Important Risk Information for Gonal-f^® RFF* Redi-ject^® (follitropin alfa injection)

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.

Indications and Usage

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

 For complete information, please see full Prescribing information here.

Important Risk Information for GONAL-F^® Multi-Dose (follitropin alfa for injection)

Do not use GONAL-F Multi-Dose if you are a woman or man who:

• Is allergic to recombinant human FSH or any of the ingredients in GONAL-F Multi-Dose. See the end of the patient information for a complete list of ingredients in GONAL-f Multi-Dose.
• Has a high level of FSH in your blood that show your ovaries (women only) or testes (men only) do not work at all
• Has uncontrolled thyroid, adrenal or pituitary problems
• Has a tumor in your sex organs (uterus, ovaries, or testes) or breasts
• Has a tumor in your brain, such as a tumor in your pituitary gland or hypothalamus 

Do not use GONAL-F Multi-Dose if you are a woman that:

• Has abnormal bleeding from your uterus or vagina from an unknown cause
• Have ovarian cysts or large ovaries from an unknown cause

Before you start using GONAL-F Multi-Dose, tell your healthcare provider about all your medical conditions including 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 had stomach (abdominal) surgery

FOR WOMEN: Before you start using GONAL-F Multi-Dose, tell your healthcare provider if you:

• Have had twisting of your ovary (ovarian torsion)
• Had or have a cyst on your ovary
• Have polycystic ovarian disease
• Are pregnant or think you may be pregnant. GONAL-F Multi-Dose is not for pregnant women. Your healthcare provider will give you a pregnancy test before you start using GONAL-F Multi-Dose.
• Are breastfeeding. It is not known if GONAL-F Multi-Dose passes into your breast milk. You and your healthcare provider should decide if you will take GONAL-F Multi-Dose or breastfeed. You should not do both.
• Are not an adult. GONAL-F Multi-Dose is not for children. It is not known if GONAL-F Multi-Dose is safe or works in children.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use GONAL-F Multi-Dose?

• Read the "Instructions for Use" that comes with GONAL-F Multi-Dose for information about the right way to use GONAL-F Multi-Dose.
• Use GONAL-F Multi-Dose exactly as your healthcare provider tells you to.
• GONAL-F Multi-Dose is given by injection under your skin. You can inject GONAL-F Multi-Dose under the skin in your stomach (abdomen), upper arm, or upper leg.
• Do not inject GONAL-F Multi-Dose at home until your healthcare provider has taught you the right way to inject it
• Change your injection site as your healthcare provider showed you
• Do not change your dose or the time you are scheduled to use GONAL-F Multi-Dose unless your healthcare provider tells you to
• If you miss or forget to take a dose, do not double your next dose. Ask your healthcare provider for instructions
• Your healthcare provider will do blood and urine hormone tests while you are using GONAL-F Multi-Dose. Make sure to follow-up with your healthcare provider to have your blood and urine tested when told to do so.
• Call your healthcare provider if you have any questions about your dose or how to use GONAL-F Multi-Dose.

Women:

Your healthcare provider may do ultrasound scans of your ovaries. Make sure to follow-up with your healthcare provider to have your ultrasound scans.

 Men:

Your healthcare provider may test your semen while you are using GONAL-F Multi-Dose. Make sure to follow-up with your healthcare provider to give a semen sample for testing.

What are the possible side effects of GONAL-F Multi-Dose?

GONAL-F Multi-Dose may cause serious side effects in women and men, including:

Severe allergic reactions. Women or men who have used GONAL-F Multi-Dose in the past may have a severe allergic reaction right away when they use GONAL-F Multi-Dose again. This severe allergic reaction may lead to death. If you have any of the following symptoms of a severe allergic reaction, stop using GONAL-F Multi-Dose and go to the nearest hospital emergency room right away:

• Shortness of breath
• Swelling of your face
• Itchy, red bumps or rash on your skin (hives)

Lung problems. GONAL-F Multi-Dose may cause serious lung problems including fluid in your lungs (atelectasis), trouble breathing (acute respiratory distress syndrome), and worsening of asthma.

