Medication Support

Gonal-f® RFF Pen

Gonal-f® RFF Pen

Gonal-f® RFF Pen

The Gonal-f® RFF Pen is for women seeking pregnancy and is used to help ovaries make more eggs. It is used in ovulation induction (OI) and in vitro fertilization (IVF)

In a 2006 survey 1:

  • 2 out of 3 patients* preferred the Gonal-f® RFF Pen to other FSH injection devices
  • The majority of women preferred the Gonal-f® RFF Pen due to:
    • Ease of use
    • Ready to use
    • Simplicity and reliability of dosing mechanism
    • Design minimizes chance of dosing errors

Ready to Use

The Gonal-f® RFF Pen is preloaded with medication and ready to use; there's no mixing, no loading of cartridges.

Simple and Reliable Dosing

The Gonal-f® RFF Pen dosing adjusts with a turn of the dial, making it easy to inject your precise medication dose for every injection prescribed.

Precision You Can See

The Gonal-f® RFF Pen has a visual confirmation scale that lets you know the precise dose you set is ready to inject, reducing the chance of dosing errors. The Gonal-f® RFF Pen is the only ready-to-use FSH pen available in three, multiple-dose presentations.

Important Considerations:
Gonal-f® RFF Pen (follitropin alfa injection) is indicated for the induction of ovulation and pregnancy in the oligo-anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Gonal-f® RFF Pen is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program. Gonal-f® RFF Pen (follitropin alfa injection) should only be prescribed by physicians specializing in fertility or reproductive health. Gonal-f® is a potent gonadotropic substance capable of causing mild to severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications, and multiple births. Gonal-f® is contraindicated in women who exhibit prior hypersensitivity to FSH preparations, primary gonadal failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Nursing women should not use Gonal-f®. Common side effects include headache, abdominal pain, enlarged abdomen, and injection site disorders. For complete product details, see full prescribing information.

Warnings, side effects and other important considerations

Gonal-f® RFF Pen can cause serious side effects including ovarian hyperstimulation syndrome (OHSS), with or without lung or blood vessel problems, and multiple births.

The most common side effects observed with the use of the Gonal-f® RFF Pen may include headache, stomach pain, stomach bloating, OHSS and nausea. Bruising, pain and redness can happen at the injection site. For complete product details, see the Full Prescribing Information.

You should review with your Fertility Specialist the risks and benefits of using the Gonal-f® RFF Pen. As with any medication, report any and all side effects, symptoms or physical changes to your healthcare provider.

Instructions for Use

Gonal-f® RFF Pen is available in three sizes of a prefilled and ready-to-use pen.

Watch this brief video to learn how to administer the Gonal-f® RFF Pen.

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Important Considerations:
Gonal-f® RFF Pen (follitropin alfa injection) is indicated for the induction of ovulation and pregnancy in the oligo-anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Gonal-f® RFF Pen is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program. Gonal-f® RFF Pen (follitropin alfa injection) should only be prescribed by physicians specializing in fertility or reproductive health. Gonal-f® is a potent gonadotropic substance capable of causing mild to severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications, and multiple births. Gonal-f® is contraindicated in women who exhibit prior hypersensitivity to FSH preparations, primary gonadal failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Nursing women should not use Gonal-f®. Common side effects include headache, abdominal pain, enlarged abdomen, and injection site disorders. For complete product details, see full prescribing information.

Storage

Before First Use

Up to 3 months at room temperature (20 – 25°C / 68 – 77°F) or until expiration date, whichever occurs first, or refrigerate (2 – 8°C / 36 – 46°F) until expiration date.

After First Use

Up to 28 days either at room temperature or refrigerated.

Keep away from light and extreme temperature.

Do not freeze

Important Considerations:
Gonal-f® RFF Pen (follitropin alfa injection) is indicated for the induction of ovulation and pregnancy in the oligo-anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Gonal-f® RFF Pen is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program. Gonal-f® RFF Pen (follitropin alfa injection) should only be prescribed by physicians specializing in fertility or reproductive health. Gonal-f® is a potent gonadotropic substance capable of causing mild to severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications, and multiple births. Gonal-f® is contraindicated in women who exhibit prior hypersensitivity to FSH preparations, primary gonadal failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Nursing women should not use Gonal-f®. Common side effects include headache, abdominal pain, enlarged abdomen, and injection site disorders. For complete product details, see full prescribing information.

