Follistim AQ (Follitropin Beta Subcutaneous) - Summary

FOLLISTIM AQ SUMMARY

Follistim® AQ Cartridge (follitropin beta injection) contains human follicle-stimulating hormone (hFSH), a glycoprotein hormone which is manufactured by recombinant DNA (rDNA) technology.

Follistim® AQ Cartridge (follitropin beta injection) is indicated for the development of multiple follicles in ovulatory patients participating in an Assisted Reproductive Technology (ART) program. Follistim® AQ Cartridge is also indicated for the induction of ovulation and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure.

Selection of Patients

Before treatment with Follistim® AQ Cartridge (follitropin beta injection) is initiated:

1. A thorough gynecologic and endocrinologic evaluation of the patient must be performed. The evaluation should include a hysterosalpingogram (to rule out uterine and tubal pathology) and documentation of anovulation by means of reviewing a patient’s history, performing a physical examination, determining serum hormonal levels as indicated, and optionally performing an endometrial biopsy. Patients with tubal pathology should receive Follistim® AQ Cartridge only if enrolled in an ART program.
2. Primary ovarian failure should be excluded by the determination of circulating gonadotropin levels.
3. Careful examination should be made to rule out early pregnancy.
4. Evaluation of the partner’s fertility potential should be included in the workup procedure.

NEWS HIGHLIGHTS

Media Articles Related to Follistim AQ (Follitropin Beta Subcutaneous)

International Event At Queen's Focuses On Male Infertility
Source: Conferences News From Medical News Today [2009.11.19]
Male infertility and tackling falling birth rates across Europe will be among the topics addressed at this year's British Andrology Society's annual conference at Queen's University in Belfast. World leaders in the field of andrology - the study of male reproduction - will meet at Queen's this week (Thursday and Friday) to discuss the latest developments in the field of fertility including the potential to create artificial sperm from stem cells.

European Urology: Male Factor Infertility Associated With Comorbidities
Source: Fertility News From Medical News Today [2009.11.11]
The December issue of European Urology, the official journal of the European Association of Urology, features an article entitled 'Are Infertile Men Less Healthy than Fertile Men? Results of a Prospective Case-Control Survey' by Dr. Andrea Salonia et al. The conclusion is that male factor infertility is associated with a number of medical comorbidities, as objectively scored with the hospital-based Charlson Comorbidity Index. Dr.

Male Infertility Tied to Testicular Cancer Risk
Source: MedicineNet Testicular Cancer Specialty [2009.02.24]
Title: Male Infertility Tied to Testicular Cancer Risk
Category: Health News
Created: 2/24/2009 2:00:00 AM
Last Editorial Review: 2/24/2009

Study: Infertility Treatments No Help
Source: MedicineNet Polycystic Ovary Specialty [2008.08.08]
Title: Study: Infertility Treatments No Help
Category: Health News
Created: 8/8/2008
Last Editorial Review: 8/8/2008

Infertility
Source: MedicineNet Endometrial Biopsy Specialty [2007.02.07]
Title: Infertility
Category: Diseases and Conditions
Created: 11/17/2004
Last Editorial Review: 2/7/2007

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Published Studies Related to Follistim AQ (Follitropin Beta Subcutaneous)

Patient and nurse evaluation of recombinant human follicle-stimulating hormone administration methods: comparison of two follitropin injection pens. [2008.03]
OBJECTIVE: Ovarian stimulation by injection of gonadotrophins is an essential part of assisted reproductive technology (ART) protocols. Two studies (a German pilot study and an Australian study) aimed to assess and compare the ease-of-use, safety and efficacy of two follitropin injection pens... CONCLUSIONS: Taken together, results from these two small studies suggest that the follitropin alfa pen was effective, well tolerated, and patient and nurse acceptance appeared to be higher for the follitropin alfa pen versus the follitropin beta pen, which may benefit compliance, leading to improved outcomes.

