Follistim AQ Cartridge
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Follistim AQ Cartridge
FOLLISTIM® AQ Cartridge
(follitropin beta injection)
Follistim AQ Cartridge contains human follicle-stimulating hormone (hFSH), a glycoprotein hormone which is manufactured by recombinant DNA (rDNA) technology. The active drug substance, 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 activity [as determined by the Ph. Eur. test for FSH in vivo bioactivity and on the basis of the molar extinction coefficient at 277 nm ( εs:mg-1cm-1) = 1.066].
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 international unit per 40,000 international units 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 hFSH of urinary source. Also, based on available data derived from physico-chemical tests and bioassay, follitropin beta and follitropin alfa, another recombinant follicle-stimulating hormone product, are indistinguishable.
Follistim AQ Cartridge is a ready for use, prefilled with solution, disposable cartridge containing either 175 IU of follitropin beta in 0.210 mL (833 IU/mL), 350 IU in 0.420 mL (833 IU/mL), 650 IU in 0.780 mL (833 IU/mL) or 975 IU in 1.170 mL (833 IU/mL) of aqueous solution for multiple dose use, with a maximal deliverable dose of either 150 IU, 300 IU, 600 IU or 900 IU, respectively. Inactive ingredients in the cartridges include: benzyl alcohol NF 10 mg/mL; L-methionine USP 0.5 mg/mL; polysorbate 20 NF 0.2 mg/mL; sodium citrate (dihydrate) USP 14.7 mg/mL; sucrose NF 50 mg/mL; and water for injection USP. Hydrochloric acid NF and/or sodium hydroxide NF are used to adjust the pH to 7.
Follistim AQ Cartridge is for use only with the Follistim Pen, which features an adjustable dosing system for administering the drug in a microvolume of solution. The Follistim Pen with Follistim AQ Cartridge is intended for SUBCUTANEOUS USE ONLY. The recombinant protein in Follistim AQ Cartridge has been standardized for FSH in vivo bioactivity in terms of the WHO International Standard for Follicle Stimulating Hormone (FSH) Recombinant, Human for Bioassay (code 92/642), issued by the World Health Organization Expert Committee on Biological Standardization (1995). Under current storage conditions, Follistim AQ may contain up to 11% 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.
Last reviewed on RxList: 9/6/2011
This monograph has been modified to include the generic and brand name in many instances.
Additional Follistim AQ Cartridge Information
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