Follitropin Beta
- Atc Codes:G03GA06
- CAS Codes:150490-84-9
- PHARMGKB ID:150490-84-9
Table of contents
- Brand Names
- Chemistry
- Pharmacologic Category
- Mechanism of Action
- Therapeutic Use
- Pregnancy and Lactation Implications
- Contraindications
- Warnings and Precautions
- Adverse Reactions
- Genes that may be involved
- Drug Interactions
- Dosage
- Pharmacokinetics and Pharmacodynamics
- Special Considerations
Brand Names
Europe
Austria: Fertavid, Puregon; Belgium: Puregon; Bulgaria: Fertavid, Puregon; Cyprus: Puregon; Czech Republic: Fertavid, Puregon; Denmark: Puregon; Estonia: Fertavid, Puregon; Finland: Puregon; France: Puregon; Germany: Fertavid, Puregon; Greece: Puregon; Hungary: Puregon; Ireland: Fertavid, Puregon; Italy: Puregon; Latvia: Fertavid, Puregon; Lithuania: Fertavid, Puregon; Luxembourg: Puregon; Malta: Fertavid, Puregon; Netherlands: Fertavid, Puregon; Poland: Fertavid, Puregon; Portugal: Fertavid, Puregon; Romania: Puregon; Slovakia: Fertavid, Puregon; Slovenia: Fertavid, Puregon; Spain: Puregon; Sweden: Fertavid, Puregon; UK: Puregon.
North America
Canada: Puregon; USA: Follistim AQ.
Latin America
Argentina: Puregon; Brazil: Puregon; Mexico: Puregon.
Asia
Japan: Follistim.
Drug combinations
Chemistry
Follitropin Beta: C~975~H~1513~N~267~O~304~S~26~. Human follicle-stimulating hormone. Dimeric structure containing two glycoprotein subunits (alpha and beta). Both the 92 amino LRN: 900934-UFT-PEN acid alpha-chain and the 111 aa beta-chain have complex heterogeneous structures arising from two N-linked oligosaccharide chains. Follitropin beta is synthesized in a Chinese hamster ovary (CHO) cell line that has been transfected with a plasmid containing the two subunit DNA sequences encoding for hFSH. CAS-150490-84-9.
Pharmacologic Category
Hormones and Synthetic Substitutes; Gonadotropins. Ovulation Stimulator. (ATC-Code: G03GA06).
Mechanism of action
Follitropin Beta is a human FSH preparation of recombinant DNA origin. Follitropins stimulate ovarian follicular growth in women who do not have primary ovarian failure. FSH is required for normal follicular growth, maturation, gonadal steroid production, and spermatogenesis.
Therapeutic use
In the female, indicated for the treatment of female infertility in the following clinical situations: anovulation (including polycystic ovarian disease, PCOD) in women who have been unresponsive to treatment with clomifene citrate; controlled ovarian hyperstimulation to induce the development of multiple follicles in medically-assisted reproduction programs [e.g. in vitro fertilization/embryo transfer (IVF/ET), gamete intrafallopian transfer (GIFT) and intracytoplasmic sperm injection (ICSI)]. In the male, indicated for deficient spermatogenesis due to hypogonadotrophic hypogonadism.
Pregnancy and lactiation implications
Should not be used during pregnancy. Ectopic pregnancy, congenital abnormalities, and multiple births have been reported. The incidence of congenital abnormality may be slightly higher after ART than with spontaneous conception; higher incidence may be related to parenteral characteristics (maternal age, sperm characteristics). Not recommended during lactation.
Unlabeled use
Contraindications
Hypersensitivity to the active substance or to any of the excipients. Tumors of the ovary, breast, uterus, testis, pituitary or hypothalamus. Undiagnosed vaginal bleeding. Primary ovarian failure. Ovarian cysts or enlarged ovaries, not related to polycystic ovarian disease (PCOD). Malformations of the sexual organs incompatible with pregnancy. Fibroid tumors of the uterus incompatible with pregnancy. Primary testicular failure. Pregnancy.
Warnings and precautions
Treatment with follitropin beta should be initiated under the supervision of a physician experienced in the treatment of fertility problems. Treatment with follitropin beta may result in abnormal ovarian enlargement, ovarian hyperstimulation syndrome (OHSS)(if serious OHSS occurs, treatment should be stopped and the patient hospitalized), pulmonary and vascular complications, ovarian torsion, multi-fetal gestation and birth, congenital anomalies, ectopic pregnancy, spontaneous abortion, ovarian neoplasm.