The following side effects are associated with the pharmacological action of leuprorelin on steroidogenesis:
Neoplasms benign, malignant and unspecified (including cysts and polyps): progression of prostate cancer.
From the side of metabolism: increase or decrease in body weight.
From the nervous system: headache, muscle weakness, increased emotional lability.
From the side of the vascular system: vasodilation, "hot flashes", lowering of arterial pressure, orthostatic hypotension.
From the skin and subcutaneous tissue: acne, seborrhea, dry skin, hyperhidrosis, rash, urticaria, abnormal skin odor, abnormal hair growth, hair disorders, night sweats, hypotrichosis, pigmentation disorders, cold sweat, hirsutism, eczema, nail abnormalities.
From the reproductive system and the breast: gynecomastia, vaginal bleeding, menstrual irregularities, breast tenderness, mammary gland congestion, mammary atrophy, vaginal discharge, breast enlargement, mammary gland pain, galactorrhea, metrorrhagia, menopause symptoms, dyspareunia, vaginitis, menorrhagia, pain in the prostate gland, swelling of the penis, testicular atrophy, erectile dysfunction, pain in the testicles, loss or decrease of sexual desire, increased sexual desire.
Other: dryness of mucous membranes, a feeling of heat, irritability, a decrease in bone density, an increase in the concentration of PSA (prostate-specific antigen).
Long exposure (6-12 months): diabetes mellitus, impaired glucose tolerance, increased total cholesterol concentration, increased LDL (low-density lipoprotein) concentration, increased triglyceride concentration, and osteoporosis.
Below are the side effects observed in clinical studies and post-marketing observations.
Since the drug Lyukrin Depot® has several indications for use, not all of the side effects listed below can be attributed to each patient.For most side effects, the cause-and-effect relationship with taking the drug has not been established.
Infections and infestations: infection, bronchitis, pyelonephritis, boils, urinary tract infection, bladder infection, viral infection, candidiasis, sepsis, influenza.
Neoplasms benign, malignant and unspecified (including cysts and polyps): pseudolymphoma.
From the side of the blood and lymphatic system: anemia, eosinophilia.
From the immune system: hypersensitivity reactions.
From the side of metabolism: anorexia, increased appetite, hyperglycemia, hypoglycaemia, dehydration, hypercholesterolemia, excessive weight gain, excessive weight loss.
From the nervous system: mood swings, personality disorders, nervousness, decreased sexual desire, insomnia, depression, anxiety, delirium, confusion, euphoria, hostility, apathy, dizziness, headache, paresthesia, drowsiness, fainting, migraine, hypertonia, ataxia, tremor, simple partial seizures, peripheral neuropathy.
From the sense organs: decreased visual acuity, visual impairment, including amblyopia, dry eyes, eye pain, vestibular dizziness.
From the side of the cardiovascular system: stenocardia, tachycardia, heart failure, palpitations, bradycardia, atrioventricular blockade, "hot flashes", vasodilation, lymphedema, increased blood pressure, thrombophlebitis, aneurysm, vascular collapse, hematoma.
On the part of the respiratory system: nose bleeding, shortness of breath, hemoptysis, emphysema, cough, asthma, bronchospasm, chronic obstructive pulmonary disease (COPD).
On the part of the digestive system: constipation, nausea, vomiting, gastritis, gastrointestinal bleeding, flatulence, bloating, diarrhea, indigestion, gingival hemorrhage, dry mouth, abdominal pain, impaired liver function, tenderness in the liver, hepatic cholestasis, hepatocellular lesions.
From the skin and subcutaneous fat: alopecia, ecchymosis, maculopapular rash, dry skin, acne, seborrhea, photosensitivity reactions, hyperhidrosis, hirsutism, hair growth disorders, itching.
From the musculoskeletal system: pain in the bones, myalgia, arthralgia, back pain, arthritis, stiff neck, muscle weakness, pain in the extremities, muscle spasms.
From the genitourinary system: urinary incontinence, dysuria, pollakiuria, hematuria, nocturia, urinary retention, urinary disorders, gynecomastia, erectile dysfunction, pain in the mammary glands, enlargement of mammary glands, mammary atrophy, breast engorgement, galactorrhea, vaginitis, genital excretion, pelvic pain , swelling of the penis, pain in the prostate gland.
Other: pain, chest pain, edema, peripheral edema, facial edema, gravitational edema, lower extremity edema, dry mucous membranes, asthenia, fatigue, reaction at the injection site, compaction at the injection site, pain at the injection site, edema at the injection site, elevated sensitivity at the injection site, chills, thirst, malaise, flu-like condition, gait disturbance.
