Luveris® (lutropin alfa for injection)

Luveris® is the first and only recombinant human luteinizing hormone (r–hLH) approved in the world. Now Luveris® is available in the US 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.

Important Safety Information

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 and FAQ's.