IMPORTANT INFORMATION ABOUT THE PROPER USE AND RISKS OF Gonal-f RFF® Redi-jectTM (follitropin alfa injection)
Indications and Usage:
- Induction of ovulation (OI) and pregnancy in oligo-anovulatory women in whom the cause of infertility is functional and not due to primary ovarian failure
- Development of multiple follicles in ovulatory women as part of an Assisted Reproductive Technology (ART) cycle.
- Prior to treatment, complete an evaluation of female and male partners to determine infertility diagnosis. Primary ovarian failure and potential pregnancy should be excluded.
- hypersensitivity to rhFSH preparations or excipients
- high levels of FSH indicating primary gonadal failure
- pregnancy (Pregnancy Category X)
- uncontrolled non-gonadal endocrinopathies (thyroid, adrenal, pituitary disorders)
- sex hormone dependent tumors of the reproductive tract and accessory organs
- tumors of pituitary gland or hypothalamus
- abnormal uterine bleeding
- ovarian cyst or enlargement of undetermined origin, not due to polycystic ovary syndrome.
Warnings and Precautions:
- For use by physicians specializing in fertility treatment or reproductive health and only when appropriate monitoring facilities are available.
- Gonal-f® RFF Redi-ject™ is a potent gonadotropin. The lowest effective dose should be used given risk of abnormal ovarian enlargement and Ovarian Hyperstimulation Syndrome (OHSS). Ultrasound monitoring of ovarian response and/or measurement of estradiol levels are important to minimize risks. If symptoms of OHSS (severe pelvic or abdominal pain and distension, nausea, vomiting, diarrhea, severe ovarian enlargement, weight gain, dyspnea, oliguria) develop, all gondotropin treatment should be stopped, hCG should be withheld, and intercourse should be prohibited. OHSS can be severe and requires hospitalization and treatment of fluid and electrolyte imbalances. OHSS may occur with or without pregnancy. Women should be assessed for the development of OHSS for at least two weeks after hCG administration.
- Serious systemic hypersensitivity reactions, including anaphylaxis, have been reported in the postmarketing experience. Symptoms have included dyspnea, facial edema, pruritis, and urticaria. If an anaphylactic or other serious allergic reaction occurs, initiate appropriate therapy including supportive measures if cardiovascular instability and/or respiratory compromise occur, and discontinue further use.
- Thromboembolic events both in association with, and separate from OHSS have been reported in women treated with gonadotropins. Women with generally recognized risk factors for thrombosis, such as 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 infarctions. In rare cases, pulmonary complications and/or thromboembolic reactions have resulted in death. In women with recognized risk factors, the benefits of OI and ART need to be weighed against the risks.
- Serious pulmonary conditions (e.g., atelectasis, acute respiratory distress syndrome and exacerbation of asthma) have been reported in women treated with gonadotropins.
- Ovarian torsion has been reported after treatment with 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.
- The couple should be advised of the potential risk of multi-fetal gestation and birth before beginning therapy. During clinical trials, multiple births occurred in 20% of live births in women receiving therapy for ovulation induction and 35.1 % of live births in women undergoing ART.
- The incidence of congenital malformations after some ART [specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)] may be slightly higher than after spontaneous conception. This slightly higher incidence is thought to be related to differences in parental characteristics (e.g., maternal age, maternal and paternal genetic background, sperm characteristics) and to the higher incidence of multi-fetal gestations after IVF or ICSI.
- Since women undergoing ART often have tubal abnormalities, the incidence of ectopic pregnancy may be increased
- The incidence of spontaneous abortion may be increased. However, causality has not been established. This may be a factor of the underlying infertility.
- Both benign and malignant ovarian neoplasms have been infrequently reported; causality has not been established.
- 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.
The most common adverse reactions (≥5%) in OI include: headache, abdominal pain, and ovarian hyperstimulation. The most common adverse reactions (≥5%) in ART include: abdominal pain, nausea, abdominal enlargement, headache, and injection site reactions (pain, bruising).
In addition to advising patients about the proper use of treatment, the duration and necessity of monitoring, handling of missed doses, OHSS, and multi-fetal gestation and birth, patients should be advised to review the Patient Information Leaflet which contains risk information, follow the Instructions for Use for the Gonal-f® RFF Redi-ject™, not share the device or reuse needles, and to ask their HCP about questions.
HCP should refer to the full Prescribing Information for full disclosure.
*revised formulation female
IMPORTANT INFORMATION ABOUT THE PROPER USE AND RISKS OF GONAL-F® (follitropin alfa for injection):
For women, Gonal-f® (follitropin alfa for injection) and Gonal-f® RFF* (follitropin alfa injection) are indicated for 1) the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure and 2) for the development of multiple follicles in the ovulatory patient participating in an ART program.
Gonal-f® is also indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.
Important Risk Information:
These products should only be prescribed by physicians specializing in fertility or reproductive health. Use of Gonal-f® or Gonal-f® RFF by women can result in multiple births. Gonal-f® and Gonal-f® RFF are potent gonadotropins capable of causing mild to severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary complications. Gonal-f® and Gonal-f® RFF are contraindicated in women and men who exhibit prior hypersensitivity to recombinant FSH preparations or one of their 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, and an organic intracranial lesion such as a pituitary tumor. Additionally, Gonal-f® and Gonal-f® RFF should not be given to women with abnormal bleeding, presence or enlargement of an ovarian cyst of undetermined origin, or who are pregnant or nursing. The most common side effects reported in women using Gonal-f® and Gonal-f® RFF include headache, abdominal pain, enlarged abdomen, ovarian cysts, nausea, and upper respiratory infections. Men using Gonal-f® have commonly reported acne, breast pain and growth, fatigue. Injection site reactions have been reported.
*revised formulation female