Uses

This medication is used to treat certain fertility problems in women. It is the hormone (hCG) that causes the growth and release of a mature egg (ovulation). This medication is usually used in combination with another hormone (FSH) that helps cause healthy ovaries to produce eggs.

This medication is not recommended for women whose ovaries no longer make eggs properly (primary ovarian failure).

This medication has not been shown to be effective for weight loss and should not be used for this purpose due to risk of serious side effects.

How To Use

This medicine comes with a Patient Information Leaflet. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine.

Learn all the preparation and usage instructions in the product package. If any of the information is unclear, consult your health care professional.

After injecting the mixing liquid into the vial, gently roll the vial to mix the drug. Do not shake the liquid. Doing so may make this medicine less effective. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Wash your hands with soap and water before using this medication. Before injecting the dose, clean the injection site with rubbing alcohol.

Inject this medication under the skin, usually the day after your last dose of follicle stimulating medicine (such as menotropins) or as directed by your doctor. Dosage is based on your medical condition and response to treatment. Your doctor will do lab/medical tests (such as estrogen blood levels, ultrasound) to decide when it is time to use this medication.

Be sure to keep all medical appointments so your doctor can closely monitor your response and determine the time you should use this medication.

Learn how to store and discard needles and medical supplies safely. Consult your pharmacist for more information.

Side Effects

Nausea, vomiting, mild abdominal pain/swelling, headache, and pain/bruising/redness/swelling at the injection site may occur. If any of these effects persist or worsen, tell your doctor promptly.

Remember that this medication has been prescribed because your doctor 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 right away 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 treatment or after treatment is finished. 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 very serious side effects:

• severe pain/swelling in the lower abdominal (pelvic) area
• severe nausea/vomiting/diarrhea
• sudden shortness of breath
• sudden/rapid weight gain
• decreased urination

Seek immediate medical attention if any of these very unlikely but very serious side effects occur:

• chest/jaw/left arm pain
• sudden severe headache
• confusion
• weakness on one side of the body
• trouble speaking
• swelling of the hands/ankles/feet
• sudden vision changes (such as double vision, loss of vision)
• pain/redness/swelling in the legs
• sudden difficulty breathing

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including:

• 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 or at www.fda.gov/medwatch.

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 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:

• unusual vaginal bleeding
• problems of the uterus
• certain type of fertility problem (primary ovarian failure)
• thyroid problem
• adrenal gland problem
• cancer of the reproductive organs (breast, uterus, ovary)
• tumor in the brain (such as pituitary tumor)
• unexplained ovarian cyst/enlargement

Tell your doctor your medical history, especially of:

• liver disease
• blood clots
• stroke
• heart disease (such as chest pain, heart attack)
• lung problems (such as asthma)

Successful treatment with this medication (pregnancy) may result in multiple births. Discuss the risks and benefits of having such a pregnancy with your doctor.

If you become pregnant or think you may be pregnant after treatment with this drug, stop using this medication and tell your doctor right away. This drug must not be used during pregnancy because it may cause harm to an unborn baby.

It is not known if this medication passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• gonadorelin

This product can affect the results of certain lab tests (such as hormone levels), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Laboratory and/or medical tests (such as ultrasound, hormone levels) may be performed to monitor your progress.

Missed Dose

If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.

Storage

Store unopened vials at room temperature away from light and moisture. Do not freeze. Do not store in the bathroom. Once mixed, the vial must be used right away. Discard any unused solution. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.