Deviations of laboratory indicators: increased erythrocyte sedimentation rate, increased alkaline phosphatase activity in the blood, increased lactate dehydrogenase activity in the blood,an increase in the concentration of the prostate-specific antigen, an increase in the activity of alanine aminotransferase (ALT), an increase in activity of aspartate aminotransferase (ACT), increased gamma-glutamyltranspeptidase activity, abnormalities in the electrocardiogram, increased testosterone concentration in the blood, abnormal liver function tests, decreased platelet count, decreased potassium levels in the blood, increased prothrombin time, increased activated partial thromboplastin time, heart murmur, increased lipoprotein concentration low density, an increase in the concentration of triglycerides in the blood, an increase in the concentration of bilirubin in the blood.
Postmarketing research
Below are the side effects observed in post-marketing studies; the incidence of these side effects is unknown.
Infections and infestations: pharyngitis, pneumonia.
Neoplasms benign, malignant and unspecified (including cysts and polyps): skin cancer.
From the immune system: anaphylactic reactions.
From the endocrine system: goiter, apoplexy of the pituitary gland.
From the side of metabolism: diabetes mellitus, hyperlipidemia, hyperphosphatemia, hypoproteinemia.
From the nervous system: mood swings, increased libido, sleep disorders, suicide attempts, lethargy, memory impairment, including amnesia, dysgeusia, hypoesthesia, peripheral neuropathy, cerebrovascular disorders, unconsciousness, including syncope, transient ischemic attack, seizures, paralysis, neuromyopathy.
From the sense organs: decreased visual acuity, dry eyes, ringing in the ears, hearing impairment.
From the side of the cardiovascular system: congestive heart failure, arrhythmia, myocardial infarction, sudden cardiac death, phlebitis, thrombosis, lowering of arterial pressure, varicose veins.
On the part of the respiratory system: pleural friction noise, pulmonary fibrosis, hemoptysis, effusion in the pleural cavity, lung infiltration, sinus congestion, pulmonary embolism, interstitial lung disease.
On the part of the digestive system: gastrointestinal bleeding, dysphagia, ulcer dvenadza digestive ulcer, a peptic ulcer, polyps of the rectum, a violation of liver function, severe hepatic insufficiency, jaundice.
From the skin and subcutaneous fat: hives, dermatitis, hair growth disorders, pigmentation disorders, rashes on the skin.
From the musculoskeletal system: swelling of the bones, arthropathy, ankylosing spondylitis, tenosynovitis.
From the genitourinary system: persistent urination, bladder spasm, urinary tract obstruction, breast tenderness, vaginal bleeding, menstrual irregularities, metrorrhagia, testicular atrophy, testicular pain, swelling of the penis, pain in the prostate gland.
Other: fever, reaction at the injection site, inflammation at the injection site, compaction at the injection site, aseptic abscess at the injection site, hematoma at the injection site, nodule, inflammation, intracelastic fibrosis, vertebral fracture.
Deviations of laboratory indicators: increase in the concentration of blood urea nitrogen, increase in the concentration of blood creatinine, an increase in the concentration of calcium in the blood, signs of myocardial ischemia on the ECG, deviation from the norm of liver function tests, a decrease in the number of platelets, a decrease in the concentration of potassium in the blood, an increase in the number of leukocytes, a decrease in the number of leukocytes, an increase in prothrombin time,increased activated partial thromboplastin time, noise in the heart, increased concentration of low-density lipoproteins, increased concentration of triglycerides in the blood, increased concentrations of bilirubin in the blood.
Men's
Serious cases of venous and arterial thromboembolism were noted, including deep vein thrombosis, pulmonary embolism, myocardial infarction, stroke and transient ischemic attack. Although in some cases, a temporary connection was noted, in most cases, there were risk factors or the taking of concomitant medications. It is not known whether there is a causal relationship between the use of GnRH agonists and these events.
Women
Changes in bone density
In a clinical study in patients with endometriosis who received Lucrin Depot® 3.75 mg for 6 months, the density of the spine bones was measured by X-ray absorptiometry (DEXA) and there was a decrease of an average of 3.9% compared with the level of density before treatment. In patients examined 6 or 12 months after the end of treatment, the average bone density of the tissue was restored to the original (± 2%).When using Lucrin Depot® 3.75 mg for three months in patients with uterine myoma, the mineral density of the sponge bones of the spine was assessed by the quantitative X-ray method (QDR) and was 2.7% lower than the original. Six months after the cessation of treatment, there was a tendency for recovery.