Summary of Contraindications

Gonal-f^® (follitropin alfa injection) RFF* Redi-ject^® and Gonal-f^® (follitropin alfa for injection) Multi-Dose are contraindicated in patients with prior hypersensitivity to r-hFSH or excipients, high levels of FSH indicating primary gonadal failure, pregnancy, uncontrolled thyroid, adrenal or pituitary disorders, sex hormone dependent tumors of the reproductive tract/accessory organs, tumors of pituitary gland or hypothalamus, abnormal uterine bleeding of undetermined origin and ovarian cyst or enlargement of undetermined origin.

Please scroll for full IMPORTANT RISK INFORMATION for Gonal-f® RFF* Redi-ject®, Gonal-f® Multi-Dose and click here for full Prescribing Information for each individual product.

RFF : Revised Formulation Female

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.

*RFF, Revised Formulation Female

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 Cetrotide^® (cetrorelix acetate for injection)

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.

Indication

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.

 Please see full Prescribing information here.

Important Risk Information for Ovidrel^® PreFilled Syringe (choriogonadotropin alfa injection)

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.

Indication

What are the uses of Ovidrel^® Pre-Filled Syringe (choriogonadotropin alfa 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

 For complete information, please see full Prescribing information here.