Luprolex

Luprolex

leuprorelin

Manufacturer:

Takeda

Distributor:

Takeda
Concise Prescribing Info
Contents
Leuprorelin acetate
Indications/Uses
Central precocious puberty, uterine myoma/fibroids, endometriosis, premenopausal breast cancer, prostate cancer. Luprolex 3.75 mg/Luprolex 11.25 mg: Premenopausal breast cancer, prostate cancer.
Dosage/Direction for Use
IM/SC Luprolex 1.88 mg Once a mth. Luprolex 3.75 mg Once a mth. Childn >20 kg 3.75 mg of 44.1 mg sustained-release microcapsules in 1 mL vehicle soln to administer once a mth as a single SC inj, <20 kg 1.88 mg once a mth as a single SC inj. Depending on the activity of the central precocious puberty, it may be necessary to increase the dosage in the presence of inadequate suppression (clinical evidence eg, spotting or inadequate gonadotropin suppression in the LHRH test). The duration of treatment depends on the clinical parameters at the start of treatment or during the course of treatment (final height prognosis, growth velocity, bone age &/or bone age acceleration). Bone age should be monitored during treatment w/ 6-12 mth intervals. Luprolex 11.25 mg Once every 3 mth. Childn Suppress pituitary gonadotropins & peripheral sex steroids, & to arrest progression of secondary sexual characteristics 11.25 mg once every 3 mth as a single IM inj.
Contraindications
Hypersensitivity to GnRH, GnRH agonist analogs. Undiagnosed abnormal vag bleeding. Not indicated in women >65 yr. Pregnancy & lactation. Luprolex 3.75 mg: Undiagnosed vag bleeding in girls w/ central precocious puberty. Luprolex 11.25 mg: Active or history of thrombophlebitis, thromboembolic disorders, cerebral apoplexy; markedly impaired liver function or liver disease; known or suspected carcinoma of the breast.
Special Precautions
Inhibits ovulation & stops menstruation. Contraception is not ensured, patients should use nonhormonal methods of contraception. Discontinue if sudden partial or complete loss of vision or if there is sudden onset of proptosis, diplopia or migraine. Thrombophlebitis & pulmonary embolism. Women w/ risk factors, including lipid abnormalities or cigarette smoking. Patients missing successive doses may experience breakthrough bleeding. Exam bone mass during long-term treatment. Possibility of the development or worsening of depression & occurrence of memory disorders. Not for prevention of relapse after curative operation (premenopausal breast cancer). Discontinue when any progression of tumor is observed. May transiently aggravate bone pain in the early period after 1st administration of the drug. Urethral obstruction or spinal cord compression may occur. Monitor blood glucose &/or HbA1c periodically. Increased risk of MI, sudden cardiac death & stroke. 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. History of depression, seizures, epilepsy, cerebrovascular disorders, CNS anomalies or tumors, in concomitant medications associated w/ convulsions eg, bupropion & SSRIs. Prematures, newborns & nursing infants.
Adverse Reactions
In treatment of endometriosis, uterine myoma/fibroids, premenopausal breast cancer: Hair loss; arthralgia, myalgia; headache, dizziness & paresthesia; increased sweating; visual disturbance; decreased libido, emotional lability, depression & sleep disorders, decreased breast size, dry vag/vaginitis; hot flushes, edema & wt changes; anaphylactic reaction, rash & pruritus; nausea, vomiting & anorexia; abnormal liver function test values; inj site reactions. In treatment of endometriosis, uterine myoma/fibroids: Venous & arterial thromboembolism, DVT, pulmonary embolism, MI, stroke, TIA. In treatment of prostate cancer: Flare phenomenon; anaphylactic reaction, rash & pruritus; hot flushes, diaphoresis, decreased libido, impotence, orchiatrophy & gynecomastia; nausea, vomiting, anorexia & diarrhea; decreased bone mass; abnormal liver function test values; inj site reaction; headache, edema, dizziness & depression. In treatment of central precocious puberty: General allergic reactions; emotional lability; headache, pituitary haemorrhage, seizure; abdominal pain/cramps, nausea/vomiting; acne; vag bleeding, spotting, discharge; inj site reactions.
ATC Classification
L02AE02 - leuprorelin ; Belongs to the class of gonadotropin releasing hormone analogues. Used in endocrine therapy.
Presentation/Packing
Form
Luprolex powd for inj 3.75 mg
Packing/Price
1's
Form
Luprolex powd for inj 11.25 mg
Packing/Price
1's
Form
Luprolex powd for inj 1.88 mg
Packing/Price
1's
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