Luveris® [Lutropin alfa]

Brand Merck Serono

In stock 581 Items

Available since: 2019-09-19

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Clinical Pharmacology

Luveris® - follicle-stimulating, luteinizing, estrogenic.

Pharmacodynamics

Luveris®^® (lutropin alfa), recombinant LH (r-hLG), identical to the natural human hormone, created using biotechnological methods. It belongs to a family of hormones called gonadotropins, which are involved in the physiological regulation of reproductive function.

Luveris®^® compensates for the lack of LH in the body. Under the influence of Luveris®^® the formation of estradiol follicles is stimulated. Introduction of Luveris®^® in the middle of the cycle starts the process of formation of the yellow body and ovulation. Introduction of Luveris®^® in the postovulatory period supports the functioning of the corpus luteum.

Pharmacokinetics

After s / c injection, the drug is quickly distributed to organs and tissues, the absolute bioavailability is approximately 60%; T_1/2 about 12 hours. Lutropin alfa has linear pharmacokinetic properties. The drug practically does not accumulate in the body. Urine contains less than 5% of the administered dose. The pharmacokinetics of lutropina alpha after a single injection is comparable to that after repeated administration of the drug Luveris®^®.

Indications

Treatment of infertility caused by hypothalamic-pituitary disorders, leading to a decrease in LH and FSH levels in the body.

Composition

1 bottle contains:

Active substance: lutropin alfa 75 IU;

Excipients: sucrose, polysorbate 20, methionine, sodium hydrogen phosphate dihydrate, sodium dihydrogen phosphate monohydrate, phosphoric acid, sodium hydroxide;

Solvent: water d / and - 1 ml.

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Dosage and Administration

The drug is injected s / c. The solution is prepared immediately before injection using the attached solvent. Each bottle is intended for single use.

The drug is administered every day for 3 weeks in parallel with FSH injections.

As a rule, start with a dose of 75 ME of the drug (1 bottle) along with 75 IU or 150 IU of FSH. Depending on the ovarian response, it is possible to increase the dose of FSH by approximately 37.5-75 IU every 7-14 days.

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 the drug and FSH, a single injection of human chorionic gonadotropin (hCG) is administered in a dose of 5000-10 000 ME (or 250 μg of recombinant hCG). It is recommended to have sexual intercourse on the day of hCG administration and the next day.

Alternatively, assisted reproductive technologies can be used. If there is an excessive / excessive response, discontinue treatment and discontinue hCG administration. Treatment can be resumed during the next cycle using a lower dose of FSH than during the previous cycle.

Adverse reactions

The most common side effects described are headache, abdominal pain, breast pain, nausea, vomiting, drowsiness, and ovarian cysts.

In some cases, local manifestations were observed at the injection site (pain, redness, itching, swelling and bruising). Treatment with FSH and LH with the subsequent administration of hCG can lead to ovarian hyperstimulation. Symptoms of hyperstimulation are pain in the lower abdomen, possibly in combination with nausea, vomiting and weight loss. If a patient has severe abdominal pain in combination with the listed symptoms, no more injections should be given and you should consult a doctor as soon as possible.

In rare cases, the use of such drugs was observed venous thrombosis, therefore, it is possible with the application of Luveris®^®.

Not described cases of torsion of ovarian cysts and bleeding into the abdominal cavity when using the drug Luveris®^®however, in rare cases, such disorders occurred after treatment with human menopausal gonadotropin (hMG), isolated from urine and containing LH. Ectopic pregnancy may develop, especially in women with a primary lesion of the fallopian tubes in history. If the patient finds any side effects not mentioned above, she should consult a doctor.

Contraindications

Tumors of the hypothalamic-pituitary region.
Hyperprolactinemia.
Diseases of the adrenal glands and thyroid gland.
Ovarian cyst (not caused by polycystic ovary syndrome).
Polycystic ovary.
Abnormal development of the genital organs (incompatible with the normal course of pregnancy).
Uterine fibroids.
Metrorrhagia (unexplained etiology).
Estrogen-dependent tumors (ovarian cancer, uterine cancer, breast cancer).
Primary ovarian failure.
Pregnancy.
Lactation.
Hypersensitivity to the drug.

