Important Risk Information

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

CONSUMER IMPORTANT RISK INFORMATION: Gonal‐f^® Multi-Dose (follitropin alfa for injection) 

Gonal‐f^® Multi-Dose 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

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

Do not use Gonal‐f^® Multi-Dose if you: 

• Are allergic to recombinant human FSH or any of the ingredients listed on the product carton or insert
• Have uncontrolled thyroid or adrenal problems
• Have a tumor in your female organs, including your ovaries, breast, or uterus or permanent damage to the male sex organs (testes)
• Have a tumor in your brain, such as a tumor in your pituitary 
• Have abnormal bleeding from your uterus or vagina
• Have ovarian cysts or large ovaries, not due to polycystic ovary syndrome (PCOS)
• Are pregnant or think you may be pregnant

Before using Gonal‐f^® Multi-Dose, 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^® Multi-Dose may cause serious side effects, including: 

• Ovarian hyperstimulation syndrome (OHSS) is a serious side effect. OHSS can be mild, moderate or severe, and in rare cases, has caused death. Mild symptoms can progress to more serious symptoms and immediate evaluation by your doctor is necessary. Early signs of OHSS include trouble breathing, severe lower stomach (pelvic) area pain, nausea, vomiting, weight gain. Call your health care provider right away. Symptoms include stomach pain, stomach bloating, nausea, vomiting and diarrhea, enlargement of ovaries, difficulty breathing and a drop in urine output
• Gonal-f^® Multi-Dose can also cause or worsen lung problems (including acute respiratory distress syndrome and asthma), blood and blood vessel problems (including clots and stroke) which in rare cases have caused death.
• Use of Gonal‐f^® Multi-Dose can result in pregnancy with more than one baby and the birth of multiple babies.
• 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:

• Gonal‐f^® Multi-Dose 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
• 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.
• It is not known if this drug is excreted in human milk. Because of the potential for serious adverse reactions in the nursing infant from Gonal-f, a decision should be made whether to stop nursing or stop the drug taking into account the importance of the drug to the mother.

The most common side effects of Gonal‐f^® Multi-Dose include 

• Headache 
• Stomach pain 
• Stomach bloating 
• Bruising at the injection site
• Nausea
• Other side effects reported include sinus infections and ovarian cysts.

In men, common side effects include 

• Skin pimples 
• Breast pain and growth
• 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^® Multi-Dose as directed and do not change your dose unless directed. Do not share your Gonal‐f^® Multi-Dose 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.

CONSUMER IMPORTANT RISK INFORMATION for Gonal-f^® RFF* 75 IU (follitropin alfa for injection) 

Gonal‐f^® RFF* 75 IU (follitropin alfa for 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 develop multiple (more than one) eggs as part of an Assisted Reproductive Technology (ART) program

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 levels of FSH indicating primary gonadal failure
• 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 uterine bleeding of undetermined origin
• have ovarian cysts or large ovaries, not due to polycystic ovary syndrome (PCOS)
• are pregnant or think you may be pregnant

Before using Gonal-f^® RFF* 75 IU, tell your healthcare provider about your medical history including any prescription or over-the-counter medicines, vitamins and herbal supplements used.

Gonal‐f^® RFF* 75 IU may cause serious side effects, including: 

• Severe or fatal allergic reactions. Stop using Gonal‐f^® RFF* 75 IU 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* 75 IU 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* 75 IU can result in pregnancy with more than one baby and the birth of multiple babies. 
• It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in the nursing infant from Gonal-f^® RFF* 75 IU, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

The most common side effects of Gonal‐f^® RFF* 75 IU include headache, stomach pain, stomach bloating, bruising at the injection site, and nausea. Other side effects reported include sinus infections and ovarian cysts. 

These are not all the possible side effects of Gonal‐f^® RFF* 75 IU. 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* 75 IU as directed and do not change your dose unless directed. Do not share your Gonal‐f^® RFF* 75 IU and needles with another person; you may give another person an infection or get an infection from them.

*RFF, Revised Formulation Female

Consumer Important Risk Information (IRI) – Cetrotide^® (cetrorelix acetate for injection) 

IMPORTANT INFORMATION ABOUT THE PROPER USE AND RISKS OF CETROTIDE^® 

What are the uses of Cetrotide^®? 

