Indications & Uses
Gonal-F is indicated for: Induction of ovulation and pregnancy in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure. Development of multiple follicles in ovulatory infertile women as part of an assisted reproductive technology (ART) cycle. ... Read moreGonal-F is indicated for: Induction of ovulation and pregnancy in oligo-anovulatory infertile women for whom the cause of infertility is functional and not due to primary ovarian failure. Development of multiple follicles in ovulatory infertile women as part of an assisted reproductive technology (ART) cycle. Induction of spermatogenesis in infertile men with azoospermia and primary or secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Initial Dose (First Cycle) for Ovulation Induction- Give 75 International Units of follitropin alfa subcutaneously each day for 14 days as the initial dosage. Individualize the dosage after the 14-day period, and do not exceed 300 International Units per day. Initial Dose (First Cycle) for Development of Multiple Follicles in Assisted Reproductive Technology (ART)- Give 150 International Units subcutaneously per day as the initial dosage. Adjust the dosage after 3 to 5 days, in increments of 75 to 150 International Units at each adjustment, and do not exceed 450 International Units per day. Males with Hypogonadotropic Hypogonadism and Azoospermia- Use together with hCG. Before starting combined therapy with follitropin alfa and hCG, pretreat with hCG alone at 1,000 to 2,250 USP units two to three times a week to bring serum testosterone to normal levels, which can take 3 to 6 months. Once testosterone has normalized, give 150 International Units of follitropin alfa subcutaneously three times a week along with 1,000 USP units of hCG (or the dose needed to keep serum testosterone within the normal range) three times a week.
Side Effects
In ovulation induction, the most common side effects (occurring in 5% or more of patients) are ovarian cyst, headache, abdominal pain, ovarian hyperstimulation syndrome (OHSS), nausea, flatulence, pain, and bleeding between periods. In assisted reproductive technology (ART), where multiple follicles develop, the most common side effects (5% or more) are headache, nausea, pelvic pain, and abdominal pain. In men with hypogonadotropic hypogonadism undergoing induction of spermatogenesis, the most common side effects (more than 5%) are acne, pain at the injection site, fatigue, gynecomastia, and seborrhea.
Cautions & Contraindications
Warnings & Precautions
Hypersensitivity Reactions and Anaphylaxis: If occurs, initiate appropriate therapy including supportive measures, and discontinue Gonal-F.Ovarian Hyperstimulation Syndrome: If serious, stop gonadotropins, including hCG, and determine if the woman needs to be hospitalized. Treatment is primarily symptomatic and consists of bed rest, fluid and electrolyte management, and analgesics.Pulmonary and Vascular Complications: In women with recognized risk factors, the benefits of induction of ovulation and ART need to be weighed against the risks. During or after use of Gonal-F, monitor for venous or arterial thromboembolic events.Ovarian Torsion: Early diagnosis and immediate detorsion limit damage to the ovary due to reduced blood supply.Abnormal Ovarian Enlargement: If the ovaries are abnormally enlarged on the last day of Gonal-F therapy, inform women not to administer hCG and to avoid intercourse.Multi-fetal Gestation and Births: The rate of multiple births is dependent on the number of embryos transferred. Advise the woman and her partner of the potential risk of multi-fetal gestation and birth before beginning therapy with Gonal-F.Embryofetal Toxicity: Inform women that the incidence of congenital malformations (birth defects) after some Assisted Reproductive Technology [(ART) specifically in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI)] may be slightly higher than after spontaneous conception. There is no evidence that the use of gonadotropins during IVF or ICSI is associated with an increased risk of congenital malformations.Ectopic Pregnancy: Advise women who become pregnant following ART and have: abdominal/pelvic pain (particularly on one side); shoulder, neck or rectal pain; and nausea and vomiting to seek immediate medical attention. Confirm the presence of an intrauterine pregnancy early by β-hCG testing and transvaginal ultrasound.Spontaneous Abortion: The risk of spontaneous abortion (miscarriage) is increased with gonadotropin products, however, causality has not been established.Ovarian Neoplasm: Both benign and malignant ovarian neoplasms are reported in women who have had multiple drug therapy for controlled ovarian stimulation, however, causality has not been established.
Contraindications
Follitropin Alfa should not be used by women or men who have any of the following: known hypersensitivity to recombinant FSH products or any of their excipients; high FSH levels indicating primary gonadal failure; uncontrolled endocrinopathies unrelated to the gonads; sex hormone dependent tumors of the reproductive tract or accessory organs; or tumors of the pituitary gland or hypothalamus. In women, it is also contraindicated in cases of abnormal uterine bleeding of undetermined origin or ovarian cyst or enlargement of undetermined origin.