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Composition:


active ingredient: hydroxycarbamide (hydroxyurea)


1 capsule contains 500 mg of hydroxycarbamide (hydroxyurea);


excipients: lactose, monohydrate; calcium citrate; sodium citrate; magnesium stearate;


capsule shell: gelatin, titanium dioxide (E 171).


Dosage form. Capsules.


Basic physical and chemical properties: opaque white gelatin capsules containing an almost white powder.


Pharmacotherapeutic group. Other antineoplastic agents. ATX code L01X X05.


Pharmacological properties.


Pharmacodynamics.


The exact mechanism of antitumor action of the drug has not been elucidated, but it is believed that it is associated with blocking the ribonucleotide reductase complex, which causes inhibition of DNA synthesis. Cellular resistance is usually caused by increased levels of ribonucleotide reductase as a result of gene amplification.


Pharmacokinetics.


Information on pharmacokinetics is limited. The drug is well absorbed from the digestive tract, bioavailability is complete. The maximum concentration in the blood serum is reached 0.5 - 2 hours after administration.


Hydroxycarbamide penetrates the blood-brain barrier.


Hydroxycarbamide metabolism in humans has not been studied in detail.


Hydroxyurea is partially excreted by renal excretion. The Half - Life of the drug is 3-4 hours. From 9 to 95% of the drug is excreted in the urine.


Clinical characteristics.


Indications.


Treatment of patients with chronic myeloid leukemia (CML) in the chronic or progressive stage of the disease.


Treatment of patients with essential thrombocythemia or polycythemia with a high risk of thromboembolic complications.


Contraindications.


Hypersensitivity to the active substance or to any other component of the drug. If hypersensitivity is detected during treatment, the drug should be discontinued.


Suppressed bone marrow function (white blood cell count less than 2.5 109/L, platelet count less than 100 109/L) or the presence of severe anemia.


Interactions with other drugs and other types of interactions.


An in vitro study demonstrated the ability of hydroxycarbamide to enhance the cytotoxic effect of Ara-C and fluoropyrimidines.


Hydroxyurea may enhance the antiretroviral activity of reverse transcriptase inhibitors such as didanosine and Stavudine. Hydroxyurea inhibits HIV DNA synthesis and HIV replication by reducing the number of intracellular deoxynucleotides. Hydroxyurea may also increase potential side effects of reverse transcriptase inhibitors, such as hepatotoxicity, pancreatitis, and peripheral neuropathy.


Studies have shown that there is an analytical interference of hydroxycarbamide with enzymes (urease, uricase, and lactate dehydrogenase) used to determine urea, uric acid, and lactic acid, which leads to false positive results in patients treated with hydroxycarbamide.


Vaccination.


There is an increased risk of serious infections with fatal outcomes in the case of concomitant use of live vaccines. Live vaccines are not recommended for immunocompromised patients.


Application features.


During treatment with the drug, it is necessary to check blood parameters, as well as kidney and liver functions. Experience in treating patients with impaired renal or hepatic function is limited. Therefore, treatment of such patients is carried out with caution and under constant supervision, especially at the beginning of treatment.


Hydroxycarbamide can cause bone marrow depression, which is most often manifested by leukopenia, as well as (less often) thrombocytopenia and anemia.


A complete blood test, including determination of hemoglobin levels, total white blood cell count, and differentiated platelet count, should be performed on a regular basis, as well as after setting an individual optimal dose. The frequency of monitoring is determined individually, but the normal period is weekly. If the content of white blood cells in the blood decreases to a level of less than 2.5 109/L or platelets to a level of less than 100 109/L, treatment should be discontinued until their content returns to normal.


If you miss taking the drug, the next dose should be taken after consulting your doctor.


If anemia occurs before or during treatment, red blood cells may be replaced. Transient megaloblastic erythropoiesis is often observed at the beginning of a course of hydroxycarbamide therapy. The morphological change resembles pernicious anemia, but is not associated with vitamin B12 or folic acid deficiency.


During the use of the drug, it is necessary to consume a sufficiently large amount of liquid.


Patients receiving long-term treatment with hydroxycarbamide for myeloproliferative diseases such as true polycythemia and thrombocythemia may develop secondary leukemia. To what extent this is due to the underlying disease or treatment with hydroxycarbamide is still unknown.


There have been reports of skin cancer in patients who have been taking hydroxyurea for a long time. Patients should be advised to protect their skin from sun exposure. In addition, patients should perform self-examination of the skin during treatment and after discontinuation of hydroxyurea therapy and be tested for secondary malignancies during routine examinations.


Hydroxyurea can cause the development of painful leg ulcers, which are usually poorly treated and require discontinuation of hydroxyurea treatment. After stopping treatment, the ulcers gradually heal over several weeks.


Toxic skin vasculitis, including vasculitis and gangrene, was observed during hydroxycarbamide therapy in patients with myeloproliferative diseases. The risk of toxic vasculitis increases in patients who have received or received interferon in the past. The digital localization of these vasculitis ulcers and the progressive clinical course of peripheral vascular insufficiency, which leads to infarct damage to the digital areas or gangrene, clearly differs from the typical skin ulcers usually described with the use of hydroxycarbamide. Due to the potentially dangerous clinical consequence of cutaneous vasculitis ulcers in patients with myeloproliferative diseases, the use of hydroxycarbamide should be discontinued and alternative cytoreductive drugs should be prescribed.