Cetrotide^® blocks the effects of a natural hormone, called gonadotropin-releasing hormone (GnRH). GnRH controls the secretion of another hormone, called luteinizing hormone (LH), which induces ovulation during the menstrual cycle.

Cetrotide^® blocks undesirable premature ovulation. Premature ovulation may lead to eggs that are not available for egg retrieval.

Who should not use Cetrotide^®? 

• Patients that are allergic to cetrorelix acetate, mannitol, or exogenous peptide hormones (medicines similar to Cetrotide^®) should not use Cetrotide^®. 
• If you have had severe allergic reactions to any drugs in a previous IVF cycle, tell your doctor.
• Cetrotide^® should not be used in patients who are pregnant, think they might be pregnant, or are breastfeeding.
• Cetrotide^® should not be used in patients with kidney disease.

Before starting Cetrotide^®, tell your healthcare professional about all your medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements

What is the most important information I should know before starting Cetrotide^®?

• Your doctor will confirm you are not pregnant. 

What are the possible side effects of Cetrotide^®? 

Cetrotide^® may cause serious side effects including:

• Allergic reactions including anaphylactic reaction with the first dose. Treatment with Cetrotide^® is not advised in women with severe allergic conditions.
• Your doctor should review with you the risks and benefits of using Cetrotide^®.
• It is not known if Cetrotide^® is excreted in human milk. Because the effects of Cetrotide^® on nursing mothers or the nursing infant are not known, do not use Cetrotide^® if you are breastfeeding.

Common side effects of using Cetrotide^® include:

• Mild and short-lasting reactions may occur at the injection site like reddening, itching, and swelling. Nausea and headache have also been reported.

Call your doctor if you have any other side effect or if you are unsure about the effect of this medicine.

These are not all the possible side effects of Cetrotide^®. 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.

Consumer Important Risk Information (IRI): OVIDREL^®  PRE-FILLED SYRINGE (choriogonadotropin alfa injection) 

IMPORTANT INFORMATION ABOUT THE PROPER USE AND RISKS OF OVIDREL^® PRE-FILLED SYRINGE (choriogonadotropin alfa for injection) 

What are the uses of Ovidrel^® Pre-Filled Syringe (choriogonadotropin alfa for injection)? 

Ovidrel^® Pre-Filled Syringe (choriogonadotropin alfa injection) is indicated for the final egg maturation to get ready for egg retrieval. Women who receive Ovidrel® have undergone pituitary desensitization and have been appropriately pre-treated with follicle stimulating hormone (FSH) as a part of an Assisted Reproductive Technology (ART) program such as in vitro (IVF) fertilization and embryo transfer.

Ovidrel^® Pre-Filled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in infertile patients who do not ovulate, and in whom the cause of infertility is functional and not due to primary ovarian failure.

Who should not use Ovidrel^® PreFilled Syringe? 

Ovidrel^® Pre-Filled Syringe should not be used in patients:

• With allergies to hCG or any other ingredients in the medication
• With primary ovarian failure (the ovaries no longer produce eggs)
• With uncontrolled thyroid or adrenal disease
• Cancer of the brain such as pituitary tumor
• With a history of abnormal bleeding from the uterus or vagina
• With swollen, enlarged, or painful ovaries
• With cancer of the sex organs
• Who are pregnant 

Before starting Ovidrel^®, tell your healthcare professional about all your medical conditions. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What is the most important information I should know before taking Ovidrel^®? 

• Mild to moderate uncomplicated ovarian enlargement which may be accompanied by abdominal distention and/or abdominal pain may occur in patients treated with FSH and hCG. 
• Ovarian Hyperstimulation Syndrome (OHSS) may progress rapidly from uncomplicated ovarian enlargement and become a serious medical event. Early signs of OHSS include severe pelvic pain, nausea, vomiting, and weight gain. Call your doctor right away if you think you might be having symptoms of OHSS.
• Treatment with Ovidrel^® may result in becoming pregnant with more than one baby.
• Blood clots may result from treatment with Ovidrel^®.
• It is not known whether this drug is present in human milk. Because many drugs are excreted in human milk, tell your doctor if you are nursing.

What are the most common side effects of Ovidrel^® Pre-Filled Syringe? 

The most common side effects in women using Ovidrel^® Pre-Filled Syringe include abdominal pain, nausea, and vomiting. Needle injections may cause some discomfort.

These are not all the possible side effects of Ovidrel^®. 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.