A fertility pen, redesigned to incorporate updates and new features developed from patient and provider feedback, has been FDA approved and will be available December 2013.
Gonal-f RFF Redi-ject (recombinant follitropin alfa), a disposable pre-filled drug injector pen intended for the subcutaneous injection of a liquid formulation of Gonal-f RFF (revised formulation female), has been approved by the FDA. Marketed as Gonal-f RFF Redi-ject by Merck Serono subsidiary EMD Serono Inc, this redesigned system is based on feedback from both patients and health care providers.
According to EMD Serono, Gonal-f RFF Redi-ject is part of a global family of prefilled pens designed for patient self-administration of Gonal-f, an injectable recombinant follitropin alfa. These prefilled pens have demonstrated dose accuracy and are designed with physicians and patients in mind. Gonal-f is prescribed to supplement or replace naturally occurring follicle-stimulating hormone, an essential hormone to treat infertility, which affects approximately 1 in 8 couples in the United States.
This redesigned system will be available in December 2013 in three pen sizes: 300 IU, 450 IU, and 900 IU. According to prescribing information, Gonal-f RFF Redi-ject is indicated for induction of ovulation and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not caused by primary ovarian failure and development of multiple follicles in ovulatory women as part of an assisted reproductive technology cycle.
Reference
EMD Serono receives FDA approval for redesigned fertility pen [news release]. Available
here
. Accessed October 22, 2013.
Pioglitazone outperforms metformin in IVF for PCOS-related infertility
May 6th 2024A recent double-blind, randomized clinical trial revealed a higher clinical pregnancy rate with pioglitazone compared to metformin in polycystic ovarian syndrome patients undergoing in vitro fertilization, suggesting potential for improved outcomes.
Read More
S1E4: Dr. Kristina Adams-Waldorf: Pandemics, pathogens and perseverance
July 16th 2020This episode of Pap Talk by Contemporary OB/GYN features an interview with Dr. Kristina Adams-Waldorf, Professor in the Department of Obstetrics and Gynecology and Adjunct Professor in Global Health at the University of Washington (UW) School of Medicine in Seattle.
Listen
Reducing multifetal pregnancy through publicly funded IVF programs
April 26th 2024Learn how a mandatory elective single-embryo transfer policy in publicly funded in vitro fertilization programs significantly decreases multifetal pregnancy rates, offering insights into mitigating risks in assisted reproduction.
Read More