Luveris^®

Luveris^® is the brand name for the medication lutropin alfa, which is a synthetic version of a protein naturally found in the body.¹

Luveris^® provides you with the luteinizing hormone (LH) that may be necessary to be given along with GONAL-F^® (follitropin alfa for injection) that provides you with follicle stimulating hormone (FSH). Luveris^® and GONAL-F^® are given to help develop ovarian follicles.

Luveris^® is provided as a white freeze-dried powder in a small glass container (vialviala small glass container for holding liquids) with a rubber stopper. An additional vialviala small glass container for holding liquids that contains 1 mL of sterile water is also provided. A needle and syringesyringea hollow cylinder fitted with a sliding plunger that is used for injections when a needle is attached are used to withdraw the right amount of sterile water from the one vialviala small glass container for holding liquids and then inject it into the vialviala small glass container for holding liquids of powder. The powder is dissolved in the sterile water and should be mixed gently to make a liquid form of the medication that can then be injected with a different needle. The liquid medicine should only be made just before you are ready to use it. Each viaviala small glass container for holding liquidsl is intended for a single use.

Luveris^® is available at a strength of 75 IU/vial (note that IU stands for International Units and is a unit of measure). [1]

Your doctor will recommend the appropriate treatment regimen for you. Luveris^® is usually taken every day for up to three weeks, together with injections of follicle stimulating hormonehormonea chemical substance produced in one part of the body that controls and regulates the activity of certain cells or organs in another part of the body (FSHfollicle-stimulating hormone (FSH)a hormone produced by the pituitary gland in the brain that stimulates the growth of follicles in the ovaries of women and sperm development in men). The usual dose starts with 75 IU of Luveris^® together with 75 IU or 150 IU of FSHfollicle-stimulating hormone (FSH)a hormone produced by the pituitary gland in the brain that stimulates the growth of follicles in the ovaries of women and sperm development in men. According to your response, your doctor may increase your dose of FSHfollicle-stimulating hormone (FSH)a hormone produced by the pituitary gland in the brain that stimulates the growth of follicles in the ovaries of women and sperm development in men by preferably 37.5 IU to 75 IU at 7-14 day intervals. Your doctor may decide to extend your treatment up to five weeks.[1]

Luveris^® is used (usually with GONAL-f^®) to stimulate the development of folliclesfolliclessmall fluid-filled sacs in the ovary that contain the eggs released at ovulation; each month an egg develops inside the ovary in a follicle in patients with hypogonadotropic hypogonadismhypogonadotropic hypogonadismin women, a rare condition in which the pituitary glands do not release follicle-stimulating hormone or luteinizing hormone. Those with hypogonadotropic hypogonadismhypogonadotropic hypogonadismin women, a rare condition in which the pituitary glands do not release follicle-stimulating hormone or luteinizing hormone have pituitary glands that do not release follicle-stimulating hormone (FSH)follicle-stimulating hormone (FSH)a hormone produced by the pituitary gland in the brain that stimulates the growth of follicles in the ovaries of women and sperm development in men or luteinizing hormonehormonea chemical substance produced in one part of the body that controls and regulates the activity of certain cells or organs in another part of the body (LHluteinizing hormone (LH)a hormone release by the pituitary gland in the brain that acts in the ovary to stimulate ripening of the follicle and formation of the corpus luteum). Without these hormones, folliclesfolliclessmall fluid-filled sacs in the ovary that contain the eggs released at ovulation; each month an egg develops inside the ovary in a follicle in the ovariesovariesthe two sexual glands of the female where the eggs are stored and that produce the hormones estrogen and progesterone are unable to develop and mature so ovulationovulationrelease of an egg from the ovary cannot take place. [1]

LUVERIS provides you with LH that may be necessary to be given along with GONAL-F^® (follitropin alfa for injection) that provides you with FSH. FSH is necessary for the recruitment, growth, and maturation of the ovarian follicles which contain eggs known as ova or oocytes. The addition of LUVERIS to GONAL-F may enhance this process. This occurs during the first half of the female reproductive cycle. After LUVERIS and GONAL-F are given to help develop ovarian follicles, another hormone, hCG (human chorionic gonadotropin), may be given mid-cycle to mature the eggs and cause ovulation.

Do not use Luveris^® if you:

• are allergic (hypersensitive) to gonadotropins (such as luteinizing hormone, follicle stimulating hormone or human chorionic gonadotropin), or any of the other ingredients of LUVERIS.
• have been diagnosed as having ovarian, uterine or breast cancer.
• have had a brain tumour diagnosed.
• have ovarian enlargement or ovarian cyst unrelated to polycystic ovarian disease and of unknown origin.
• have unexplained vaginal bleeding.
• The medicine must not be used when a condition exists which would make a spontaneous pregnancy impossible, such as:
• Premature menopause
• Malformation of sexual organs
• Specific tumours of the womb

Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Luveris^® has not been shown to affect the activity of co-administered Gonal-f^®.

As with any drug, you may experience side effects when taking Luveris®. In clinical trials, the most common side effects (experienced by more than 2% of patients) were headache, pelvic and abdominal pain, nausea, ovarianovarianrelating to an ovary or the ovaries hyperstimulation syndrome (OHSSovarian hyperstimulation syndrome (OHSS)OHSS is caused when the ovaries become overstimulated by the various hormones that cause follicular development; there is a sudden ovarian enlargement accompanied by fluid accumulation in the abdominal cavity and this may occur with or without pain, and with or without accumulation of fluid in the lungs), breast pain/pain in the soft tissues of chest/underarm, ovarianovarianrelating to an ovary or the ovaries cysts, flatulenceflatulenceexcess gas in the intestinal tract, injection site reactions, general pain, constipation, fatigue, painful menstruationmenstruationshedding of the uterine lining by bleeding, which (in the absence of pregnancy) normally occurs about once a month in the mature female, ovarianovarianrelating to an ovary or the ovaries disorder, diarrhea, and upper respiratory tract infections.

