Serono laboratories inc
follitropin alfa for injection
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.
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.
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.
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.
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?