Blood clots. GONAL-F Multi-Dose may increase your chance of having blood clots in your blood vessels. Blood clots can cause:

• Blood vessel problems (thrombophlebitis)
• Stroke
• Loss of your arm or leg
• Blood clot in your lung (pulmonary embolus)
• Heart attack

GONAL-F Multi-Dose may cause serious side effects in women, including:

Ovarian Hyperstimulation Syndrome (OHSS). OHSS is both a serious and common side effect. Using GONAL-F^® Multi-Dose may cause OHSS. OHSS is 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 Multi-Dose. Stop using GONAL-F Multi-Dose and call your healthcare provider right away if you have symptoms of OHSS, including:

• Trouble Breathing
• Severe Lower Stomach (Pelvic) Area Pain
• Weight Gain
• Nausea
• Vomiting
• Diarrhea
• Decreased Urine Output

Twisting (torsion) of your ovary. GONAL-F Multi-Dose may increase the chance of your ovary twisting if you already have certain conditions such as OHSS, pregnancy and previous abdominal surgery. Twisting of your ovary may lead to blood flow being cut off to your ovary.

Ovaries that are too large. GONAL-F Multi-Dose may cause your ovaries to be abnormally large. Symptoms of large ovaries include bloating or pain in your lower stomach (pelvic) area.

Pregnancy with and birth of multiple babies. GONAL-F Multi-Dose may increase your chance of having a pregnancy 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. A baby born after an ART cycle may have an increased chance of having birth defects. Your chances of having a baby with birth defects may increase depending on:

o    Your age

o    Certain sperm problems

o    Your genetic background and that of your partner

o    A pregnancy with more than one baby at a time

Ectopic pregnancy (pregnancy outside your womb). GONAL-F Multi-Dose may increase your chance of having a pregnancy that is abnormally outside of your womb. Your chance of having a pregnancy outside of your womb is increased if you also have fallopian tube problems. Call your healthcare provider right away if you have symptoms of an ectopic pregnancy including:

o    Stomach or pelvic pain, especially on one side

o    Shoulder pain

o    Neck pain

o    Rectal pain

o    Nausea and vomiting

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 medicines like GONAL-F Multi-Dose more than one time to get pregnant, you may have an increased chance of having tumors in your ovary(ies) (including cancer).

Common side effects of GONAL-F Multi-Dose include:

In Women:

• Ovarian Cyst
• Headache
• OHSS
• Stomach pain
• Pelvic pain
• Nausea
• Gas
• Bleeding in between periods

In Men:

• Skin Problems
• Breast Enlargement
• Injection site pain
• Seborrhea
• Tiredness

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of GONAL-F Multi-Dose. For more information, ask your healthcare provider or pharmacist.

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

Indications and Usage

GONAL-F^® Multi-Dose is a prescription medicine containing follicle‐stimulating hormone (FSH). GONAL-F Multi-Dose is used in:

Infertile women to:

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

Infertile men to:

Help develop and produce mature sperm

Important Risk Information for GONAL-F^® RFF* 75 IU (follitropin alfa for injection)

Do not use GONAL-F RFF 75 IU if you:

• Are allergic to recombinant human FSH or any of the ingredients listed on the product carton or package insert
• Have high levels of FSH in your blood that show your ovaries do not work at all
• Have uncontrolled thyroid, adrenal, or pituitary problems
• Have a tumor in your female organs, including your ovaries, breast, or uterus that may get worse with high levels of estrogen
• Have a tumor in your brain, such as a tumor in your pituitary gland or hypothalamus
• Have abnormal bleeding from your uterus or vagina from an unknown cause
• Have ovarian cysts or large ovaries from an unknown cause

Before using GONAL-F RFF 75 IU, tell your healthcare provider about your medical conditions including 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 stomach (abdominal) surgery
• Have had twisting of your ovary (ovarian torsion)
• Had or have a cyst on your ovary
• Have polycystic ovarian disease
• Are pregnant or think you may be pregnant. GONAL-F RFF 75 IU is not for pregnant women. Your healthcare provider will give you a pregnancy test before you start using GONAL-F RFF 75 IU.
• Are breastfeeding. It is not known if GONAL-F RFF 75 IU passes into your breast milk. You and your healthcare provider should decide if you will take GONAL-F RFF 75 IU or breastfeed. You should not do both.
• Are not an adult. GONAL-F RFF 75 IU is not for children. It is not known if GONAL-F RFF 75 IU is safe or works in children.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use GONAL-F RFF 75 IU?

