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IMPORTANT RISK INFORMATION & INDICATIONS
Summary of CONTRAINDICATIONS
Gonal-f® RFF* Redi-ject® (follitropin alfa injection) and Gonal-f® Multi-Dose (follitropin alfa for injection) 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® and Gonal-f® Multi-Dose talk to your doctor.
*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:
Please see full Prescribing information here and talk to your doctor.
*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:
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:
Other serious side effects include:
The most common side effects of Gonal‐f® Multi-Dose include
In men, common side effects include
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.
Indications for Gonal-f® Multi-Dose
Gonal‐f® Multi-Dose is a prescription medicine containing follicle‐stimulating hormone (FSH) used in infertile women to:
Gonal‐f® Multi-Dose can also be prescribed to increase sperm production in men with a rare medical condition.
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 for 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.
Please see full Prescribing information here and talk to your doctor.
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 for Ovidrel®
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
Please see full Prescribing information here and talk to your doctor.