LUCRIN depot. 3.75 mg. 1. flacon
LUCRIN depot. 3.75 mg. 1. flacon
What Lucrin Depot and what it is used?
Your medicine is called Lukrin Depot . Its active ingredient is a synthetically leuprorelin acetate likeness of said gonadotropin releasing hormone normally produced in the human body. The injection of this hormone administration leads to the increase of the initial production of the ovaries and testes sex hormones , followed by their reduction and maintenance of low similar to castration levels. The goal of treatment is to achieve a drug castration. After discontinuation of treatment described effects disappear .
Lucrin Depot is administered to treat these diseases that require suppression of the formation of the sex hormones :
Prostate cancer treatment of advanced prostate cancer . The product provides an alternative treatment of prostate cancer , where castration or administration of estrogen are not shown or are not acceptable to the patient.
Endometriosis : treating endometriosis for a period of six months. The product can be used either alone or as an adjunct to surgery .
Endometriosis is a painful condition characterized by the development of the characteristic of uterine tissue outside the body of the uterus.
Breast Cancer : Treatment of breast cancer in women before or around the time of menopause , in which is shown a hormonal treatment .
Uterine fibroids : treatment of uterine leiomyomata , for up to 6 months. Use of the product may precede surgery or be intended to relieve the symptoms in women around menopause who do not want surgery . Leiomyoma represents a condition characterized by the formation of nodular formation in the wall of the uterus . Often it has no event, of any symptoms , but at significantly increased the amount of nodes , it can cause a number 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 9 years ago in boys . Before starting treatment with this medicine , your doctor will conduct a series of tests to your child :
- Conducting GnRH- stimulation test;
- Determination of bone age ;
- Determining the levels of sex hormones ;
- Determining the levels of adrenal steroids exclusion congenital adrenal hyperplasia ;
- Determining the level of human chorionic gonadotropin beta , choriogonadotropin Exclusion - secreting tumors ;
- Ultrasound of the pelvis / adrenal and testicular shutdown of steroid secreting tumor;
- The performance of computed tomography of the head to exclude intracranial tumor.
Before you are given Lucrin Depot
This medicinal product must 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 Lukrin Depot for monthly administration ;
- Established hormone insensitivity of tumors post-surgical castration , leuprorelin acetate does not lead to further decrease the level of testosterone is not recommended for use ;
- Pregnancy or in women likely to become pregnant ;
- Undiagnosed or abnormal vaginal bleeding.
Taking other medicines:
No evidence of interaction of this medicine with other medicines. However, please 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 with child-bearing potential .
Tell your doctor if you are breast feeding and he will consider the possibility to choose 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 applies to a greater extent in the reaction with alcohol .
How to use Lukrin depot ?
As with other products for injection , the injection site should be changed at every injection .
The usual recommended adult dose is 3.75 mg leuprorelin acetate administered subcutaneously or intramuscularly once every month.
Dosage in central precocious puberty
It is individually determine the dosage 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 the 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
over 37.5 kg 3.75 mg x 4 2 15 mg
If the achievement of the desired total dose required two injections , they should be put together.
The majority of children originally assigned dose is sufficient to achieve the desired effect , and this dose was administered as maintenance throughout the period of treatment. After the original dose does not result in the desired therapeutic effect , the doctor will take a gradual increments of 3.75 mg every four weeks up to that effect and will apply this dose throughout the treatment period .
To confirm the therapeutic effect in the first two months of treatment or when changing the dose , your doctor will perform certain tests.
Measurement of bone age in children will be conducted 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 injectable suspension
The contents of the vial should be dissolved immediately before application , which is performed by subcutaneous or intramuscular injection , once every month.
Possible side effects :
Adverse reactions observed in prostate cancer :
In the majority of patients during the first weeks of treatment, blood testosterone increased from baseline , followed by a reduction thereof to 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 spinal cord and / or obstruction of the urinary tract or hematuria , which in some cases progress to the appearance of neurological disorders such as weakness and temporary / or numbness of the lower limbs or worsening of symptoms of urinary system.
There have also been following adverse reactions, listed by system organ class :
Gastrointestinal disorders - weight gain , lack of appetite.
Renal and urinary disorders - frequent night urination , difficulty urinating , testicular damage , urinary tract infections
Skin and subcutaneous tissue - reactions at the injection site pruritus
Endocrine disorders - a decrease in sexual desire , hot flushes, increased sweating .
Musculo - skeletal and connective tissue disorders: bone pain
Others - fatigue, muscle weakness.
Treatment of endometriosis was based on the suppression of female sex hormones . In the initial phase of treatment, a transient increase in serum estradiol levels to post- decreasing as seen in postmenopausal . In most cases during the first weeks of therapy is bleeding .
In the application of leuprorelin acetate in women with endometriosis and uterine fibroids , the following side effects: fatigue, generalized pain, headache , flushing, increased sweating , sore tongue , nausea, vomiting , edema, excessive hair growth , joint disorders , muscle pain, depression, decrease in libido , nervousness, changes from the chest , kidney inflammation , damage to the urinary tract , inflammation of the vagina , dry skin, menstrual disorders .
In clinical studies the application of leuprorelin acetate in women with breast cancer have reported the following side effects: increase / decrease in weight , hot flushes, increased sweating , headache, decrease / increase in appetite, flu syndrome , nervousness , back pain pain in the neck , insomnia , depression, constipation , diarrhea, dizziness , fever , inflammation of the vagina.
The active substance is leuprorelin acetate . One vial of preparing an injectable suspension contains 3.75 mg of leuprorelin acetate in the form of a sterile lyophilized microparticles.
The other ingredients are: powder for suspension for injection - a copolymer of lactic acid and mannitol
A solution for the preparation of a suspension for injection - sodium carboxymethylcellulose, mannitol , polysorbate 80, water for injections.