This medication is used to help women with fertility problems get pregnant. It is generally used in combination with 2 other hormones (FSH and hCG). Lutropin alfa provides luteinizing hormone (LH), which together with FSH helps your body get an egg ready for ovulation to help you get pregnant.

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

Read the Patient Information Leaflet if available from your pharmacist before you start using lutropin alfa and each time you get a refill. Ask your health care professional how to prepare and use this medication. If you have any questions, ask your doctor or pharmacist.

Inject this medication under the skin as directed by your doctor, usually once daily. The injection is given in the abdomen or upper thigh. The dosage is based on your medical condition and response to treatment. Lutropin alfa is usually given at the same time as FSH. The dose of hCG is usually given 1 day after the last dose of LH and FSH. Follow your doctor's instructions carefully to make sure these medications are timed properly.

If the medication and the solution used to mix it are refrigerated, take them out of the refrigerator to allow them to reach room temperature before mixing. After mixing, gently swirl to completely dissolve the powder. Do not shake. Use the mixed medication right away. Do not save for future use. Before using, check this product for particles or discoloration. If either is present, do not use the liquid. Before injecting each dose, clean the skin you are going to inject into (the injection site) with rubbing alcohol. Change the injection site each time to lessen injury under the skin. To lessen bruising, do not rub the injection site after a shot. Learn how to store and discard medical supplies safely.

Use this medication exactly as directed by your doctor to get the most benefit from it. To help you remember, use it at the same time as scheduled. Do not change the dose unless instructed by your doctor, and do not use this drug for a longer period than prescribed.

Usually, daily sexual intercourse is recommended beginning on the day before the hCG hormone is given and continuing until clear signs of ovulation occur (such as a rise in basal body temperature). Follow your doctor's instructions.

Redness/pain at the injection site, headache, tiredness, or mild nausea 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:

• bloating
• pain/swelling in the lower abdominal (pelvic) area
• 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.

Before using lutropin alfa, tell your doctor or pharmacist if you are allergic to it; or to other products containing luteinizing hormone (LH); 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 bleeding from the uterus/vagina
• unexplained ovarian cysts or enlarged ovaries
• blood clots
• stroke
• certain heart problems (such as heart attack)
• liver disease
• lung problems (such as asthma)

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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. It may harm an unborn baby. If you think you may be pregnant, tell your doctor right away.

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

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.

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

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.

Store in the refrigerator or at room temperature away from light and heat. Do not freeze. 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.