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All about: Gonal-f RFF Pen Solution

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

Gonal-f RFF Pen Solution is used for:

Treating infertility in certain women. It may also be used for other conditions as determined by your doctor.

This is a fertility medicine that helps develop eggs in the ovaries in women trying to become pregnant. Gonal-f RFF Pen Solution is usually used with fertility programs and other fertility medicines.

Do NOT use Gonal-f RFF Pen Solution if:

  • you are allergic to any ingredient in Gonal-f RFF Pen Solution
  • you have primary ovarian failure (eg, 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 (eg, 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 Gonal-f RFF Pen Solution:

Some medical conditions may interact with Gonal-f RFF Pen 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, planning 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 (eg, asthma)

Some MEDICINES MAY INTERACT with Gonal-f RFF Pen Solution. Tell your health care provider if you are taking any other medicines.

Ask your health care provider if Gonal-f RFF Pen 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 Gonal-f RFF Pen Solution:

Use Gonal-f RFF Pen Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • An extra patient leaflet is available with Gonal-f RFF Pen Solution. Talk to your pharmacist if you have questions about this information.
  • This medicine is sometimes used at home as an injection. Use Gonal-f RFF Pen 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.
  • Gonal-f RFF Pen 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 Gonal-f RFF Pen 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 Gonal-f RFF Pen 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 Gonal-f RFF Pen Solution.

Important safety information:

  • Gonal-f RFF Pen Solution may cause dizziness. This effect may be worse if you take it with alcohol or certain medicines. Use Gonal-f RFF Pen Solution with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • You will need to have a complete gynecological and hormone evaluation prior to starting therapy with Gonal-f RFF Pen Solution. Your partner should be evaluated for fertility problems.
  • Ovarian hyperstimulation syndrome (OHSS) is a severe side effect that may occur in some patients who use Gonal-f RFF Pen Solution. Contact your doctor right away if you develop severe stomach pain or bloating; nausea, vomiting, or diarrhea; sudden unexplained weight gain; shortness of breath; or decreased urination.
  • Gonal-f RFF Pen Solution may cause multiple births (eg, twins). Talk with your doctor to discuss your chances of multiple births.
  • Lab tests, including ultrasound or drawing an estradiol level, may be performed while you use Gonal-f RFF Pen Solution. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Gonal-f RFF Pen Solution should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Do not use Gonal-f RFF Pen Solution if you are pregnant. If you think you may be pregnant, contact your doctor right away. If you are or will be breast-feeding while you use Gonal-f RFF Pen Solution, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Gonal-f RFF Pen 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:

Breast pain; discomfort, pain, or mild bruising at the injection site; headache; mild stomach pain or nausea; sinus inflammation; sore throat; stuffy nose.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal vaginal bleeding; calf pain or tenderness; chest pain; confusion; decreased urination; diarrhea; fever; one-sided weakness; severe or persistent stomach pain, upset, or bloating; severe or persistent nausea; severe pelvic or back pain; shortness of breath; slurred speech; sudden, unexplained weight gain; unusual vaginal itching, discharge, or odor; vision changes; vomiting.

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 Gonal-f RFF Pen Solution:

Store Gonal-f RFF Pen 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 Gonal-f RFF Pen Solution out of the reach of children and away from pets.

General information:

  • If you have any questions about Gonal-f RFF Pen Solution, please talk with your doctor, pharmacist, or other health care provider.
  • Gonal-f RFF Pen 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 Gonal-f RFF Pen 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: September 5, 2007
Database Edition 07.3.1.003
Copyright © 2007 Wolters Kluwer Health, Inc.

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