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Ovidrel® PreFilled Syringe

Ovidrel® PreFilled Syringe

Ovidrel® PreFilled Syringe

Ovidrel® PreFilled Syringe is the first and only recombinant human chorionic gonadotropin (r-hCG) approved in the world. Ovidrel® PreFilled Syringe is available in a ready-to-inject, prefilled syringe, eliminating the need for reconstituting.

The Ovidrel® PreFilled Syringe is manufactured to the highest standards of purity using recombinant human DNA technology. Ovidrel® PreFilled Syringe is the only hCG available for subcutaneous (just under the skin) injection in the United States. Other hCG products available in the U.S. are extracted from human urine and may require deeper, intramuscular injections.

Why Ovidrel® PreFilled Syringe is used

  • Ovidrel® PreFilled Syringe is used in fertility treatment cycles to help follicles mature and trigger the release of mature eggs from a woman's ovaries following treatment with products containing the human follicle stimulating hormone, like Gonal-f® (follitropin alfa for injection).

Ask your healthcare provider if Ovidrel® PreFilled Syringe is right for you.

Important Considerations: Ovidrel® (choriogonadotropin alfa for injection) PreFilled Syringe is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Ovidrel® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure. Ovidrel should only be used by physicians who are thoroughly familiar with infertility problems and their management. Ovidrel® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Ovidrel® is contraindicated in women who exhibit prior sensitivity to hCG preparations or their ingredients, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Women who are nursing should also not use Ovidrel®. The most common side effects in women using Ovidrel® include abdominal pain, injection site reactions, nausea and vomiting. Reports of multiple births have been associated with Ovidrel treatment. For complete product details, see the Full Prescribing Information.

Warnings, Side Effects and Other Important Considerations

Ovidrel® PreFilled Syringe can cause serious side effects including ovarian hyperstimulation syndrome (OHSS) and lung and blood vessel problems.

Contact your healthcare provider if you experience severe pain or bloating in the stomach or pelvic area, severe upset stomach, vomiting and weight gain.

Use of fertility drugs can be associated with fertilization of more than one egg. This can lead to complications for the mother and the birth of two or more babies.

The most common side effects in women using Ovidrel® PreFilled Syringe include abdominal pain, nausea and vomiting. Needle injections may cause some discomfort. For complete product details, see the Full Prescribing Information.

You should review with your Fertility Specialist the risks and benefits of using Ovidrel® PreFilled Syringe. As with any medication, report any and all side effects, symptoms or physical changes to your healthcare provider.

Important Considerations: Ovidrel® (choriogonadotropin alfa for injection) PreFilled Syringe is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Ovidrel® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure. Ovidrel should only be used by physicians who are thoroughly familiar with infertility problems and their management. Ovidrel® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Ovidrel® is contraindicated in women who exhibit prior sensitivity to hCG preparations or their ingredients, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Women who are nursing should also not use Ovidrel®. The most common side effects in women using Ovidrel® include abdominal pain, injection site reactions, nausea and vomiting. Reports of multiple births have been associated with Ovidrel treatment. For complete product details, see the Full Prescribing Information.

Instructions for Use

Watch this brief video that demonstrates how to administer Ovidrel® PreFilled Syringe.

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Important Considerations: Ovidrel® (choriogonadotropin alfa for injection) PreFilled Syringe is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Ovidrel® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure. Ovidrel should only be used by physicians who are thoroughly familiar with infertility problems and their management. Ovidrel® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Ovidrel® is contraindicated in women who exhibit prior sensitivity to hCG preparations or their ingredients, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Women who are nursing should also not use Ovidrel®. The most common side effects in women using Ovidrel® include abdominal pain, injection site reactions, nausea and vomiting. Reports of multiple births have been associated with Ovidrel treatment. For complete product details, see the Full Prescribing Information.

Storage

Ovidrel® PreFilled Syringe should be stored refrigerated (2 – 7°C / 36 – 46°F) to allow the product to be used until the expiration date shown on the syringe or carton.

OR

The Ovidrel® PreFilled Syringe may be stored by the patient for no more than 30 days at room temperature (20 – 25° / 68 – 77°F) and in this case must be used within those 30 days.

Do not freeze.

Protect from light.

