Luveris® (lutropin alfa for injection), 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).
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.
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 (see "Selection of Patients").Ovarian cyst or enlargement of undetermined origin (see "Selection of Patients").Sex hormone dependent tumors of the reproductive tract and accessory organs.Pregnancy.
-- Altered reactivity to an antigen, which can result in pathologic reactions upon subsequent exposure to that particular antigen.
-- Neoplasms which arise from or metastasize to the PITUITARY GLAND. The majority of pituitary neoplasms are adenomas, which are divided into non-secreting and secreting forms. Hormone producing forms are further classified by the type of hormone they secrete. Pituitary adenomas may also be characterized by their staining properties (see ADENOMA, BASOPHIL; ADENOMA, ACIDOPHIL; and ADENOMA, CHROMOPHOBE). Pituitary tumors may compress adjacent structures, including the HYPOTHALAMUS, several CRANIAL NERVES, and the OPTIC CHIASM. Chiasmal compression may result in bitemporal HEMIANOPSIA.
-- Bleeding from blood vessels in the UTERUS, sometimes manifested as vaginal bleeding.
-- General term for CYSTS and cystic diseases of the OVARY.
-- General increase in bulk of a part or organ due to CELL ENLARGEMENT and accumulation of FLUIDS AND SECRETIONS, not due to tumor formation, nor to an increase in the number of cells (HYPERPLASIA).
-- New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.
Gonadotropins, including Luveris® (lutropin alfa for injection), should only be used by physicians who are thoroughly familiar with infertility problems and their management.
Like other gonadotropin products, Luveris® is a potent gonadotropic substance capable of contributing to the development of Ovarian Hyperstimulation Syndrome (OHSS) in women with or without pulmonary or vascular complications.
Gonadotropin therapy requires a certain time commitment by physicians and supportive health professionals, and requires the availability of appropriate monitoring facilities (see "PRECAUTIONS/Laboratory Tests").
Safe and effective use of Luveris® requires monitoring of ovarian response with serum estradiol and ovary ultrasound on a regular basis.
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