Vaidaza
Instructions for use:
- 1. Release form and composition
- 2. Indications for use
- 3. Contraindications
- 4. Method of application and dosage
- 5. Side effects
- 6. Special instructions
- 7. Drug interactions
- 8. Analogs
- 9. Terms and conditions of storage
- 10. Terms of dispensing from pharmacies
Vaidaza is an antimetabolite, antineoplastic drug.
Release form and composition
Dosage form - lyophilisate for preparation of a suspension for subcutaneous (s / c) administration: a powdery or porous mass of white color, after dissolution retains its color (in glass vials without color with a volume of 30 ml, in a cardboard box 1 bottle).
1 bottle contains:
- active substance: azacytidine - 100 mg;
- auxiliary component: mannitol.
Indications for use
The use of Vidaza is indicated in case of impossibility of hematopoietic stem cell transplantation in the treatment of adult patients:
- myelodysplastic syndrome (MDS) with intermediate-2 or high risk on the IPSS scale (International Prognostic Scoring System);
- chronic myelomonocytic leukemia without symptoms of MDS;
- acute myeloid leukemia.
Contraindications
- childhood;
- widespread liver metastases;
- the period of pregnancy and breastfeeding;
- hypersensitivity to the components of the drug.
Care should be taken when prescribing the drug to patients with cardiovascular pathologies, impaired renal and / or liver function, extensive metastatic liver lesions, lung diseases.
Method of administration and dosage
The ready-made solution of the lyophilisate (suspension) is intended for subcutaneous administration to the thigh, shoulder or abdomen area.
The suspension is prepared before direct administration by adding 4 ml of water for injection to the contents of the vial and shaking vigorously until a white solution with a homogeneous structure and a concentration of 25 mg per ml is obtained. In the presence of large undissolved particles, the drug cannot be used.
For subcutaneous injection, a 25-gauge needle should be used, which is inserted under the skin at an angle of 45–90 °.
After taking the suspension into the syringe, it is recommended to roll it vigorously between the palms before administration, so that the suspension acquires a uniform white color. The temperature of the injected drug should be 20-25 ° C.
No more than 4 ml can be injected into one area, therefore, with a dose of more than 4 ml, 2 injections are made in different areas.
At a temperature of 25 ° C, the suspension is suitable for use within 45 minutes, at a temperature of 2-8 ° C - up to 480 minutes. If time limits are exceeded, the suspension must be disposed of properly.
The injection area should be alternated, while the site of the next injection should not be closer than 2.5 cm from the previous one. The drug should not be injected into painful, compacted or damaged areas of the skin (including hemorrhages).
The introduction of Vidaza is recommended after taking an antiemetic.
The recommended dosage of the first cycle of therapy for all patients, regardless of the initial hematological parameters: initial dose - at the rate of 75 mg per 1 m2 of body surface 1 time per day, procedures are carried out for 7 days, followed by a 21-day break.
The course of treatment consists of at least six therapeutic cycles. Therapy should be continued as long as it remains effective or until signs of disease progression appear.
Treatment must be accompanied by regular monitoring of blood counts; if symptoms of toxicity appear, the dose is adjusted or the start of the next course is postponed.
With a decrease in the number of platelets during the cycle of therapy to 50 × 10 9 / L or less and / or the absolute number of neutrophils (ANC) to 1 × 10 9 / L or less, hematological toxicity occurs.
If, against the background of the use of Vidaza in patients with baseline leukocyte counts above 3 × 10 9 / L, ANC above 1.5 × 10 9 / L, platelet counts more than 75 × 10 9 / L, signs of hematological toxicity appear, then the next cycle of treatment should be postponed until baseline platelet count and ANC are restored. If the recovery period does not exceed 14 days, the dose is not changed in the next cycle. If within 14 days the number of blood cells has not reached the required level (ANC does not exceed 1 × 10 9 / l, the number of platelets is not more than 50 × 10 9 / l), the dose should be reduced by 50%. After dose modification, cycle duration should be restored to 28 days.
If in patients with an initial leukocyte count less than 3 × 10 9 / L, ANC less than 1.5 × 10 9 / L, platelets up to 75 × 10 9 / L before the next cycle, these indicators are reduced by 50% or less or 50% and more, but there are signs of improvement in the differentiation of any cell lineage, the dose and administration schedule of the drug do not change.
In the absence of symptoms of improved differentiation of cell lines in patients with the number of blood cells not exceeding the 50% threshold compared to the baseline level, the next cycle of therapy is postponed until the recovery of ANC and platelets. If the recovery period lasted up to 14 days, the dose of the drug is not adjusted. If the number of blood cells has not reached the desired level within 14 days, it is necessary to determine the cellular saturation of the bone marrow. If the cell saturation index is more than 50%, a change in the Vidaza dose is not required, if it is less than or equal to 50%, the drug administration should be postponed and the dose should be reduced in the next cycle. When the cellular saturation of the bone marrow reaches the level of 15-50% within no more than 21 days, the dose of the previous cycle is not changed, more than 21 days it is reduced by 2 times. When the cellular saturation of the bone marrow is below 15%,if recovery occurred within 21 days, the dose is retained; if for more than 21 days, 33% of the initial dose is prescribed. After dose adjustment, the cycle duration should be restored to 28 days.
In case of impaired renal function, adjustment of the initial dose is not required. In the following cycles, the dose is modified based on the results of hematological studies and indicators of renal function. The dose of Vaidaza is reduced by 50% when the serum bicarbonate concentration is unexplained below 20 mmol / L. In case of an unexplained increase of 2 times or more from the initial values, as well as when the upper limit of the normal level of the concentration of creatinine in the blood serum or the content of urea nitrogen in the blood is exceeded, the next cycle of therapy should be postponed until the normal or initial values of these parameters are restored, the dose of the drug in the next cycle - reduce by 50%.