Interstitial lung diseases, including pulmonary fibrosis, lung infiltration, pneumonitis, and alveolitis/allergic alveolitis, have occurred in patients treated with myeloproliferative neoplasms and may be fatal. Patients with fever, cough, shortness of breath, or other respiratory symptoms should be carefully examined, examined, and treated.


If pulmonary complications occur, hydroxyurea should be discontinued immediately and corticosteroid treatment should be initiated.


Hydroxycarbamide may be genotoxic. Men should use reliable contraceptives during therapy and for another 3 months after the end of therapy. They should be informed about the possibility of sperm preservation before starting therapy.


Patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption should not take this medication.


Elderly patients may be more sensitive to the effects of hydroxyurea and may need to reduce the dose.


Hydroxycarbamide should be used with caution in patients undergoing or previously undergoing concomitant radiation or cytotoxic therapy. In these cases, patients have an increased risk of bone marrow suppression, stomach irritation, and mucositis. In addition, there may be an exacerbation of erythema caused by previous or simultaneous radiation exposure.


Vaccination concomitant use of medac hydroxyurea with a live antiviral vaccine may increase viral replication of the vaccine and/or may increase some adverse reactions of the vaccine virus, since normal defense mechanisms may be suppressed by hydroxycarbamide. Live vaccination of patients taking medac hydroxyurea can lead to serious infection. The patient's humoral immune response to the vaccine may be reduced. The use of live vaccines should be avoided during treatment and for at least 6 months after the end of treatment.


Use during pregnancy or lactation.


Pregnancy


Hydroxyurea can be a powerful mutagenic agent. Animal studies have found an increased incidence of birth defects. Hydroxyurea should not be used in pregnant women, except in cases where the clinical condition of the woman requires treatment with hydroxycarbamide. Hydroxyurea should not be prescribed to pregnant or lactating women, except in cases where the benefits outweigh the risks. Women of reproductive age should take birth control precautions before and during treatment with the drug.


If pregnancy occurs during treatment, it is necessary to offer the patient a genetic consultation. Hydroxycarbamide passes through the placenta.


Breast-feeding period


Since hydroxycarbamide is excreted in breast milk, breast-feeding should be discontinued before starting treatment.


Fertility


Hydroxycarbamide can be genotoxic, so patients who plan to become pregnant after hydroxycarbamide therapy are recommended for genetic consultation.


Men should use reliable contraceptives during therapy and for another 3 months after the end of therapy. They should be informed about the possibility of preserving sperm before starting treatment.


Ability to influence the reaction rate when driving vehicles or other mechanisms.


The reaction rate may be disrupted during the use of hydroxyurea. This should be taken into account when increased attention is needed, for example, when driving vehicles and working with other mechanisms.


Dosage and administration.


Capsules should be swallowed whole, without chewing.


Therapy should be performed by a doctor who has experience in oncology and hematology. All dosage regimens of the drug should be based on the actual or ideal body weight of the patient (depending on which one is smaller).


Treatment of chronic myeloid leukemia. Hydroxyurea is usually prescribed at an initial dose of 40 mg/kg of body weight per day, taking into account the level of white blood cells in the blood. The dose should be halved (20 mg/kg/day) if the white blood cell count decreases below 20 × 109/L. then the dosage is adjusted individually to maintain the white blood cell count at 5-10 × 109/L. 


If the white blood cell count falls below 2.5 × 109/L or the platelet count is less than 100 × 109/L, therapy should be discontinued until normal blood counts are established.


A sufficient period to achieve an antineoplastic effect is 6 weeks. If there is a progression of the disease, the use of the drug should be stopped immediately. If there is an appropriate therapeutic effect, treatment is continued indefinitely.


Treatment of essential thrombocythemia. The initial dose of hydroxyurea is 15 mg/kg/day, which is adjusted to maintain the number of platelets in the blood at the level of 600 × 109/L, making sure that the level of white blood cells is not lower than 4 × 109/L.


Treatment of polycythemia. Hydroxyurea begins to be prescribed at a dose of 15-20 mg/kg/day. Further, the dosage is selected individually to maintain hematocrit below 45% and platelets below 400 × 109/L. in most patients, this is achieved by constant intake of hydroxyurea at a dose of 500-1000 mg daily.


If the hematocrit level and platelet count in the blood are successfully controlled, therapy should be continued indefinitely.


Children. Since these diseases are rare in children, the dosage regimen for children has not been studied.


Elderly people. Elderly patients may be more sensitive to the effects of hydroxyurea and may need to reduce the dose.


Patients with renal and hepatic insufficiency. Sufficient information is missing. There are no recommendations on the dosage regimen for this group of patients.


Children.


The safety and efficacy of treatment in this category of patients have not been established.


Overdose.


In patients who used the drug in doses several times higher than the usual recommended ones, acute pathologies of the skin and mucous membranes were observed, namely: irritation, erythema Violet, swelling of the palms and feet with subsequent peeling of the skin of the hands and feet, intense generalized hyperpigmentation of the skin and stomatitis.


Immediate treatment is required, which includes gastric lavage followed by maintenance therapy and monitoring of the hematopoietic system.


Tags: Hydroxycarbamide