Cabergoline (Kabergolin)

Before the appointment of cabergoline in order to treat violations associated with hyperprolactinemia, it is necessary to conduct a complete examination of the pituitary gland. In addition, an assessment of the state of the cardiovascular system, including echocardiography, should be conducted to identify abnormalities in valve function that occur asymptomatically.

As with other ergot derivatives, after prolonged administration of cabergoline, patients experienced pleural effusion / pleural fibrosis and valvulopathy. In some cases, patients received previous therapy with dopamine agonist agonists. therefore cabergoline Do not use in patients with existing signs and / or clinical symptoms of cardiac or respiratory function disorder associated with fibrotic changes or with such conditions in the anamnesis. It is necessary to cancel taking the drug in case of signs of appearance or deterioration of regurgitacin blood, narrowing of the lumen of the valves or thickening of valve flaps (see section "Contraindications"). It has been established that the rate of erythrocyte sedimentation increases with the development of pleural effusion or fibrosis. In the case of an unexplained increase in the rate of erythrocyte sedimentation, radiographic examination of the chest is recommended. In the diagnosis can also help study the concentration of creatinine in the blood plasma, the evaluation of renal function. After discontinuation of the drug cabergoline In patients with pleural effusion / pleural fibrosis or valvulopathy, symptom improvement was noted. It is not known whether cabergoline worsen the condition of patients with signs of regurgitation of blood. Cabergoline should not be used to identify fibrotic lesions of the valvular heart apparatus (see section "Contraindications"). Fibrotic disorders can develop asymptomatically. In this regard, the condition of patients receiving long-term therapy with cabergoline and paying particular attention to the following symptoms should be regularly monitored:

- pleuro-pulmonary disorders: such as shortness of breath, difficulty breathing, an impassable cough or pain in the chest;

- renal failure or obstruction of the vessels of the ureters or abdominal organs that may be accompanied by pain in the side or in the lumbar region and edema of the lower extremities, any swelling or tenderness when touching the abdomen, that may indicate the development of retroperitoneal fibrosis;

- pericardial fibrosis and fibrosis of valvular valve flaps often manifest as heart failure.In this regard, it is necessary to exclude the fibrosis of the valves of the heart valves (in constrictive pericarditis) with the appearance of symptoms of heart failure.

It is necessary to regularly monitor the patient's condition for the development of fibrotic disorders. The first time EchoCG should be performed 3-6 months after the start of therapy. This study should then be performed depending on the clinical evaluation of the patient's condition, paying special attention to the symptoms described above, at least every 6-12 months of therapy.

The need for other monitoring methods (for example, physical examination, including auscultation of the heart, radiography, computed tomography) is assessed individually for each patient.

With increasing doses, patients should be under the supervision of a physician to establish the lowest effective dose that provides a therapeutic effect. After the effective dosing regimen is selected, it is recommended to conduct a regular (1 time per month) determination of prolactin concentration in the blood plasma. Normalization of prolactin concentration is usually observed within 2-4 weeks of treatment.

After drug withdrawal cabergoline usually a relapse of hyperprolactinemia is observed, however, in some patients there is a persistent decrease in prolactin concentration for several months. In most women, ovulatory cycles persist for at least 6 months. after drug discontinuation cabergoline.

Cabergoline restores ovulation and fertility in women with hyperprolactinemic hypogonadism. Since pregnancy can occur before the recovery of menstruation, it is recommended to carry out pregnancy tests at least once every 4 weeks during the amenorrhea period, and after the recovery of menstruation - every time there is a delay in menstruation for more than 3 days. Women who wish to avoid pregnancy should use barrier methods of contraception during treatment with the drug cabergoline, as well as after discontinuation of the drug before the recurrence of anovulation. Women who have become pregnant should have iodine monitored by a doctor to detect symptoms of pituitary gland enlargement, because during pregnancy it is possible to increase the size of pre-existing pituitary tumors.

Cabergoline should be administered at lower doses to patients with severe hepatic impairment (Child-Pugh class C), which shows prolonged therapy with the drug. With a single application to such patients, doses of 1 mg there was an increase in AUC (area under the concentration-time curve) compared to healthy volunteers and patients with less severe hepatic insufficiency.

The use of cabergoline causes drowsiness. In patients with Parkinson's disease, the use of dopamine receptor agonists can cause sudden falling asleep. In such cases, it is recommended to reduce the dose of the drug cabergoline or discontinue therapy.

Studies on the use of the drug in elderly patients with impairments associated with hyperprolactinemia have not been conducted. Safety and effectiveness of the drug in children younger than 16 years are not established.