Important Considerations: Ovidrel® (choriogonadotropin alfa for injection) PreFilled Syringe is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Ovidrel® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure. Ovidrel should only be used by physicians who are thoroughly familiar with infertility problems and their management. Ovidrel® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Ovidrel® is contraindicated in women who exhibit prior sensitivity to hCG preparations or their ingredients, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Women who are nursing should also not use Ovidrel®. The most common side effects in women using Ovidrel® include abdominal pain, injection site reactions, nausea and vomiting. Reports of multiple births have been associated with Ovidrel treatment. For complete product details, see the Full Prescribing Information.

FAQs

What is the Ovidrel® PreFilled Syringe, and what is it used for?

Ovidrel® PreFilled Syringe is intended for use by women seeking pregnancy. After a thorough medical exam to determine your specific medical condition, your healthcare provider may prescribe Ovidrel® PreFilled Syringe as one of several drugs prescribed to you as part of your treatment program.

Ovidrel® PreFilled Syringe contains recombinant hCG, an injectable hormone. This is the hormone that causes your eggs to finish maturing and be released. You have been given Ovidrel® PreFilled Syringe to complete this final stage of your cycle.

The hormone in the Ovidrel® PreFilled Syringe is manufactured to meet standards for quality and purity. It cannot be taken by mouth since the acids in your stomach would destroy the hormone before it was absorbed into the body.

Ovidrel® PreFilled Syringe is provided in a prefilled syringe and is ready to use. The syringe contains 250 mcg of the active ingredient (choriogonadotropin alfa) in 0.5 ml of liquid. It is intended for subcutaneous administration. Each syringe contains the single dose needed.

Ovidrel® PreFilled Syringe is available only with a prescription.

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Who should not use the Ovidrel® PreFilled Syringe?

You should not use Ovidrel® PreFilled Syringe if you answer "yes" to any of the following questions. If you are unsure if you should use Ovidrel® PreFilled Syringe, talk with your healthcare provider.

  • Do you have allergies to any of the following:
    • Human chorionic gonadotropin or choriogonadotropin
    • Mannitol
    • O-phosphoric acid
    • L-methionine
    • Poloxamer 188
    • Sodium hydroxide?
  • Are you pregnant or breastfeeding?
  • Do you have abnormal bleeding from the uterus or vagina?
  • Do you have swollen, enlarged or painful ovaries?
  • Do you have cancer of the sex organs (uterus, ovaries)?
  • Do you have uncontrolled thyroid or adrenal problems?
  • Do you have cancer of the brain?
  • Do you have primary ovarian failure (your ovaries no longer make eggs)?

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How should the Ovidrel® PreFilled Syringe be stored?

Ovidrel® PreFilled Syringe should be stored refrigerated (2° – 8°C / 36° – 46°F) to allow the product to be used until the expiration date shown on the syringe or carton. Alternatively, the Ovidrel® PreFilled Syringe may be stored by the patient for no more than 30 days at room temperature (up to 25°C / 77°F ), and in this case must be used within those 30 days. When stored at room temperature, discard after 30 days. Store away from light. Do not freeze.

When stored refrigerated, do not use after the expiration date shown on the syringe or carton. Keep out of the reach of children.

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When should I use the Ovidrel® PreFilled Syringe?

Your healthcare provider will advise you on when you are ready to complete your cycle and, thus, when to use your Ovidrel® PreFilled Syringe.

Always take your injection exactly as your healthcare provider has instructed. If you are unsure of how or when to use your Ovidrel® PreFilled Syringe, please contact your healthcare provider.

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Are there any side effects associated with the use of Ovidrel® PreFilled Syringe?

You should review with your Fertility Specialist the risks and benefits of using Ovidrel® PreFilled Syringe. As with any medication, report any and all side effects, symptoms or physical changes to your healthcare provider. The most common side effects in women using Ovidrel® PreFilled Syringe include abdominal pain, nausea and vomiting.

Ovidrel® PreFilled Syringe can cause serious side effects including ovarian hyperstimulation syndrome (OHSS) and lung and blood vessel problems.

Contact your healthcare provider if you experience severe pain or bloating in the stomach or pelvic area, severe upset stomach, vomiting and weight gain.

Use of fertility drugs can be associated with fertilization of more than one egg. This can lead to complications for the mother and the birth of two or more babies.

The most common side effects in women using Ovidrel® PreFilled Syringe include abdominal pain, nausea and vomiting. Needle injections may cause some discomfort. For complete product details, see the Full Prescribing Information.

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What should I do if I forget to take Ovidrel® PreFilled Syringe?

Contact your healthcare provider if you forget to take Ovidrel® PreFilled Syringe.

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Can I take Ovidrel® PreFilled Syringe with other medications?

