Composition, form of production and packaging
Liofilizate for the preparation of a solution for sc administration in the form of a powder or a porous mass of white color.
1 f.
lutropin alfa 75 IU (3.4 Ојg)
Excipients: sucrose, polysorbate 20, methionine, sodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate monohydrate, phosphoric acid, sodium hydroxide.
Solvent: water d / and (1 ml).
Vials of glass volume of 3 ml (1) complete with a solvent (amp / fl. 1 pc.) - plastic containers (1) - packs of cardboard.
Glass vials with a volume of 3 ml (3) complete with a solvent (amp / fl. 3 pcs.) - plastic containers (1) - cardboard packs.
Vials of glass volume of 3 ml (10) complete with a solvent (amp / fl. 10 pcs.) - plastic containers (1) - packs of cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Recombinant luteinizing hormone, identical to the natural human hormone, was created using biotechnological methods. It is a gonadotropin involved in the physiological regulation of the reproductive function. Compensates the lack of LH in the body. Under its influence there is a stimulation of the formation of estradiol follicles. The introduction of LH in the middle of the menstrual cycle triggers the formation of the yellow body and ovulation, the introduction in the postovulatory period supports the functioning of the yellow body.
PHARMACOKINETICS
Suction
After SC administration, the absolute bioavailability is approximately 60%. Lutropin alfa has linear pharmacokinetic properties.
Distribution and deduction
After sc administration, the drug is quickly distributed to organs and tissues. Practically does not cumulate in the body.
T 1/2 - about 12 hours. Urine contains less than 5% of the administered dose.
Pharmacokinetics after a single administration is comparable with that after repeated administration of Luveris В® .
INDICATIONS
- Infertility treatment due to hypothalamic-pituitary disorders, leading to a decrease in the level of LH and FSH in the body.
DOSING MODE
The drug is administered sc. The solution is prepared immediately before injection using the supplied solvent. Each bottle is for single use.
The drug is administered every day for 3 weeks in parallel with FSH injections.
Typically, start with a dose of 75 IU of the drug (1 vial) along with 75 IU or 150 IU of FSH. Depending on the response of the ovaries, an increase in the FSH dose of approximately 37.5-75 IU every 7-14 days is possible.
In some cases it may be necessary to extend the treatment to 5 weeks.
When the desired result is achieved 24-48 hours after the last injection of Luveris В® and FSH, a single injection of human chorionic gonadotropin (hCG) in a dose of 5000-10 000 IU or 250 Ојg of recombinant hCG is performed. It is recommended to have sexual contact on the day of administration of hCG and the next day.
Alternatively, assisted reproductive technologies may be used. If the answer is excessive / excessive, the treatment should be discontinued and the hCG should be withdrawn. Treatment can be resumed during the next cycle using a lower FSH dose than during the previous cycle.
Rules for solution preparation and drug administration
With self-administration of the drug, patients should carefully study the instructions.
Injection should be carried out in accordance with the rules of asepsis and antiseptics.
To carry out the injection, it is necessary to decompose on a clean surface: a thin needle for administration, 1 bottle of Luveris В® , 1 vial of solvent, 2 tampons impregnated with alcohol, 1 syringe, 1 needle for dissolving the powder in a solvent, sharps container for safe disposal of glass parts and needles.
Remove the protective cap from the vial with a solvent or open the ampoule with the solvent, pressing on the marking point on the head of the ampoule. Connect the mixing needle to the syringe and draw some air into it, pulling the piston to about 1 ml. Then insert the needle into the vial (or ampoule), drown the piston to release air, and gently fill all the solvent. Carefully put the syringe on the work surface, trying not to touch the needle.
Prepare the solution for injection: remove the protective cap of the vial with the drug, take a syringe, pierce the rubber stopper with a needle and slowly introduce the solvent into the vial with the drug. Smoothly shake the bottle without removing the needle. Do not shake it.
After the powder has dissolved (which usually occurs immediately), you should make sure that the resulting solution is clear and contains no solid particles. Turn the vial and gently recruit the solution back into the syringe.
You can also mix Luveris В® and follitropin alfa as an alternative to the separate administration of each drug. After dissolving the Luveris В® preparation, draw the solution back into the syringe and reintroduce it into the container with the follitropin alfa preparation. Once the drug dissolves, draw the solution back into the syringe. Inspect the solution for solid particles, as in the previous case, do not use the solution if it is not transparent. In 1 ml of solvent can dissolve up to 3 vials with the drug.
Replace the needle with a thin one and release air bubbles: if air bubbles are visible in the syringe, hold the syringe with the needle up, gently knock on it until all the air accumulates at the top. Gently push the plunger to remove air.