Highly purified human-derived follicle-stimulating hormone (Bravelle) has equivalent efficacy to follitropin-beta (Follistim) in infertile women undergoing in vitro fertilization. [2003.10.03]
BACKGROUND: These data compare the efficacy and safety of highly purified human-derived follicle-stimulating hormone (Bravelle) and recombinant follitropin-beta (Follistim) in women undergoing in vitro fertilization... CONCLUSIONS: Bravelle and Follistim had comparable efficacy in controlled ovarian hyperstimulation in women undergoing IVF-ET. There were no differences in the nature or number of adverse events between the treatment groups although Bravelle injections were reported to be significantly less painful.

An open, randomized single-centre study to compare the efficacy and convenience of follitropin beta administered by a pen device with follitropin alpha administered by a conventional syringe in women undergoing ovarian stimulation for IVF/ICSI. [2003.06]
BACKGROUND: A pen device, similar to an insulin pen, has been recently marketed for the administration of follitropin beta in cartridges. A randomized controlled trial was performed to compare the efficacy and convenience of this pen device delivering follitropin beta with a conventional syringe delivering follitropin alpha... CONCLUSIONS: Self-injection with the pen device is safe and easy, more convenient and less painful for the patient, requires less FSH and shortens the treatment duration.

Comparison of the efficacy and safety of a highly purified human follicle-stimulating hormone (Bravelle) and recombinant follitropin-beta for in vitro fertilization: a prospective, randomized study. [2002.06]
OBJECTIVE: To compare the efficacy and safety of Bravelle s.c., Bravelle i.m., and Follistim s.c...

A prospective randomized clinical trial of differing starter doses of recombinant follicle-stimulating hormone (follitropin-beta) for first time in vitro fertilization and intracytoplasmic sperm injection treatment cycles. [2001.01]
OBJECTIVE: Comparison of the efficacy of differing starter doses of recombinant follicle stimulating hormone (rFSH) for IVF and intracytoplasmic sperm injection cycles when the treatment is administered both subcutaneously and intramuscularly... Otherwise, there is little advantage to using the higher dosage.

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Clinical Trials Related to Follistim AQ (Follitropin Beta Subcutaneous)

CONSORT Randomised Controlled Trial in Assisted Reproductive Technology [Recruiting]

MENOPUR® Versus FOLLISTIM® [Recruiting]
To compare the efficacy and safety of MENOPUR® with that of FOLLISTIM® in patients who are undergoing GnRH antagonist IVF cycles

Menopur® Versus Follistim® in Polycystic Ovarian Syndrome (PCOS) [Recruiting]
This multicenter, randomized, open-label exploratory study will be performed in approximately 200 PCOS but otherwise healthy females undergoing IVF. Each study center will follow its standard practice for IVF within the study parameters as noted in this protocol. The study centers will use marketed products purchased from Schraft's Pharmacy for all phases of the study (down-regulation, stimulation, ovulation induction, and luteal support). Subjects will be randomly assigned to Menopur® or Follistim Pen® for stimulation and Endometrin® or progesterone in oil for luteal support. Subjects will return to the study center for regular scheduled clinic visits as required per IVF protocol at the site and at specified times during the cycle (Stimulation Day 6, Day of hCG, and first serum pregnancy test) for estradiol (E2), progesterone (P4) and hCG labs. All subjects will be required to complete a final study visit at completion of luteal support or negative serum pregnancy test following embryo transfer.

AS900672-Enriched in Ovulation Induction [Recruiting]
Study to evaluate a new investigational long-acting follicle stimulating hormone in oligo-anovulatory women undergoing ovulation induction. This study will compare 4 doses of the investigational drug vs a currently marketed medication (GONAL-f) prefilled pen with regards to ovulation rate.

Clinical Efficacy and Tolerability of Two FSH Preparations (Human FSH Versus rFSH - Follitropin Alpha) in Women Undergoing IVF [Completed]
The purpose of the study is to evaluate the clinical efficacy and general tolerability of two different subcutaneous FSH preparations (Fostimon®, IBSA vs Gonal-F®, Serono Inc.) when administered to patients undergoing controlled ovarian stimulation for IVF.

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