Gonal
Generic Name: Follitropin alfa
Brand Name: Gonal-F
Indications
Gonal-F (follitropin alfa for injection) is indicated for the induction of ovulation and pregnancy anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure. Gonal-F is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.
Dosage and Administration
Gonal-F (follitropin alfa for injection) is supplied in a sterile lyophilized form in single dose ampules containing 75 or 150 IU FSH activity. The following package combinations are available:
- 1 ampule 75 IU Gonal-F® and 1 ampule 1 mL Sterile Water for Injection
- 10 ampules 75 IU Gonal-F® and 10 ampules 1 mL Sterile Water for Injection
- 100 ampules 75 IU Gonal-F® and 100 ampules 1 mL Sterile Water for Injection
- 1 ampule 150 IU Gonal-F® and 1 ampule 1 mL Sterile Water for Injection
Normal Dosage:
The dose of Gonal-F (follitropin alfa for injection) to stimulate development of the follicle must be individualized for each patient. The lowest dose consistent with the expectation of good results should be used. Over the course of treatment doses of Gonal-F may range up to 300 IU per day depending on the individual patient response. Gonal-F should be administered until adequate follicular development is indicated by serum estradiol and vaginal ultrasonography. A response is generally evident after 5 to 7 days. Subsequent monitoring intervals should be based on individual patient response.
Overdose: Aside from possible ovarian hyperstimulation and multiple gestations, there is no information on the consequences of acute overdosage with Gonal-F.
Drug Description
Gonal-F (follitropin alfa) is a human follicle stimulating hormone (FSH) preparation of recombinant DNA origin, which consists of two non-covalently linked, non-identical glycoproteins designated as the α- and β-subunits. The α- and β-subunits have 92 and 111 amino acids, respectively, and their primary and tertiary structure are indistinguishable from those of human follicle stimulating hormone. Recombinant FSH production occurs in genetically modified Chinese Hamster Ovary (CHO) cells cultured in bioreactors. Purification by immunochromatography using an antibody specifically binding FSH results in a highly purified preparation with a consistent FSH isoform profile, and a high specific activity. The biological activity of follitropin alfa is determined by measuring the increase in ovary weight in female rats. Gonal-f contains no luteinizing hormone (LH) activity.
Side Effects
The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.
- Irritation in area of use
- Over stimulation of the ovaries causing production of many ova (eggs) in the woman.
- Blood clots in the blood vessels (thrombosis) that may detach and travel in the circulation to another area of the body (thromboembolism)
- Pregnancy with two or more foetuses
Precautions
- Follicle stimulating hormone will not induce ovulation if the ovaries are not capable of producing an egg. Also, it will not induce the production of sperm if the testes are not capable of producing sperm.
- Before using this medication, tell your doctor if you:
- have a thyroid problem
- have adrenal dysfunction
- have cancer or a tumor of the breast, ovary, uterus, hypothalamus, or pituitary gland
- have ovarian cysts or enlargement not due to polycystic ovary disease (PCOD)
- Treatment with this medication increases the likelihood of multiple births. Multiple births carry additional risk both for the mother and for foetuses.
- Tell your doctor if you are allergic to neomycin or streptomycin. The Follistim AQ Cartridge may contain traces of these antibiotics and may cause allergic reactions.
- This medication is in the FDA pregnancy category X and this means that taking this drug during pregnancy may cause birth defects in an unborn baby.
Drug Interactions
Clomiphene citrate used with Gonal-F may enhance follicular response, and caution is indicated when using the two together. No other clinically significant drug or food interactions have been reported during Gonal-F therapy.