Fertinex

Prior to the therapy with Fertinex (urofollitropin) TM patients should be informed of the duration of treatment and monitoring of their condition that will be required. Possible adverse reactions (see ADVERSE REACTIONS) and the risk of multiple births should also be discussed.

Fertinex is a prescription medication used to treat infertility in women.

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.
 

Fertinex is part of the drug class:

• Gonadotropins

Serious side effects have been reported with Fertinex. See the “Drug Precautions” section.

Common side effects of Fertinex include the following:

• headache
• stomach pain
• bloating
• vaginal bleeding

This is not a complete list of Fertinex side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

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

The following adverse reactions reported during urofollitropin therapy are listed in decreasing order of potential severity :

1. Pulmonary and vascular complications (see WARNINGS),
2. Ovarian Hyperstimulation Syndrome (see WARNINGS),
3. Adnexal torsion (as a complication of ovarian enlargement),
4. Mild to moderate ovarian enlargement,
5. Abdominal pain,
6. Sensitivity to urofollitropin
   (Febrile reactions which may be accompanied by chills, musculoskeletal aches, joint pains, malaise, headache, and fatigue have occurred after the administration of urofollitropin. It is not clear whether or not these were pyrogenic responses or possible allergic reactions.)
7. Ovarian cysts,
8. Gastrointestinal symptoms (nausea, vomiting, diarrhea, abdominal cramps, bloating),
9. Pain, rash, swelling, and/or irritation at the site of injection,
10. Breast tenderness,
11. Headache,
12. Dermatological symptoms (dry skin, body rash, hair loss, hives)
13. Hemoperitoneum has been reported during menotropins therapy and, therefore, may also occur during urofollitropin therapy.
14. There have been infrequent reports of ovarian neoplasms, both benign and malignant, in women who have undergone multiple drug regimens for ovulation induction; however, a causal relationship has not been established.

The following medical events have been reported subsequent to pregnancies resulting from urofollitropin therapy:

1. Ectopic Pregnancy
2. Congenital abnormalities
   (Three incidents of chromosomal abnormalities and four birth defects have been reported following urofollitropin-hCG or urofollitropin, Pergonal® (menotropins for injection, USP)-hCG therapy in clinical trials for stimulation prior to in vitro fertilization. The aborted pregnancies included one Trisomy 13, one Trisomy 18, and one fetus with multiple congenital anomalies (hydrocephaly, omphalocele, and meningocele). One meningocele, one external ear defect, one dislocated hip and ankle, and one dilated cardiomyopathy in presence of maternal Systemic Lupus Erythematosis were reported. None of these events were thought to be drug-related. The incidence does not exceed that found in the general population).

DRUG ABUSE AND DEPENDENCE

There have been no reports of abuse or dependence with FertinexTM (urofollitropin for injection, purified).

Read the entire FDA prescribing information for Fertinex (Urofollitropin)

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.

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional 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

Appropriate studies have not been performed on the relationship of age to the effects of urofollitropin injection in the pediatric population. Safety and efficacy have not been established.

Geriatric

Appropriate studies on the relationship of age to the effects of urofollitropin injection have not been performed in the geriatric population.

Pregnancy

Breast Feeding

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell 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 used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems

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

• Abnormal or unusual vaginal bleeding or
• Adrenal gland problems, uncontrolled or
• Cysts in the ovaries or enlarged ovaries or
• High levels of FSH or
• Pituitary gland problems, uncontrolled or
• Thyroid gland problems, uncontrolled or
• Tumor in the brain (hypothalamus area or pituitary gland) or
• Tumor in the breast or
• Tumor in the ovary or uterus—Should not be used in patients with these conditions.

• Blood clots (eg, pulmonary embolism, venous thromboembolism), or history of or
• Blood vessel problems or
• Lung or breathing problems or
• Ovarian torsion (twisting of the ovary), history of or
• Stroke, or history of—Use with caution. May make these conditions worse.

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.

It is very important that your doctor check your progress at regular visits to make sure that the medicine is working properly and to check for unwanted effects. Blood and urine tests, and 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 you are 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 you are using this medicine.

If your doctor has asked you to record your basal body temperature (BBT) daily, make sure that 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, a 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.