Hydrea

2024 Author: Rachel Wainwright | [email protected]. Last modified: 2023-12-15 07:39

Hydrea: instructions for use and reviews

1. Release form and composition
2. Pharmacological properties
3. Indications for use
4. Contraindications
5. Method of application and dosage
6. Side effects
7. Overdose
8. Special instructions
9. Application during pregnancy and lactation
10. Drug interactions
11. Analogs
12. Terms and conditions of storage
13. Terms of dispensing from pharmacies
14. Reviews
15. Price in pharmacies

Latin name: Hydrea

ATX code: L01XX05

Active ingredient: Hydroxycarbamide (Hydroxycarbamide)

Manufacturer: Bristol-Myers Squibb (USA); Bristol-Myers Squibb SrL (Italy)

Description and photo update: 2019-07-08

Prices in pharmacies: from 212 rubles.

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Hydrea is an antineoplastic drug.

Release form and composition

The drug is produced in the form of capsules: gelatinous solid, opaque, size No. 0, with the black inscription "BMS 303", the body is matte, pale pink, the lid is matte, green; capsule contents - white compacted mass or powder (100 pcs. in dark glass bottles, 1 bottle in a cardboard box; 10 pcs. in blisters, 2 blisters in a cardboard box).

1 capsule contains:

Active ingredient: hydroxycarbamide - 500 mg;
Auxiliary components: lactose monohydrate - 42.2 mg, citric acid - 12.8 mg, magnesium stearate - 9 mg, sodium hydrogen phosphate - 36 mg.

The composition of the capsule shell: titanium dioxide - 2.016 mg, gelatin - 93.743 mg, yellow iron oxide dye - 0.110 mg, red iron oxide dye - 0.115 mg, FD&C blue 2 indigo carmine dye - 0.017 mg.

Ink composition: black iron oxide, shellac, propylene glycol, N-butyl alcohol, isopropyl alcohol, industrial methylated alcohol, purified water.

Pharmacological properties

Pharmacodynamics

Hydroxycarbamide, the active ingredient of Hydrea, belongs to phase-specific cytostatic drugs (according to some reports, it is an antimetabolite of alkylating action), the peak of activity of which falls on the S phase of the cell cycle. This compound inhibits the growth of cells in the G1-S interphase, which is important for simultaneous radiation therapy due to the emergence of a synergistic sensitivity of tumor cells in the G1 phase to radiation.

Hydroxycarbamide enhances the effect of an RNA reductase inhibitor - ribonucleoside diphosphate reductase, causing inhibition of DNA synthesis. The drug does not affect the synthesis of proteins and RNA.

Pharmacokinetics

After oral administration, hydroxycarbamide is relatively quickly absorbed from the gastrointestinal tract. The maximum level of the substance in the blood plasma is reached within 2 hours after ingestion. There is no information on the relationship between the absorption of Hydrea and food intake. Hydroxycarbamide is rapidly distributed throughout all body tissues and easily penetrates the blood-brain barrier. In the cerebrospinal fluid, the active component of Hydrea is determined in the amount of 10–20%, and in the ascitic fluid - in the amount of 15–50% of the total concentration in the blood plasma.

Hydroxycarbamide is accumulated in erythrocytes and leukocytes. Its half-life is 3-4 hours. The compound is partially metabolized in the liver, and about 80% of hydroxycarbamide is excreted in the urine within 12 hours (about 50% - unchanged, minor amounts - in the form of urea). Also, the active ingredient Hydrea is excreted through the respiratory tract in the form of carbon dioxide. 24 hours after administration, hydroxycarbamide is not detected in blood plasma.

In patients with renal dysfunction, it is necessary to reduce the dose of Hydrea, since most of the hydroxycarbamide is excreted through the kidneys.

Indications for use

Malignant tumors of the head and neck, except for lip cancer (simultaneously with radiation therapy);
Polycythemia vera (erythremia);
Chronic myeloid leukemia;
Osteomyelofibrosis;
Essential thrombocythemia;
Cervical cancer (at the same time as radiation therapy);
Melanoma.

Contraindications

Absolute:

Thrombocytopenia below 100,000 / μL, leukopenia below 2500 / μL;
Pregnancy and lactation;
Children's age (the effectiveness and safety of using Hydrea for this age group of patients have not been established);
Hypersensitivity to drug components.

