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MANUFACTURER
Serono laboratories inc
CHEMICAL NAME
follitropin alfa for injection
INDICATIONS
For Women.
Gonal–f® (follitropin alfa for injection) is used for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of fertility difficulties 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 Technologies (ART) program.
For Men.
Gonal–f® (follitropin alfa for injection) is used for the induction of spermatogenesis in men with primary and secondary hypogonadatropic hypogonadism in whom the cause of infertility is not due to primary testicular failure.
Ask your healthcare provider if Gonal–f® is right for you.
INGREDIENTS
follitropin alfa for injection
DIRECTIONS
http://www.fertilitylifelines.com/assets/pdfs/products/gonalf450/gonal-f450iu_printableinstructions.pdf
SIDE EFFECTS
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.
PRECAUTIONS
Gonal–f® should only be prescribed by doctors specializing in infertility or reproductive health. Gonal–f® can cause serious side effects including: ovarian hyperstimulation syndrome (OHSS), with or without blood vessel and lung complications and multiple births. Gonal–f® should not be used in patients who are allergic to recombinant FSH products, have permanent damage to the male sex organs, have swollen, enlarged or painful ovaries in women, have uncontrolled thyroid or adrenal problems, have cancer of the sex organs, have cancer of the brain, have abnormal bleeding from the uterus or vagina in women or are pregnant or think they may be pregnant. The most common side effects in patients using Gonal–f® are headache, ovarian cysts, upset stomach, and sinus infections in women and skin pimples, breast pain and growth, and tiredness in men. Needle injections may cause some discomfort.
OVERDOSAGE
Consult Your Physician.
INFORMATION
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.
NOTES
The above information is intended to supplement, not substitute for, the
expertise and judgment of your physician, pharmacist, or other healthcare professional. It should not be
construed to indicate that the use of the product is safe, appropriate, or effective for you. Consult your
healthcare professional before taking the product.
DRUG INTERACTIONS
Consult Your Physician.
WARNINGS
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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