Follistim AQ

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, 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 »

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 »

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 »

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 »

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 »

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 »


Follistim AQ Consumer (continued)

SIDE EFFECTS: Headache, stomach pain, bloating, redness/pain at the injection site, breast tenderness/pain, and dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these serious side effects occur: flu-like symptoms (e.g., fever, chills, muscle aches, tiredness), swelling of ankles/hands/feet, bleeding from the vagina.

Seek immediate medical attention if any of these unlikely but very serious side effects occur: weakness on one side of the body, slurred speech, vision changes, sudden severe headache, pain/swelling of the calf muscles, chest pain, rapid breathing.

This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during therapy or after treatment has been discontinued. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Seek immediate medical attention if you develop the following side effects: severe pain or swelling in the lower abdominal (pelvic) area, nausea/vomiting, sudden/rapid weight gain, or a change in the amount of urine.

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: 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 ovarian failure).

Tell your doctor your medical history, especially of: blood clots, stroke, certain heart diseases (e.g., heart attacks), lung problems (e.g., asthma).

Multiple births may occur because of this treatment.

Stop using this medication when you become pregnant. This medication must not be used during pregnancy. If you think you may be pregnant, tell your doctor immediately.

It is unknown if this drug passes into breast milk. Because of the possible harm to a nursing infant, consult your doctor before breast-feeding.


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

What is follicle stimulating hormone (Follistim AQ)?

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)?

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)?

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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