LUKRIN depot Fl. 3.75 mg. 1 fl
LUKRIN depot Fl. 3.75 mg. 1 fl
What Lukrin Depot and what it is used?
Your medicine is called Lukrin Depot. Its active ingredient leuprorelin acetate is a synthetic like the so-called gonadotropin-releasing hormone normally produced in the human body. Injections of this hormone leads to an initial increase in production by the ovaries and testes sex hormones, followed by their lower and maintain low similar to castration levels. The goal of treatment is to achieve a drug castration. After discontinuation described effects disappear.
Lukrin Depot is used to treat the following diseases requiring suppress the formation of sex hormones:
Prostate cancer: treatment of advanced prostate cancer. The product offers an alternative treatment for prostate cancer when castration or estrogen administration are not displayed or are unacceptable to the patient.
Endometriosis: treating endometriosis for six months. The product can be used both independently and as an adjunct to surgery.
Endometriosis is a painful condition characterized by the development of characteristic of uterine tissue outside the uterine body.
Breast cancer: treatment of breast cancer in women before or around the time of menopause, where hormonal therapy is indicated.
Uterine fibroids: treatment of uterine leiomyomas for up to six months. Application of the product may precede surgery or be intended to relieve the symptoms in women around menopause who do not want surgery. Leiomyoma is a condition characterized by the formation of nodules formation in the uterine wall. Very often it has no event to any symptoms, but significant increases size of the nodes, it can cause a range of symptoms and complications.
Central precocious puberty: treatment of children with clinically confirmed diagnosis of central precocious puberty - idiopathic or neurogenic, characterized by the appearance of sexual characteristics before age 8 in girls and before 9 years in boys. Before starting treatment with this medicine, your doctor will conduct a series of tests to your child such as:
Conducting GnRH-stimulation test;
Determination of bone age;
Determining the levels of sex hormones;
Determining the levels of adrenal steroids to exclude congenital adrenal hyperplasia;
Determining the levels of human beta-chorionic gonadotropin, extinguish chorionic gonadotropin - secreting tumor;
Ultrasound of the pelvic / testicular and adrenal steroids for off-secreting tumor;
Conduct a CT scan of the head to exclude intracranial tumor.
Before you are given Lukrin Depot
This medicine should not be used in:
Hypersensitivity to leuprorelin similar substances or to any of the excipients of the product, there is evidence of isolated cases of anaphylaxis with the depot Lukrin monthly administration;
Established hormone insensitivity of tumors post-surgical castration, leuprorelin acetate results in an additional decrease testosterone levels and is not recommended for use;
Pregnancy or in women likely to become pregnant;
Atypical or undiagnosed vaginal bleeding.
Taking other medicines:
No evidence of interaction of this medicine with other medicines. However, tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.
Pregnancy and lactation:
This product should not be administered during pregnancy and in women capable of becoming pregnant.
Tell your doctor if you are breast feeding and he will consider a choice between continuing to breastfeed or treatment with this medicine.
Driving and using machines:
This medicine may impair your ability to drive or operate machinery. This is true to a large extent by interaction with alcohol.
How is Lukrin Depot?
As with other injectable products, the injection site should be changed with each injection.
The usual recommended adult dose is 3.75 mg of leuprorelin acetate, administered subcutaneously or intramuscularly once a month.
Dosage for central precocious puberty
It is individualized dose for each child.
The recommended starting dose of leuprorelin acetate is 0.3 kg / kg, administered every 4 weeks intramuscularly or subcutaneously.
The initial dose may be determined based on body weight as follows:
Weight of Child Dose Total Number of injections month. dose
below 25 kg 3.75 mg x 2 1 7.5 mg
25 to 37.5 kg 3.75 mg x 3 2 11.25 mg
than 37.5 kg 3.75 mg x 4 2 15 mg
If achieving the desired total dose required two injections, they should be put together.
In most children, the recommended dose is initially sufficient to achieve the desired effect and that is administered as a supportive throughout the treatment period. If the initial set dose not lead to the desired therapeutic effect, your doctor will take a gradual increments of 3.75 mg every four weeks to achieve the effect and will apply this dose throughout the treatment period.
To confirm the therapeutic effect in the first two months of treatment and when changing the dose, your doctor will perform certain tests.
Measurement of bone age in children will be repeated every 6 to 12 months.
Discontinuation of treatment with leuprorelin acetate should be done before the age of 11 years for girls and 12 for boys.
Preparation of slurry injection
The contents of the vial should be dissolved immediately before application, which is done by subcutaneous or intramuscular injection every month.
Possible side effects:
Adverse reactions observed in prostate cancer:
The majority of patients during the first weeks of treatment, testosterone levels increased from baseline, followed by a decrease to them or lower end of the second week of treatment.
During the first few weeks of treatment should be given to the possibility of strengthening the complaints in patients with metastases in the spine and / or blockage of the urinary tract or hematuria, which in some cases progresses to the development of neurological problems such as temporary weakness and / or tingling of the lower limbs or worsening of symptoms of urinary system.
Observed the following adverse reactions, presented by system organ class:
Gastrointestinal Disorders - increased weight, lack of appetite.
Renal and urinary disorders - frequent night urination, difficulty in urination, testicular damage, urinary tract infections
Skin and subcutaneous tissue disorders - Reactions at the injection site, itching
Endocrine system - decrease in sexual desire, hot flashes, increased sweating.
Musculo-skeletal and connective tissue disorders: bone pain
Other - fatigue, muscle weakness.
Treatment of endometriosis is based on the suppression of female hormones. In the initial phase of treatment, a transient increase in serum estradiol with a subsequent decrease to values as seen in postmenopausal women. In most cases during the first week of treatment is bleeding.
With administration of leuprorelin acetate in women with endometriosis and uterine fibrosis, the following side effects: fatigue, joint pain, headache, flushing, increased sweating, sore tongue, nausea, vomiting, edema, increased hair growth, joint disorders, muscle pain, depression, decreased libido, nervousness, changes of the breast, kidney inflammation, damage to the urinary tract, vaginal irritation, dry skin, menstrual disorders.
During clinical trials, administration of leuprorelin acetate in women with breast cancer have reported the following side effects: increase / decrease the weight, hot flushes, increased sweating, headache, decreased / increased appetite, flu syndrome, anxiety, backache , pain in the neck, insomnia, depression, constipation, diarrhea, dizziness, fever, inflammation of the vagina.
The active substance is leuprorelin acetate. One vial to prepare a suspension for injection contains 3.75 mg of leuprorelin acetate as a sterile lyophilized microparticles.
The other ingredients are: powder for suspension for injection - a copolymer of lactic acid and mannitol
Solution preparation suspension for injection - sodium carboxymethylcellulose, mannitol, polysorbate 80, water for injections.