Gonal-f® RFF Redi-ject™ Instructions for Use Video

Selected Patient Information for Gonal-f^® RFF* Redi-ject™ (follitropin alfa injection) for subcutaneous use

*revised formulation female

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:

o shortness of breath

o swelling of your face

o 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.

Read the Patient Information found in your drug carton and talk to your healthcare provider. For more information, go to www.fertilitylifelines.com, or call 1-866-538-7879.

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