Ganirelix Acetate Injection

DRUG DESCRIPTION

Ganirelix Acetate Injection (ganirelix) is a synthetic decapeptide with high antagonistic activity against naturally occurring gonadotropin-releasing hormone (GnRH). Ganirelix Acetate is derived from native GnRH with substitutions of amino acids at positions 1, 2, 3, 6, 8, and 10 to form the following molecular formula of the peptide: N-acetyl-3-(2-naphthyl)-D-alanyl-4-chloro-D?­phenylalanyl-3-(3-pyridyl)-D-alanyl-L-seryl-L-tyrosyl-N9,N10-diethyl-D-homoarginyl-L-leucyl?­N9,N10-diethyl-L-homoarginyl-L-prolyl-D-alanylamide acetate. The molecular weight for Ganirelix Acetate is 1570.4 as an anhydrous free base. The structural formula is as follows:

Ganirelix Acetate Structural Formula Illustration

Ganirelix Acetate Injection (ganirelix) is supplied as a colorless, sterile, ready-to-use, aqueous solution intended for SUBCUTANEOUS administration only. Each sterile, prefilled syringe contains 250 ?µg/0.5 mL of Ganirelix Acetate, 0.1 mg glacial acetic acid, 23.5 mg mannitol, and water for injection adjusted to pH 5.0 with acetic acid, NF and/or sodium hydroxide, NF.

What are the possible side effects of ganirelix (Antagon, Ganirelix Acetate)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment cycle. OHSS can be a life-threatening condition. Call your doctor right away if you have any of the following symptoms of OHSS:

  • severe pelvic pain;
  • swelling of the hands or legs;
  • stomach...

Read All Potential Side Effects and See Pictures of Ganirelix Acetate Injection »

What are the precautions when taking ganirelix (Ganirelix Acetate Injection)?

Before using this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing gonadotropin releasing hormone (GnRH); or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Multiple births may occur because of this treatment program. Consult your doctor for more details.

This medication must not be used during pregnancy because of possible harm to an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately.

It is not known whether this drug passes into breast...

Read All Potential Precautions of Ganirelix Acetate Injection »


Ganirelix Acetate Injection Consumer (continued)

SIDE EFFECTS: Redness or pain at the injection site, headache, mild nausea/stomach pain, and tiredness 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 unlikely but serious side effects occur: unusual vaginal bleeding.

This medication may cause a condition known as Ovarian Hyperstimulation Syndrome (OHSS). This condition may occur during therapy and 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, severe nausea/vomiting, sudden/rapid weight gain, or 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 gonadotropin releasing hormone (GnRH); or if you have any other allergies. This product may contain inactive ingredients (such as latex), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history.

Multiple births may occur because of this treatment program. Consult your doctor for more details.

This medication must not be used during pregnancy because of possible harm to an unborn baby. If you become pregnant or think you may be pregnant, inform your doctor immediately.

It is not known whether this drug passes into breast milk. Because of the potential risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Ganirelix Acetate Injection Patient Information Including Side Effects

Brand Names: Antagon, Ganirelix Acetate

Generic Name: ganirelix (Pronunciation: GA ni REL ix)

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

What is ganirelix (Ganirelix Acetate Injection)?

Ganirelix is a man-made form of a protein that reduces the amount of certain hormones in the body, including estrogen.

Ganirelix is used along with other medications to regulate hormones during treatment for infertility in women.

Ganirelix may also be used for other purposes not listed in this medication guide.

What are the possible side effects of ganirelix (Ganirelix Acetate Injection)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment cycle. OHSS can be a life-threatening condition. Call your doctor right away if you have any of the following symptoms of OHSS:

  • severe pelvic pain;
  • swelling of the hands or legs;
  • stomach pain and swelling;
  • shortness of breath;
  • weight gain;
  • diarrhea;
  • nausea or vomiting; or
  • urinating less than normal.

Less serious side effects may include:

  • pelvic pain (similar to menstrual cramps);
  • mild nausea or stomach pain;
  • headache;
  • vaginal bleeding; or
  • pain, redness, or irritation at the injection site.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ganirelix (Ganirelix Acetate Injection)?

You should not use this medication if you are allergic to ganirelix or similar medications such as leuprolide (Lupron, Eligard), goserelin (Zoladex), or nafarelin (Synarel).

Before using ganirelix, tell your doctor if you are allergic to latex rubber.

Do not use ganirelix if you are already pregnant. Your doctor may give you a pregnancy test to make sure you are not pregnant before you receive ganirelix.

Do not use this medication without telling your doctor if you are breast-feeding a baby.

During your treatment with ganirelix, your blood may need to be tested often. Do not miss any follow-up visits to your doctor. You must remain under the care of your doctor while using ganirelix.

Some women using this medicine have developed a condition called ovarian hyperstimulation syndrome (OHSS), especially after the first treatment cycle. OHSS can be a life-threatening condition. Call your doctor right away if you have any of the following symptoms of OHSS: severe pelvic or stomach pain, swelling or rapid weight gain, shortness of breath, diarrhea, nausea, vomiting, or urinating less than usual.

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