GONAL-F® RFF* Redi-ject® (follitropin alfa injection)
Consumer Important Risk Information for GONAL-F® RFF* Redi-ject® (follitropin alfa injection)
Gonal‐f® RFF* Redi‐ject® (follitropin alfa injection) is a prescription medicine containing follicle‐stimulating hormone (FSH) used in infertile women to:
- help ovulation and pregnancy in women who are infertile due to a cause other than primary ovarian failure
- cause your ovaries to make multiple (more than 1) eggs as part of an Assisted Reproductive Technology (ART) program
Do not use Gonal‐f® RFF* Redi‐ject® if you:
- are allergic to recombinant human FSH or any of the ingredients listed on the product carton or package insert
- have levels of FSH indicating primary gonadal failure
- are pregnant or think you may be pregnant due to the potential hazard to a fetus
- have uncontrolled thyroid, adrenal or pituitary 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 with unknown cause, not due to polycystic ovary syndrome (PCOS)
Before using Gonal‐f® RFF* Redi‐ject®, tell your healthcare provider about your medical history including any prescription or over-the-counter medicines, vitamins and herbal supplements used, whether you have or have had asthma, abdominal surgery, ovarian cysts, polycystic ovarian disease, blood clots (thrombosis) or family history of blood clots, or are breastfeeding or plan to breastfeed.
Gonal‐f® RFF* Redi‐ject® may cause serious side effects, including:
- Severe or fatal allergic reactions. Stop using Gonal‐f® RFF* Redi‐ject® and go to the hospital right away if you have symptoms of an allergic reaction which can include shortness of breath, swelling of your face, itchy, red bumps or rash on your skin (hives).
- Stomach bloating or pain caused by enlargement of your ovaries, or fluid build-up in your stomach, chest and heart caused by ovarian hyperstimulation syndrome (OHSS). OHSS can require hospitalization and in rare cases has caused death. 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, and diarrhea.
- Gonal-f® RFF* can also cause or worsen lung problems (including severe shortness of breath and asthma), blood and blood vessel problems (including clots and stroke) which in rare cases have caused death.
- Twisting of your ovary, which requires medical attention.
- Chances of having a baby with birth defects may increase in a baby born after an ART cycle and can be impacted by maternal age, paternal sperm problems, and genetic background associated with the egg and sperm.
- Use of Gonal‐f® RFF* Redi‐ject® can result in pregnancy with more than 1 baby and the birth of multiple babies.
- Ectopic pregnancy (pregnancy outside your womb).
- An increased risk of miscarriage.
- 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).
- Ultrasound and lab tests should be used to monitor treatment.
The most common side effects of Gonal‐f® RFF* Redi‐ject® include:
- In Ovulation Induction headache, abdominal pain, and ovarian hyperstimulation
- In ART - abdominal pain, nausea, abdominal enlargement, headache and injection site bruising
These are not all the possible side effects of Gonal‐f® RFF* Redi‐ject®. For more information, read the product labeling, and ask your healthcare provider or pharmacist.
Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1‐800‐FDA‐1088.
Use Gonal‐f® RFF* Redi‐ject® as directed and do not change your dose unless directed. 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.
Carefully review 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.
*RFF, Revised Formulation Female