Relative (the agent is prescribed with caution in the presence of the following diseases / conditions):

Glucose-galactose malabsorption, lactose intolerance, lactase deficiency;
Severe anemia (must be compensated before starting therapy);
Renal and / or hepatic impairment;
Condition after chemotherapy or radiotherapy (due to the likelihood of exacerbation of radiation erythema, development of myelosuppression).

Instructions for use of Hydrea: method and dosage

The capsules are taken orally. If you have difficulty swallowing, you can open the capsule, pour the contents into a glass of water and drink immediately. However, some of the water-insoluble auxiliary components may remain on the surface of the solution.

The doctor determines the dosage regimen individually, based on the data of special literature.

During therapy, it is necessary to take liquid in a sufficiently large amount.

Depending on the indication, the drug is usually prescribed as follows:

Resistant chronic myeloid leukemia: once a day, 20-30 mg / kg daily (continuous therapy). Evaluation of the effectiveness of Hydrea should be carried out after 1.5 months of treatment. If there is an acceptable clinical response, therapy can be carried out indefinitely. Treatment is suspended if the leukocyte count is less than 2500 / mm ³ or the platelet count is less than 100,000 / mm ³… After 3 days, the blood test is repeated. Therapy can be resumed after an increase in the number of red blood cells and leukocytes to an acceptable level. Recovery, as a rule, occurs quickly enough, otherwise, with the simultaneous use of Hydrea with radiation therapy, the latter can also be suspended. Anemia, even severe, does not usually lead to interruption of the course of treatment, provided that adequate therapy is carried out (red blood cell transfusion);
Polycythemia vera: Hydrea is started at 15-20 mg / kg per day. The dose is set individually, while it is desirable to maintain the platelet count below 400,000 / μl, and the hematocrit below 45%. In most cases, this is possible with the constant use of hydroxycarbamide in a daily dose of 500-1000 mg;
Essential thrombocythemia: Hydrea is prescribed at an initial dose of 15 mg / kg per day. The dose is then adjusted so as to maintain the platelet count below 600,000 / μl without causing the leukocyte count to drop below 4000 / μl. For solid tumors and melanoma, intermittent (once a day, 80 mg / kg every three days; 6-7 doses) or continuous (daily for 3 weeks, 20-30 mg / kg once a day) therapy;
Carcinoma of the cervix, carcinoma of the head and neck: once a day at 80 mg / kg, every three days in combination with radiation therapy. Hydrea is prescribed at least 7 days before the start of the course of radiation therapy and do not interrupt the drug intake during the entire course. In the absence of severe or unusual toxic reactions in the patient after the end of radiation therapy, the use of the drug should be continued for an unlimited time under strict medical supervision.

Patients with functional impairments of the liver should be closely monitored for blood counts. There is no data on the need to change doses in this group of patients.

When Hydrea is prescribed to patients with functional impairment of the kidneys, it is necessary to adjust the dose. With creatinine clearance up to 60 ml per minute, the drug is usually prescribed at a dose of 15 mg / kg. Patients with end-stage renal failure should use Hydrea in the same dose twice, with an interval of 7 days: the first time - at the end of a four-hour hemodialysis session, the second - before the hemodialysis session.

For elderly patients, the drug is recommended to be prescribed in doses not exceeding 60 mg / kg per day.

Side effects

Nervous system: with an unknown frequency - drowsiness, dizziness, disorientation, headache, convulsions, hallucinations, peripheral neuropathy (in HIV-infected patients who are simultaneously receiving antiretroviral therapy, for example, stavudine and didanosine), increased fatigue;
Urinary system: with an unknown frequency - interstitial nephritis, urinary retention, an increase in the content of uric acid in the blood serum, the content of urea nitrogen and creatinine in the blood plasma; rarely - dysuria;
Respiratory system: with unknown frequency - diffuse lung infiltration, pulmonary fibrosis, dyspnea;
Skin and cutaneous appendages: with an unknown frequency - cutaneous vasculitis, macular-papular rashes, skin ulceration, peripheral erythema and erythema of the face, dermatomyositis-like changes and exfoliation of the skin, erythema, hyperpigmentation, peeling, purple papules, dermal toxicity of nails and skin, atrophy of nails and skin vasculitis (including gangrene and vasculitic ulceration); rarely - skin cancer, alopecia;
Digestive organs: with an unknown frequency - hepatotoxicity, pancreatitis (in some cases fatal) (in HIV-infected patients who are simultaneously receiving antiretroviral therapy, for example, stavudine and didanosine), dyspepsia, stomatitis, diarrhea, anorexia, vomiting, nausea, constipation, mucositis, ulceration of the mucous membrane of the gastrointestinal tract, irritation of the gastric mucosa, increased plasma bilirubin concentration and the activity of liver enzymes;
Hematopoietic organs: with an unknown frequency - suppression of bone marrow function (anemia, leukopenia, thrombocytopenia);
Infections: with unknown frequency - gangrene;
Others: with an unknown frequency - asthenia, allergic skin reactions, chills, general malaise, fever, increased erythrocyte sedimentation rate (ESR); rarely - shortness of breath, diffuse lung infiltration.

