Repronex (Intramuscular, Subcutaneous)

Menotropins injection is used to help women who are having trouble getting pregnant. Menotropins are a mix of follicle-stimulating hormone (FSH) and luteinizing hormone (LH), which are made by the pituitary gland in the body.

Menotropins injection is for women with healthy ovaries who are part of a fertility program called assisted reproductive technology (ART). ART includes methods like in vitro fertilization (IVF). Menotropins is used along with human chorionic gonadotropin (hCG) in these treatments.

Many women who choose menotropins have already tried clomiphene (for example, Serophene) and have not become pregnant. Menotropins can also be used to make the ovary produce several follicles, which can then be collected for gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).

This medicine is only available with your doctor's prescription.

It is very important that your doctor checks your progress at regular visits to ensure that the medicine is working properly and to look for any side effects. Blood and urine tests, along with ultrasound examinations, are needed to check for any side effects caused by this medicine.

Call your doctor right away if you think you have become pregnant while using this medicine. You may have a higher risk of an ectopic pregnancy or miscarriage if you get pregnant while undergoing IVF procedures. An ectopic pregnancy can be a serious and life-threatening condition. It can also cause issues that may make it harder for you to become pregnant in the future.

If your doctor has asked you to record your basal body temperatures (BBTs) daily, make sure you know how to do this. Carefully follow your doctor's instructions.

This medicine may increase your risk of a problem with the ovaries called ovarian hyperstimulation syndrome (OHSS). OHSS is a serious issue that can be life-threatening. Call your doctor right away if you have severe pain in the lower stomach area, nausea, vomiting, weight gain, diarrhea, decreased urine output, or trouble breathing.

This medicine may increase your risk of having a blood clot, heart attack, or stroke. This is more likely in people who already have heart disease. Contact your doctor right away if you have chest pain, tightness in the chest, a fast or irregular heartbeat, unusual flushing or warmth of the skin, increased coughing, trouble with breathing, sudden difficulty breathing at night, or abnormal swelling in your ankles or legs. These could be symptoms of serious heart issues or blood clots.

This medicine may cause more than one egg to be released from your ovary at the same time. This means you could become pregnant with more than one baby. Discuss this possibility with your doctor before you start using this medicine.

This medicine may increase your risk of ovarian cancer if you have received it more than once to get pregnant. Talk to your doctor about this risk.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the benefits it will provide. This is a decision you and your doctor will make together. For this medicine, consider the following:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have not been appropriate studies on how age affects the use of menotropins injection in children. Safety and effectiveness have not been established.

Geriatric

There have not been appropriate studies on how age affects the use of menotropins injection in older adults.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction may happen. In these situations, your doctor may adjust the dose, or other precautions may be needed. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around the time of eating food or consuming certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also cause interactions. Talk to your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Make sure to tell your doctor if you have any other medical problems, especially:

• Abnormal or unusual vaginal bleeding or
• Uncontrolled adrenal gland problems or
• Cysts in the ovaries or enlarged ovaries or
• High levels of FSH or
• Uncontrolled pituitary gland problems or
• Uncontrolled thyroid gland problems or
• Tumor in the brain (in the hypothalamus area or pituitary gland) or
• Tumor in the breast or
• Tumor in the ovary or uterus—This medicine should not be used in patients with these conditions.

• Blood clots (for example, pulmonary embolism, venous thromboembolism), or a history of or
• Blood vessel problems or
• Lung or breathing problems or
• History of ovarian torsion (twisting of the ovary) or
• Stroke, or a history of—Use with caution. This medicine may worsen these conditions.

Along with its needed effects, a medicine may cause some unwanted effects. Not all of these side effects may occur, but if they do, they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

For females only

Less common

• Back pain
• breast tenderness
• feeling of warmth, redness of the face, neck, arms, and occasionally, upper chest
• menstrual changes
• muscle aches and pains
• unusual tiredness or weakness

Less common or rare

• Abdominal or stomach pain (severe)
• bloating (moderate to severe)
• chest pain or trouble breathing
• decreased amount of urine
• feeling of indigestion
• general feeling of discomfort or illness
• headache, severe and throbbing
• nausea, vomiting, or diarrhea (continuing or severe)
• pain or swelling in the arms or legs
• pelvic pain (severe)
• severe cramping of the uterus
• shortness of breath or wheezing
• swelling of the lower legs
• weight gain (rapid)

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Your health care professional may also be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For females only

Less common

• Enlargement of the breasts
• headache
• pain, swelling, or irritation at the injection site
• rash at the injection site
• stomach cramps, fullness, or pain

After you stop using this medicine, it may still produce some side effects that need attention. During this time, check with your doctor immediately if you notice the following side effects:

For females only

• Abdominal or stomach pain (severe)
• bloating (moderate to severe)
• decreased amount of urine
• feeling of indigestion
• nausea, vomiting, or diarrhea (continuing or severe)
• pelvic pain (severe)
• shortness of breath
• weight gain (rapid)

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Menopur
• Pergonal
• Repronex

Available Dosage Forms:

• Powder for Solution

Therapeutic Class: Endocrine-Metabolic Agent

Pharmacologic Class: Human Luteinizing Hormone

A nurse or other trained health professional will give you this medicine. This medicine is given as a shot under the skin.

Menotropins injection is used with another hormone called human chorionic gonadotropin (hCG). At the proper time, your doctor or nurse will give you this medicine.

This medicine comes with a patient information leaflet. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions.

You might be taught how to give your medicine at home. If you are using this medicine at home:

• Wash your hands with soap and water and use a clean work area to prepare your injection.
• Make sure you understand and carefully follow your doctor's instructions on how to give yourself an injection, including the proper use of a needle and syringe.
• Check the solution in the vial. It should be clear and colorless. If it is cloudy, discolored, or contains large particles, do not use it.
• Do not inject more or less of the medicine than your doctor ordered.
• You will be shown the body areas (eg, stomach) where this shot can be given. Use a different body area each time you give yourself a shot. Keep track of where you give each shot to make sure you rotate body areas. This will prevent skin problems.
• Use a new needle and syringe each time you inject your medicine.
• It is very important that you keep track of each dose you inject. Your doctor or nurse will help you with this.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For injection dosage form: For help in becoming pregnant while using other pregnancy-promoting methods (assisted reproductive technology [ART]): Adults—At first, 225 International Units (IU) (150 IU of Menopur® and 75 IU of Bravelle® or 75 IU of Menopur® and 150 IU of Bravelle®) injected under the skin once a day. Your doctor will adjust your dose after 5 days, if needed. However, the dose is usually not more than 450 IU per day. Do not use this medicine for more than 20 days. Children—Use is not recommended.

Missed Dose

Call your doctor or pharmacist for instructions.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the unused medicine in the refrigerator or at room temperature until it is mixed. Protect it from light.

Throw away used needles and syringes in a hard, closed container that the needles cannot poke through. Keep this container away from children and pets.