Medication Support

Serophene® (clomiPHENE citrate tablets USP)

Serophene®

Serophene® (clomiPHENE citrate tablets USP)

Serophene® is an oral prescription brand of clomiPHENE citrate. Serophene® is commonly prescribed as an initial treatment by an Obstetrician / Gynecologist (OB/GYN) or a Fertility Specialist, also called a Reproductive Endocrinologist (RE). It is indicated for the treatment of ovulation dysfunction in women desiring pregnancy. It initiates a series of endocrine events culminating in a rise of follicle stimulating hormone (FSH).

Why Serophene® is used

Clomiphene citrate is an initial treatment. It works by initiating the release of gonadotropin releasing hormone (GnRH) from the hypothalamus. This causes the pituitary gland to release more follicle stimulating hormone (FSH) and luteinizing hormone (LH) to stimulate follicle development and ovulation. Learn more about how clomiphene citrate works.

Ask your healthcare provider if Serophene® is right for you.

If you have questions about Serophene® or any other EMD Serono product, call Fertility LifeLines™ at 1-866-LETS-TRY (1-866-538-7879). All calls are free and confidential.

Important Safety Information: Serophene® (clomiPHENE citrate tablets USP) is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiPHENE citrate therapy. Serophene® should only be prescribed by doctors specializing in infertility or reproductive health. Serophene® can cause serious side effects including, visual symptoms such as spots or flashes, ovarian hyperstimulation syndrome (OHSS), with or without blood vessel and lung complications, and multiple births. Serophene® should not be used in women who are allergic to clomiphene citrate preparations or their ingredients, who have liver disease, who have abnormal bleeding from the uterus, have ovarian cysts or enlarged ovaries, have uncontrolled thyroid or adrenal problems, have a pituitary tumor or other tumor in the brain or who are pregnant. Prolonged use of Serophene® may increase the risk of ovarian cancer. The most common side effects in patients using Serophene® include hot flashes, stomach discomfort and bloating, nausea and vomiting, breast discomfort, visual symptoms, headache and vaginal bleeding. Please see Full Prescribing Information.

Warnings, Side Effects and Important Safety Information

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

Serophene® can cause serious side effects including ovarian hyperstimulation syndrome (OHSS) and lung and blood vessel complications.

As with all medications, it is important to report any physical changes and all symptoms to your healthcare provider. With Serophene® you should be aware that blurring or other visual symptoms may occur. These may make activities such as driving or operating machinery more hazardous than usual, particularly under conditions of variable lighting. While their significance is not yet understood, patients having any visual symptoms should discontinue treatment and have a complete ophthalmologic evaluation.

The most common side effects include hot flashes, stomach discomfort and bloating, nausea and vomiting, breast discomfort, headache, and vaginal bleeding. For complete product details, see the Full Prescribing Information.

Important Safety Information: Serophene® (clomiPHENE citrate tablets USP) is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiPHENE citrate therapy. Serophene® should only be prescribed by doctors specializing in infertility or reproductive health. Serophene® can cause serious side effects including, visual symptoms such as spots or flashes, ovarian hyperstimulation syndrome (OHSS), with or without blood vessel and lung complications, and multiple births. Serophene® should not be used in women who are allergic to clomiphene citrate preparations or their ingredients, who have liver disease, who have abnormal bleeding from the uterus, have ovarian cysts or enlarged ovaries, have uncontrolled thyroid or adrenal problems, have a pituitary tumor or other tumor in the brain or who are pregnant. Prolonged use of Serophene® may increase the risk of ovarian cancer. The most common side effects in patients using Serophene® include hot flashes, stomach discomfort and bloating, nausea and vomiting, breast discomfort, visual symptoms, headache and vaginal bleeding. Please see Full Prescribing Information.

Storage

Store Serophene® at controlled room temperature. Protect from heat, light, excessive humidity and store in a closed container.

Important Safety Information: Serophene® (clomiPHENE citrate tablets USP) is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiPHENE citrate therapy. Serophene® should only be prescribed by doctors specializing in infertility or reproductive health. Serophene® can cause serious side effects including, visual symptoms such as spots or flashes, ovarian hyperstimulation syndrome (OHSS), with or without blood vessel and lung complications, and multiple births. Serophene® should not be used in women who are allergic to clomiphene citrate preparations or their ingredients, who have liver disease, who have abnormal bleeding from the uterus, have ovarian cysts or enlarged ovaries, have uncontrolled thyroid or adrenal problems, have a pituitary tumor or other tumor in the brain or who are pregnant. Prolonged use of Serophene® may increase the risk of ovarian cancer. The most common side effects in patients using Serophene® include hot flashes, stomach discomfort and bloating, nausea and vomiting, breast discomfort, visual symptoms, headache and vaginal bleeding. Please see Full Prescribing Information.

