Luveris^®

About Luveris^® (lutropin alfa for injection)

Overview:

Luveris^® is the first and only recombinant human luteinizing hormone (r-hLH) approved in the world. Now Luveris^® is available in the U.S. for concomitant use with Gonal-f^® (follitropin alfa for injection) to stimulate follicular development in profoundly LH-deficient hypogonadotropic hypogonadal (HH) women (LH < 1.2 IU/L). A definitive effect on pregnancy in this population has not been demonstrated. The safety and effectiveness of concomitant administration of Luveris^® with any other preparation of recombinant human FSH or urinary human FSH is unknown.

LH is a hormone that is normally produced by the pituitary gland and plays an important role in the female reproductive system. Luveris^® is manufactured to the highest standards of purity using recombinant human DNA technology. Luveris^® is the only source of pure hLH and is the only hLH product with advantages of recombinant technology.

Luveris^® should only be prescribed by doctors specializing in infertility or reproductive health. Luveris^® can cause serious side effects including: ovarian hyperstimulation syndrome (OHSS), with or without blood vessel and lung problems and multiple births. Luveris^® should not be used in women who, are allergic to hLH products, have ovaries that no longer make eggs, have uncontrolled thyroid or adrenal problems, have cancer in their female organs, have a pituitary tumor or other tumor in their brain, have abnormal bleeding from the uterus or vagina, have ovarian cysts or enlarged ovaries not due to polycystic ovary syndrome (PCOS) and are pregnant or think they may be pregnant. The most common side effects include headache, abdominal pain, nausea, OHSS, breast pain and ovarian cyst. For complete product details, see the Full Prescribing Information for Luveris^® and FAQs.

Important Safety Information: Luveris^® (lutropin alfa for injection), concomitantly administered with Gonal-f^® (follitropin alfa for injection), is indicated for the stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound LH deficiency (LH<1.2 IU/L). A definitive effect on pregnancy in this population has not been demonstrated. Luveris should only be prescribed by doctors specializing in infertility or reproductive health. Luveris can cause serious side effects including: Ovarian hyperstimulation syndrome (OHSS), with or without blood vessel and lung problems and multiple births. Luveris^® (lutropin alfa for injection) is contraindicated in women who exhibit, prior hypersensitivity to hLH preparations or one of their excipients, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction, an uncontrolled organic intracranial lesion such as a pituitary tumor, abnormal uterine bleeding of undetermined origin, ovarian cyst or enlargement of undetermined origin, sex hormone dependent tumors of the reproductive tract and accessory organs and pregnancy. The most common side effects include headache, abdominal pain, nausea OHSS, breast pain and ovarian cyst. For complete product details, see the Full Prescribing Information.

Instructions for Use

Watch this brief video that demonstrates how to administer Luveris^® Multi-dose.

• Luveris^® Instructions for Use

Important Safety Information: Luveris^® (lutropin alfa for injection), concomitantly administered with Gonal-f^® (follitropin alfa for injection), is indicated for the stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound LH deficiency (LH<1.2 IU/L). A definitive effect on pregnancy in this population has not been demonstrated. Luveris^® should only be prescribed by doctors specializing in infertility or reproductive health. Luveris^® can cause serious side effects including: Ovarian hyperstimulation syndrome (OHSS), with or without blood vessel and lung problems and multiple births. Luveris^® (lutropin alfa for injection) is contraindicated in women who exhibit, prior hypersensitivity to hLH preparations or one of their excipients, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction, an uncontrolled organic intracranial lesion such as a pituitary tumor, abnormal uterine bleeding of undetermined origin, ovarian cyst or enlargement of undetermined origin, sex hormone dependent tumors of the reproductive tract and accessory organs and pregnancy. The most common side effects include headache, abdominal pain, nausea OHSS, breast pain and ovarian cyst. For complete product details, see the Full Prescribing Information.

