Lucrin Depot® [Leuprorelin]

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Lucrin Depot® [Leuprorelin]

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IM or SubQ, 1 time per month. The injection site should be changed periodically. Suspension for injection is prepared immediately before administration using the attached solvent at a concentration of 3.75 mg / 1 ml.

In cancer of the prostate or breast single dose - 3.75 mg. The duration of treatment is determined by the doctor.

With endometriosis, uterine fibroids single dose - 3.75 mg.

For women of reproductive age, the first injection is performed on the 3rd day of menstruation. The duration of treatment is not more than 6 months.

When PPS in children Initial dose - 0.3 mg / kg (minimum - 7.5 mg) 1 time in 4 weeks.

The initial dose can be determined based on the child’s body weight:

Body weight of the child, kg	Dosage mg	Number of syringes or vials for injection	Total dose, mg
≤25	3,75	2	7,5
> 25 to 37.5	3,75	3	11,25
> 37,5	3,75	4	15

Note: If 2 or more injections are necessary to obtain the desired total dose, they should be carried out simultaneously.

Maintenance dose with PPP

If complete suppression of the progression of the disease is not achieved, the dose should be increased every 4 weeks by 3.75 mg.

The abolition of the drug Lyukrin Depot® should be considered before the age of 11 years in girls and 12 years in boys.

Instructions for the preparation of the suspension and the injection of the drug Lyukrin depot® in vials:

1. Type in a syringe with a needle, available in the kit, 1 ml of solvent from the ampoule and put it in a vial with lyophilisate (residual solvent should be disposed of).

2. Shake the bottle well until a homogeneous suspension is obtained. The suspension becomes milky.

3. Immediately after dilution, pour all the contents of the bottle (or 2 bottles) into a syringe (maximum 2 ml per syringe) and make a sc or i / m injection. Although the prepared suspension of the drug Lyukrin Depot® remains stable for 24 hours after reconstitution, it should be used immediately after preparation. The residue should be disposed of.

Instructions for the injection of the drug Lyukrin depot® in two-chamber syringes:

1. Screw the white piston into the end cap until the cap starts to rotate.

2. Hold the syringe in an upright position. Inject solvent by slowly pressing (for 6–8 s) on the plunger until the first stopper is on the blue line in the middle of the syringe.

3. Continue to hold the syringe vertically. Carefully shaking the lyophilisate thoroughly with the solvent until a homogeneous suspension (suspension) is formed. The suspension becomes milky.

4. Hold the syringe vertically. With your other hand, remove the needle cap up, not unscrewing it.

5. Hold the syringe vertically. Push the plunger forward to remove air from the syringe.

6. Immediately after the formation of the suspension, immediately enter the entire contents of the syringe in a / m or s / c, since suspension settles very quickly.

The drug is contraindicated during pregnancy and lactation, therefore, prior to the use of the drug it is recommended to exclude the presence of pregnancy.

Lyukrin Depot® should be used only under medical supervision.

Prostate cancer

In most patients, the concentration of testosterone increases compared with baseline during the first week, and then decreases to or below the initial concentration by the end of the second week of treatment. The post-concentration concentration is reached within 2–4 weeks and is maintained throughout the entire period of regular use of the drug.

During the first few weeks of treatment with Lyukrin Depot®, transient symptoms of deterioration may develop or additional signs and symptoms of the underlying disease may appear. A small number of patients may increase bone pain, which is relieved by symptomatic treatment. An increase in symptoms of deterioration during the first few weeks of treatment with Lyukrin Depot® in patients with metastasis to the spine, urinary tract obstruction or hematuria, can lead to neurological problems such as temporary weakness of the lower extremities, paresthesia, and weighting of urological symptoms.As with other GnRH analogs, the use of Lyukrin Depot® resulted in isolated cases of urinary tract obstruction and spinal cord compression, which can be complicated by paralysis with or without a fatal outcome. Therefore, during the first few weeks of treatment, patients with metastases in the spine and severe obstruction of the urinary tract require careful monitoring.

Uterus Endometriosis / Fibromyoma

At the very beginning of the course of treatment, a transient increase in the concentration of sex hormones is usually noted, which determines the physiological manifestations of the drug's action. Some worsening of symptoms at the beginning of therapy with Lukrin Depot® is quite fast with continued treatment with adequately selected doses of the drug. Cases of severe vaginal bleeding have been reported, requiring conservative or surgical treatment.

