Urofollitropin

Urofollitropin is a prescription medication used to treat infertility in women with FSH deficiency. It is also used to help the ovaries produce multiple eggs for use in "in-vitro" fertilization.

• Urofollitropin is available under various brand names: Bravelle, Fertinex

Common side effects of Urofollitropin include:

• stomach cramps or bloating;
• headache, general pain;
• nausea;
• trouble breathing;
• hot flashes; or
• mild pelvic pain, pain after an egg is removed for in-vitro fertilization.

Serious side effects of Urofollitropin include:

• hives, 
• difficult breathing,
• swelling of the face, lips, tongue, or throat,
• stomach pain, bloating;
• nausea, vomiting, diarrhea;
• rapid weight gain, especially in your face and midsection;
• sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• chest pain, sudden cough, wheezing, rapid breathing, coughing up blood; 
• pain, swelling, warmth, or redness in one or both legs;
• little or no urination; or
• pain while breathing, rapid heart rate, and feeling short of breath (especially when lying down)

Rare side effects of Urofollitropin include:

• none

Seek medical care or call 911 at once if you have the following serious side effects:

• Severe headache, confusion, slurred speech, arm or leg weakness, trouble walking, loss of coordination, feeling unsteady, very stiff muscles, high fever, profuse sweating, or tremors;
• Serious eye symptoms such as sudden vision loss, blurred vision, tunnel vision, eye pain or swelling, or seeing halos around lights;
• Serious heart symptoms such as fast, irregular, or pounding heartbeats; fluttering in the chest; shortness of breath; sudden dizziness, lightheartedness, or passing out.

This is not a complete list of side effects and other serious side effects or health problems that may occur because of the use of this drug. Call your doctor for medical advice about serious side effects or adverse reactions. You may report side effects or health problems to FDA at 1-800-FDA-1088.

Adult dosage

Ovulation Induction 

• Adult dosage
  • Initial: 150 International units IM/SC every day for 5 days
  • Titrate by 75-150 International units every other day
  • Maximum dose 450 International units, maximum time 12 days

ART (Assisted Reproductive Technology)

Adult dosage

• Initial dose for women who have received a GnRH agonist for pituitary suppression is 225 IU SC every day
• May be coadministered with menotropins (Menopur), and the total initial dose when the products are combined should not exceed 225 IU (ie, urofollitropin 150 IU and menotropins 75 IU OR urofollitropin 75 IU and menotropins 150 IU)

Dosage Considerations – Should be Given as Follows: 

• See “Dosages”

If your medical doctor is using this medicine to treat your pain, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Urofollitropin has no noted severe interactions with any other drugs.
• Urofollitropin has no noted serious interactions with any other drugs.
• Urofollitropin has no noted moderate interactions with any other drugs.
• Urofollitropin has no noted minor interactions with any other drugs.

This information does not contain all possible interactions or adverse effects. Visit the RxList Drug Interaction Checker for any drug interactions. Therefore, before using this product, tell your doctor or pharmacist about all your products. Keep a list of all your medications with you and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions or concerns.

Contraindications

• Hypersensitivity to Urofollitropin
• Primary ovarian failure;
• Cancer of the breast, uterus, or ovary;
• An untreated or uncontrolled disorder of your thyroid or adrenal gland;
• Infertility that is not caused by lack of ovulation;
• Abnormal vaginal bleeding that has not been checked by a doctor;
• An ovarian cyst;
• A tumor of your pituitary gland; or
• If you are pregnant.

Effects of drug abuse

• None

Short-Term Effects

• See “What Are Side Effects Associated with Using Urofollitropin?”

Long-Term Effects

• See “What Are Side Effects Associated with Using Urofollitropin?”

Cautions

• You should not use this medicine if you have primary ovarian failure, abnormal vaginal bleeding, uncontrolled thyroid or adrenal gland disorders, an ovarian cyst, breast cancer, uterine or ovarian cancer, a pituitary gland tumor, or infertility that is not caused by a lack of ovulation.
• Stop using urofollitropin, do not have sexual intercourse, and call your doctor right away if you have any of the following symptoms: stomach pain, bloating, nausea, vomiting, diarrhea, rapid weight gain, little or no urinating, or pain when you breathe, rapid heart rate, or shortness of breath
• Your doctor will perform blood tests and a pelvic exam to make sure you do not have conditions that would prevent you from safely using urofollitropin.
• Your male sexual partner's fertility should also be checked before you are treated with urofollitropin
• Using urofollitropin can increase your chances of having multiple pregnancies (twins, triplets, quadruplets, etc). Multiple pregnancies are high-risk pregnancies for the mother and the babies. Follow your doctor's instructions about any special care you may need during your pregnancy.
• Urofollitropin may also increase your risk of tubal pregnancy, miscarriage, stillbirth, premature labor, birth defects, or fever after childbirth if you become pregnant after being treated with this medicine. Talk with your doctor if you are concerned about these risks.
• Urofollitropin may increase your risk of developing uterine cancer. Ask your doctor about your specific risk. Report any unusual vaginal bleeding right away.

Pregnancy and Lactation

• FDA pregnancy category X. Although urofollitropin can help you become pregnant, this medicine can harm an unborn baby or cause birth defects. Do not use urofollitropin if you are pregnant. Tell your doctor right away if you become pregnant during treatment.
• Lactation
  • It is not known whether urofollitropin passes into breast milk or if it could harm a nursing baby. You should not breastfeed while using this medicine.