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IMPORTANT INFORMATION ABOUT THE PROPER USE AND RISKS OF Gonal-f® RFF* Redi-ject™ (follitropin alfa injection) for subcutaneous use

Gonal-f® RFF Redi-ject™ is an injection Pen that delivers a prescription medicine containing follicle-stimulating hormone (FSH) used in infertile women to:

  • help healthy ovaries develop (mature) and release an egg
  • cause your ovaries to make multiple (more than 1) eggs as part of an Assisted Reproductive Technology (ART) program

Do not use the Gonal-f® RFF Redi-ject™ if you:

  • are allergic to recombinant human FSH or any of the ingredients listed here:  follitropin alfa (r-hFSH), sucrose, meta-cresol, di-sodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate monohydrate, methionine, Poloxamer 188, O-phosphoric acid, sodium hydroxide
  • have ovaries that no longer make eggs (primary ovarian failure)
  • are pregnant or think you may be pregnant
  • have uncontrolled thyroid or adrenal problems
  • have a tumor in your female organs, including your ovaries, breast, or uterus
  • have a tumor in your brain, such as a tumor in your pituitary or hypothalamus
  • have abnormal bleeding from your uterus or vagina
  • have ovarian cysts or large ovaries, not due to polycystic ovary syndrome (PCOS)

Before you use Gonal-f® RFF Redi-ject™, tell your healthcare provider if you:

  • have or have had asthma
  • have been told by a healthcare provider that you have an increased risk for blood clots (thrombosis)
  • have ever had a blood clot (thrombosis), or anyone in your family has ever had a blood clot (thrombosis)
  • have had abdominal surgery
  • have had twisting of your ovary (ovarian torsion)
  • had or have a cyst on your ovary
  • have polycystic ovarian disease
  • have any other medical conditions
  • are breastfeeding or plan to breastfeed
  • are taking any other prescription or over-the-counter medicines, vitamins, and herbal supplements

Gonal-f® RFF Redi-ject™ may cause serious side effects, including:

  • severe allergic reactions in women who have used Gonal-f®, Gonal-f® RFF, or Gonal-f® RFF Redi-ject™ in the past.  New allergic reactions can occur immediately after an injection.  Severe allergic reaction may lead to death. If you have any of the following symptoms of a severe allergic reaction, stop using Gonal-f® RFF Redi-ject™ and go to the hospital right away:
    • shortness of breath
    • swelling of your face
    • itchy, red bumps or rash on your skin (hives)
  • ovaries that are too large; symptoms of bloating or pain in your lower stomach (pelvic) area.
  • ovarian hyperstimulation syndrome (OHSS); a serious medical condition that can happen when your ovaries produce too many eggs (overstimulated). OHSS can cause fluid to suddenly build up in the area of your stomach, chest, and heart, and can cause blood clots to form. In rare cases OHSS has caused death. OHSS may also happen after you stop using Gonal-f® RFF Redi-ject™.  Stop using Gonal-f® RFF Redi-ject™ and call your healthcare provider right away if you have symptoms of OHSS, including:
    • trouble breathing                                                           
    • severe lower stomach (pelvic) area pain      
    • decreased urine output
    • nausea
    • vomiting
    • weight gain
    • diarrhea
  • lung problems; that cause trouble breathing (acute respiratory distress syndrome, atelectasia) and worsening of asthma.
  • blood clots can cause:
    • blood vessel problems (thrombophlebitis)
    • stroke
    • loss of your arm or leg
    • blood clot in your lung (pulmonary embolism)
  • twisting (torsion) of your ovary if you already have certain conditions such as ovarian cysts, OHSS, pregnancy and previous abdominal surgery. Twisting of your ovary may lead to blood flow being cut off to your ovary.
  • pregnancy with and birth of multiple babies with more than 1 baby. Having a pregnancy and giving birth to more than 1 baby at a time increases the health risk for you and your babies. Your healthcare provider should tell you about your chances of multiple births.
  • birth defects in a baby born after an ART cycle (IVF or ICSI).  Your chances of having a baby with birth defects may increase depending on:
    • your age
    • certain sperm problems
    • your genetic background and that of your partner
    • a pregnancy with more than 1 baby at a time
  • ectopic pregnancy (pregnancy outside your womb).  Your chance of having a pregnancy outside of your womb is increased if you also have fallopian tube problems.
  • miscarriage. Your chance of loss of an early pregnancy may be increased if you had difficulty becoming pregnant.
  • tumors of the ovary. If you have used fertility medicines like Gonal-f® RFF Redi-ject™ before to get pregnant, you may have an increased chance of having tumors in your ovary(ies) (including cancer).

