Fertinex (Intramuscular, Subcutaneous)

Urofollitropin injection is used to treat infertility in women. This medicine is a synthetic hormone called follicle-stimulating hormone (FSH). FSH is made by the pituitary gland in the body. FSH helps to develop eggs in women's ovaries.

Urofollitropin will help develop and release eggs in women who have trouble becoming pregnant due to ovulation problems and have already received a medicine to manage their pituitary gland.

This medicine is also used for women with healthy ovaries who are part of a fertility program known as assisted reproductive technology (ART). ART includes procedures like in vitro fertilization (IVF). Urofollitropin is used along with human chorionic gonadotropin (hCG) in these procedures.

Urofollitropin is often used in women who have low levels of FSH and high levels of LH. Women with polycystic ovary syndrome typically have these hormone levels and are treated with urofollitropin to compensate for the low FSH. Many women treated with urofollitropin have already tried clomiphene (eg, Serophene) and have not been able to conceive. Urofollitropin may also be used to stimulate the ovaries to produce multiple follicles, which can then be collected for gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).

This medicine is available only 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 unwanted effects. Blood and urine tests, along with ultrasound examinations, are needed to check for any unwanted 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 problems that may make it harder for you to become pregnant in the future.

This medicine may cause serious allergic reactions, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash, itching, trouble breathing, trouble swallowing, or any swelling of your hands, face, or mouth while using this medicine.

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

This medicine may increase your risk of having a problem with the ovaries called ovarian hyperstimulation syndrome (OHSS). OHSS is a serious problem 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 with breathing at night, or abnormal swelling in your ankles or legs. These could be symptoms of serious heart problems or blood clots.

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

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

In deciding to use a medicine, you and your doctor must weigh the risks against the benefits. For this medicine, consider the following:

Allergies

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

Pediatric

Studies have not been conducted on the effects of urofollitropin injection in children. Safety and effectiveness have not been established for this age group.

Geriatric

Studies on the effects of urofollitropin injection in older adults have not been conducted.

Breast Feeding

There are no adequate studies on the risk to infants when this medication is used during breastfeeding. Consider the potential benefits and risks before taking this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together, while others may be used together with caution, even if an interaction could occur. In these cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicines.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtimes or with specific foods due to possible interactions. Using alcohol or tobacco with certain medicines may also lead to interactions. Talk to your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be 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 (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 (e.g., 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 necessary effects, a medicine may cause some unwanted effects. Not all of these side effects will occur, but if they do, you may need medical attention.

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

More common

• Abdominal or pelvic pain
• bloating (mild)

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
• headache, sudden and severe
• nausea, vomiting, or diarrhea (continuing or severe)
• pelvic pain (severe)
• shortness of breath or wheezing
• skin rash or hives
• swelling of the arms or 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 have ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Less common or rare

• Breast tenderness
• diarrhea (mild)
• headache
• hot flashes
• nausea
• redness, pain, or swelling at the injection site
• vomiting

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

• 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
• swelling of the lower legs
• 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.

• Fertinex

Pharmacologic Class: Human Follicle Stimulating Hormone

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

Urofollitropin 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 becoming pregnant while having a condition called polycystic ovary syndrome: Adults—75 International Units (IU) injected under the skin or into a muscle once a day for 7 or more days. Your doctor will give you another medicine called chorionic gonadotropin (hCG) the day after the last dose. Your doctor will increase your dose to 150 IU per day for another 7 or more days, if needed. Children—Use is not recommended. For induction of ovulation in women: Adults—At first, 150 International Units (IU) injected under the skin or into a muscle once a day for 5 days in the first cycle of treatment. 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 12 days. Children—Use is not recommended. For women with healthy ovaries undergoing assisted reproductive technology (ART): Adults—At first, 225 International Units (IU) (150 IU of Bravelle® and 75 IU of Menopur® or 75 IU of Bravelle® and 150 IU of Menopur®) 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 12 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, protect from light. After mixing, use it immediately. Throw away any unused mixed medicine.

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.