This medication is a hormone used in boys (before puberty) to cause the normal dropping of the testicles into the scrotum. It is also used in certain boys to help with normal sexual development. It works by causing the testes to release male sex hormones (such as testosterone).

This medication is also used in women to treat fertility problems. It is given after finishing another medication (menotropins) to cause the release of an egg (ovulation). It should not be used in 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.

This medication is given by injection into a muscle as directed by your doctor. It is usually given by a health care professional. For boys, it is usually used 3 times a week. For women, it is usually used for 1 dose after finishing your menotropins treatment. The dosage is based on your age, weight, medical condition, and response to treatment.

If you are using this medication at home, learn all preparation and usage instructions from your health care professional. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Headache, restlessness, tiredness, or pain at injection site may occur. If any of these effects last or get worse, tell 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:

• swelling of the hands/ankles/feet
• mental/mood changes (such as depression, irritability)
• signs of early puberty in boys (such as facial/pubic hair, voice change, acne)
• pain/swelling of the breast (in boys)
• unusual vaginal bleeding (women)

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.

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

• chest/jaw/left arm pain
• sudden severe headache
• confusion
• weakness on one side of the body
• trouble speaking
• sudden vision changes
• pain/redness/swelling in the legs

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.

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.

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

• early puberty (in boys)
• blood clots
• heart disease (such as chest pain, heart attack)
• high blood pressure
• kidney disease
• liver disease
• lung problems (such as asthma)
• migraine
• seizure disorder
• stroke
• unusual vaginal bleeding
• problems of the uterus
• unexplained ovarian cyst/enlargement
• certain type of fertility problem (primary ovarian failure)
• thyroid problem
• adrenal gland problem
• cancer of the reproductive organs (breast, uterus, ovary, prostate)
• brain tumor

This medication should not be used during pregnancy. If you become pregnant or think you may be pregnant, tell your doctor right away.

When this medication is used in women to treat infertility, it may cause multiple births (such as twins, triplets).

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

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 interfere with certain lab tests (including luteinizing hormone-LH/follicle stimulating hormone-FSH levels), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.

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 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this medication with others.

If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Store the vials of powder at room temperature away from light and moisture. Store the mixed medication in the refrigerator. Depending on your product, discard the unused mixed medication after 1 to 2 months. Check the product package for the storage time for your product. 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.