Storage

Important Safety Information: Luveris^® (lutropin alfa for injection), concomitantly administered with Gonal-f^® (follitropin alfa for injection), is indicated for the stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound LH deficiency (LH<1.2 IU/L). A definitive effect on pregnancy in this population has not been demonstrated. Luveris should only be prescribed by doctors specializing in infertility or reproductive health. Luveris can cause serious side effects including: Ovarian hyperstimulation syndrome (OHSS), with or without blood vessel and lung problems and multiple births. Luveris^® (lutropin alfa for injection) is contraindicated in women who exhibit, prior hypersensitivity to hLH preparations or one of their excipients, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction, an uncontrolled organic intracranial lesion such as a pituitary tumor, abnormal uterine bleeding of undetermined origin, ovarian cyst or enlargement of undetermined origin, sex hormone dependent tumors of the reproductive tract and accessory organs and pregnancy. The most common side effects include headache, abdominal pain, nausea OHSS, breast pain and ovarian cyst. For complete product details, see the Full Prescribing Information.

FAQs

• What is Luveris^®?
• Why has Luveris^® been prescribed to you?
• Who can use Luveris^®?
• What is Hypogonadotropic Hypogonadism?
• What is the role of hLH (human luteinizing hormone) in the reproductive cycle?
• When should you NOT use Luveris^®?
• How should Luveris^® be stored before you use it?
• Are there any side effects associated with the use of Luveris^®?
• Has Luveris^® been proven safe and effective in women?
• Is Luveris^® associated with multiple births?
• Is Luveris^® associated with congenital birth defects?
• Can you take Luveris^® with other medicines?
• What should you do if you forget to take Luveris^®?
• Where can you obtain more information about Luveris^®?
• Can Luveris^® be used with FSH preparations other than Gonal-f^®?
• How is Luveris^® supplied?

What is Luveris^®?

Luveris^® is a medicine containing lutropin alfa, a recombinant form of the luteinizing hormone (LH) naturally found in humans. LH belongs to the group of hormones called gonadotropins, involved in the normal control of reproduction.

Follicle stimulating hormone (FSH) and luteinizing hormone (LH) work together to help your ovaries to produce eggs. The hormone in Luveris^® 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. Luveris^® is provided as a powder in a vial containing 82 IU (International Units) of the active ingredient (lutropin alfa). Since some medicine remains in the syringe, the vial has been filled with 82 IU to deliver 75 IU.

Each vial of Luveris^® is intended for a single dose administration under the skin (subcutaneous). Instructions and illustrations on how to inject Luveris^®.

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Why has Luveris^® been prescribed to you?

Luveris^® is approved for treating women seeking pregnancy who have very low levels of some of the hormones involved in the natural reproductive cycle. It is prescribed to patients needing hormone replacement or supplementation to produce eggs. After a thorough medical exam to determine your specific medical condition, your healthcare provider may prescribe Luveris^® as one of the several drugs prescribed to you as part of your treatment program. Gonal-f^® (follitropin alfa for injection) and Luveris^® are given as an injection usually every day, for a specified number of days, at the appropriate time during your treatment cycle.

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Who can use Luveris^®?

Luveris^®, concomitantly administered with Gonal-f^® (follitropin alfa for injection), is indicated for stimulation of follicular development in infertile Hypogonadotropic Hypogonadal women with profound LH deficiency (LH < 1.2 IU/L).

Selection of Patients:

• Patients should have baseline serum hormone levels of LH < 1.2 IU/L and FSH < 5 IU/L.
• Before treatment with gonadotropins is instituted, a thorough gynecologic and endocrinologic evaluation must be performed. This should include an assessment of pelvic anatomy and exclusion of pregnancy.
• Patients should have a negative progestin challenge test.
• Patients in later reproductive life have a greater predisposition to endometrial carcinoma as well as a higher incidence of anovulatory disorders. A thorough diagnostic evaluation should always be performed in patients who demonstrate abnormal uterine bleeding or other signs of endometrial abnormalities before starting Luveris^® and follitropin alfa therapy.
• Evaluation of the partner's fertility potential should be included in the initial evaluation.

