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Follistim

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Follistim AQ

Follistim® AQ
(follitropin beta) Injection

FOR SUBCUTANEOUS OR INTRAMUSCULAR USE ONLY

DRUG DESCRIPTION

Follistim® AQ (follitropin beta injection) 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 ina 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® AQ (follitropin beta) is presented as a sterile aqueous solution intended for SUBCUTANEOUS or INTRAMUSCULAR administration. Each single-use vial of Follistim® AQ (follitropin beta) contains the following per 0.5 mL: 75 IU or 150 IU of FSH activity; 25 mg sucrose, NF; 7.35 mg sodium citrate (dihydrate), USP; 0.25 mg L-methionine, USP; 0.1 mg polysorbate 20, NF; and water for injection, USP. Hydrochloric acid, NF and/or sodium hydroxide, NF are used to adjust the pHto 7.

The recombinant protein in Follistim® AQ (follitropin beta) 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® AQ (follitropin beta) 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.

Therapeutic Class: Infertility.

What are the possible side effects of follicle stimulating hormone (Follistim AQ, Follistim AQ Cartridge, Gonal-F, Gonal-f RFF, Gonal-f RFF Pen)?

Some women using this medicine have developed a sudden buildup of fluid in the stomach or chest area. This condition is called ovarian hyperstimulation syndrome (OHSS), and can be a life-threatening. Avoid having sex and call your doctor right away if you have any of the following symptoms of OHSS:

  • severe pain in your lower stomach;
  • nausea, vomiting, diarrhea, bloating;
  • feeling short of breath;
  • swelling in your hands or legs;
  • weight gain;
  • urinating less than...

Read All Potential Side Effects and See Pictures of Follistim AQ »

What are the precautions when taking follitropin beta (Follistim AQ)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing follicle-stimulating hormone (FSH), or to streptomycin, or neomycin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: abnormal bleeding from the vagina or uterus, thyroid problems, adrenal gland problems, cancer of the reproductive organs (breast, uterus, ovary, testis), tumors in the brain (e.g., pituitary tumor), ovarian cysts or enlargement, other fertility problems (e.g., primary...

Read All Potential Precautions of Follistim AQ »

REFERENCES

What are the possible side effects of follicle stimulating hormone (Follistim AQ, Follistim AQ Cartridge, Gonal-F, Gonal-f RFF, Gonal-f RFF Pen)?

Some women using this medicine have developed a sudden buildup of fluid in the stomach or chest area. This condition is called ovarian hyperstimulation syndrome (OHSS), and can be a life-threatening. Avoid having sex and call your doctor right away if you have any of the following symptoms of OHSS:

  • severe pain in your lower stomach;
  • nausea, vomiting, diarrhea, bloating;
  • feeling short of breath;
  • swelling in your hands or legs;
  • weight gain;
  • urinating less than...

Read All Potential Side Effects and See Pictures of Follistim AQ »

What are the precautions when taking follitropin beta (Follistim AQ)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing follicle-stimulating hormone (FSH), or to streptomycin, or neomycin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: abnormal bleeding from the vagina or uterus, thyroid problems, adrenal gland problems, cancer of the reproductive organs (breast, uterus, ovary, testis), tumors in the brain (e.g., pituitary tumor), ovarian cysts or enlargement, other fertility problems (e.g., primary...

Read All Potential Precautions of Follistim AQ »

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

What are the possible side effects of follicle stimulating hormone (Follistim AQ, Follistim AQ Cartridge, Gonal-F, Gonal-f RFF, Gonal-f RFF Pen)?

Some women using this medicine have developed a sudden buildup of fluid in the stomach or chest area. This condition is called ovarian hyperstimulation syndrome (OHSS), and can be a life-threatening. Avoid having sex and call your doctor right away if you have any of the following symptoms of OHSS:

  • severe pain in your lower stomach;
  • nausea, vomiting, diarrhea, bloating;
  • feeling short of breath;
  • swelling in your hands or legs;
  • weight gain;
  • urinating less than...

Read All Potential Side Effects and See Pictures of Follistim AQ »

What are the precautions when taking follitropin beta (Follistim AQ)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing follicle-stimulating hormone (FSH), or to streptomycin, or neomycin; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: abnormal bleeding from the vagina or uterus, thyroid problems, adrenal gland problems, cancer of the reproductive organs (breast, uterus, ovary, testis), tumors in the brain (e.g., pituitary tumor), ovarian cysts or enlargement, other fertility problems (e.g., primary...

Read All Potential Precautions of Follistim AQ »

Last reviewed on RxList: 11/17/2008
This monograph has been modified to include the generic and brand name in many instances.

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