This medication is used to treat certain fertility problems in women. It provides follicle stimulating hormone (FSH) and luteinizing hormone (LH) that help healthy ovaries to make eggs. This medication is usually used in combination with another hormone (human chorionic gonadotropin-hCG) to help you become pregnant by bringing about the growth and release of a mature egg (ovulation).

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

Read the Patient Information Leaflet and Instructions for Use if available from your pharmacist before starting this medication 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. The injection is given in the abdomen. The dosage and length of treatment are based on your medical condition, response to treatment and other medications you may be taking. Be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Use the solution immediately after the medication is mixed. 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 in order to get the most benefit from it. To help you remember, use it at the same time each day. Do not change the dose or use this drug for a longer period than prescribed unless instructed by your doctor.

Headache, mild stomach pain/bloating, redness/pain at the injection site, breast tenderness, or dizziness 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:

• flu-like symptoms (such as fever, chills, joint pain, muscle ache, tiredness)

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

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

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 this medication, tell your doctor or pharmacist if you are allergic to it; or to other products containing follicle stimulating hormone or luteinizing hormone; 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)
• abnormal uterine/vaginal bleeding
• thyroid problems
• adrenal gland problems
• cancer of the reproductive organs (breast, uterus, ovary)
• tumor in the brain (such as a pituitary tumor)
• ovarian cysts/enlarged ovaries (not due to polycystic ovary syndrome)
• twisting of the ovary (ovarian torsion)
• personal/family history of blood clots
• blood clotting disorders (such as thrombophilia)
• obesity
• stroke
• certain heart diseases (such as heart attack)
• lung problems (such as asthma)

This drug may make you dizzy. Alcohol or marijuana (cannabis) can make you more dizzy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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

Lifestyle changes that may help improve the effect of this medication include limiting alcohol and stopping smoking. Consult your doctor or pharmacist to discuss lifestyle changes that might benefit you.

It is important to use this medication on a fixed schedule exactly as prescribed by your doctor. If you miss a dose, contact your doctor or pharmacist right away for instructions. Do not double the dose to catch up.

Store the unmixed medication in the refrigerator or at room temperature. Protect from light. Do not freeze. Discard any unused portion after use. 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.