Uses

This medication is used to treat certain fertility problems in women. It provides follicle stimulating hormone (FSH) and luteinizing hormone (LH) that help stimulate 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).

How To Use

Read the Patient Information Leaflet provided by your pharmacist before starting this medication and each time you get a refill. You will be trained by a healthcare professional on how to properly use this medication. Learn and understand all preparation and usage instructions. If you have any questions regarding this information, consult your doctor or pharmacist.

Inject under the skin (subcutaneously) or into a muscle (intramuscularly) exactly as directed by your doctor. The dosage and length of treatment are based on your medical condition, response to therapy, 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). Be sure to keep all medical appointments so your doctor can closely monitor your response to determine the dosage that is right for you. The manufacturer recommends that your dose should not exceed 450 international units per day and that the medication should not be used for more than 12 days per treatment cycle. Do not change the dose or use this drug for a longer period than prescribed unless instructed by your doctor.

Follow all instructions for proper mixing with the correct fluid provided with this medication. Use the solution immediately after the medication is mixed. Before using, check the solution visually for particles or discoloration. If either is present, do not use the liquid. Discard any unused solution. If you have questions regarding the use of this medication, consult your pharmacist.

Wash hands with soap and water before using this medication. Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site daily to avoid discomfort or problem areas under the skin.

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

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. Consult your doctor or pharmacist if you have any questions about your therapy.

Side Effects

Headache, mild stomach pain/bloating, redness/pain at the injection site, breast tenderness, or dizziness may occur. If any of these effects persist or worsen, 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 any of these unlikely but serious side effects occur:

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

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

• weakness on one side of the body
• trouble speaking
• sudden vision changes or 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 therapy and after treatment has been discontinued. 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 side effects:

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

A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include:

• 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 FSH or 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)
• abnormal uterine/vaginal bleeding
• thyroid or adrenal gland problems
• cancer of the reproductive organs (breast, uterus, ovary)
• tumor in the brain (such as pituitary tumor)
• ovarian cysts or 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 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.

Some products that may interact with this drug include:

• gonadorelin

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 blood hormone tests such as estradiol level, vaginal ultrasound) should be performed regularly to monitor your progress or check for side effects. Consult your doctor for more details.

It is important to keep all regular medical and laboratory appointments so your doctor can closely monitor your response to help reduce the risk of serious side effects and determine the timing of your hCG dose.

Missed Dose

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

Storage

Store the medication refrigerated or at room temperature between 37-77 degrees F (3-25 degrees C). Protect from light. Do not freeze. Do not store in the bathroom. Keep all medicines 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 for more details about how to safely discard your product.