Ganirelix Acetate

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 purposes not listed in this medication guide.

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.

You should not breast-feed while you are being treated with ganirelix.

During your treatment with ganirelix, your blood may need to be tested often. Visit your doctor regularly. 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 weight gain, shortness of breath, diarrhea, nausea, vomiting, or urinating less than usual.

Ganirelix is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

Ganirelix is usually given once daily for several days in a row during certain phases of your fertility treatment cycle. Follow your doctor's instructions and try not to miss any doses.

Each single use vial (bottle) of this medicine is for one use only. Throw away after one use, even if there is still some medicine left in it after injecting your dose.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

During your treatment with ganirelix, your blood may need to be tested often. Visit your doctor regularly. You must remain under the care of your doctor while using ganirelix.

Store the prefilled syringe at room temperature, away from heat, moisture and light.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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 usual.

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.

Gonadotropin-releasing hormone (GnRH) antagonist.1 2 3 4 5

General

• Should be prescribed by clinicians experienced in infertility treatment.1

• Prior to use of ganirelix, initiate COH therapy with FSH on the morning of day 2 or 3 of the menstrual cycle.1 Individualize dosage of FSH based on the patient’s ovarian response to allow sufficient follicular development.1

• Initiate therapy with ganirelix on the morning of day 7 or 8 of the cycle (day 6 of FSH therapy) and continue combination therapy until sufficient follicular growth is verified (e.g., ultrasound).1 2

• When ultrasound assessement shows sufficient follicular maturation, discontinue FSH therapy and ganirelix and administer hCG to complete final follicular maturation and induce ovulation.1 Perform oocyte retrieval, followed by in vitro fertilization or intracytoplasmic sperm injection, with subsequent attempts at implantation and pregnancy.1 2 3

• Do not administer hCG if the ovaries show an excessive response to treatment with FSH because of an increased risk of ovarian hyperstimulation syndrome.1

Administration

Sub-Q Administration

Administer by sub-Q injection once daily during the mid- to late-follicular phase of the menstrual cycle.1

Administer into abdomen, preferably around the umbilicus, or upper thigh; rotate injection sites.1

Dosage

Adults

250 mcg once daily in combination with FSH therapy; initiate on the morning of day 6 of FSH therapy.1 Continue until an an adequate follicular response to stimulation therapy is achieved; a mean duration of 5.4 days was required in clinical trials.1 (See General under Dosage and Administration.)

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.