Accidental administration may lead to a disruption of the menstrual cycle. See the lupron depot ped package insert for the use of leuprolide acetate in children with central precocious puberty. Most types of prostate cancer need the male hormone testosterone to grow and spread. Highlights of prescribing information recommended dose of. Lupron depot leuprolide acetate for depot suspension 7. To obtain a package insert, contact veterinary technical product support at 18003383659. The usual initial dose of leuprolide subcutaneous injection for children with central precocious puberty is 50 mcg per kg of body weight once a day about 22. By connor th, mackenzie ba, debord dg, trout db, ocallaghan jp. The gnrh agonists that have been developed and marketed for prostate cancer are leuprolide, goserelin, triptorelin, and histrelin. Lupron injection leuprolide acetate rx only description. The analog possesses greater potency than the natural hormone. Leuprolide fda prescribing information, side effects and. Leuprolide injection eligard, lupron depot is used to treat the symptoms associated with advanced prostate cancer.
Insulin syringes are used because the measurement on the syringe is in units i. Lupron depot leuprolide acetate for depot suspension fda. See full prescribing information for lupron depot leuprolide acetate for. Eligard leuprolide acetate is indicated for the palliative due to incorrect reconstitution or administration of the product see monitoring and laboratory gently insert the long, white replacement plunger rod into the gray. Leuprolide works by decreasing the amount of testosterone in males and estrogen in females made by the body. Eligard is an injectable suspension of leuprolide acetate available in a singledose kit. Niosh list of antineoplastic and other hazardous drugs in healthcare settings, 2016. Leuprolide acetate is indicated in the palliative treatment of advanced prostatic cancer. See full prescribing information for lupron depot 11. See the lupron depot ped package insert for the use of leuprolide.
Leuprolide acetate api dmfs us drug master file dmf. Lupron, lupron depot leuprolide dosing, indications. Leuprolide acetate lupron leuprolide acetate lupron is a gnrh agonist. Lupron injection for pediatric use package insert tapus, rev 0496, rec 040198. Lupron, is used for hormonal manipulation in art ivf, gift and zift patients. You are encouraged to report negative side effects of prescription drugs to the fda. Leuprolide acetate lupron center for human reproduction. List of drug master files dmf of leuprolide acetate active pharmaceutical ingredient api submitted to the u. This label reflects clinical trials for lupron depot in prostate cancer in which the majority of the subjects studied were at. Reports of anaphylactic reactions to synthetic gnrh or gnrh agonist analogs have been reported in the medical literature.
Leuprolide acetate is administered as a subcutaneous injection using insulin syringes. Animal and human studies indicate that following an initial stimulation of gonadotropins, chronic administration of leuprolide acetate results in suppression of ovarian and testicular steroidogenesis. Lupron depot leuprolide acetate for depot suspension 3. This effect is reversible on discontinuation of drug therapy. Highlights of prescribing information these highlights. Eligard 45 mg powder and solvent for solution for injection. Leuprolide is used to treat advanced prostate cancer in men. Measure prostatespecific antigen psa in first few weeks of therapy. The dose may be increased by 10 mcg per kg body weight about 4.
For complete product information refer to the product insert. See other lupron depot and lupron injection package inserts for other events reported in different. Lupron is contraindicated in women who are or may become pregnant while receiving the drug. These lupron depot formulations are not indicated for use in children. Precautions and warnings with leuprolide because leuprolide can worsen memory, raise blood sugar levels, and increase your risk of heart attacks and sudden death, the precautions and warnings should be fully discussed with your healthcare provider before starting treatment. Leuprolide reduces the amount of testosterone in men or estrogen in women leuprolide is used in men to treat the symptoms of prostate cancer but does not treat the cancer itself. It is a synthetic form of the naturally occurring gonadotropinreleasing hormone gnrh, a hormone that controls the release of two other hormones from the pituitary gland a tiny gland located beneath the brain. By continuing to browse this site you are agreeing to our use of cookies. Lupron depot leuprolide acetate for depot suspension. Results from an exparel phase 4, doubleblind, randomized, controlled trial that compared the efficacy and safety of exparel 266 mg 20 ml n70 and bupivacaine hcl n69 in a total knee arthroplasty study.