When taking Luveris^®, there is a risk of developing OHSSovarian hyperstimulation syndrome (OHSS)OHSS is caused when the ovaries become overstimulated by the various hormones that cause follicular development; there is a sudden ovarian enlargement accompanied by fluid accumulation in the abdominal cavity and this may occur with or without pain, and with or without accumulation of fluid in the lungs. The early warning signs of development of OHSSovarian hyperstimulation syndrome (OHSS)OHSS is caused when the ovaries become overstimulated by the various hormones that cause follicular development; there is a sudden ovarian enlargement accompanied by fluid accumulation in the abdominal cavity and this may occur with or without pain, and with or without accumulation of fluid in the lungs are severe abdominal pain, nausea, vomiting, and weight gain. Since OHSSovarian hyperstimulation syndrome (OHSS)OHSS is caused when the ovaries become overstimulated by the various hormones that cause follicular development; there is a sudden ovarian enlargement accompanied by fluid accumulation in the abdominal cavity and this may occur with or without pain, and with or without accumulation of fluid in the lungs develops rapidly, if you experience any of these symptoms, contact your doctor immediately.

This is not a complete list of side effects. For any unexpected effects while taking Luveris^®, contact your doctor or pharmacist. [1]

It is important to regularly tell your health care professional how you are feeling and if you have developed any new symptoms while taking Luveris^®.

Before you use Luveris^®, talk to your doctor or pharmacist if:

• you have sex hormonehormonea chemical substance produced in one part of the body that controls and regulates the activity of certain cells or organs in another part of the body–dependent tumours of the reproductive tract and accessory organs
• you have active, untreated tumours of the hypothalamushypothalamusthe gland at the base of the brain that controls the release of hormones from the pituitary glands or pituitary glandpituitary glandthe gland located at the base of the brain that secretes a number of important hormones that regulate fertility, as well as normal growth and development of the body
• you are pregnant or are feeding a baby your own milk
• you have ovarianovarianrelating to an ovary or the ovaries failure
• you have abnormal uterineuterinerelating to the uterus (womb) bleeding of unknown origin
• you are allergic to gonadotropinsgonadotropins or gonadotrophinsreproductive hormones including luteinizing hormone and follicle-stimulating hormone (released by the pituitary gland) and human chorionic gonadotropin (released by the placenta) or to any of the non-medicinal ingredients[1]

Compared with natural conceptionconceptionfertilization; when the sperm meets and penetrates the egg, the incidence of multiple pregnancies (mainly twins) and births is increased in patients undergoing this type of treatment. However, this effect can be minimized by using the recommended dose and schedule of administration. [1]

Miscarriages are higher than in the general population, but comparable with the rates found in those receiving fertility treatment. [1]

Patients with a history of fallopian tube disease are at a risk of ectopic pregnancyectopic pregnancypregnancy where the embryo is implanted outside the womb, whether the pregnancy is obtained by spontaneous conceptionconceptionfertilization; when the sperm meets and penetrates the egg or with fertility treatments. [1]

There have been reports of tumours of the ovary and other reproductive organs, both benignbenigndescribes any tumour or growth that is not malignant; or cancerous and malignantmalignantcancerous, in patients who have undergone multiple drug regimens for infertility treatment. [1]

If you are at risk of thromboembolic events (formation of a blood clot in vein or artery), because of your personal or family history, treatment with gonadotropingonadotropins or gonadotrophinsreproductive hormones including luteinizing hormone and follicle-stimulating hormone (released by the pituitary gland) and human chorionic gonadotropin (released by the placenta)s (like pregnancy itself), may further increase the risk. If you think you may have such a risk, please ask your doctor. [1]

Congenital disabilities after assisted reproduction techniques (ARTassisted reproductive technologies (ART)a variety of procedures used to bring about conception without sexual intercourse, including in vitro fertilization (IVF) and other techniques) may be slightly higher than after spontaneous conceptions, although this finding is not confirmed. It could be due to differences in parental factors such as maternal age or genetics, as well as the ARTassisted reproductive technologies (ART)a variety of procedures used to bring about conception without sexual intercourse, including in vitro fertilization (IVF) and other techniques procedures and multiple pregnancies. [1]

Lyophilized vials are stable when stored at 2-25°C and protected from light. Do not expose to extreme heat or cold. Do not use the product after the expiry date indicated on the label. 

Do not use LUVERIS^® if you notice any signs of deterioration or damage to the container. The solution should not be administered if it contains particles or is not clear. 

Once you have finished your injection, immediately throw away the needles and syringesyringea hollow cylinder fitted with a sliding plunger that is used for injections when a needle is attached (without recapping the needle) into the disposal container. [1]

You may also mix Luveris and GONAL-f^® (follitropin alfa for injection) monodose (75 IU /5.5 µg) together as an alternative to injecting each product separately. Add the GONAL-f^® solution into the reconstituted vialviala small glass container for holding liquids of Luveris^®. For more information on how to co-administration Luveris^® with GONAL-f^®, please contact our support program. [1]