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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:
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:
The most common side effects of Gonal‐f® RFF* Redi‐ject® include:
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:
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:
Do not use GONAL-F Multi-Dose if you are a woman that:
Before you start using GONAL-F Multi-Dose, tell your healthcare provider about all your medical conditions including if you:
FOR WOMEN: Before you start using GONAL-F Multi-Dose, tell your healthcare provider if you:
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?
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:
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:
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:
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:
In Men:
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:
Infertile men to:
|
Important Risk Information for Cetrotide® (cetrorelix acetate for injection) Who should not use Cetrotide®?
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®?
What are the possible side effects of Cetrotide®? Cetrotide® may cause serious side effects including:
Common side effects of using Cetrotide® include:
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:
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?
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. |
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:
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:
The most common side effects of Gonal‐f® RFF* Redi‐ject® include:
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:
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:
Do not use GONAL-F Multi-Dose if you are a woman that:
Before you start using GONAL-F Multi-Dose, tell your healthcare provider about all your medical conditions including if you:
FOR WOMEN: Before you start using GONAL-F Multi-Dose, tell your healthcare provider if you:
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?
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:
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:
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:
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:
In Men:
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:
Infertile men to:
|
Important Risk Information for Cetrotide® (cetrorelix acetate for injection) Who should not use Cetrotide®?
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®?
What are the possible side effects of Cetrotide®? Cetrotide® may cause serious side effects including:
Common side effects of using Cetrotide® include:
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:
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?
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. |