The most common side effects of Gonal-f® RFF Redi-ject™ include:

  • headache
  • stomach pain
  • stomach bloating
  • bruising at the injection site
  • nausea

These are not all the possible side effects of Gonal-f® RFF Redi-ject™. For more information, call your healthcare provider or pharmacist. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

Do not share your Gonal-f® RFF Redi-ject™ and needles with another person. You may give another person an infection or get an infection from them.

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Also read the Gonal-f® RFF Redi-ject™ “Instructions for Use” that comes with Pen for information about the correct use of Gonal-f® RFF Redi-ject™ and follow all training and instruction provided by your healthcare provider.

*revised formulation female

IMPORTANT INFORMATION ABOUT THE PROPER USE AND RISKS OF GONAL-F® (follitropin alfa for injection):

What are the uses of Gonal-f® (follitropin alfa for injection) and Gonal-f® RFF*(follitropin alfa for injection)?

Gonal-f® Multi-Dose and Gonal-f® RFF are 2 products that contain follitropin alfa, which is similar to the human hormone follicle-stimulating hormone, referred to as FSH. FSH belongs to a group of human reproductive hormones.

Gonal-f® Multi-Dose and Gonal-f® RFF are used in certain infertile women to help with ovulation (production and release of a mature egg) and pregnancy. Gonal-f® will not help women whose ovaries no longer work because of a condition called Primary Ovarian Failure. Gonal-f® may also be used in women who are in an Assisted Reproductive Technology (ART) program such as in vitro fertilization to help their ovaries make more eggs.

Gonal-f® Multi-Dose can also be prescribed to increase sperm production in men with a rare condition that affects sperm production.

Both products should be prescribed only by doctors specializing in infertility problems and their treatment.

Who should not use Gonal-f® and Gonal-f® RFF?

Gonal-f® Multi-Dose and Gonal-f® RFF should not be used in patients who are pregnant or think they might be pregnant, in patients with primary ovarian failure (the ovaries no longer produce eggs), or in patients with allergies to recombinant human FSH products or any other ingredients in the medication.

Patients with cancer of the sex organs or brain, or with uncontrolled thyroid or adrenal disease, should not use Gonal-f® Multi-Dose or Gonal-f® RFF. Women with a history of abnormal bleeding from the uterus or vagina or with swollen, enlarged, or painful ovaries should speak to their doctor before starting treatment.

What are the possible side effects of Gonal-f® and Gonal-f® RFF?

The lowest dose expected to achieve the desired results should be used. A doctor should monitor a woman’s response often to avoid overdose, which can lead to serious side effects, including blood clots.

Women should contact their doctor if severe pain or bloating in the stomach or pelvic area, severe upset stomach, vomiting, or weight gain are experienced during treatment. These could be signs of a rare but serious condition known as Ovarian Hyperstimulation Syndrome, or OHSS, which can result in hospitalization.

Use of Gonal-f® Multi-Dose or Gonal-f® RFF by a woman can be associated with fertilization of more than 1 egg. This can lead to complications for the woman and the birth of 2 or more babies.

The most common side effects reported by women were headache, ovarian cysts, upset stomach, and sinus infection. The most common side effects reported by men taking Gonal-f® Multi-Dose were skin pimples, breast pain and growth, and tiredness. Injections may cause some discomfort.

*RFF, Revised Formulation Female

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