Generic name: urofollitropin
Brand names: Bravelle, Metrodin, Fertinex
Dosage form: injectable powder for injection (75 intl units)
Drug class: Gonadotropins
What is urofollitropin used for?
Urofollitropin is a prescription medicine that is used to help women get pregnant. Urofollitropin may be given to you for other reasons. Talk to your doctor.
FertinexTM (urofollitropin for injection, purified) is a preparation of highly purified Follicle Stimulating Hormone (FSH) extracted from the urine of post-menopausal women. Purification is by immunoaffinity chromatography using murine monoclonal antibody to human FSH. The purification process results in a consistent FSH isoform profile, significantly enhanced specific activity (8,500-13, 500 IU FSH/mg protein), and ≥95% purity. Each ampule of Fertinex (urofollitropin) TM contains either 75 IU or 150 IU of highly purified FSH and 10 mg lactose in a sterile, lyophilized form. If required, pH is adjusted with 0.1 M hydrochloric acid and/or 0.1 M sodium hydroxide. Fertinex (urofollitropin) TM is administered by subcutaneous injection.
Before taking urofollitropin, tell your doctor:
- If you are allergic to urofollitropin; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
- If your ovaries no longer make eggs (primary ovarian failure).
- If you have any of these health problems: Adrenal gland disease, brain tumor, pituitary gland disease, or thyroid gland disease.
- If you have any of these health problems: A tumor in your female organs, enlarged ovaries or ovarian cysts, or vaginal bleeding where the cause is not known.
- If you are pregnant or may be pregnant. Do not take urofollitropin if you are pregnant.
- If you are breast-feeding or plan to breast-feed.
This is not a list of all drugs or health problems that interact with urofollitropin.
Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take urofollitropin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.
What are some things I need to know or do while I take urofollitropin?
- Tell all of your health care providers that you take urofollitropin. This includes your doctors, nurses, pharmacists, and dentists.
- Have blood work checked as you have been told by the doctor. Talk with the doctor.
- You will need to have ultrasounds done while using urofollitropin. Talk with your doctor.
- This medicine may raise the chance of getting pregnant with more than one baby.
- This medicine may raise the chance of very bad side effects like blood clots and lung problems. Rarely, these effects have been deadly. Talk with the doctor.
- This medicine may raise the chance of very bad side effects like enlarged ovaries and ovarian cysts that burst. Rarely, these effects have been deadly. Talk with the doctor.
- If your ovaries get too big, your doctor may tell you that you need to avoid sex. This may cause an ovarian cyst to burst. Talk with your doctor.
- This medicine may raise the chance of twisting of the ovaries (ovarian torsion) in women with some health problems. This can cause blood flow to the ovary to be cut off. Talk with the doctor.
- The chance of pregnancy outside of the uterus (ectopic pregnancy) may be raised in some women. Talk with your doctor.
- Limit working out while undergoing ovarian stimulation. Talk with your doctor.
- If you have used drugs like this one more than 1 time to get pregnant, the chance of having tumors in your ovaries or other sex organs may be raised.
- The rate of pregnancy loss (miscarriage) is higher in women using drugs like this one than in women who have a natural pregnancy. Talk with the doctor.
- This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking urofollitropin, call your doctor right away.
How is urofollitropin best taken?
Use urofollitropin as ordered by your doctor. Read all information given to you. Follow all instructions closely.
- It is given as a shot into the fatty part of the skin.
- If you will be giving yourself the shot, your doctor or nurse will teach you how to give the shot.
- Wash your hands before and after use.
- Do not use if the solution is cloudy, leaking, or has particles.
- Do not use if solution changes color.
- Throw away needles in a needle/sharp disposal box. Do not reuse needles or other items. When the box is full, follow all local rules for getting rid of it. Talk with a doctor or pharmacist if you have any questions.
Injection (if given in the muscle):
- It may be given as a shot into a muscle.
- Your doctor will give urofollitropin.
What do I do if I miss a dose?
- Call your doctor to find out what to do.
What are the side effects of urofollitropin that I need to call my doctor about immediately?
WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:
- Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
- Vaginal bleeding that is not normal.
- Pelvic pain.
- Ovarian hyperstimulation syndrome (OHSS) is a severe side effect that may happen in some women who use urofollitropin. Call your doctor right away if you have severe stomach pain or bloating; very upset stomach, throwing up, or diarrhea; a big weight gain; shortness of breath; or change in how much urine is passed.
- Blood clots have happened with urofollitropin. Sometimes, these blood clots have been deadly. Call your doctor right away if you have chest, arm, back, neck, or jaw pain or pressure; coughing up blood; numbness or weakness on 1 side of your body, trouble speaking or thinking, change in balance, or change in eyesight; shortness of breath; or swelling, warmth, or pain in the leg or arm.
What are some other side effects of urofollitropin?
All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:
- Irritation where the shot is given.
- Upset stomach.
- Stomach cramps.
- Hot flashes.
- Belly pain.
These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.
You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.
If overdose is suspected:
If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.
How do I store and/or throw out urofollitropin?
- Store at room temperature or in a refrigerator. Do not freeze.
- Protect from light.
- Use right away after mixing.
- Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
- Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.
SRC: NLM .