Relevance of Follicle-Stimulating Hormone Isoforms in Fertility Treatment?
  3. Anobile CJ et al., Mol Hum Reprod, 1998. Glycoform composition of serum gonadotrophins through the normal menstrual cycle and in the post-menopausal state.
  4. Vitt et al, Biology of reproduction, 2001. Embryonic Development after Follicle Culture Is Influenced by Follicle-Stimulating Hormone Isoelectric Point Range.
  5. Jeppesen JV et al., JCEM ONLINE, 2012. LH-receptor gene expression in human granulosa and cumulus cells from antral and preovulatory follicles.
  6. Yong EL et al., Journal of Clinical Endocrinology and Metabolism, 1992. Hormonal regulation of the growth and steroidogenic function of human granulosa cells.
  7. Lockwood G et al. A randomized controlled trial comparing the efficacy and safety of two HMG preparations gaining their LH bioactivity from different HCG sources. Reproductive BioMedicine Online (2017)
  8. Alviggi et al., Gynecol Endocrinol, 2013. A prospective, randomised, investigator-blind, controlled, clinical study on the clinical efficacy and tolerability of two highly purified hMG preparations administered subcutaneously in women undergoing IVF.
  9. IBSA data on file (hCG content). (UK/201809/00002/01)
  10. Menopur SPC Apr 2017 revision
  11. Cole LA. Reprod Biol Endocrinol, 2010. Biological functions of hCG and hCG-related molecules.
  12. Cole LA. Reprod Biol Endocrinol, 2012. hCG, the wonder of today’s science. Mar 28;10:24.
  13. Cole LA. Clin Chim Acta, 2012. hCG, five independent molecules.
  14. Birken S et al. Mol Cell Endocrinol, 1996. Metabolism of hCG and hLH to multiple urinary forms.
  15. Fostimon SPC Dec 2017 revision
  16. Gonal-f SPC Aug 2018 revision
  17. Lombardi A et al., Electrophoresis, 2013. Evaluation of the oligosaccharide composition of commercial follicle stimulating hormone preparations.
  18. Nayudu PL et al., Reprod Biomed Online, 2002. Intact follicle culture: what it can tell us about the roles of FSH glycoforms during follicle development.
  19. Cerpa-Poljak et al. Endocrinology, 1993. Isoelectric charge of recombinant human follicle-stimulating hormone isoforms determines receptor affinity and in vitro bioactivity.
  20. Fatemi HM et al., Reprod Biomed Online, 2013. Implantation in assisted reproduction: a look at endometrial receptivity.
  21. Aboulghar M et al., Fertility and Sterility, 2010. Prospective, randomized study comparing highly purified urinary follicle-stimulating hormone (FSH) and recombinant FSH for in vitro fertilization/intracytoplasmic sperm injection in patients with polycystic ovary syndrome.
  22. Lubion PIL Mar 2017 revision
  23. Venturella R et al., Gynecol Endocrinol, 2018. Progesterone for preparation of the endometrium for frozen-thawed blastocyst transfer in vitro fertilization cycles: a prospective study on patients' opinions on a new subcutaneous formulation.