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|Follitropin Alfa Solution

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Follitropin Alfa Solution

Generic Name: Follitropin Alfa Injection Solution (FALL-lee-tro-pin)
Brand Name: Gonal-f RFF Pen

Follitropin Alfa Solution is used for:

Treating infertility in women. Follitropin Alfa Solution helps women seeking pregnancy to produce eggs. It is sometimes prescribed with other medicines or as an addition to an Assisted Reproductive Technology (ART) program, such as in vitro fertilization. Follitropin Alfa Solution will not work in women whose ovaries do not produce eggs because of primary ovarian failure.

This is a fertility medicine that helps develop eggs in the ovaries in women trying to become pregnant. Follitropin Alfa Solution is usually used with fertility programs and other fertility medicines.

Do NOT use Follitropin Alfa Solution if:

you are allergic to any ingredient in Follitropin Alfa Solution
you have primary ovarian failure (your ovaries do not make eggs)
you have uncontrolled thyroid or adrenal problems
you have hormone-sensitive tumors
you have pituitary tumor or other brain lesion or tumor
you are pregnant or think you may be pregnant
you have cancer in your female organs (ovaries, breast, uterus)
you have heavy or irregular bleeding from your uterus or vagina
you have ovarian cysts or enlargement, not due to polycystic ovary syndrome (PCOS)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Follitropin Alfa Solution:

Some medical conditions may interact with Follitropin Alfa Solution. Tell your health care provider if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, plan to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have urinary tract bleeding
if you have an adrenal gland or thyroid problem
if you have blood clotting or breathing problems

Some MEDICINES MAY INTERACT with Follitropin Alfa Solution. Tell your health care provider if you are taking any other medicines.

This may not be a complete list of all interactions that may occur. Ask your health care provider if Follitropin Alfa Solution may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Follitropin Alfa Solution:

Use Follitropin Alfa Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Carefully read and follow the patient instructions that are provided with Follitropin Alfa Solution.
Follitropin Alfa Solution is sometimes used at home as an injection. Use Follitropin Alfa Solution exactly as prescribed. Do not change the dose unless your doctor tells you to. Your doctor will tell you the number of units of the pen to use each day and the number of days to use the same pen.
Follitropin Alfa Solution is an injection given under the skin. Your doctor or health care provider will instruct you as to how to inject yourself. Do not use Follitropin Alfa Solution at home until your health care provider has shown you the correct way.
Make sure that you understand how to properly prepare and measure your dose. If you have any questions about preparing or measuring the dose, contact your health care provider.
Prime the pen before the first use. You only need to prime the first time you use a new pen.
Do not touch the needle or allow it to touch any surface.
Allow the liquid solution to come to room temperature before you inject.
Check that the liquid is clear before you inject. Do not use the injection if it contains any particles. Report this to your health care provider immediately.
It is normal for a small amount of drug to be left over in the medicine pen. Discard any remaining medicine in the pen after your injection.
If you are traveling, keep the pen away from light and extreme temperatures.
If you use too much medicine in the pen, call your health care provider at once.
If you miss a dose of Follitropin Alfa Solution, do not double the dose. Contact your doctor if to find out when you should take your next dose.

Ask your health care provider any questions you may have about how to use Follitropin Alfa Solution.

Important safety information:

You will need to have a complete gynecological and hormone evaluation prior to starting therapy with Follitropin Alfa Solution. Your partner should be evaluated for fertility problems.
Follitropin Alfa Solution may cause multiple births (eg, twins). Talk with your doctor to discuss your chances of multiple births.
LAB TESTS, such as ultrasound or drawing an estradiol level, may be required to monitor your progress. Be sure to keep all doctor and lab appointments.
Follitropin Alfa Solution is not recommended for use in CHILDREN; safety and effectiveness have not been confirmed.
PREGNANCY and BREAST-FEEDING: Do not use Follitropin Alfa Solution if you are pregnant or think you may be pregnant. Check with your health care provider about the risks and benefits of using Follitropin Alfa Solution while breast-feeding.

Possible side effects of Follitropin Alfa Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Acne; abnormal menses; back pain; breast pain; constipation; coughing; dizziness; enlarged abdomen; fever; frequent urination; gas; headache; hot flushes; indigestion; injection site bruising, pain, or swelling; malaise; migraine; oral infection; pain; painful menstruation; runny nose; sinus inflammation; spotting; sore throat; toothache; vaginal bleeding between menstrual periods; virus infection.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bladder or urination problems; breathing or lung problems; chest pain; confusion; diarrhea; infrequent urination; multiple births; nausea; one-sided weakness; ovarian hyperstimulation syndrome (stomach pain or bloating; nausea; vomiting; diarrhea; weight gain; infrequent urination; pounding in the chest); sharp pain in the stomach area, groin, or calves; stomach bloating; trouble breathing; vomiting; weight gain; worsening of asthma.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms of overdose may include nausea; severe headache; severe stomach pain or swelling; vomiting; weakness; weight gain.

Proper storage of Follitropin Alfa Solution:

Store Follitropin Alfa Solution in the refrigerator (36 to 46 degrees F; 2 to 8 degrees C) until the expiration date. It can be kept at room temperature (68 to 77 degrees F; 20 to 25 degrees C) for up to 1 month or until the expiration date, whichever comes first. Protect from light. Do not freeze. Keep Follitropin Alfa Solution out of the reach of children and away from pets.

General information:

If you have any questions about Follitropin Alfa Solution, please talk with your doctor, pharmacist, or other health care provider.
Follitropin Alfa Solution is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Follitropin Alfa Solution. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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