In severe hepatic insufficiency, the initial dose of the drug is not changed. Dose modification in subsequent cycles can be made based on blood test results.
Elderly patients do not require a special dosing regimen.
Side effects
- infections: very often - nasopharyngitis, pneumonia; often - herpes simplex, sinusitis, sepsis on the background of neutropenia, upper respiratory and urinary tract infections, rhinitis, pharyngitis, inflammation of the subcutaneous tissue;
- from the hematopoietic system: very often - leukopenia, neutropenia, anemia, febrile neutropenia, thrombocytopenia; often pancytopenia;
- on the part of the cardiovascular system: often - hematomas, decrease or increase in blood pressure (BP);
- from the biliary tract and liver: infrequently - progressive hepatic coma, liver failure;
- from the digestive system: very often - nausea, vomiting, diarrhea, constipation, abdominal pain; often - dyspepsia, gastrointestinal bleeding, bleeding gums, stomatitis, hemorrhoidal bleeding;
- from the side of metabolism: very often - anorexia; often hypokalemia; rarely - tumor lysis syndrome;
- from the side of the psyche: anxiety, confusion, insomnia;
- from the nervous system: very often - headache, dizziness; often - drowsiness, intracranial bleeding;
- from the urinary system: often - an increase in the level of creatinine concentration, renal failure, hematuria; infrequently - renal tubular acidosis;
- from the respiratory system: very often - shortness of breath; often - pain in the larynx and pharynx, shortness of breath on exertion; rarely - lung diseases of an interstitial nature;
- dermatological reactions: very often - itching, rash, petechiae, ecchymosis; often - alopecia, purpura, spotted rash, erythema;
- on the part of the organ of vision: often - hemorrhages in the conjunctiva, intraocular bleeding;
- from the musculoskeletal system: very often - arthralgia; often - myalgia, bone pain;
- from the immune system: infrequently - hypersensitivity reactions;
- local reactions: very often - nonspecific reactions, pain and redness at the injection site; often - hematoma, bleeding, hemorrhage, induration, inflammation, discoloration of the skin, soreness and formation of nodules at the injection site; rarely - tissue necrosis at the injection site;
- others: very often - weakness, pain in the chest, fever; often - weight loss.
special instructions
The use of Vaidaza should be carried out in a hospital under the supervision of an oncologist.
In severe congestive heart failure and other cardiovascular or pulmonary pathologies, the safety of use and the effectiveness of drug therapy have not been established.
Treatment in each cycle should be started after receiving the results of the study of serum creatinine, liver functional activity, and a detailed blood test. Conducting regular blood tests allows you to monitor the general condition of the patient and the effectiveness of the drug.
Most often, the risk of developing hematological reactions [leukopenia, thrombocytopenia, neutropenia (usually 3-4 degrees of severity)] occurs during the first and second cycles of therapy. In patients with recovered hematological parameters, the frequency of their occurrence decreases. With hematological reactions, a delay in the start of the next cycle of therapy is indicated, with neutropenia - the prophylactic administration of antibiotics, a colony-stimulating factor, with anemia or thrombocytopenia - blood transfusions.
Careful monitoring of body temperature and symptoms indicating the development of bleeding is required, especially in patients with thrombocytopenia.
Patients with infectious complications are shown the appointment of etiotropic therapy, with neutropenia - a colony-stimulating factor.
If anaphylactic reactions develop, the use of azacitidine should be discontinued immediately.
With the development of local adverse reactions in the form of rash, inflammation, itching at the injection site, erythema, it is possible to prescribe antihistamines, non-steroidal anti-inflammatory drugs, corticosteroids.
The use of the drug in patients with common metastatic liver lesions is associated with a risk of death in the development of hepatic coma.
In rare cases, during therapy with azacitidine, renal dysfunction occurs with varying severity, including an increase in creatinine levels, renal tubular acidosis, and renal failure with a fatal outcome.
In the event of an unexplained decrease in serum bicarbonate levels, an increase in blood urea concentration or serum creatinine level, the start of the next cycle of therapy should be postponed until the parameters of these parameters are restored to their original or normal values, while the dose of the drug must be adjusted in the next cycle. Patients with renal insufficiency need to ensure careful monitoring of the state of renal function.
Men and women of childbearing age need to use reliable contraceptive methods during and after treatment for three months. The physician should advise men to consider the preservation of semen samples before using Vaidaza.
The appointment of symptomatic therapy is shown: with nausea and vomiting - antiemetics, with diarrhea - antidiarrheals, with constipation - laxatives.
Disposal of unused or consumable Vidaza should be carried out in accordance with the requirements for cytotoxic drugs.
In case of accidental contact of the suspension with the skin or mucous membrane, rinse the area thoroughly with water.
Patients need to be especially careful when driving vehicles and mechanisms.
Drug interactions
Since the likelihood of the participation of isoenzymes of the cytochrome P 450 system, sulfotransferase, glutathione transferase, UDP-glucuronyl transferase in the metabolism of azacitidine is insignificant, the interaction with these enzymes is not clinically significant.
Analogs
Vaidaza analogs are: Aleksan, Gemtaz, Gemzar, Gemita, Gemcitabine, Tutabin, Fluorouracil.
Terms and conditions of storage
Keep out of the reach of children.
Store at temperatures up to 30 ° C.
Shelf life is 4 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
