Uses

This medication is used as part of a treatment program for certain fertility problems in women. It is generally used in combination with another hormone (FSH). This medication provides the hormone (hCG), which stimulates the release of a mature egg (ovulation) and helps you become pregnant.

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

Read the Patient Information Leaflet if available from your pharmacist before you start using this medication and each time you get a refill. You will be trained by a healthcare professional on how to properly use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin (subcutaneously) as directed by your doctor, usually one day after your last dose of the hormone FSH. Follow your doctor's instruction closely to ensure proper timing of this medication.

Wash hands with soap and water before using this medication. Before using, check this product visually for particles or discoloration. If either is present, do not use the liquid.

Before injecting each dose, clean the injection site with rubbing alcohol. Inject the prescribed dose as directed by your doctor. Discard any unused portion of the medication immediately after the injection. Do not save it for future use. Do not change the dose unless instructed by your doctor or use this medication for a longer period than prescribed.

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

Side Effects

Redness or pain at the injection site, mild abdominal pain, mood changes, or mild nausea/vomiting may occur. If any of these effects last or get worse, notify your doctor or pharmacist 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 you have any serious side effects, including:

• unusual vaginal bleeding

Get medical help right away if you have any very serious side effects, including:

• weakness on one side of the body
• trouble speaking
• vision changes
• sudden/severe headache
• pain/swelling of the calf muscles
• chest pain
• shortness of breath
• swelling of ankles/hands/feet

This medication may cause a condition known as ovarian hyperstimulation syndrome (OHSS). This condition may occur during or after treatment. Rarely, serious OHSS causes fluid to suddenly build up in the stomach, chest, and heart area. Get medical help right away 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 decreased urination.

A very serious allergic reaction to this drug is rare. However, get medical help right away 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 to other products containing chorionic gonadotropin (hCG); 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.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• other fertility problems (such as primary ovarian failure)
• thyroid or adrenal gland problems
• cancer of the reproductive organs (such as breast, uterus, ovary)
• tumor in the brain (such as pituitary tumor)
• abnormal uterine/vaginal bleeding
• unexplained ovarian cysts or enlarged ovaries
• blood clots
• stroke
• certain heart diseases (such as heart attacks)
• liver disease
• lung problems (such as asthma)

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

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 right away.

It is not known whether this drug 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 medication may affect the results of certain lab tests (gonadotropin levels). Be sure to tell your doctor or laboratory personnel that you are taking this medication.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Alberta residents can call PADIS (Poison and Drug Information Service) 24 hours a day at 1-800-332-1414. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as blood hormone tests such as estradiol levels, vaginal ultrasound) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

It is important to use this medication at the scheduled time. If you miss a dose and forget to use your medication, contact your doctor or pharmacist right away for instructions. Do not double the dose to catch up.

If you have questions about missing a dose or you don't have more medication, contact your healthcare provider or pharmacist.

Storage

Store in the refrigerator. Protect from light. Do not freeze. If necessary, the prefilled syringe may be stored at room temperature for up to 30 days. Do not store in the bathroom. 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.