Cases of development of hepatotoxicity and pancreatitis (with a possible fatal outcome), as well as severe peripheral neuropathy, were observed in HIV patients who took Hydrea simultaneously with antiretroviral drugs, in particular, didanosine with or without stavudine.

The most common disorders observed with the combined use of Hydrea and radiation therapy are the same as with monotherapy - bone marrow suppression (anemia, leukopenia) and irritation of the gastric mucosa. In addition, taking hydroxycarbamide can lead to an increase in some of the side effects that are usually seen with radiation therapy (mucositis, stomach discomfort).

Overdose

When taking the drug in doses several times higher than therapeutic, the patients showed symptoms of acute dermatological toxicity: stomatitis, soreness, intense generalized hyperpigmentation of the skin, swelling followed by peeling of the feet and palms of the hands, purple erythema.

The specific antidote is currently unknown. In case of an overdose, symptomatic treatment is prescribed.

special instructions

Hydrea can only be used under the supervision of a physician with experience in anticancer therapy.

Before starting each course and periodically during therapy, it is necessary to monitor the functions of the bone marrow, liver and kidneys. Determination of leukocytes, platelets and hemoglobin should be carried out at least 1 time in 7 days throughout the entire treatment period. Therapy is prescribed only in cases where the leukocyte count is higher than 2500 / μl, and the platelet count is 100,000 / μl. When their level decreases, therapy is interrupted until their normalization.

Severe anemia should be compensated for prior to treatment.

During the use of Hydrea, myelosuppression may develop, most often - leukopenia. Anemia and thrombocytopenia develop less frequently, and in very rare cases - without prior leukopenia. The most likely development of myelosuppression in patients after recent chemotherapy with other drugs or radiation therapy.

After recent radiation or chemotherapy, Hydrea should be used with caution, which is associated with the likelihood of exacerbation of post-radiation erythema and increased severity of side effects (ulceration of the gastrointestinal tract, dyspepsia, bone marrow aplasia). With the development of severe disorders of the digestive system, such as vomiting, nausea, anorexia, therapy, as a rule, is suspended.

Local anesthetics and oral analgesics are usually prescribed for pain and discomfort caused by mucositis in the radiation area. In severe cases, treatment is temporarily suspended, in very severe cases, concomitant radiation therapy is temporarily canceled.

Hydrea can slow down plasma iron clearance and reduce the rate of iron utilization by erythrocytes, but this does not affect the erythrocyte lifetime.

In the early stages of using Hydrea, moderate megaloblastic erythropoiesis is often observed. Morphological changes usually resemble pernicious anemia, but they are not associated with a deficiency of folate or vitamin B12. Due to the fact that macrocytosis can mask a lack of folic acid, it is necessary to consider the issue of its prophylactic appointment to the patient.

Against the background of myeloproliferative diseases during the use of Hydrea, cutaneous toxic vasculitis, including gangrene and vasculitic ulceration, was observed. Most often, toxic vasculitis has been reported in patients who have received or are currently receiving interferon. The drug should be discontinued if vasculitic ulceration progresses.

With prolonged use of Hydrea in patients with myeloproliferative diseases, such as thrombocythemia and polycythemia vera, cases of secondary leukemia have been reported. The reason for the development of secondary leukemia (taking hydroxycarbamide or the underlying disease) is unknown. Also, long-term therapy can lead to the development of skin cancer, therefore, during therapy, it is recommended to protect the skin from sunlight and systematically self-monitor its condition. During planned visits to the doctor, it is necessary to monitor the condition of the patient's skin to identify possible malignant changes.

