Luveris® (lutropin alfa for injection)
Luveris® is the first and only recombinant human luteinizing hormone (r-hLH) approved in the world. 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.
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.
