Before the appointment of the drug Dostinex ® for the treatment of violations associated with hyperprolactinemia, it is necessary to conduct a full study of the pituitary gland function. In addition, an assessment should be made of the condition of the cardiovascular system, including EchoCG, in order to detect 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, Dostinex ® should not be used 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 blood regurgitation, narrowing of the lumen of the valves or thickening of valve flaps (see section "Contraindications").
It was found 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 Dostinex ® in patients with pleural effusion / pleural fibrosis or valvulopathy, symptoms improved.
It is not known whether
cabergoline worsen the condition of patients with signs of regurgitation of blood.
Cabergoline It should not be used in the detection of fibrous lesions of the valvular heart apparatus (see Fig.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, which may indicate the development of retroperitoneal fibrosis;
- Pericardial fibrosis and fibrosis of the valves of the heart valves often manifest as heart failure. In this regard, it is necessary to exclude the fibrosis of the valves of the heart valves (and 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 (once a month) determination of the concentration of prolactin in the serum. Normalization of prolactin concentration is usually observed within 2-4 weeks of treatment.
After the abolition of the drug Dostinex®, a relapse of hyperprolactinemia is usually observed, however, in some patients persistent inhibition of prolactin concentration is observed for several months. In most women, ovulatory cycles persist for at least 6 months after discontinuation of the Dostinex® drug.
Dostinex® restores ovulation and fertility in women with hyperprolactinemic hypogonadism. Since pregnancy can occur before the recovery of menstruation, it is recommended that pregnancy tests be performed at least once every 4 weeks during the amenorrhea period, and after the recovery of menstruation, every time the menstrual period is delayed by more than 3 days. Women who want to avoid pregnancy should use barrier methods of contraception during treatment with Dostinex®, and after the drug is discontinued before the anovulation recurs. Women who have become pregnant should be under the supervision of a doctor to detect symptoms of pituitary gland enlargement in time, since during pregnancy it is possible to increase the size of pre-existing pituitary tumors.
Dostinex® should be administered at lower doses to patients with severe hepatic impairment (Child-Pugh class C), who show prolonged therapy with the drug. With a single dose of 1 mg to such patients, there was an increase in AUC (area under the concentration-time curve) compared with healthy volunteers and patients with lessmarked 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 Dostinex® or discontinue therapy.
Studies on the use of the drug in elderly patients with impairments associated with hyperprolactinemia have not been conducted. The safety and efficacy of the drug in children younger than 16 years is not established.