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follitropin alfa (Bemfola®)

 

Following a full submission

AWMSG advice
Status: Recommended

Follitropin alfa (Bemfola®) is recommended as an option for use within NHS Wales for the following licensed indications:

  • Anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate;
  • Stimulation of multifollicular development in women undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT);
  • In association with a luteinising hormone (LH) preparation for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patient were defined by an endogenous serum LH level < 1.2 IU/l;
  • Stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotropin (hCG) therapy.
 Final Recommendation: follitropinalfa (Bemfola) 2088 (PDF, 362Kb)
 Appraisal Report: follitropinalfa (Bemfola) 2088 (PDF, 396Kb)

Medicine details
Medicine name follitropin alfa (Bemfola®)
Formulation 75 IU/0.125 ml solution for injection, 150 IU/0.25 ml solution for injection, 225 IU/0.375 ml solution for injection, 300 IU/0.50 ml solution for injection, 450 IU/0.75 ml solution for injection
Reference number 2088
Indication

In adult women for anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomiphene citrate; stimulation of multifollicular development in patients undergoing superovulation for assisted reproductive technologies (ART) such as in vitro fertilisation (IVF), gamete intra-fallopian transfer (GIFT) and zygote intra-fallopian transfer (ZIFT); or in association with a luteinising hormone (LH) preparation for the stimulation of follicular development in women with severe LH and FSH deficiency. In clinical trials these patients were defined by an endogenous serum LH level < 1.2 IU/l. In adult men for the stimulation of spermatogenesis in men who have congenital or acquired hypogonadotrophic hypogonadism with concomitant human chorionic gonadotrophin (hCG) therapy
Company Gedeon Richter UK Ltd
BNF chapter Endocrine system
Submission type Full
Status Recommended
Advice number 4114
NMG meeting date 19/11/2014
AWMSG meeting date 17/12/2014
Ratification by Welsh Government 28/01/2015
Date of issue 29/01/2015
Date of last review 31/01/2018
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