Important Risk Information for Gonal-f® RFF* 75 IU (follitropin alfa for injection)
- Prior hypersensitivity to rhFSH preparations or excipients
- High levels of FSH indicating primary gonadal failure
- Uncontrolled thyroid or adrenal dysfunction
- Sex hormone dependent tumors of the reproductive tract and accessory organs
- Organic intracranial lesion such as a pituitary tumor
- Abnormal uterine bleeding of undetermined origin
- Ovarian cyst or enlargement of undetermined origin
For use by physicians specializing in fertility treatment or reproductive health and only when appropriate monitoring facilities are available. Gonal-f® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Monitor ovarian response with serum estradiol and vaginal ultrasound on a regular basis. The lowest effective dose should be used.
Overstimulation of the Ovary During FSH Therapy:
- Ovarian Enlargement: If the ovaries are abnormally enlarged on the last day of Gonal-f® RFF* therapy, hCG should not be administered in this course of therapy
- Ovarian Hyperstimulation Syndrome (OHSS): OHSS is a medical event distinct from uncomplicated ovarian enlargement. Severe OHSS may progress rapidly to become a serious medical event. If severe OHSS occurs, treatment must be stopped and the patient should be hospitalized.
Pulmonary and Vascular Complications:
- Serious pulmonary complications (e.g., atelectasis, acute respiratory distress syndrome and exacerbation of asthma) have been reported. Thromboembolic events both in association with, and separate from OHSS have been reported in women treated with gonadotropins including Gonal-f® RFF*. Sequelae of such events have included venous thrombophlebitis, pulmonary embolism, pulmonary infarction, cerebral vascular occlusion (stroke), and arterial occlusion resulting in loss of limb. In rare cases, pulmonary complications and/or thromboembolic reactions have resulted in death.
- In Study 2240 for women receiving Gonal-f® RFF* over three treatment cycles, 20% of live births were multiple births. In Study 21884, 35.1% of live births were multiple births in women receiving Gonal-f® RFF*. The rate of multiple births is dependent on the number of embryos transferred. The patient should be advised of the potential risk of multiple births before starting treatment
- General: Careful attention given to the diagnosis of infertility
- Information for Patients: Inform patients of duration of treatment, required monitoring of their condition, risks of ovarian hyperstimulation syndrome and multiple births
- Laboratory Tests: Both ultrasound and serum estradiol measurement should be used to monitor follicular growth and maturation, timing of the ovulatory trigger, detecting ovarian enlargement, and minimizing the risk of the OHSS and multiple gestation.
- Nursing Mothers: It is not known whether this drug is excreted in human milk and because of the potential for serious adverse reactions in the nursing infant, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother
The most common adverse reactions (≥5%) in OI include: headache, abdominal pain, ovarian hyperstimulation, breast pain, vaginal hemorrhage, sinusitis, pharyngitis and rhinitis. The most common adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal enlargement, headache, and injection site reactions (pain, bruising).
Indications and Usage:
- Induction of ovulation and pregnancy in the oligo-anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure
- Development of multiple follicles in the ovulatory patient as part of an Assisted Reproductive Technology (ART) cycle.
Prior to treatment complete an evaluation of female and male partners to determine infertility diagnosis and fertility status. Patients with a tubal obstruction should receive Gonal-f® only if enrolled in an in vitro fertilization program. Primary ovarian failure and pregnancy should be excluded.
For more information, please see the full Prescribing Information and Instructions for Use for Gonal-f® RFF* 75 IU
* RFF: Revised Formulation Female