• Gonal-f® RFF Redi-ject™ (follitropin alfa injection)
  • Gonal-f® Multi-Dose (follitropin alfa for injection)
  • Gonal-f® RFF 75 IU (follitropin alfa for injection)

Gonal-f® RFF* Redi-ject®

Product highlights include:

  • Gonal-f® RFF* Redi-ject® is the only disposable, prefilled, ready-to-use, preassembled follicle-stimulating hormone pen in the U.S.1
  • After attaching the needle and setting the dose, the pen is ready to inject - no priming needed
  • Adjust your dose up or down without spillage, thanks to the bi-directional dose knob
  • Dose Display communicates how much liquid is ready to be injected and how much still needs to be injected:
    • If the full preset dose hasn’t been injected, the dose display stops at the number needed to complete the dose
    • If the full preset dose has been injected, the dose display returns to 0, confirming the preset dose has been given

The pen will be prescribed in the amount your doctor recommends: 300 IU, 450 IU, or 900 IU. Your doctor (or healthcare provider) will then provide dosing instructions.

 

Available in 300 IU, 450 IU, and 900 IU.

Patient Resources

Injection Instruction Guide:

 

Full Prescribing Information:

 

Reference: 1. Mahony M, Dwyer A, Barkume R, et al. US human factors engineering evaluation of an updated follitropin alpha pen injector (Gonal-f® RFF Redi-ject®) and instructions for use. Expert Opin Drug Deliv. 2018;15(1):5-15.

Gonal-f® Multi-Dose

Product highlights include:

  • Gonal-f® Multi-Dose is a follicle-stimulating hormone. It comes in a powder-filled vial that you reconstitute with a fluid-filled syringe before injection
  • Some men diagnosed with hypogonadotropic hypogonadism can be prescribed Gonal-f® Multi-Dose to stimulate sperm production

Gonal-f® Multi-Dose will be prescribed in the vial size your doctor recommends: 450 IU or 1,050 IU. Your doctor (or healthcare provider) will then provide dosing instructions.

Patient Resources

Injection Instruction Guide:

 

Full Prescribing Information:

Gonal-f® RFF 75 IU

Product highlights include:

  • Gonal-f® RFF* 75 IU is a follicle-stimulating hormone. It comes in a powder-filled vial that you reconstitute with a fluid-filled syringe before injection
  • Your doctor will tell you the amount or dose to administer each day with one or more 75 IU vials. Unused medication must be discarded

Patient Resources

Injection Instruction Guide:

 

Full Prescribing Information:

 

To help eligible patients manage the financial burden, we offer a range of savings programs for EMD Serono medications
IMPORTANT RISK INFORMATION Expand+
  • 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 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 Gonal-f® RFF Redi-ject® if you:

    • are allergic to recombinant human FSH or any of the ingredients listed on the product carton or insert
    • 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 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).

    Other serious side effects include 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 asthma), blood and blood vessel problems (including clots and stroke), or twisting of your ovary, which require medical attention.

    Use of Gonal-f® RFF Redi-ject® can result in pregnancy with more than 1 baby and the birth of multiple babies, miscarriage, or ectopic pregnancy (pregnancy outside your womb). 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.

    The most common side effects of Gonal-f® RFF Redi-ject® include headache, stomach pain, stomach bloating, bruising at the injection site, and nausea. Other side effects reported include sinus infections and ovarian cysts. 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).

    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

    US-RDJ-1013-0006(2)

  • IMPORTANT RISK INFORMATION for Gonal-f® (follitropin alfa for injection):

    Gonal-f® (follitropin alfa for injection) is 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

    Gonal-f® can also be prescribed to increase sperm production in men with a rare medical condition.

    Do not use Gonal-f® if you:

    • are allergic to recombinant human FSH or any of the ingredients listed on the product carton or insert
    • 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)
    • permanent damage to the male sex organs (testes)

    Before using Gonal-f®, tell your healthcare provider about your medical history including any prescription or overthe-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® may cause serious side effects, including severe or fatal allergic reactions. Stop using Gonal-f® 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).

    Other serious side effects include 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® can also cause or worsen lung problems (including asthma), blood and blood vessel problems (including clots and stroke), or twisting of your ovary, which require medical attention.

    Use of Gonal-f® can result in pregnancy with more than 1 baby and the birth of multiple babies, miscarriage, or ectopic pregnancy (pregnancy outside your womb). 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.

    The most common side effects of Gonal-f® include headache, stomach pain, stomach bloating, bruising at the injection site, and nausea. Other side effects reported include sinus infections and ovarian cysts. If you have used fertility medicines like Gonal-f® before to get pregnant, you may have an increased chance of having tumors in your ovary(ies) (including cancer).

    In men, common side effects include skin pimples, breast pain and growth, and tiredness.

    These are not all the possible side effects of Gonal-f®. 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® as directed and do not change your dose unless directed. Do not share your Gonal-f® and needles with another person; you may give another person an infection or get an infection from them.

    Carefully review the Gonal-f® Multi-dose Patient Information Leaflet that comes with the product and follow all training and instruction provided by your healthcare provider. The injection syringes provided with the product should only be used with Gonal-f® Multi-dose and should not be used to administer any other drug or hormone.

  • IMPORTANT RISK INFORMATION for Gonal-f® RFF* (follitropin alfa for injection):

    Gonal-f® RFF* (follitropin alfa for injection) is 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 ReproductiveTechnology (ART) program

    Do not use Gonal-f® RFF if you:

    • are allergic to recombinant human FSH or any of the ingredients listed on the product carton or insert
    • 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 using Gonal-f® RFF, 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 may cause serious side effects, including severe or fatal allergic reactions. Stop using Gonal-f® RFF 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).

    Other serious side effects include 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 asthma), blood and blood vessel problems (including clots and stroke), or twisting of your ovary, which require medical attention.

    Use of Gonal-f® RFF can result in pregnancy with more than 1 baby and the birth of multiple babies, miscarriage, or ectopic pregnancy (pregnancy outside your womb). 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.

    The most common side effects of Gonal-f® RFF include headache, stomach pain, stomach bloating, bruising at the injection site, and nausea. Other side effects reported include sinus infections and ovarian cysts. If you have used fertility medicines like Gonal-f® RFF before to get pregnant, you may have an increased chance of having tumors in your ovary(ies) (including cancer).

    These are not all the possible side effects of Gonal-f® RFF. 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 as directed and do not change your dose unless directed. Do not share your Gonal-f® RFF and needles with another person; you may give another person an infection or get an infection from them.

    *RFF, Revised Formulation Female

    US-FOL-1014-0001

    • Gonal-f® RFF Redi-ject® (follitropin alfa injection)

    • Gonal-f® Multi-Dose (follitropin alfa for injection)

    • Gonal-f® RFF 75 IU (follitropin alfa for injection)