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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Indication:
For women, Gonal-f® (follitropin alfa for injection), Gonal-f® RFF (follitropin alfa injection) and Gonal-f® RFF Pen (follitropin alfa injection) are indicated for 1) 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 and 2) for the development of multiple follicles in the ovulatory patient participating in an ART program.

Gonal-f® is also indicated to increase sperm production in men with a rare condition called hypogonadotropic hypogonadism.

Important Safety Information:
These products should only be prescribed by physicians specializing in fertility or reproductive health. Use of Gonal-f® or Gonal-f® RFF by women can result in multiple births. Patients should let their doctor know of any allergic reactions to recombinant FSH preparations or other product ingredients. Patients should also inform their doctor of a history of cancer of the sex organs or brain and uncontrolled thyroid or adrenal disease before starting or continuing treatment. Women with a history of abnormal bleeding from the uterus or vagina, swollen, enlarged, or painful ovaries should speak to their doctor before starting treatment. Gonal-f® and Gonal-f® RFF are potent gonadotropic substances capable of severe adverse reactions, including Ovarian Hyperstimulation Syndrome (OHSS) in women, which can result in hospitalization. Women should inform their doctor if they experience severe stomach pain, vomiting, bloating, or weight gain while taking Gonal-f® or Gonal-f RFF®. The most common side effects are headache, ovarian cysts, upset stomach, and sinus infections in women taking Gonal-f® or Gonal-f® RFF. The most common side effects in men taking Gonal-f® are skin acne, breast pain and growth, and tiredness. Needle injections may cause some discomfort.

For more information, refer to the prescribing and patient information offered below and talk to your doctor.

*RFF Revised Formulation Female


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