|The name of the preparation||Character; dose; package||Manufacturer||Price 100%||Price after refund||In which pharmacy?|
|Adriblastina PFS||solution for injection; 2 mg / ml (10 mg / 5 ml); 1 fiol 5 ml||Pfizer Europe||b / d||Check|
|Adriblastina PFS||solution for injection; 2 mg / ml (50 mg / 25 ml); 1 fiol 25 ml||Pfizer Europe||b / d||Check|
Note: reimbursed drug prices are in line with the regulations in force from July 1, 2018.
It is an anti-cancer antibiotic used in cancer Chemotherapy .
The active substance is doxorubicin , an antibiotic from the anthracycline group with cytotoxic activity (toxic to cells). The action of doxorubicin is based on the formation of stable complexes with DNA nucleic acid molecules and with enzymes responsible for the proper DNA structure which leads to nucleic acid fragmentation, prevents its replication and transcription, and consequently leads to cell death. The effect applies particularly to rapidly dividing cells, including cancer cells. Doxorubicin is widely used in cancer chemotherapy.
The preparation is indicated for the treatment of the following types of cancer:
• acute lymphoblastic leukemia
• acute myeloid leukemia
• chronic leukemia
• Hodgkin's disease
• non-Hodgkin's lymphomas
• multiple myeloma
• soft tissue sarcomas and bone tissue
• sympathetic neuroma (neuroblastoma)
• Williams' tumor
• breast cancer, also as a component of adjuvant treatment in women after resection of breast cancer with axillary involvement
• endometrial cancer
• non-seminomatous testicular cancer
• prostate cancer
• bladder cancer
• lung cancer
• primary hepatocellular carcinoma
• head and neck cancer
• thyroid cancer.
Unfortunately, even if there are indications to use the preparation, it can not always be used. You can not use the product if you are allergic (you are hypersensitive) to any of the ingredients or to other preparations with a similar chemical structure (other anthracyclines, anthracenediones). The use of the preparation is contraindicated in pregnant women and during breastfeeding. You can not use the preparation if you have been diagnosed with:
• long-term bone marrow suppression
• severe liver failure
• severe heart failure
• severe arrhythmias
• a recent heart attack
and, if you have already received the maximum cumulative dose of doxorubicin or daunorubicin and / or other anthracyclines and anthracenediones.
Doxorubicin should not be administered intramuscularly or subcutaneously.
Certain diseases and other circumstances may constitute a contraindication to use or indication to change the dosage of the preparation. In certain situations, it may be necessary to carry out specific check-ups. Treatment may only be carried out under the supervision of an oncologist who has experience in the use of cancer chemotherapy. Hospital treatment is recommended, at least in the initial period, as close observation and laboratory tests are necessary. Before starting treatment, your doctor will recommend heart and liver function tests as well as hematological tests.Treatment may be initiated only after the acute symptoms of toxicity of previously used cytotoxic treatment such as stomatitis, thrombocytopenia, neutropenia (decrease in neutrophil counts in blood counts) and generalized infections have resolved.
The use of the preparation is associated with the risk of dose-dependent cumulative cardiotoxicity. Do not exceed the cumulative dose of 450-550 mg / m2 body surface area. Symptoms of cardiac dysfunction may occur at the beginning of treatment (early actions) and also after many months or even years after the end of treatment (late effects). Early cardiotoxic effects (ECG changes, tachyarrhythmia, ventricular tachycardia, reduction of cardiac function, atrioventricular block) are rarely clinically relevant. Among late cardiotoxic actions, life-threatening congestive heart failure is the most dangerous (symptoms include dyspnoea, pulmonary edema, leg edema, enlargement of the heart and liver, oliguria, ascites, pleural effusion, gallbladder rhythm). The risk of cardiotoxicity is higher in people undergoing mediastinal irradiation, taking other anthracycline antibiotics and / or anthracenediones, in people with a history of cardiac disease and in children and adolescents. Before starting treatment, during and after treatment, your doctor will recommend regular ECG (or echocardiography or scintigraphy) to monitor cardiac function. Some changes in ECG or echocardiography may require discontinuation of doxorubicin.