Inform your Fertility Specialist and pharmacist if you are taking or have taken any other medications, including those that do not require a prescription.

If you have any additional questions, be sure to contact your Fertility Specialist for more information or guidance. You can also call Fertility LifeLines™ toll-free at 1-866-LETS-TRY (1-866-538-7879). All calls are free and confidential.

Important Considerations: Ovidrel® (choriogonadotropin alfa for injection) PreFilled Syringe is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Ovidrel® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure. Ovidrel should only be used by physicians who are thoroughly familiar with infertility problems and their management. Ovidrel® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Ovidrel® is contraindicated in women who exhibit prior sensitivity to hCG preparations or their ingredients, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Women who are nursing should also not use Ovidrel®. The most common side effects in women using Ovidrel® include abdominal pain, injection site reactions, nausea and vomiting. Reports of multiple births have been associated with Ovidrel treatment. For complete product details, see the Full Prescribing Information.

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Prescribing Information and Important Considerations

Ovidrel® (choriogonadotropin alfa for injection) PreFilled Syringe is indicated for the induction of final follicular maturation and early luteinization in infertile women who have undergone pituitary desensitization and who have been appropriately pretreated with follicle stimulating hormones as part of an Assisted Reproductive Technology (ART) program such as in vitro fertilization and embryo transfer. Ovidrel® PreFilled Syringe is also indicated for the induction of ovulation (OI) and pregnancy in anovulatory infertile patients in whom the cause of infertility is functional and not due to primary ovarian failure. Ovidrel should only be used by physicians who are thoroughly familiar with infertility problems and their management. Ovidrel® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Ovidrel® is contraindicated in women who exhibit prior sensitivity to hCG preparations or their ingredients, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Women who are nursing should also not use Ovidrel®. The most common side effects in women using Ovidrel® include abdominal pain, injection site reactions, nausea and vomiting. Reports of multiple births have been associated with Ovidrel treatment. For complete product details, see the Full Prescribing Information and FAQs.

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Important Considerations:
Gonal-f® RFF Pen (follitropin alfa injection) is indicated for the induction of ovulation and pregnancy in the oligo-anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Gonal-f® RFF Pen is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program. Gonal-f® RFF Pen (follitropin alfa injection) should only be prescribed by physicians specializing in fertility or reproductive health. Gonal-f® is a potent gonadotropic substance capable of causing mild to severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications, and multiple births. Gonal-f® is contraindicated in women who exhibit prior hypersensitivity to FSH preparations, primary gonadal failure, uncontrolled thyroid or adrenal dysfunction and pregnancy. Nursing women should not use Gonal-f®. Common side effects include headache, abdominal pain, enlarged abdomen, and injection site disorders. For complete product details, see full prescribing information.

Important Considerations:
Women: Gonal-f® (follitropin alfa for injection) is indicated for the induction of ovulation and pregnancy in the anovulatory infertile patient in whom the cause of infertility is functional and not due to primary ovarian failure. Gonal-f® is also indicated for the development of multiple follicles in the ovulatory patient participating in an Assisted Reproductive Technology (ART) program.
Men: Gonal-f® (follitropin alfa for injection) is indicated for the induction of spermatogenesis in men with primary and secondary hypogonadotropic hypogonadism in whom the cause of infertility is not due to primary testicular failure. Gonal-f® (follitropin alfa for injection) should only be prescribed by physicians who are thoroughly familiar with infertility problems and their management. Gonal-f® is a potent gonadotropic substance capable of causing Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications. Gonal-f® is contraindicated in women and men who exhibit prior hypersensitivity to recombinant FSH preparations or one of their excipients, high levels of FSH indicating primary gonadal failure, uncontrolled thyroid or adrenal dysfunction, sex hormone dependent tumors of the reproductive tract and accessory organs, and an organic intracranial lesion such as a pituitary tumor; and in women who exhibit abnormal uterine bleeding of undetermined origin, ovarian cyst or enlargement of undetermined origin and pregnancy. Women who are pregnant or nursing should not use Gonal-f®. The most common side effects in patients using Gonal-f® include headache, ovarian cysts, nausea and upper respiratory infections in women and in men, acne, breast pain and growth, and fatigue. Injection site reactions were also reported. Reports of multiple births have been associated with Gonal-f® treatment. For complete product details, see the full prescribing information.

For complete product details, please read the Prescribing Information offered below.


© EMD Serono, Inc. CIM Last Update 2008-09-16
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