FAQs

Why has my healthcare provider prescribed Serophene® (clomiPHENE citrate tablets USP) and how does it work?

Serophene® is typically considered an initial therapy for patients experiencing ovulatory failure or dysfunction. Serophene® works by stimulating the body to release follicle stimulating hormone (FSH) and luteinizing hormone (LH), the hormones necessary for follicle growth and ovulation.

How is Serophene® administered?

Serophene® is an orally administered drug.

How many cycles of Serophene® should I take?

Serophene® (clomiPHENE citrate tablets USP) has been proven safe and effective in clinical trials. However, the American Society for Reproductive Medicine recommends that treatment with Serophene® (clomiPHENE citrate tablets USP) be limited to no more than six ovulatory cycles. If a patient fails to conceive after successful clomiphene citrate–induced ovulation, a Fertility Specialist, also called a Reproductive Endocrinologist (RE) may conduct further evaluation. And frequently, a more advanced treatment, such as FSH, is recommended.

Who should not use Serophene®?

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

  • Do you have allergies to clomiphene citrate preparations or their ingredients?
  • Are you pregnant?

Prolonged use of Serophene® may increase the risk of ovarian cancer.

Are there any side effects associated with Serophene®?

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

Serophene® can cause serious side effects including ovarian hyperstimulation syndrome (OHSS) and lung and blood vessel complications.

As with all medications, it is important to report any physical changes and all symptoms to your healthcare provider. With Serophene® you should be aware that blurring or other visual symptoms may occur. These may make activities such as driving or operating machinery more hazardous than usual, particularly under conditions of variable lighting. While their significance is not yet understood, patients having any visual symptoms should discontinue treatment and have a complete ophthalmologic evaluation.

The most common side effects include hot flashes, stomach discomfort and bloating, nausea and vomiting, breast discomfort, headache, and vaginal bleeding. For complete product details, see the Full Prescribing Information.

Is Serophene® associated with multiple births?

Multiple births have been associated with the use of fertility medications. You should discuss the potential risk of multiple births with your fertility team before beginning treatment.

Is Serophene® associated with congenital birth defects?

The incidence of birth defects associated with Serophene® is no different from that of the untreated population.

Is Serophene® associated with ovarian cancer?

Prolonged use of clomiphene citrate may increase the risk of a borderline or invasive ovarian tumor. A causal association between fertility medications and ovarian cancer has not been established.

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 Safety Information: Serophene® (clomiPHENE citrate tablets USP) is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiPHENE citrate therapy. Serophene® should only be prescribed by doctors specializing in infertility or reproductive health. Serophene® can cause serious side effects including, visual symptoms such as spots or flashes, ovarian hyperstimulation syndrome (OHSS), with or without blood vessel and lung complications, and multiple births. Serophene® should not be used in women who are allergic to clomiphene citrate preparations or their ingredients, who have liver disease, who have abnormal bleeding from the uterus, have ovarian cysts or enlarged ovaries, have uncontrolled thyroid or adrenal problems, have a pituitary tumor or other tumor in the brain or who are pregnant. Prolonged use of Serophene® may increase the risk of ovarian cancer. The most common side effects in patients using Serophene® include hot flashes, stomach discomfort and bloating, nausea and vomiting, breast discomfort, visual symptoms, headache and vaginal bleeding. Please see Full Prescribing Information.

Prescribing Information and Important Safety Information

Serophene® (clomiPHENE citrate tablets USP) is indicated for the treatment of ovulatory dysfunction in women desiring pregnancy. Impediments to achieving pregnancy must be excluded or adequately treated before beginning clomiPHENE citrate therapy. Serophene® should only be prescribed by doctors specializing in infertility or reproductive health. Serophene® can cause serious side effects including, visual symptoms such as spots or flashes, ovarian hyperstimulation syndrome (OHSS), with or without blood vessel and lung complications, and multiple births. Serophene® should not be used in women who are allergic to clomiphene citrate preparations or their ingredients, who have liver disease, who have abnormal bleeding from the uterus, have ovarian cysts or enlarged ovaries, have uncontrolled thyroid or adrenal problems, have a pituitary tumor or other tumor in the brain or who are pregnant. Prolonged use of Serophene® may increase the risk of ovarian cancer. The most common side effects in patients using Serophene® include hot flashes, stomach discomfort and bloating, nausea and vomiting, breast discomfort, visual symptoms, headache and vaginal bleeding. Please see Full Prescribing Information and FAQs for more information.

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Important Safety Information:
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 Safety Information:
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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