Follitropin alfa

G. Other considerations Recombinant follitropin alfa has been designated an orphan product 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. 

Follicle-stimulating hormone (FSH) products Follitropin alfa [FDA NAM] follicle-stimnlating hormone [SY]... 

Three forms of purified FSH are available. Urofollitropin, also known as uFSH, is a purified preparation of human FSH that is extracted from the urine of postmenopausal women. Virtually all the LH activity has been removed through a form of immunoaffinity chromatography that uses anti-hCG antibodies. Two recombinant forms of FSH (rFSH) are also available follitropin alfa and follitropin beta. The amino acid sequences of these two products are identical to that of human FSH. They differ from each other and urofollitropin in the composition of the carbohydrate side chains. The rFSH preparations have a shorter half-life than preparations derived from human urine but stimulate estrogen secretion at least as efficiently and, in some studies, more efficiently. The rFSH preparations are considerably more expensive. 

Lutropin alfa, the recombinant form of human LH, was introduced in the USA in 2004. When given by subcutaneous injection, it has a half-life of about 10 hours. Lutropin has only been approved for use in combination with follitropin alfa for stimulation of follicular development in infertile women with profound LH deficiency. It has not been approved for use with the other preparations of FSH nor for simulating the endogenous LH surge that is needed to complete follicular development and precipitate ovulation. 

Follitropin alfa Activates FSH receptors Mimics effects of endogenous FSH Controlled ovulation hyperstimulation in women infertility due to hypogonadism in men SC injection 3-7 x/wk Toxicity Ovarian hyperstimulation syndrome and multiple pregnancies in women gynecomastia in men headache, depression, edema in both sexes... 

Follitropin beta A recombinant product with the same peptide sequence as follitropin alfa but differs in its carbohydrate side chains ... 

Parenteral powder to reconstitute 500, 1000, 2000 IU/mL for IM injection Follitropin alfa [rFSH] (Gonal-f)... 

Nasal 100 ngJrnL spray pump and rhinal tube delivery system Parenteral 4 g/mL solution for injection Oral 0.1, 0.2 mg tablets Follitropin alfa (Gonal-F)... 

Follitropin alfa (FSH) Gonal-F (Serono) Ovulatory failure... 

Gonadotropins. 773-775. 774f Goiial-F. See Follitropin alfa GoisLYdin. 437... 

Gonal-F (follitropin alfa) [CFIO-expressed glycoproteins of... 

Finland follitropin alfa protein Gonal-F Recombinant human FSH in its alpha glycoform expressed in CHO cells Hormone... 

Follitropin alfa is a human FSH preparation of rDNA origin. Because FSH is a glycoprotein, alterations in the carbohydrate side-chain attachments afford different isoforms, which leads to different pharmacokinetic and pharmacodynamic properties. Because it is of recombinant origin and not isolated from urine, it is free of any additional substances, such as urinary proteins and LH. 

Men with infertility also can benefit from therapy with follitropin alfa if their infertility is related to hypothalamic or pituitary hormonal dysfunction and not primary testicular failure, because it... 

Lutropin alfa Is the first recombinant human form of LH approved by the U.S. FDA. This agent serves as LH replacement therapy for those women who are hypogonadotropic and hypogonadal with a substantial deficiency in LH (<1.2 lU/L). Lutropin alfa typically is utilized in combination with follitropin alfa to induce follicular growth and development. Both of these agents are administered subcutaneously. 

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