Immediately after this should be an injection. The injection site chosen by the doctor's advice (for example, the forearm, the front surface of the thigh), wiped with a swab impregnated with alcohol. Collect the skin in a crease and insert the needle at an angle of 45-90 В° with a rapid movement. Introduce the drug under the skin, gently pressing the piston. When injected, use as long as necessary to introduce the entire solution. Immediately after this, it is necessary to remove the needle and circular movements to wipe the skin with a swab impregnated with alcohol. Do not administer the drug into a vein.
After the injection, immediately place all the needles and empty glass containers in a container for sharp objects. Dispose of unused solution.
SIDE EFFECT
From the digestive system: often - pain in the abdomen, nausea, vomiting.
From the side of the central nervous system: often - headache, drowsiness.
On the part of the reproductive system: often - pains in the mammary glands, ovarian cysts. Treatment with FSH and LH with subsequent administration of hCG can lead to ovarian hyperstimulation (symptoms of hyperstimulation include pain in the lower abdomen, possibly in combination with nausea, vomiting and weight loss).In rare cases, with the use of such drugs, vein thrombosis was observed, hence, it is possible with Luveris. There have been no cases of torsion of the ovarian cyst and bleeding in the abdominal cavity with Luveris, but in rare cases such disorders occurred after treatment with human menopausal gonadotropin (hMG) isolated from urine and containing LH. There is a possibility of an ectopic pregnancy (especially in the case of a primary history of tubal laceration in an anamnesis).
Local reactions: pain, redness, itching, swelling, bruising are possible.
CONTRAINDICATIONS
- tumors of the hypothalamic-pituitary region;
hyperprolactinemia;
- adrenal and thyroid gland diseases;
- Persistent increase in ovaries;
- ovarian cyst (not due to the presence of polycystic ovary syndrome);
- polycystic ovary;
- Anomalies of development of genital organs (incompatible with the normal course of pregnancy);
- fibroids of the uterus;
- Metrorrhagia (of unknown etiology);
- estrogen-dependent tumors (ovarian cancer, uterine cancer, breast cancer);
- primary failure of the ovaries;
- Pregnancy;
- lactation (breastfeeding);
- Hypersensitivity to the components of the drug.
PREGNANCY AND LACTATION
The drug is contraindicated in pregnancy and lactation (breastfeeding).
APPLICATION FOR CHILDREN
Not applicable.
APPLICATION IN ELDERLY PATIENTS
Not applicable.
SPECIAL INSTRUCTIONS
Before starting treatment, it is necessary to check the fertility of the patient and her partner. The concentration of LH in the blood was considered low if the level of endogenous hormone in the serum was below 1.2 IU / L. The drug is used in combination with FSH to promote the growth and development of follicles containing eggs. After that, treatment continues with a single administration of hCG, which results in the release of the ovules from the follicle (ovulation).
The use of the drug increases the risk of the syndrome of ovarian hyperstimulation. With careful selection of the dose and observance of the regimen, the ovarian hyperstimulation syndrome appears rarely. Against the background of the use of the drug, there is rarely a serious form of hyperstimulation, unless a preparation containing hCG is prescribed for the final maturation of the follicles. Thus, it is important not to use hCG in the occurrence of ovarian hyperstimulation syndrome and to refrain from sexual intercourse or use barrier barrier methods for four days, at least.
The patient should be warned about the need to stop the administration of the drug and seek medical attention in the event of severe pain in the abdomen.
It is necessary to carefully monitor the response from the ovaries with the help of ultrasound and blood tests before and during the course of treatment. In patients undergoing treatment, the frequency of multiple pregnancies (mainly twins) increases, the probability of which can be minimized by adhering to the recommended dose and regimen.
If the patient has allergic reactions to similar drugs, she should inform her doctor about it.
In the event that the patient forgot to enter the next dose of Luveris В® , you can not enter a double dose, but you should see a doctor.
Impact on the ability to drive vehicles and manage mechanisms
The drug does not affect the ability to drive vehicles and control mechanisms.
OVERDOSE
Symptoms of overdose are unknown. There is a possibility of a syndrome of ovarian hyperstimulation. A single dose of up to 40,000 IU of the drug was well tolerated and was not accompanied by severe side effects.
DRUG INTERACTION
Do not mix Luveris В® with other medicinal substances in one syringe, except for follitropin alfa, because studies have shown that these two drugs can be mixed and administered simultaneously without affecting the therapeutic activity.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored out of the reach of children, protected from light at a temperature of no higher than 25 В° C, in the original packaging. Shelf life - 3 years.