S ections or subsections omitted from the full prescribing information are not listed. Leuprolide acetate sun pharmaceutical industries ltd. It is given by injection into a muscle or under the skin common side effects include hot flashes, unstable mood, trouble sleeping, headaches, and pain at the site of injection. Leuprolide acetate is also being studied in the treatment of other types of cancer. This label reflects clinical trials for lupron depot in prostate cancer in which the majority of the subjects studied were at least 65 years of age.
The total duration of therapy with lupron depot 11. Capitals indicate lifethreatening, underlines indicate most frequent. Leuprolide acetate injection is a sterile, aqueous solution intended for subcutaneous injection. Leuprorelin, also known as leuprolide, is a manufactured version of a hormone used to treat prostate cancer, breast cancer, endometriosis, uterine fibroids, and early puberty. Department of health and human services, centers for disease control and prevention, national institute for occupa. Dosages may be given once a day, once a month, once every three months, or once every six months. Leuprolide acetate provider documents clinical inappropriateness to hormonal therapy and at least one of the following is occurring.
The total duration of therapy with lupron depot plus addback therapy. Lupron depot is a prescription medication that must be administered in your doctors office. Highlights of prescribing information hyperglycemia and. Niosh list of antineoplastic and other hazardous drugs in. The kit consists of a twosyringe mixing system, a sterile safety needle table 3, a desiccant, and a package insert for reconstitution and administration procedures. Drug approvals by the medicines control council in south africa containing leuprolide. This medicine is given as a shot under your skin or into a muscle. Leuprolide acetate leuprolide acetate dose, indications. Reports of anaphylactic reactions to gnrh agonist analogs have been reported in the medical literature. A new, nonbiodegradable, subcutaneous implant, containing 72mg leuprolide acetate equivalent to 65mg leuprolide free base, uses osmotic pressure to deliver leuprolide at a constant rate over 1. Follow the pictorial directions on the reverse side of this package insert for administration. Leuprolide injection lupron depotped is used to treat central precocious puberty cpp. Leuprolide acetate is approved for palliative treatment of.
These preparations are a diluted concentration of the prescription leuprolide acetate 1 mg0. Leuprolide dosage the amount of leuprolide you are prescribed will depend on several factors, such as the condition being treated and how you respond to leuprolide. Comparison of singleagent androgen suppression for. A few of the commonly available strengths of leuprolide dilution are 40 mcg0. Leuprolide acetate, an lhrh agonist, acts as a potent inhibitor of gonadotropin secretion when given continuously and in therapeutic doses.
A nurse or other trained health professional may give you this medicine. Definition from the nci drug dictionary detailed scientific definition and other names for this drug. Leuprolide is used in women to treat symptoms of endometriosis overgrowth of uterine. In mice, no leuprolide acetateinduced tumours or pituitary abnormalities were observed at a dose as high as 60 mgkg for two years. The use of lupron depotped in children under 2 years is not. Lupron injection is contraindicated in patients known to be hypersensitive to gnrh, gnrh agonist analogs or any of the excipients in lupron injection. Leuprolide acetate for depot suspension injection lupron depot is a synthetic nonapeptide analog of naturally occurring gonadotropinreleasing hormone gnrh or lhrh. Leuprolide acetate market research report forecast to. Leuprolide dilutionmicro leuprolide is administered as a subcutaneous injection using insulin syringes. Leuprolide overstimulates the bodys own production of certain hormones, which causes that production to shut down temporarily.
This causes the ovaries to enter a state of rest, putting the woman in a temporary menopausal state. Includes leuprolide acetate side effects, interactions and indications. Fda approved indications leuprolide acetate is indicated for. Patients have been treated with leuprolide acetate for up to two years with doses as high as 20 mgday without demonstrable pituitary abnormalities. Leuprolide appeared to be released at a constant rate following the onset of steadystate levels during the third week after dosing and mean levels then declined gradually to near the lower limit of detection by 12 weeks. In controlled clinical trials, administration of lupron depot 3. For the role it plays in assisted reproductive technologies, leuprolide acetate is used to reduce the amount of estrogen and testosterone. No carcinogenicity studies have been conducted with eligard.
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