Follistim AQ Cartridge

DRUG DESCRIPTION

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 ( ?s: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.

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

Stop using follicle stimulating hormone and seek emergency medical attention or notify your doctor immediately if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • pain, warmth, redness, numbness, or tingling in an arm or leg (which may indicate a blood clot);
  • confusion, severe dizziness, severe headache; or
  • ...

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


Follistim AQ Cartridge Patient Information Including Side Effects

Brand Names: Follistim, Follistim AQ, Gonal-F, Gonal-f RFF, Gonal-f RFF Pen

Generic Name: follicle stimulating hormone (injectable) (Pronunciation: PAH lich cull STIM u lay ting HORE moan)

  • What is follicle stimulating hormone (Follistim AQ Cartridge)?
  • What are the possible side effects of follicle stimulating hormone (Follistim AQ Cartridge)?
  • What is the most important information I should know about follicle stimulating hormone (Follistim AQ Cartridge)?
  • What should I discuss with my healthcare provider before using follicle stimulating hormone (Follistim AQ Cartridge)?
  • How should I use follicle stimulating hormone (Follistim AQ Cartridge)?
  • What happens if I miss a dose (Follistim AQ Cartridge)?
  • What happens if I overdose (Follistim AQ Cartridge)?
  • What should I avoid while using follicle stimulating hormone (Follistim AQ Cartridge)?
  • What other drugs will affect follicle stimulating hormone (Follistim AQ Cartridge)?
  • Where can I get more information?

What is follicle stimulating hormone (Follistim AQ Cartridge)?

Follicle stimulating hormone (FSH) is a naturally occurring hormone. FSH is important in the development of follicles (eggs) produced by the ovaries. FSH is also important in the development of sperm.

Follicle stimulating hormone is used to stimulate a follicle (egg) to develop and mature. It is used when a woman desires pregnancy and her ovaries can produce a follicle but hormonal stimulation is not sufficient to make the follicle mature. Follicle stimulating hormone is also used to stimulate the development of multiple eggs for in vitro fertilization. Follicle stimulating hormone can be used by men to increase the production of sperm.

Follicle stimulating hormone may also be used for purposes other than those listed in this medication guide.

What are the possible side effects of follicle stimulating hormone (Follistim AQ Cartridge)?

Stop using follicle stimulating hormone and seek emergency medical attention or notify your doctor immediately if you experience any of the following serious side effects:

  • an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);
  • pain, warmth, redness, numbness, or tingling in an arm or leg (which may indicate a blood clot);
  • confusion, severe dizziness, severe headache; or
  • difficulty breathing.

Approximately 5% of patients treated with follicle stimulating hormone develop ovarian hyperstimulation syndrome (OHSS), especially after the first cycle of therapy. Symptoms of OHSS include severe pelvic pain, swelling of the hands or legs, abdominal pain and swelling, shortness of breath, weight gain, low urine output, diarrhea, and nausea or vomiting. OHSS can be fatal. Notify your doctor immediately or seek emergency medical attention if you develop any of these symptoms.

Other side effects may also occur. Notify your doctor if you experience

  • ovarian enlargement presenting as abdominal or pelvic pain, tenderness, pressure, or swelling;
  • nausea, vomiting, diarrhea, or flatulence (gas);
  • fever or chills;
  • headache;
  • dizziness;
  • rapid pulse or heart rate;
  • muscle or joint weakness or aching;
  • breast tenderness;
  • spotting or menstrual changes;
  • pain, swelling, or irritation at the injection site; or
  • dry skin, a rash, or hair loss.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about follicle stimulating hormone (Follistim AQ Cartridge)?

Treatment with follicle stimulating hormone increases the likelihood of multiple births. Multiple births carry additional risk both for the mother and for fetuses. Discuss the risk of multiple births with your healthcare provider.

Related Drug Centers
  • Gonal-F
  • Gonal-f RFF
  • Follistim
  • Follistim AQ Cartridge


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