Hypogonadotropic Hypogonadism in the U.S. female population is rare. It is difficult to estimate its prevalence because there are limited published data.

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What is Hypogonadotropic Hypogonadism?

Hypogonadotropic Hypogonadism (HH) is a rare condition in which impaired activity of the hypothalamus or pituitary gland in adults results in abnormally low FSH and LH serum levels and impaired function of the gonads. (The gonads are the ovaries and testes and the hormones they normally produce include estrogen, progesterone and testosterone).

Luveris^®, concomitantly administered with Gonal-f^® (follitropin alfa for injection), is indicated for stimulation of follicular development in infertile Hypogonadotropic Hypogonadal women with profound LH deficiency (LH < 1.2 IU/L).

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What is the role of hLH (human luteinizing hormone) in the reproductive cycle?

Endogenous human LH (hLH) is produced in the pituitary gland. Human luteinizing hormone stimulates the production of another hormone — testosterone — by the ovarian follicles. Testosterone is the precursor required for the production of estradiol by these follicles. Estradiol is one of the hormones that prepare the endometrial lining and the uterus for embryo implantation.

In the absence of hLH, full development of follicles in the ovaries, ovulation and endometrial growth to support implantation of a fertilized egg are unlikely to occur.

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When should you NOT use Luveris^®?

Important: do NOT use Luveris^® if you have allergies to any of these materials:

• Any preparations of human luteinizing hormone
• Sucrose
• Sodium phosphates
• Polysorbate
• L-methionine
• O-phosphoric acid
• Sodium hydroxide

MEDICAL CONDITIONS YOU SHOULD TELL YOUR HEALTHCARE PROVIDER ABOUT

Please inform your health care provider if you:

• Have primary ovarian failure (your ovaries no longer make eggs);
• Are pregnant or think you may be pregnant;
• Have uncontrolled thyroid or adrenal probems;
• Have cancer in your female organs (ovaries, breasts, uterus);
• Have a pituitary tumor or other tumor in your brain;
• Have abnormal bleeding from your uterus or vagina;
• Have ovarian cysts or enlarged ovaries, not due to polycystic syndrome (PCOS).

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How should Luveris^® be stored before you use it?

Luveris^® is stored refrigerated or at room temperature (2°- 25°C / 36°- 77°F) in the original package. Store away from light. Do not freeze. Do not store above 77°F (25°C). Do not use after the expiration date shown on the vial or the carton. Keep out of the reach of children. Use immediately after reconstitution. Discard any unused materials.

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Are there any side effects associated with the use of Luveris^®?

Your health care professional should review the risks and benefits of using Luveris^® with you. As with any medication, report any and all side effects, symptoms or physical changes to your healthcare provider. Treatment with FSH and LH followed by human chorionic gonadotropin (hCG) can lead to a condition called Ovarian Hyperstimulation Syndrome (OHSS). This condition can occur when the ovaries overreact to the treatment and become enlarged. A potential for the occurrence of blood clots in the arteries exists, which can be serious. Your doctor should monitor your response to avoid overdose.

Important: Contact your health care professional immediately if you experience severe pain or bloating in the stomach or pelvic area, severe upset stomach, vomiting and/or 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. Pregnancy loss (miscarriage) is higher in women receiving fertility drugs than in women not taking fertility drugs.

The most common side effects are headache, abdominal pain, nausea, OHSS, breast pain and ovarian cysts. Needles may cause some discomfort at the site of the injection.

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Has Luveris^® been proven safe and effective in women?

Luveris^® is FDA approved.

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Is Luveris^® associated with multiple births?

Reports of multiple births have been associated with all fertility treatments, including Luveris^®. You should discuss the potential risk of multiple births with your fertility team before beginning treatment.

