Health Guide
Drug Guide

Urofollitropin (Intramuscular route, subcutaneous route)

Pronunciation:

ure-oh-FOL-li-troe-pin

Brand Names:

Dosage Forms:

Classifications:

Therapeutic

Female Reproductive Agent

Pharmacologic

Human Follicle Stimulating Hormone

Uses of This Medicine:

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

Urofollitropin will help develop and release eggs in women who have not been able to become pregnant because of problems with ovulation, and have already received a medicine to control their pituitary gland.

This medicine is also used in women with healthy ovaries who are enrolled in a fertility program called assisted reproductive technology (ART). ART uses procedures such as in vitro fertilization (IVF). Urofollitropin is used together with human chorionic gonadotropin (hCG) in these procedures.

Urofollitropin is often used in women who have low levels of FSH and too-high levels of LH. Women with polycystic ovary syndrome usually have hormone levels such as this and are treated with urofollitropin to make up for the low amounts of FSH. Many women being treated with urofollitropin have already tried clomiphene (eg, Serophene) and have not been able to conceive yet. Urofollitropin may also be used to cause the ovary to produce several follicles, which can then be harvested for use in gamete intrafallopian transfer (GIFT) or in vitro fertilization (IVF).

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

Before Using This Medicine:

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.

Children

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.

Older adults

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

Pregnancy

Pregnancy CategoryExplanation
All TrimestersXStudies in animals or pregnant women have demonstrated positive evidence of fetal abnormalities. This drug should not be used in women who are or may become pregnant because the risk clearly outweighs any possible benefit.

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.

Other 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.

Other interactions

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:

Proper Use of This Medicine:

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:

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.

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.

Precautions While Using This Medicine:

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.

Side Effects of This Medicine:

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they 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. Also, your health care professional may 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:

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 produce some side effects that need attention. During this period of 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.


Last Updated: 10/12/2016

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