During treatment and before menstruation is restored, non-hormonal methods of contraception should be used.

The ability to fertilize or fertility, suppressed as a result of therapy, is restored in the period up to 24 weeks after the end of treatment.

A decrease in bone density in bone densitometry in women as a result of a decrease in estrogen concentration is reversible, and after cessation of treatment with leuprorelin, bone density is restored.

The use of Lyukrin Depot® in women causes depression of the function of the pituitary-gonadotropic system. After treatment, the function is restored after 3 months. However, diagnostic tests that indicate the function of the pituitary gland or the sex glands during the treatment and up to 3 months after its termination may be distorted.

The drug is prescribed for the treatment of PPS, based on the following criteria:

1. Clinical diagnosis of PPS (idiopathic or neurogenic) with the appearance of secondary sexual characteristics up to 8 years in girls and up to 9 years in boys.

2. The diagnosis must be confirmed by the GnRH stimulation test, and it is also necessary to take into account that the bone age is one year ahead of the biological one.

3. The initial examination includes:

• height and weight measurement;
• determination of the concentration of sex hormones;
• determination of the concentration of adrenal steroids to exclude congenital adrenal hyperplasia;
• determination of the concentration of human chorionic gonadotropin to exclude the presence of a tumor secreting chorionic gonadotropin;
• Ultrasound of the small pelvis and adrenal glands to exclude steroid-producing tumors;
• computed tomography of the head to exclude intracranial tumors.

The dose of Lyukrin Depot® for the preparation of a depot suspension should be individualized for each child. The dose is based on the ratio of the amount of the drug to body weight (mg / kg). Younger children require higher doses in mg / kg.

When using any form of dosing after 1 or 2 months. After the start of therapy or a dose change, a follow-up examination of the child should be carried out with the GnRH stimulation test, sex hormones and Tammer staging to confirm suppression. Measurements of bone age should be carried out every 6–12 months. The dose should be titrated to achieve no progression of the disease, according to clinical and / or laboratory studies.

The first dose, which was sufficient to maintain adequate suppression, can be maintained throughout the course of therapy in most children. However, a sufficient amount of data on the establishment of the adjusted dose in the transition of patients to higher weight categories after the start of therapy at a very young age and with the use of low dosages does not exist.

It is recommended that adequate suppression be confirmed in patients whose weight has increased significantly during treatment.

The abolition of the drug Lyukrin Depot® should be considered before the age of 11 years in girls and 12 years in boys.

Violations of the mode of administration of the drug or the wrong dose can lead to inadequate control of the pubertal process. The consequences of inadequate control include the recurrence of pubertal symptoms, such as menstruation, breast development, and growth of the testicles. The long-term effects of inadequate control over the secretion of gonadal steroids are unknown, but perhaps they include a subsequent dysplasia in adulthood.

Laboratory research

Monitoring of the response to therapy with Lukrin Depot® should be carried out after 1 or 2 months. after initiating therapy with the GnRH stimulation test and determining the concentrations of sex hormones. Measurement of bone age ahead of time should be carried out every 6–12 months.

Concentration of sex hormones may increase above the limits of the prepubertal level in case of inadequate dose. After the therapeutic dose is established, the concentration of gonadotropins and sex hormones will decrease to prepubertal levels.

Information for parents

Before starting therapy with Lucrin Depot®, parents or guardians should be warned about the importance of continuous therapy.

During the first 2 months of therapy, girls may have menstruation or bleeding. If the bleeding continues for more than 2 months, you must inform the doctor. The physician should immediately report the occurrence of irritation at the injection site and any unusual symptoms or signs.

Impact on the ability to drive vehicles and other mechanisms that require high concentration of attention

Data on the impact on the ability to drive a car and work with mechanisms not. In connection with the possibility of such side effects as drowsiness, dizziness, etc. (see "Side effects") it is recommended to refrain from driving and other activities that require increased concentration of attention and speed of psychomotor reactions.

There is no data regarding leuprorelin overdose. The administration of leuprorelin to patients with prostate cancer at a dose of up to 20 mg / day for 2 years did not cause the development of adverse events other than those observed with the use of the drug at a dose of 1 mg / day.

In case of overdose, the patient should be given symptomatic treatment.