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Other strengths and forms by Janata Traders
Indications & Uses
Gonal-F, with the active ingredient follitropin alfa, is used in several fertility treatments. It is prescribed to bring on ovulation and help pregnancy in women who have oligo-anovulatory infertility, meaning they ovulate rarely or not at all. This applies only when the cause is functional and not due to primary ovarian failure. In ovulatory infertile women, it is also used to encourage the development of multiple follicles as part of an assisted reproductive technology (ART) cycle. In men, follitropin alfa is used to start sperm production in infertile men with azoospermia (no sperm in the semen) caused by primary or secondary hypogonadotropic hypogonadism. Gonal-F is given for this only when the infertility is not due to primary testicular failure.
Pharmacology
Follitropin alfa stimulates ovarian follicular growth in women who do not have primary ovarian failure. To bring about final maturation of the follicle and ovulation in the absence of a natural LH surge, human chorionic gonadotropin (hCG) must be given after Follitropin Alfa, once monitoring shows that sufficient follicular development has been achieved. In men with hypogonadotropic hypogonadism, Follitropin Alfa stimulates sperm production when given together with hCG.
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 these occur, start appropriate treatment, including supportive measures, and stop Gonal-F. Ovarian Hyperstimulation Syndrome: If it is serious, stop gonadotropins, including hCG, and decide whether the woman needs to be admitted to hospital. Treatment is mainly symptomatic. It involves bed rest, managing fluids and electrolytes, and pain relief (analgesics). Pulmonary and Vascular Complications: In women with known risk factors, the benefits of inducing ovulation and ART have to be weighed against the risks. During or after using Gonal-F, watch for venous or arterial thromboembolic events. Ovarian Torsion: An early diagnosis and immediate detorsion (untwisting) limit damage to the ovary caused by reduced blood supply. Abnormal Ovarian Enlargement: If the ovaries are abnormally enlarged on the last day of Gonal-F therapy, tell the woman not to take hCG and to avoid intercourse. Multi-fetal Gestation and Births: The rate of multiple births depends on the number of embryos transferred. Before starting Gonal-F, tell the woman and her partner about the potential risk of multi-fetal gestation and birth. Embryofetal Toxicity: Tell women that the chance 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 natural conception. There is no evidence that using gonadotropins during IVF or ICSI is linked to an increased risk of congenital malformations. Ectopic Pregnancy: If a woman becomes pregnant after ART and has abdominal or pelvic pain (particularly on one side), shoulder, neck or rectal pain, or nausea and vomiting, she should seek medical attention immediately. Confirm an intrauterine pregnancy early by β-hCG testing and transvaginal ultrasound. Spontaneous Abortion: The risk of spontaneous abortion (miscarriage) is higher with gonadotropin products, but a direct cause has not been established. Ovarian Neoplasm: Both benign and malignant ovarian neoplasms have been reported in women who have had multiple drug therapy for controlled ovarian stimulation, but a direct cause 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.
Pregnancy & Breastfeeding
Follitropin Alfa should not be used during pregnancy. After some assisted reproductive technology procedures, particularly in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), the rate of congenital malformations may be a little higher than after natural conception. This slightly higher rate is thought to relate to differences in parental characteristics (such as maternal age and the genetic background of both parents and their sperm), as well as to a higher rate of multiple pregnancies following IVF or ICSI. No human data show that gonadotropins, whether Follitropin Alfa alone or as part of an IVF or ICSI cycle, raise the risk of congenital malformations.
There is no information on whether Follitropin Alfa passes into human milk, what effect it may have on a breastfed infant, or what effect it may have on milk production. Since prolactin released during breastfeeding can lead to a poor response to ovarian stimulation, women are advised not to breastfeed while being treated with Follitropin Alfa.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric Use: Follitropin Alfa hasn't been shown to be safe or effective in children.
Geriatric Use: Follitropin Alfa hasn't been shown to be safe or effective in postmenopausal women, and it is not indicated for them.
Storage
Lyophilized Follitropin Alfa multi-dose vials can be kept in the refrigerator or at room temperature, anywhere between 2°-25°C.
Drug Interactions
Common questions about Gonal-F 900 IU/1.5 ml
What is Gonal-F 900 IU/1.5 ml SC Injection?
Gonal-F 900 IU/1.5 ml SC Injection is a medicine that contains Follitropin Alfa. It is made by Janata Traders. It belongs to the Drugs for Infertility group of medicines.
What is Gonal-F used for?
Gonal-F, with the active ingredient follitropin alfa, is used in several fertility treatments. It is prescribed to bring on ovulation and help pregnancy in women who have oligo-anovulatory infertility, meaning they ovulate rarely or not at all.
What are the side effects of Gonal-F?
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.
Can I take Gonal-F during pregnancy or while breastfeeding?
Follitropin Alfa should not be used during pregnancy. After some assisted reproductive technology procedures, particularly in vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), the rate of congenital malformations may be a little higher than after natural conception. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Gonal-F?
Lyophilized Follitropin Alfa multi-dose vials can be kept in the refrigerator or at room temperature, anywhere between 2°-25°C.
Can I take other medicines with Gonal-F?
Some medicines can interact with Follitropin Alfa, for example: Follitropin Alfa + Lutropin Alfa, Clomiphene Citrate. Tell your doctor or pharmacist about every medicine you take.
Do I need a prescription for Gonal-F?
Gonal-F is a prescription (Rx) medicine. Take it as your doctor advises.