Medication Support

Gonal-f® RFF 75 IU Vial

Gonal-f® RFF 75 IU

Gonal-f® RFF 75 IU Vial

It's easy to use. Gonal-f® RFF 75 IU vial comes with a prefilled syringe of diluent, eliminating an extra step of preparing your injection.

Why Gonal-f® RFF 75 IU vial is used

  • Gonal-f® RFF is indicated (used) for the induction of ovulation and pregnancy in oligo-anovulatory infertile patients for whom the cause of infertility is functional and not due to primary ovarian failure.
  • Gonal-f® RFF is also indicated for the development of multiple follicles in the ovulatory patient participating in an assisted reproductive technologies (ART) program.

Ask your healthcare provider if Gonal-f® RFF is right for you.

Important Considerations: 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.

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.

Warnings, Side Effects and Other Important Considerations

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.

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.

Instructions for Use

Watch this brief video that demonstrates how to administer Gonal-f® RFF 75 IU Vial

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Important Considerations: 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.

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.

Storage

Before Reconstitution

Room temperature or refrigerate (2 – 25°C/36 – 77°F) until expiration date.

After Reconstitution

Use immediately. Discard unused material.

Do not store drug in the syringe.

Do not freeze.

Keep away from light.

Important Considerations: 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.

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.

FAQs

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

Gonal-f® RFF 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 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 Gonal-f® RFF 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.

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

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How is Gonal-f® RFF different from urinary FSH medications?

Gonal-f® RFF is produced through 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 take Gonal-f® RFF?

Most women can safely use Gonal-f® RFF. However, you should not take Gonal-f® RFF if you answer "yes" to any of the following questions. If you are unsure if you should use Gonal-f® RFF, talk to your healthcare provider.

  • Are you pregnant or breastfeeding?
  • 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, polysorbate 20, sodium hydroxide or o-phosphoric acid?

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

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

Gonal-f® RFF 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 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?

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 with your Fertility Specialist the risks of multiple births before initiating treatment.

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How much Gonal-f® RFF should I inject?

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

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What should I do if I forget to take my Gonal-f® RFF?

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 Gonal-f® RFF.

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Can I take Gonal-f® with other medications?

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

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: 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.

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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Prescribing Information and Important Considerations

Gonal-f® RFF (follitropin alfa for injection) should only be prescribed by doctors specializing in infertility or reproductive health. Gonal-f® RFF can cause serious side effects including: ovarian hyperstimulation syndrome (OHSS) with or without lung or blood vessel complications and multiple births. Gonal-f® RFF should not be used in women who are allergic to recombinant FSH products, have ovaries that no longer make eggs, have uncontrolled thyroid or adrenal problems, have cancer in their female organs, have a pituitary tumor or other tumor in their brain, have abnormal bleeding from the uterus or vagina or are pregnant or think they may be pregnant. Women who are nursing should not use Gonal-f® RFF. Side effects in women using Gonal-f® RFF may include headache, stomach pain, stomach bloating and nausea. Bruising, pain and redness can happen at the injection site. Please see the Full Prescribing Information and FAQs for more information.

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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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