Drug interactions

Do not mix luveris with other medicinal substances in the same syringe with the exception of follitropin alfa, since Studies have shown that these two drugs can be mixed and administered simultaneously without affecting the therapeutic activity.

Pregnancy and Lactation

The drug can not be taken during pregnancy and lactation.

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 is considered low if the level of endogenous hormone in the serum is below 1.2 IU / L.

The drug is used in combination with FSH to promote the growth and development of follicles containing eggs. After this treatment continues with a single injection of hCG, which leads to the release of eggs from the follicle (ovulation).

Treatment with this drug increases the risk of a condition called ovarian hyperstimulation syndrome (see also “Side Effects”). However, with careful selection of the dose and regimen of administration, OHL occurs rarely. Drug treatment luveris^® It rarely causes a serious form of hyperstimulation if a drug containing hCG is not prescribed for the final maturation of the follicles. Thus, it is important not to take hCG in case of ovarian hyperstimulation syndrome and to refrain from sexual intercourse or use barrier-type contraceptives for at least 4 days. Careful observation of the response from the ovaries with ultrasound and blood tests before and during treatment is necessary. In patients undergoing treatment, the frequency of multiple pregnancies (mainly twins) and childbirth increases. However, it can be minimized by adhering to the recommended dose and regimen.

If a patient has an allergic reaction to similar drugs, she should inform her doctor about this. In the case when the patient forgot to enter the next dose of the drug Luveris®^®, you can not enter a double dose, and you should consult a doctor.

Do not use the vial if there is evidence of damage to the product, such as a change in the color of the powder or damage to the vial. The drug should be used immediately after dissolution. Do not inject the solution if it is opaque or contains particulate matter.

If the patient is administering Luveris®^® on her own, she should carefully read and strictly follow the instructions for administering the drug below:

Wash the hands. It is important that the patient’s hands and the items he uses are as clean as possible.

Prepare a clean surface and decompose everything you need on it:

fine needle for subcutaneous administration;
one bottle of luveris^®;
one bottle with solvent;
two tampons moistened with alcohol;
one syringe;
one needle to dissolve the powder in the solvent;
sharps container for safe disposal of glass parts and needles.

Remove protective cap from solvent vial. Connect the mixing needle to the syringe and draw some air into it by pulling the plunger up to about 1 ml. Then insert the needle into the vial, drown the piston to release the air, and smoothly collect all the solvent. Carefully place the syringe on the work surface, taking care not to touch the needle.

Prepare the solution for injection: remove the protective cap of the bottle with the drug, take a syringe, pierce the rubber stopper with a needle and slowly introduce the solvent into the bottle with the drug. Shake the bottle gently without removing the needle. Do not shake it. After the powder has dissolved (which usually happens right away), you need to make sure that the resulting solution is clear and does not contain solid particles.

Flip the bottle and gently dial the solution back into the syringe. You can also mix Luveris®^®and follitropin alfa as an alternative to the separate administration of each drug. After dissolving the drug Luveris®^®, take the solution back into the syringe and re-insert it into the container with follitropin alfa. Once the drug has dissolved, take the solution back to the syringe. Inspect it for the presence of solid particles as in the previous case and do not use the solution if it is not transparent. In 1 ml of solvent can be dissolved up to 3 fl. with the drug. Replace the needle with a thin one and release air bubbles: if air bubbles are visible in the syringe, direct the syringe with the needle upwards and gently knock it until all the air has accumulated at the top. Gently press on the piston to remove air. Introduce the solution immediately. Your doctor or nurse will advise you where to make the injection (for example, in the forearm, front surface of the thigh).Wipe the selected area with a swab moistened with alcohol. Gather the skin in a fold and with a quick movement insert the needle at an angle of 45–90 °. Inject the drug under the skin. Do not inject the contents directly into the vein. Inject the solution by gently pressing on the piston. Use as much time as needed to inject the entire solution. Immediately after that, remove the needle and wipe the skin in a circular motion with a swab moistened with alcohol.

Throw away all used objects: as soon as the injection is finished, immediately place all the needles and empty glass containers in a container for sharp objects. Unused solution should be thrown away.

Influence on driving a car and controlling other mechanisms. Does not affect.

Overdosage

Symptoms overdose unknown. There is a possibility of ovarian hyperstimulation syndrome. A single injection of up to 40,000 IU of the drug was well tolerated and was not accompanied by severe side effects.