Trade Names:Luveris- Powder for injection, lyophilized 82.5 units/vial (to deliver 75 units)
Increases estradiol secretion, thereby supporting follicle stimulating hormone (FSH)-induced follicular development.
Following subcutaneous administration, C max is reached after about 4 to 16 h. After subcutaneous administration of lutropin alfa 150 units, the C max is 1.1 units/L, the AUC is about 44 h•units/L, and T max is about 6 h.
Steady state Vd is about 10 L.
After subcutaneous administration of lutropin alfa 150 units, the t ½ is about 14 h. Mean terminal t ½ is about 18 h. Total body Cl is about 2 to 3 L/h with less than 5% excreted unchanged by the kidney.
Lutropin alfa is coadministered with follitropin alfa for stimulation of follicular development in infertile, hypogonadotropic, hypogonadal women with profound luteinizing hormone (LH) deficiency.
Women who exhibit prior hypersensitivity to human LH preparations or their excipients; primary ovarian failure; uncontrolled thyroid or adrenal dysfunction; 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; pregnancy.
Subcutaneous 75 units coadministered with follitropin alfa as 2 separate injections, both given daily until adequate follicular development as indicated by ovary ultrasonography and serum estradiol. Duration usually should not exceed 14 days, unless signs of imminent follicular development are present. To complete follicular development and effect ovulation in the absence of an endogenous LH surge, human chorionic gonadotropin (hCG) is given 1 day after the last dose of lutropin alfa and follitropin alfa. Withhold treatment with hCG if ovaries are abnormally enlarged or if excessive estradiol production has occurred. Individualize doses for subsequent cycles.
Store lyophilized powder in refrigerator or at room temperature (36° to 77°F). Protect from light.
None well documented.
None well documented.
Headache, fatigue (at least 2%).
Abdominal pain, constipation, diarrhea, flatulence, nausea (at least 2%).
Breast pain, dysmenorrhea, ovarian cyst, ovarian disorder, ovarian hyperstimulation (at least 2%).
Injection site reaction and pain (at least 2%).
Upper respiratory tract infection (at least 2%).
To reduce risk of overstimulation of the ovary and to determine the number of follicles, ensure that ovarian response to therapy is closely monitored with serum estradiol levels and ultrasonography. If excessive estradiol production has occurred, the ovaries are abnormally enlarged, or if abdominal pain occurs, discontinue treatment with lutropin alfa and follitropin alfa, do not administer hCG, and caution patient to avoid intercourse.
Category X .
Safety and efficacy not established.
Increased risk of multiple births.
Mild to moderate uncomplicated ovarian enlargement may occur.
May occur within 24 h to several days after treatment and is characterized by an increase in vascular permeability that can result in rapid accumulation of fluid in the peritoneal cavity, thorax, and potentially the pericardium. Monitor patient for signs and symptoms of ovarian hyperstimulation syndrome (eg, dyspnea, severe pelvic pain, nausea, vomiting, diarrhea, rapid weight gain, abdominal pain or distension, oliguria) during therapy and for 2 wk after hCG has been discontinued.
Potential for occurrence of arterial thromboembolism exists. Monitor patient for signs and symptoms of thromboembolic events (eg, venous thrombophlebitis, pulmonary embolism, pulmonary infarction, stroke, arterial occlusion). Report to health care provider immediately if noted or suspected.
Ovarian hyperstimulation, multiple gestations.
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