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Is Luveris^® associated with congenital birth defects?

There is no evidence that the use of any gonadotropin drug product for treatment of infertility is associated with an increased risk of congenital malformations.

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Can you take Luveris^® with other medicines?

Your healthcare provider has prescribed Luveris^® and other medicines for treating infertility associated with very low reproductive hormonal levels. Inform your healthcare provider and pharmacist if you are taking or have taken any other medicines, even those not requiring a prescription.

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What should you do if you forget to take Luveris^®?

Contact your healthcare provider immediately if you forget to take Luveris^®.

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Where can you obtain more information about Luveris^®?

This website contains a summary of the important patient information about Luveris^®. If you have any questions or problems, talk to your healthcare provider or other healthcare provider. Luveris^® is manufactured for and distributed by Serono, Inc.

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Can Luveris^® be used with FSH preparations other than Gonal-f^®?

In clinical trials Luveris^® was co-administered with Serono's follitropin alfa (Gonal-f^®). The safety and effectiveness of concomitant administration of Luveris^® with any other preparation of recombinant human FSH or urinary human FSH is unknown.

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How is Luveris^® supplied?

Luveris^® is supplied in vials containing 82.5 IU of lyophilized lutropin alfa (recombinant human luteinizing hormone, r-hLH) to deliver 75 IU after reconstitution with 1ml of diluent. Luveris^® carton contains one vial of lyophilized powder and one vial containing 1ml sterile water for injection, USP. Syringes and needles are not provided in Luveris^® cartons.

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: Luveris^® (lutropin alfa for injection), concomitantly administered with Gonal-f^® (follitropin alfa for injection), is indicated for the stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound LH deficiency (LH<1.2 IU/L). A definitive effect on pregnancy in this population has not been demonstrated. Luveris should only be prescribed by doctors specializing in infertility or reproductive health. Luveris can cause serious side effects including: Ovarian hyperstimulation syndrome (OHSS), with or without blood vessel and lung problems and multiple births. Luveris^® (lutropin alfa for injection) is contraindicated in women who exhibit, prior hypersensitivity to hLH preparations or one of their excipients, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction, an uncontrolled organic intracranial lesion such as a pituitary tumor, abnormal uterine bleeding of undetermined origin, ovarian cyst or enlargement of undetermined origin, sex hormone dependent tumors of the reproductive tract and accessory organs and pregnancy. The most common side effects include headache, abdominal pain, nausea OHSS, breast pain and ovarian cyst. For complete product details, see the Full Prescribing Information and FAQs.

Full Prescribing Information for Luveris^®.

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Prescribing Information and Important Safety Information:

Luveris^® (lutropin alfa for injection), concomitantly administered with Gonal-f^® (follitropin alfa for injection), is indicated for the stimulation of follicular development in infertile hypogonadotropic hypogonadal women with profound LH deficiency (LH<1.2 IU/L). A definitive effect on pregnancy in this population has not been demonstrated. Luveris should only be prescribed by doctors specializing in infertility or reproductive health. Luveris can cause serious side effects including: Ovarian hyperstimulation syndrome (OHSS), with or without blood vessel and lung problems and multiple births. Luveris^® (lutropin alfa for injection) is contraindicated in women who exhibit, prior hypersensitivity to hLH preparations or one of their excipients, primary ovarian failure, uncontrolled thyroid or adrenal dysfunction, an uncontrolled organic intracranial lesion such as a pituitary tumor, abnormal uterine bleeding of undetermined origin, ovarian cyst or enlargement of undetermined origin, sex hormone dependent tumors of the reproductive tract and accessory organs and pregnancy. The most common side effects include headache, abdominal pain, nausea OHSS, breast pain and ovarian cyst. For complete product details, see the Full Prescribing Information and FAQs.

• Prescribing Information for Luveris^® (lutropin alfa for injection)

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