FAQs

What is the Gonal-f® RFF Pen and what is it used for?

The Gonal-f® RFF Pen is a gonadotropin hormone produced by recombinant DNA technology (rDNA). It consists of recombinant human follicle stimulating hormone (r-hFSH) and contains neither luteinizing hormone (LH) nor urinary proteins.

FSH is primarily used in women and is necessary for the recruitment, growth and maturation of the ovarian follicles, which contain cells known as ova or oocytes. This occurs at the beginning of a woman's menstrual cycle.

After the Gonal-f® RFF Pen is used to help develop the ovarian follicle, another hormone—hCG (human chorionic gonadotropin)—is given mid-cycle to mature the egg and induce ovulation.

The amount of medication given and the length of the treatment may vary from patient to patient.

The Gonal-f® RFF Pen is injected under the skin as recommended by your Fertility Specialist.

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How is the Gonal-f® RFF Pen different from other FSH medications?

The Gonal-f® RFF Pen is the only prefilled, ready to use, multi-dose FSH pen.

The Gonal-f® RFF Pen has been designed to simplify self-administration and to facilitate precise dosing without the need for mixing powder and water or loading individual medication cartridges. Other advantages include:

  • A transparent drug reservoir for total visibility of the drug.
  • Easy dose dialing and setting.
  • A dosage confirmation scale to confirm the precise dose to be delivered prior to injection.

Gonal-f® is produced by rDNA technology and consists only of highly purified r-hFSH. Certain other FSH products — that are not derived from recombinant technology — may also contain varying amounts of urinary proteins.

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Who should not use the Gonal-f® RFF Pen?

You should not use the Gonal-f® RFF Pen if you answer "yes" to any of the following questions. If you are unsure if you should use the Gonal-f® RFF Pen, talk with your healthcare provider.

  • Are you pregnant or breast–feeding?
  • Do you have primary ovarian failure (your ovaries no longer make eggs)?
  • Do you have unexplained bleeding from the vagina or uterus?
  • Have you ever been diagnosed as having ovarian, uterine or breast cancer?
  • Do you have a pituitary tumor or other brain tumor?
  • Do you have uncontrolled thyroid or adrenal gland problems?
  • Do you have an allergy to r-hFSH preparations or any one of the following: sucrose, sodium phosphate, methionine, meta-cresol, poloxamer 188, sodium hydroxide or o-phosphoric acid?

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Are there any possible side effects due to the Gonal-f® RFF Pen?

You should review with your Fertility Specialist the risks and benefits of using the Gonal-f® RFF Pen. As with any medication, report any and all side effects, symptoms or physical changes to your healthcare provider.

The Gonal-f® RFF Pen can cause serious side effects including ovarian hyperstimulation syndrome (OHSS), with or without lung or blood vessel problems, and multiple births.

The most common side effects observed with the use of the Gonal-f® RFF Pen may include headache, stomach pain, stomach bloating, OHSS and nausea. Bruising, pain and redness can happen at the injection site. For complete product details, see the Full Prescribing Information.

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Is there a risk of multiple pregnancies with the Gonal-f® RFF Pen?

Use of fertility medications can be associated with the fertilization of more than one egg. This can lead to complications for the mother and the birth of two or more babies. You should discuss the risks of multiple births before initiating treatment with your Fertility Specialist.

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How much of the Gonal-f® RFF Pen should I inject?

Your Fertility Specialists will tell you exactly how many IUs of Gonal-f® RFF Pen you will need to inject each day.

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What should I do if I forget to take my dose of the Gonal-f® RFF Pen?

Do not take a double dose to make up for any missed doses. Contact your Fertility Specialist if you forget to take a dose of the Gonal-f® RFF Pen.

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Can I take the Gonal-f® RFF Pen with other medications?

Inform your Fertility Specialist first and then your pharmacist if you are taking or have taken any other medications, including those that do not require a prescription.

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Why are the Gonal-f® RFF Pens available in 3 different colors?

Since different people need different dosing regimens, there are 3 multi-dose pens of the Gonal-f® RFF Pen available. Your Fertility Specialist will know which pen is most appropriate for your needs.

Light blue pens are prefilled to deliver 300 IU of Gonal-f® RFF ready-to-use solution; dark blue pens are prefilled to deliver 450 IU of Gonal-f® RFF ready-to-use solution; and red pens are prefilled to deliver 900 IU of Gonal-f® RFF ready-to-use solution.