Since Hydrea has a cytotoxic effect, care must be taken when opening the capsules, and you should also avoid inhaling the drug or getting the powder on the mucous membranes and skin.

According to the instructions, Hydrea can lead to the development of dizziness and other undesirable phenomena from the nervous system, which must be taken into account when driving.

Application during pregnancy and lactation

Pregnancy is a contraindication to the appointment of Hydrea. If it is necessary to undergo a course of drug treatment during lactation, breastfeeding is stopped.

Women of reproductive age who are taking hydroxycarbamide must use reliable contraception.

Experimental studies have confirmed the embryotoxic and teratogenic effects of hydroxycarbamide.

Drug interactions

With the simultaneous use of certain drugs, the following effects may occur:

Other myelosuppressive drugs or radiation therapy: an increase in bone marrow suppression or the risk of other side effects;
Cytarabine: an increase in its cytotoxic effect;
Uricosuric drugs: increased risk of developing nephropathy.

If severe dyspepsia, nausea, anorexia, or vomiting occurs during the combination treatment, they can usually be stopped by interrupting Hydrea.

Mucositis (discomfort and soreness of the mucous membranes at the radiation site) can be relieved with local anesthetics and analgesics (by mouth). In severe mucositis, the use of Hydrea is temporarily interrupted; in very severe cases, stop radiation therapy.

The drug is capable of increasing the serum uric acid content, which may require adjusting the dose of drugs that increase the excretion of uric acid from the body.

As a result of the interaction of hydroxycarbamide and enzymes (uricase, urease, lactate dehydrogenase) during the use of Hydrea, cases of false-positive test results have been observed in the determination of uric acid, urea and lactic acid.

Analogs

Hydrea's analogues are: Hydroxycarbamide Medak, Hydroxycarbamide-Lance, Biosupressin, Hydroxyurea, Hydroxyurea-Apo.

Terms and conditions of storage

Store in a dark place, out of reach of children, at a temperature of 15-25 ° C.

The shelf life is 5 years.

Terms of dispensing from pharmacies

Dispensed by prescription.

Reviews about Hydrea

The drug is temporarily prescribed as an inexpensive first-line chemotherapy drug for patients suffering from chronic myeloid leukemia for the period of diagnosis and selection of the correct treatment tactics. Reviews of Hydrea are mostly favorable, which proves its effectiveness. Taking the drug allows you to achieve hematological remission in 20-40% of patients, as it leads to a rapid but short-term decrease in the number of leukocytes. For this reason, the drug is prescribed as a maintenance therapy in a dose of 500 or 1000 mg per day.

When treating Hydrea, it is impossible to achieve cytogenetic remission (disappearance of the Ph chromosome). It slows down the development of the disease and makes it possible for a certain period of time to normalize the leukocyte count.

Refusal of treatment can provoke a deterioration in the patient's condition. In most cases, the drug is well tolerated, and side effects are extremely rare. Peptic ulcer disease at the stage of exacerbation may become a contraindication to taking the drug. However, it should be remembered that complete recovery in chronic myeloid leukemia is possible only after allogeneic bone marrow transplantation during the first year of the disease.

Hydrea is considered a good choice and the gold standard for the treatment of polycythemia vera. Good results are obtained by cytostatic therapy, which allows to achieve a stable remission. To do this, the drug is taken according to the following scheme: the initial daily dose is 30 mg / kg, divided into 2 doses, then the dose is reduced by 2 times and a maintenance dose of 500–1000 mg per day is transferred. In primary myelofibrosis, cytostatic therapy can reduce the size of the spleen and stop thrombocytosis.

Judging by the reviews, Hydrea was most often prescribed in a daily dose of 1000-3000 mg, followed by maintenance therapy. In case of essential thrombocythemia, taking the drug is aimed at lowering the platelet level, but this was not always effective. Patients report that the most common side effect of taking the drug is hair loss.

Price for Hydrea in pharmacies

The price for Hydrea 500 mg in most pharmacies is 240-270 rubles (the package contains 20 capsules).

Hydrea: prices in online pharmacies

Drug name

Price

Pharmacy

Hydrea 500 mg capsule 20 pcs.

212 r

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Maria Kulkes Medical journalist About the author

Education: First Moscow State Medical University named after I. M. Sechenov, specialty "General Medicine".

Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!