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Follistim AQ (Follitropin Beta Subcutaneous) - 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.

See all Follistim AQ indications & dosage >>


Media Articles Related to Follistim AQ (Follitropin Beta Subcutaneous)

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

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

more news >>

Published Studies Related to Follistim AQ (Follitropin Beta Subcutaneous)

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.

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...

more studies >>

Clinical Trials Related to Follistim AQ (Follitropin Beta Subcutaneous)

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.

more trials >>

Page last updated: 2017-09-19

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