Infertility left Abby Mercado searching for answers—and connection. Rescripted became the solution for her and so many others.
By: Alexandra Frost
Infertility affects one in six women across the globe, and for some, it is a daunting time where the desire to create a family becomes a rollercoaster of emotions. In the United States, more than 12% of women ages 15-49 have sought infertility services, the Centers for Disease Control and Prevention reports, and with that can come fear, stress, confusion, and isolation.
One such parent, Abby Mercado, a 39-year-old mom of three kids and busy businesswoman in Denver, says building a family started as a pretty “typical” journey. She met her husband in college, moved to Denver for both of their jobs, and around two years into their marriage, started talking babies. Then it took a turn. They tried and tried. But, like couples dealing with infertility, they hit a wall and found little community, or answers, along the way.
“We were blindsided and really scared and lonely,” she says. At the fertility clinic, they were diagnosed with male factor infertility, and their first IUI failed. “We moved forward with IVF, and I found the medications to be very complicated.”
The stress of fertility treatments
She was working full time at her venture capital firm, in a male-dominated culture, where she hadn’t told anyone she was going through fertility treatments. After diagnosis, she was prescribed multiple medications, one of which was Follistim, manufactured by Organon, a global women’s health company.
“I found myself caught between a wave of relief and a surge of intensity. Relieved that we finally had a plan after months of uncertainty, but overwhelmed by the sheer volume of new information, the cost, and the realization that my body was now ‘part of the protocol,’” she said. Through her research, Abby realized that she wasn’t alone in any of her feelings, especially relating to cost. Luckily, through her clinic, she learned about savings programs designed for eligible cash-paying patients who are prescribed Organon medications through ReUnite, Mercado adds, “from what I have seen for patients, the ReUnite savings programs are really helpful, which can be the difference between moving forward with a cycle or not.” Organon Fertility Franchise Lead Phil O’Connell shares that the collaboration between Organon and ReUnite was designed to create improved access for self-pay patients. “By combining financial support, strategic collaborations, and user-friendly technology, ReUnite Rx reduces the economic burden of fertility treatments, enhances accessibility, and supports patients through their fertility journey,” he says. “Since the ReUnite programs went live in September 2018, Organon and ReUnite have assisted more than 73,500 eligible cash-paying patients.”
So, Mercado’s medicine came, and her journey began. “A large, ice-packed box arrived from a specialty pharmacy. Opening it felt a bit like unboxing high-stakes science equipment: vials, pens, needles, alcohol swabs, a sharps container– the works,” she says. Though she was relieved to be taking a step forward on her fertility journey, and at a reasonable cost, she says it “drove home that fertility treatments are a medical journey.”
Throughout her treatment, Abby still struggled with work-life balance as she’d wait for a phone call from a nurse she couldn’t miss while in important meetings. “If I were to miss a call or an instruction or not get back in touch because of work, was I going to have to cancel my cycle?” She’d worry. With treatments that felt “high stakes”, IVF-related “classes” felt unhelpful.
Luckily, Organon provided education as well. “Before the first injection I was nervous about getting the dose right and about injecting myself at all. I watched a couple of tutorial videos, practiced dialing the pen with the cap on, and laid everything out like a surgical tray to feel in control,” she says. “The first shot was awkward, but by night two it was almost routine. The pen design is intuitive– the dose clicks into place, and the needle is fine enough that the physical pain was minimal. While mechanically, Abby found the Follistim Pen to be user-friendly, she added that “the hardest part of the journey was the emotional hurdle.”
Building a better way
After lacking education and empowerment on their own fertility journeys, Abby and her “soul sister” in business and life, Kristyn Hodgdon, set out to create a platform for women to access better information about their bodies, health, and wellness, called Rescripted, which currently reaches around 20 million women monthly.
The role of tech in building community
Soon, with the help of AI, the Rescripted community will also have access to a Chat GPT function, Clara. If Mercado would have had Clara in her pocket when she was struggling, she’d have asked “Has IUI EVER worked for male factor infertility? What are the costs associated with IVF? What do the medications really do? What are some resources to afford IVF?” and, importantly, “How do I get my mind right?” That aspect of community for mental health is not only essential for fertility treatment success, but for a woman’s overall well-being throughout the process. And of course, maybe Clara would have had a better answer for getting through the dreaded two-week wait with good distraction techniques, she jokes.