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If you have any additional questions, be sure to contact your Fertility Specialist for more information or guidance. You can also call Fertility LifeLines™ toll-free at 1-866-LETS-TRY (1-866-538-7879). All calls are free and confidential.

Important Considerations:
Gonal-f® RFF Pen (follitropin alfa injection) is indicated for the induction of ovulation and pregnancy in the oligo-anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Gonal-f® RFF Pen is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program. Gonal-f® RFF Pen (follitropin alfa injection) should only be prescribed by physicians specializing in fertility or reproductive health. Gonal-f® is a potent gonadotropic substance capable of causing mild to severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications, and multiple births. Gonal-f® is contraindicated in women who exhibit prior hypersensitivity to FSH preparations, primary gonadal failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Nursing women should not use Gonal-f®. Common side effects include headache, abdominal pain, enlarged abdomen, and injection site disorders. For complete product details, see full prescribing information.

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Prescribing Information and Important Considerations

Gonal-f® RFF Pen (follitropin alfa injection) is indicated for the induction of ovulation and pregnancy in the oligo-anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Gonal-f® RFF Pen is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program. Gonal-f® RFF Pen (follitropin alfa injection) should only be prescribed by physicians specializing in fertility or reproductive health. Gonal-f® is a potent gonadotropic substance capable of causing mild to severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications, and multiple births. Gonal-f® is contraindicated in women who exhibit prior hypersensitivity to FSH preparations, primary gonadal failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Nursing women should not use Gonal-f®. Common side effects include headache, abdominal pain, enlarged abdomen, and injection site disorders. For complete product details, see full prescribing information.

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  • 1. Weiss N. Gonadotrophin products: Empowering patients to choose the product that meets their needs. Reprod Biomed Online. 2007;15(1):31-37
  • * patients who stated a preference

Patient preference for Gonal-f® RFF Pen over Follistim® Pen and vials/ampules was also documented in a separate study by Welcker et al.

Welcker JT, on behalf of the German Gonal-f® FbM Pen Study Group. Analysis of an observational study on the routine use of follitropin alfa in a prefilled ready to use injection pen in ovulation induction and intra-uterine insemination cycles [abstract]. Fertil Steril. 2006;86(suppl 2):S410. Abstract P-747

RFF: Revised Formulation Female

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Important Considerations:
Gonal-f® RFF Pen (follitropin alfa injection) is indicated for the induction of ovulation and pregnancy in the oligo-anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Gonal-f® RFF Pen is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program. Gonal-f® RFF Pen (follitropin alfa injection) should only be prescribed by physicians specializing in fertility or reproductive health. Gonal-f® is a potent gonadotropic substance capable of causing mild to severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications, and multiple births. Gonal-f® is contraindicated in women who exhibit prior hypersensitivity to FSH preparations, primary gonadal failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Nursing women should not use Gonal-f®. Common side effects include headache, abdominal pain, enlarged abdomen, and injection site disorders. For complete product details, see full prescribing information.

Important Considerations:
Women: Gonal-f® (follitropin alfa for injection) is indicated for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Gonal-f® is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.
Men: Gonal-f® (follitropin alfa for injection) is indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure. Gonal-f® (follitropin alfa for injection) should only be prescribed by physicians who are thoroughly familiar with infertility problems and their management. Gonal-f® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Gonal-f® is contraindicated in women and men who exhibit prior hypersensitivity to recombinant FSH preparations or one of their excipients, high levels of FSH indicating primary gonadal failure, uncontrolled thyroid or adrenal dysfunction, sex hormone dependent tumors of the reproductive tract and accessory organs, and an organic intracranial lesion such as a pituitary tumor; and in women who exhibit abnormal uterine bleeding of undetermined origin, ovarian cyst or enlargement of undetermined origin and pregnancy. Women who are pregnant or nursing should not use Gonal-f®. The most common side effects in patients using Gonal-f® include headache, ovarian cysts, nausea and upper respiratory infections in women and in men, acne, breast pain and growth, and fatigue. Injection site reactions were also reported. Reports of multiple births have been associated with Gonal-f® treatment. For complete product details, see the full prescribing information.

For complete product details, please read the Prescribing Information offered below.


© EMD Serono, Inc. CIM Last Update 2008-09-16
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