Luprolex

Endometriosis, uterine (myoma) fibroids. Central precocious puberty in girls <9 yr & boys <10 yr. 3.75 mg & 11.25 mg: Premenopausal breast cancer, prostate cancer.

Uterine fibroids & endometriosis Patient >50 kg or w/ a markedly large uterus 3.75 mg as single IM/SC inj once a mth, <50 kg 1.88 mg as single IM/SC inj once a mth. Childn ≥20 kg 3.75 mg as single IM/SC inj once a mth, or 11.25 mg of 130 mg SR microcap in 2 mL vehicle soln as single SC inj every 3 mth, <20 kg 1.88 mg as single SC inj once a mth, or 5.625 mg as single SC inj every 3 mth.

Hypersensitivity to leuprorelin, GnRH derivatives or GnRH agonist analogs. Undiagnosed abnormal uterine/vag bleeding. Postmenopausal women. Undiagnosed vag bleeding in girls w/ central precocious puberty. Pregnancy & lactation.

Increase in clinical signs & symptoms may be observed during the initial days but will dissipate w/ continued therapy. Rare post-marketing reports of symptoms consistent w/ anaphylactoid or asthmatic processes. Possibility of the development or worsening of depression & occurrence of memory disorders. Convulsions in patients w/ history of seizures, epilepsy, cerebrovascular disorders, CNS anomalies or tumours & on concomitant medications associated w/ convulsions eg, bupropion & SSRIs. Use non-hormonal methods of contraception during treatment. Female patients missing successive doses may experience breakthrough bleeding or ovulation w/ the potential for conception. Duration of treatment should be limited to 6 mth since decrease in bone mass may occur; may extend treatment period for endometriosis to 12 mth if concurrently used w/ norethindrone acetate 5 mg daily. Patients w/ major risk factors for decreased bone mineral content eg, chronic alcohol &/or tobacco use, strong family history of osteoporosis or chronic use of drugs that can reduce bone mass eg, anticonvulsants or corticosteroids. Retreatment beyond 6 mth w/ leuprorelin alone is not recommended. Severe bleeding in women w/ submucous fibroids following administration; possibility of abnormal bleeding or pain in case earlier surgical intervention is required. Precise diagnosis of idiopathic &/or neurogenic central precocious puberty is necessary before starting therapy. Monitor hormonal parameters (testosterone, estradiol) at 2-wk intervals in the event of a sterile abscess at the inj site. Investigate vag bleeding beyond the 1st/2nd mth of treatment in girls. Slipped femoral epiphysis after w/drawal of treatment. Childn w/ progressive brain tumors. Monitor ped patients for signs & symptoms of pseudotumor cerebri (PTC); permanently discontinue use if PTC is confirmed. Safety in prematures, newborns, & nursing infants has not been established. 3.75 mg & 11.25 mg: Premenopausal breast cancer: Not to be used for prevention of relapse after curative operation. Discontinue when any progression of tumor is observed. Prostate cancer: Urethral obstruction or spinal cord compression may occur, which may contribute to paralysis w/ or w/o fatal complications. Close observation during the 1st mth after initiation of treatment & appropriate measures taken in patients w/ metastatic vertebral lesions &/or w/ urinary tract obstruction. Hyperglycemia & increased risk of developing diabetes in men. Periodically monitor blood glucose &/or HbA1c. Increased risk of MI, sudden cardiac death & stroke in men; monitor for signs & symptoms suggestive of development of CV disease. Potential risk for prolonged QT/QTc interval in patients w/ congenital long QT syndrome, CHF, frequent electrolyte abnormalities & those taking drugs known to prolong the QT interval; consider periodic monitoring of ECG & electrolytes. Decreased bone density in men who had orchiectomy or those treated w/ GnRH agonist analog. 11.25 mg: Limit monotherapy exposure to 6 mth of therapy in females.

Endometriosis, uterine fibroids, & premenopausal breast cancer (for 3.75 mg & 11.25 mg): Hypoestrogenism-related symptoms: Hair loss; arthralgia, myalgia, decreased bone mass; headache, dizziness, paresthesia; increased sweating; visual disturbance; decreased libido, emotional lability, depression, sleep disorders; decreased breast size, dry vagina/vaginitis. Body as a whole: Hot flushes, edema, wt changes; anaphylactic reaction, rash, pruritus; nausea, vomiting, anorexia; abnormal LFT values, usually transient; inj site reactions. Central precocious puberty: General allergic reactions (fever, rash, itching, anaphylactic reactions); emotional lability (eg, crying, irritability, impatience, anger, aggression); headache, pituitary haemorrhage following initial administration in patients w/ pituitary adenoma, seizure, pseudotumor cerebri/idiopathic intracranial HTN; abdominal pain/cramps, nausea/vomiting; acne; myalgia; vag bleeding, spotting, discharge; inj site reactions. 3.75 mg & 11.25 mg: Prostate cancer: Bone pain, urinary tract obstruction, hematuria, weakness of lower extremity/paresthesia; anaphylactic reaction, rash, pruritus; hot flushes, diaphoresis, decreased libido, impotence, orchiatrophy, gynecomastia; nausea, vomiting, anorexia, diarrhea; decreased bone mass; abnormal LFT values, usually transient; inj site reaction; headache, edema, dizziness, depression; QT prolongation.

May prolong QT interval w/ medicinal products known to prolong QT interval or able to induce torsade de pointes eg, class IA (eg, quinidine, disopyramide) or class III (eg, amiodarone, sotalol, dofelitide, ibutilide) antiarrhythmic medicinal products, methadone, moxifloxacin, antipsychotics. Diagnostic tests of pituitary gonadotropic & gonadal functions conducted during treatment & for up to 3 mth after discontinuation may be misleading.

Trophic Hormones & Related Synthetic Drugs / Cancer Hormone Therapy

L02AE02 - leuprorelin ; Belongs to the class of gonadotropin releasing hormone analogues. Used in endocrine therapy.

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