Follistim (Follitropin Beta) - Summary

FOLLISTIM SUMMARY

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

Follistim® (follitropin beta for injection) is indicated for the development of multiple follicles in ovulatory patients participating in an Assisted Reproductive Technology (ART) program. Follistim® 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® is instituted:

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® 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 (Follitropin Beta)

Infertility Quiz: Test Your IQ of Infertility
Source: MedicineNet Anemia Specialty [2017.09.19]
Title: Infertility Quiz: Test Your IQ of Infertility
Category: MedicineNet Quiz
Created: 6/17/2011 2:45:00 PM
Last Editorial Review: 9/19/2017 6:39:53 PM

Consider Acupuncture for Incontinence, Not Certain Infertility Cases
Source: MedicineNet Acupuncture Specialty [2017.06.28]
Title: Consider Acupuncture for Incontinence, Not Certain Infertility Cases
Category: Health News
Created: 6/27/2017 12:00:00 AM
Last Editorial Review: 6/28/2017 12:00:00 AM

Infertility
Source: MedicineNet Antiphospholipid Syndrome Specialty [2017.05.16]
Title: Infertility
Category: Symptoms and Signs
Created: 10/13/2003 12:00:00 AM
Last Editorial Review: 5/16/2017 12:00:00 AM

Infertility: Types, Treatments, and Costs
Source: MedicineNet Endometrial Biopsy Specialty [2016.05.31]
Title: Infertility: Types, Treatments, and Costs
Category: Slideshows
Created: 12/10/2010 5:53:00 PM
Last Editorial Review: 5/31/2016 12:00:00 AM

For Unexplained Infertility, Breast Cancer Drug No Better Than Standard Treatment
Source: MedicineNet letrozole Specialty [2015.09.24]
Title: For Unexplained Infertility, Breast Cancer Drug No Better Than Standard Treatment
Category: Health News
Created: 9/23/2015 12:00:00 AM
Last Editorial Review: 9/24/2015 12:00:00 AM

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Published Studies Related to Follistim (Follitropin Beta)

Pharmacokinetics and follicular dynamics of corifollitropin alfa versus recombinant FSH during ovarian stimulation for IVF. [2010.11]
A single injection of corifollitropin alfa can replace seven daily injections of recombinant FSH (rFSH) using a gonadotrophin-releasing hormone antagonist protocol in ovarian stimulation prior to IVF or intracytoplasmic sperm injection...

A double-blind, non-inferiority RCT comparing corifollitropin alfa and recombinant FSH during the first seven days of ovarian stimulation using a GnRH antagonist protocol. [2009.12]
BACKGROUND: Corifollitropin alfa, a fusion protein lacking LH activity, has a longer elimination half-life and extended time to peak levels than recombinant FSH (rFSH). A single injection of corifollitropin alfa may replace seven daily gonadotrophin injections during the first week of ovarian stimulation... CONCLUSION: Corifollitropin alfa is a novel and effective treatment option for potential normal responder patients undergoing ovarian stimulation with GnRH antagonist co-treatment for IVF resulting in a high ongoing pregnancy rate, equal to that achieved with daily rFSH. The trial was registered under ClinicalTrials.gov identifier NTC00696800.

The effect of cetrorelix vs. ganirelix on pregnancy outcome using minimal gonadotropin stimulation in women with elevated day 3 serum follicle stimulating hormone levels. [2009]
CONCLUSIONS: The trend for lower pregnancy rates with ganirelix vs. cetrorelix seen in women with diminished egg reserve is consistent with the findings of a study performed in women with normal egg reserve using a normal gonadotropin stimulation regimen. It is not clear if the adverse effect is on the endometrium or the embryo.

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.

Comparison of the efficacy and safety of a new recombinant human follicle-stimulating hormone (DA-3801) with follitropin-alpha (Gonal-F((R))) in women undergoing controlled ovarian hyperstimulation for assisted reproductive technology. [2007.06]
Aim: To compare the efficacy and safety of a new recombinant human follicle-stimulating hormone (FSH; DA-3801) with follitropin-alpha (Gonal-F((R))) in women undergoing controlled ovarian hyperstimulation (COH) for assisted reproductive technology (ART)... Other secondary efficacy endpoints, including pregnancy and implantation rates and the incidence and severity of adverse events, were comparable between the two groups.

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Clinical Trials Related to Follistim (Follitropin Beta)

MENOPUR® Versus FOLLISTIM® [Completed]
To compare the efficacy and safety of highly purified menotropin (Menopur®) with that of follitropin beta (FOLLISTIM®) in patients who are undergoing gonadotropin-releasing hormone (GnRH) antagonist in vitro fertilization (IVF) cycles

Comparative Pharmacokinetics of AFOLIA and US Gonal-f� RFF Redi-ject After Single Subcutaneous Application [Recruiting]
Comparative PK study after single SC application of Afolia and the reference product (US Gonal-f®). Objective: To demonstrate equivalence within 80%-125% margin of the reference product for the area under the curve (AUC) of Afolia.

EXpression PRofile Endometrium Samples Study [Terminated]
This is a Phase IV, pilot, open-label, national, multi-centric study planned to determine the gene expression profiles and histologic changes of the endometrial tissue before and after stimulation with Gonal-f®. Physicians are interested in identifying predictive genetic markers in assisted reproductive technologies (ART) in addition to the clinical predictive factors already known. Among those predictive factors, the state of the endometrium is considered as an important implantation determining factor for which pharmacogenomic research is of great interest. The direct benefits of this study will be to know whether the endometrial gene expression profile is modified in response to stimulation treatment and have an impact or not on the endometrial tissue receptivity. The potential benefits of this study could be to assess the therapy optimization based on individual treatment response and gene expression profile compared to group treatment response in infertile women and prediction of response to therapy based on gene expression profiling before and after Gonal-f® stimulation in infertile women.

A Phase 3b Study to Evaluate Subject Satisfaction With Follitropin Alfa Injection in Oligoanovulatory Infertile Women Undergoing Ovulation Induction [Completed]
This is a prospective, open-label, multicenter, trial evaluating subject satisfaction and efficacy with follitropin alfa injection applied by Pen device compared with the subject's previous experience with injectable gonadotropins in oligoanovulatory infertile women undergoing ovulation induction

Low-dose Gonal-f® in Ovulation Induction [Completed]
This is a prospective, multicenter, open-label, comparative and parallel-group study of ovulation induction evaluating tailoring of Recombinant follicle stimulating hormone (FSH) treatment using the Gonal-f® prefilled pen in World Health Organization (WHO) Type 2 anovulatory subjects who have previously failed to conceive with clomifene treatment.

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PATIENT REVIEWS / RATINGS / COMMENTS

Follistim review by 35 year old female patient
		Rating
Overall rating:
Effectiveness:		Highly Effective
Side effects:		Mild Side Effects
		Treatment Info
Condition / reason:		Infertility
Dosage & duration:		50-100 units (dosage frequency: 6 cycles) for the period of 6 cycles
Other conditions:		none
Other drugs taken:		none
		Reported Results
Benefits:		I got pregnant.
Side effects:		One of the cycles yielded like 3-4 good follicles which I thought were too much but took the risk anyway.
Comments:		One of the cycles yielded like 3-4 good follicles which I thought were too much but took the risk anyway. Puregon is very easy and PLEASANT to use, nothing I had expected. It is very straight forward, or "Idiot Proof". Did not hurt did not burn.