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You are here: Home » eGM Resources » Health Information & Resources Portal|Home » RX Drug List (listed alphabetically) » Drug Reference (F's) » Follitropin Beta


Follistim (follitropin beta for injection)

Follostim (follitropin beta for injection) contains human follicle- stimulating hormone (hFSH), a glycoprotein hormone which is manufactured by recombinant DNA (rDNA) technology. Follitropin beta has a dimeric structure containing two glycoprotein subunits (alpha and beta). Both the 92 amino acid alpha-chain and the 111 amino acid 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. The purification process results in a highly purified preparation with a consistent hFSH isoform profile and high specific activity¹. The biological activity is determined by measuring the increase in ovary weight in female rats. The intrinsic luteinizing hormone (LH) activity in follitropin beta is less than 1 IU per 40,000 IU FSH. The compound is considered to contain no LH activity.

The amino acid sequence and tertiary structure of the product are indistinguishable from that of human follicle-stimulating hormone (hFSH) of urinary source. Also, based on available data derived from physio-chemical tests and bioassay, follitropin beta and follitropin alfa, another recombinant follicle-stimulating hormone product, are indistinguishable.

Follistim is presented as a sterile, freeze-dried cake, intended for SUBCUTANEOUS or INTRAMUSCULAR administration after reconstitution with 0.45% Sodium Chloride Injection, USP. Each vial of Follistim contains 75 IU of FSH activity plus 25.0 mg sucrose, NF; 7.35 mg sodium citrate dihydrate, USP; 0.10 mg polysorbate 20, NF, and hydrochloric acid, NF and/or sodium hydroxide, NF to adjust the pH in a sterile, Iyophilized form. The pH of the reconstituted preparation is approximately 7.0. The recombinant protein in Follistim has been standardized for FSH in vivo bioactivity in terms of the First International Reference Preparation for human menopausal gonadotropins (code 70/ 45), issued by the World Health Organization Expert Committee on Biological Standardization (1982). Under current storage conditions, Follistim may contain up to 20% of oxidized follitropin beta.

In clinical trials with Follistim, serum antibodies to FSH or anti-CHO cell derived proteins were not detected in any of the treated patients after exposure to Follistim for up to three cycles.

Therapeutic Class: Infertility.

¹As determined by the Ph. Eur. test for FSH in vivo bioactivity and on the basis of the molar extinction coefficient at 277 nm (e3: mg-¹ cm-¹) = 1.066.

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