• Read the "Instructions for Use" that comes with GONAL-F RFF 75 IU for information about the right way to use GONAL-F RFF 75 IU
• Use GONAL-F RFF 75 IU exactly as your healthcare provider tells you to
• GONAL-F RFF 75 IU is given by injection under your skin. You can inject GONAL-F RFF under the skin in the stomach (abdomen), upper arm, or upper leg.
• Do not inject GONAL-F RFF 75 IU at home until your healthcare provider has taught you the right way to inject it
• Change your injection site as your healthcare provider showed you
• Do not change your dose or the time you are scheduled to use GONAL-F RFF 75 IU unless your healthcare provider tells you to
• If you miss or forget to take a dose, do not double your next dose. Ask your healthcare provider for instructions.
• Your healthcare provider will do blood and urine hormone tests while you are using GONAL-F RFF 75 IU. Make sure you follow-up with your healthcare provider to have your blood and urine tested when told to do so.

Call your healthcare provider if you have any questions about your dose or how to use GONAL-F RFF 75 IU.

Your healthcare provider may do ultrasound scans of your ovaries. Make sure you follow-up with your healthcare provider to have your ultrasounds.

What are the possible side effects of GONAL-F RFF 75 IU?

GONAL-F RFF 75 IU may cause serious side effects, including:

• Severe Allergic Reactions. Women who have used GONAL-F, GONAL-F RFF 75 IU or GONAL-F Redi-ject^® in the past may have a severe allergic reaction right away when they use GONAL-F RFF again. This 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 and go to the nearest hospital emergency room right away:
  • Shortness of breath
  • Swelling of your face
  • Itchy, red bumps or rash on your skin (hives)

• Ovarian Hyperstimulation Syndrome (OHSS). OHSS is both a serious and common side effect. Using GONAL-F RFF 75 IU may cause OHSS. OHSS is 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 75 IU. Stop using GONAL-F RFF 75 IU and call your healthcare provider right away if you have symptoms of OHSS, including:
  • Trouble breathing
  • Weight gain
  • Severe lower stomach (pelvic) area pain
  • Nausea
  • Vomiting
  • Diarrhea
  • Decreased urine output
    
    
• Lung problems. GONAL-F RFF 75 IU may cause serious lung problems including fluid in your lungs (atelectasis), trouble breathing (acute respiratory distress syndrome), and worsening of asthma.
  
  
• Blood clots. GONAL-F RFF 75 IU may increase your chance of having blood clots in your blood vessels. Blood clots can cause:
  • Blood vessel problems (thrombophlebitis)
  • Stroke
  • Loss of your arm or leg
  • Blood clot in your lung (pulmonary embolus)
  • Heart attack
    
    
• Twisting (torsion) of your ovary. GONAL-F RFF 75 IU may increase the chance of your ovary twisting if you already have certain conditions such as OHSS, pregnancy and previous abdominal surgery. Twisting of your ovary may lead to blood flow being cut off to your ovary.

• Ovaries that are too large. GONAL-F RFF 75 IU may cause your ovaries to be abnormally large. Symptoms of large ovaries include bloating or pain in your lower stomach (pelvic) area.

• Pregnancy with and birth of multiple babies. GONAL-F RFF 75 IU may increase your chance of having a pregnancy with more than one 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. A baby born after an ART cycle may have an increased chance of having birth defects. 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). GONAL-F RFF 75 IU may increase your chance of having a pregnancy that is abnormally outside of your womb. Your chance of having a pregnancy outside of your womb is increased if you also have fallopian tube problems. Call your healthcare provider right away if you have symptoms of an ectopic pregnancy including:
  • Stomach or pelvic pain especially on one side
  • Shoulder pain
  • Neck pain
  • Rectal pain
  • Nausea and vomiting

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 medicines like GONAL-F RFF 75 IU more than one time to get pregnant, you may have an increased chance of having tumors in your ovary(ies) (including cancer).

Common side effects of GONAL-F RFF include:

• Headache
• Stomach pain
• Stomach bloating
• OHSS
• Swelling and pain at the injection site
• Diarrhea
• Nausea
• Gas
• Ovarian cyst

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all the possible side effects of GONAL-F RFF 75 IU. For more information, call your healthcare provider or pharmacist.

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

Indications and Usage

GONAL-F^® RFF 75 IU (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 to help you get pregnant
• Cause your ovaries to develop multiple (more than one) eggs as part of an Assisted

Reproductive Technology (ART) program

RFF = revised formulation female.