The role of providers in supporting patients
As she continues to build Rescripted, she has a message from families in fertility treatment to healthcare providers — “Paternalism in medicine doesn't necessarily exist in a big way anymore, but it has historically, and I think that it impacts how patients show up to their physicians. Your patients are probably really scared and have a million questions,” she says. “I want to remind you to lead with empathy.”
Organon’s commitment
Organon is steadfast in their commitment to improving access to fertility treatments. This dedication extends not only through the manufacturing lens, but along extensive government affairs policy efforts and cost reduction initiatives via their collaboration with ReUnite Rx.
SELECTED SAFETY INFORMATION:
INDICATIONS
FOLLISTIM AQ Cartridge is indicated for the induction of ovulation and pregnancy in anovulatory infertile women in whom the cause of infertility is functional and not due to primary ovarian failure.
FOLLISTIM AQ Cartridge is also indicated for pregnancy in normal ovulatory women undergoing controlled ovarian stimulation as part of in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI) cycle.
Prior to initiation of treatment with FOLLISTIM AQ Cartridge for OI or IVF/ICSI:
Women should have a complete gynecologic and endocrinologic evaluation and diagnosis of the cause of infertility.
The possibility of pregnancy should be excluded.
The fertility status of the male partner should be evaluated.
Additionally, for women undergoing OI:
Primary ovarian failure should be excluded.
Tubal patency should be demonstrated.
Selected Safety Information About FOLLISTIM AQ Cartridge
CONTRAINDICATIONS
FOLLISTIM AQ Cartridge is contraindicated in women who exhibit any of the following: prior hypersensitivity to recombinant human follicle-stimulating hormone (hFSH) products; high levels of FSH indicating primary gonadal failure; presence of uncontrolled non-gonadal endocrinopathies (eg, thyroid, adrenal, or pituitary disorders); hypersensitivity reactions to streptomycin or neomycin (FOLLISTIM AQ may contain traces of these antibiotics.); tumors of the ovary, breast, uterus, hypothalamus, or pituitary gland; pregnancy; heavy or irregular vaginal bleeding of undetermined origin; or ovarian cysts or enlargement not due to polycystic ovary syndrome (PCOS).
WARNINGS AND PRECAUTIONS
FOLLISTIM AQ Cartridge should be prescribed only by physicians who are experienced in infertility treatment. FOLLISTIM AQ Cartridge contains a potent gonadotropic substance capable of causing ovarian hyperstimulation syndrome (OHSS) with or without pulmonary or vascular complications and multiple births. Gonadotropin therapy requires the availability of appropriate monitoring facilities.
Abnormal Ovarian Enlargement
In order to minimize the hazards associated with abnormal ovarian enlargement that may occur with FOLLISTIM AQ therapy, treatment should be individualized and the lowest effective dose should be used. Intercourse should be prohibited in patients with significant ovarian enlargement after ovulation because of the danger of hemoperitoneum resulting from ruptured ovarian cysts.
Ovarian Hyperstimulation Syndrome
OHSS is a medical entity distinct from uncomplicated ovarian enlargement and may progress rapidly to become a serious medical condition. OHSS occurs after gonadotropin treatment has been discontinued, and it can develop rapidly, reaching its maximum about 7 to 10 days following treatment. Usually, OHSS resolves spontaneously with the onset of menses. If there is a risk for OHSS evident prior to human chorionic gonadotropin (hCG) administration, the hCG must be withheld. Cases of OHSS are more common, more severe, and more protracted if pregnancy occurs; therefore, women should be assessed for the development of OHSS for at least 2 weeks after hCG administration. If serious OHSS occurs, gonadotropins, including hCG, should be stopped and consideration should be given as to whether the patient needs to be hospitalized. During clinical trials with FOLLISTIM or FOLLISTIM AQ Cartridge therapy, OHSS occurred in 7.6% of 105 women (ovulation induction) and 6.4% of 751 women (IVF or ICSI) treated with FOLLISTIM and FOLLISTIM AQ Cartridge, respectively.
