Gonal–f® RFF Pen (follitropin alfa injection)

FAQ's

What is the Gonal–f® RFF Pen and what is it used for?
How is the Gonal–f® RFF Pen different from other FSH medications?
Who should not use the Gonal–f® RFF Pen?
Are there any possible side effects due to the Gonal–f® RFF Pen?
Is there a risk of multiple pregnancies with the Gonal–f® RFF Pen?
How much of the Gonal–f® RFF Pen should I inject?
What should I do if I forget to take my dose of the Gonal–f® RFF Pen?
Can I take the Gonal–f® RFF Pen with other medications?
Why are the Gonal–f® RFF Pens available in 3 different colors?

What is the Gonal–f® RFF Pen and what is it used for?top ^

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 midcycle 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.

How is the Gonal–f® RFF Pen different from other FSH medications?top ^

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.

Who should not use the Gonal–f® RFF Pen?top ^

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?

Are there any possible side effects due to the Gonal–f® RFF Pen?top ^

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.

Pregnancy loss (miscarriage) is higher in women receiving fertility drugs than in women not taking fertility drugs.

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.

Is there a risk of multiple pregnancies with the Gonal–f® RFF Pen?top ^

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.

How much of the Gonal–f® RFF Pen should I inject?top ^

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

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

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.

Can I take the Gonal–f® RFF Pen with other medications?top ^

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

Why are the Gonal–f® RFF Pens available in 3 different colors?top ^

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.

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.

Full Prescribing Information for Gonal–f® RFF Pen (follitropin alfa injection) (126 KB)

RFF: Revised Formulation Female