Pulmonary and Vascular Complications
Serious pulmonary conditions (eg, atelectasis, acute respiratory distress syndrome) have been reported in women treated with gonadotropins. In addition, thromboembolic reactions, both in association with and separate from OHSS, have been reported following gonadotropin therapy. Women with generally recognized risk factors for thrombosis, such as a personal or family history, severe obesity, or thrombophilia, may have an increased risk of venous or arterial thromboembolic events during or following treatment with gonadotropins. Sequelae of such reactions have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb, and rarely, in myocardial infarction. In rare cases, pulmonary complications and/or thromboembolic reactions have resulted in death. In women with recognized risk factors, the benefits of ovulation induction, IVF, or ICSI need to be weighed against the risks. It should be noted that pregnancy itself also carries an increased risk of thrombosis.
Ovarian Torsion
Ovarian torsion has been reported after treatment with FOLLISTIM AQ Cartridge and after intervention with other gonadotropins. This may be related to OHSS, pregnancy, previous abdominal surgery, past history of ovarian torsion, previous or current ovarian cyst, and polycystic ovaries. Damage to the ovary due to reduced blood supply can be limited by early diagnosis and immediate detorsion.
Multifetal Gestation and Births
Multifetal gestation and births have been reported with all gonadotropin treatments including treatment with FOLLISTIM AQ Cartridge. The woman and her partner should be advised of the potential risk of multifetal gestation and births before starting treatment.
Congenital Anomalies
The incidence of congenital malformations after IVF or ICSI may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (eg, maternal age, sperm characteristics) and to the higher incidence of multifetal gestations after IVF or ICSI. There are no indications that the use of gonadotropins during IVF or ICSI is associated with an increased risk of congenital malformations.
Ectopic Pregnancy
Since infertile women undergoing IVF and ICSI often have tubal abnormalities, the incidence of ectopic pregnancies might be increased. Early confirmation of an intrauterine pregnancy should be determined by β-hCG testing and transvaginal ultrasound.
Spontaneous Abortion
The risk of spontaneous abortions (miscarriage) is increased with gonadotropin products; however, causality has not been established. The increased risk may be a factor of the underlying infertility.
Ovarian Neoplasms
There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for controlled ovarian stimulation; however, a causal relationship has not been established.
Laboratory Tests – For Women
In most instances, treatment with FOLLISTIM AQ Cartridge will result only in follicular growth and maturation. In order to complete the final phase of follicular maturation and to induce ovulation, hCG must be given following the administration of FOLLISTIM AQ Cartridge or when clinical assessment indicates that sufficient follicular maturation has occurred. The degree of follicular maturation and the timing of hCG administration can both be determined with the use of sonographic visualization of the ovaries and endometrial lining in conjunction with measurement of serum estradiol levels. The combination of transvaginal ultrasonography and measurement of serum estradiol levels is also useful for minimizing the risk of OHSS and multifetal gestations.
FOLLISTIM Pen
The FOLLISTIM Pen is intended only for use with FOLLISTIM AQ Cartridge. The FOLLISTIM Pen is not recommended for the blind or visually impaired without the assistance of an individual with good vision who is trained in the proper use of the injection device.
ADVERSE REACTIONS
Adverse reactions occurring in ≥2% of patients in a clinical trial undergoing ovulation induction with FOLLISTIM included: abdominal discomfort (2.9%), abdominal pain (2.9%), abdominal pain lower (2.9%), ovarian cyst (2.9%), OHSS (7.6%), headache, abdominal distension, constipation, diarrhea, nausea, pelvic pain, uterine enlargement, vaginal hemorrhage, and injection site reaction.
Adverse reactions occurring in ≥2% of patients in a clinical trial undergoing controlled ovarian stimulation as part of an IVF or ICSI cycle with FOLLISTIM AQ Cartridge included: headache (7.3%), nausea (3.9%), OHSS (6.4%), pelvic discomfort (8.3%), pelvic pain (5.5%), and fatigue (2.3%).
USE IN SPECIFIC POPULATIONS
Lactation
Risk Summary
It is not known whether this drug is excreted in human milk. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for FOLLISTIM AQ Cartridge and any potential adverse effects on the breastfed child from FOLLISTIM AQ Cartridge or from the underlying maternal condition.
PATIENT COUNSELING INFORMATION
Prior to beginning therapy, inform women about the time commitment and monitoring procedures necessary to undergo treatment. Also inform women that if they miss or forget to take a dose of FOLLISTIM AQ Cartridge, the next dose should not be doubled and they should call the health care provider for further instruction.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Before prescribing FOLLISTIM AQ Cartridge, please read the Prescribing Information. The Patient Information is also available.
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