Your doctor will recommend regular hematological examinations during treatment because there is a risk of bone marrow suppression. There is a high risk of leucopenia and neutropenia (respectively, a decrease in the number of white blood cells [leukocytes] and neutrophils in the blood count) and a lower risk of thrombocytopenia (reduced platelet counts) and anemia. Usually the values of blood counts are at the minimum (nadir) after 10-14 days after drug administration and return to normal values within 3 weeks of administration. The results of haematological tests may sometimes require a delay in the onset (or continuation) of treatment with the preparation and may be an indication for dose reduction or for discontinuation of the preparation. Severe bone marrow suppression may lead to haemorrhage, infections, sepsis, septic shock, tissue hypoxia and death.
In the treatment of benign and malignant tumors (including cysts and polyps) doxorubicin in combination with other drugs that damage DNA increases the risk of secondary leukemia.
Administration of the preparation often causes nausea, vomiting and mucositis, sometimes with very severe course (ulcer) requiring proper treatment. Usually, mucositis will subside to the 3rd week of treatment. To prevent nausea and vomiting and to relieve it, the doctor may recommend prophylactic antiemetic preparations.
Hepatic dysfunction or failure may increase the overall toxic effect of the drug. Your doctor will monitor your liver function before and during treatment with the product (AST, ALT, alkaline phosphatase, bilirubin enzymes). If necessary, your doctor will advise you to reduce the doses of the preparation.
If during the infusion (intravenous infusion) of the drug extravasation occurs, manifested by pain and burning sensation at the injection site, the medical staff will immediately stop the infusion and remove the extravasated drug solution from the spirit. After administration of the drug, attention should be paid to extravasation around the vein, which may cause local necrosis and thrombophlebitis. Repeated injections may lead to hardening of the vein.
The preparation may increase the toxicity of other anticancer treatments (eg exacerbation of hemorrhagic cystitis after cyclophosphamide, worsening of hepatotoxicity of mercaptourine, intensification of toxic irradiation).
The use of the preparation may cause vein thrombosis and even death due to thromboembolic complications (pulmonary embolism).
The use of chemotherapy is associated with the risk of hyperuricaemia (increased uric acid in the blood) and the onset of gout or nephropathy. Your doctor will monitor the concentration of uric acid in your blood. You should consume adequate amounts of liquids, at least 3 liters / m2 of body surface area per day.
Persons being treated with the preparation (both men and women) should absolutely consult a doctor about the use of effective contraception to prevent pregnancy during the treatment period and at least for 3-6 months after its completion.
The preparation may cause red urine, especially after the first administration of the medicine. This does not require special handling.
Does this preparation affect the ability to drive vehicles?
There are no studies on the effects of the preparation on the ability to drive and use machines. However, side effects after use (drowsiness, nausea, vomiting) may reduce the ability to drive or use machines.
The preparation is a solution for injection. The solution is administered as an intravenous infusion (together with sodium chloride and Glucose ) lasting 3-10 minutes. The preparation may only be administered by qualified medical personnel. If you have any doubts regarding the use of the preparation, consult a physician. The doctor will select the dosage individually depending on the indication, the expected result, the clinical situation, and whether the preparation will be used as a monotherapy or as a component of multidrug chemotherapy:
Monotherapy usually uses one of the following two dosage regimens:
-60-90 mg / m2 of body surface area in a single intravenous infusion, every 3-4 weeks
-20-30 mg / m2 of body surface / day for 3 consecutive days, every 3-4 weeks
-30-45 mg / m2 of body surface area / day on days 1 and 8 of the cycle, every 3-4 weeks.
In multi-drug chemotherapy, the dose must be reduced (30-60 mg / m2 body surface area in one cycle).
If you have liver problems, your doctor will reduce the dose according to your bilirubin (usually 2-4 times). In case of severe hepatic insufficiency, the preparation should not be used. In people with renal impairment, no dose adjustment is usually necessary.
In the case of previous radiotherapy, anti-cancer therapy, treatment of children, the elderly, obese people or people with cancer in the bone marrow, the doctor will consider using smaller doses or extending the time interval between consecutive treatment cycles.
In the case of multi-drug chemotherapy, the bone marrow suppression may be more pronounced due to the additive effect of the drugs.
During pregnancy, do not use any medicine without consulting your doctor!
It is very important that before using any medicine during pregnancy or breastfeeding, consult a physician and explain beyond any doubt the potential risks and benefits associated with the use of the drug. If you are pregnant or plan to become pregnant, please inform the doctor prescribing the prescription for this medicine. Also, see the warnings in the "Take special care with the preparation" section.
The preparation is contraindicated during pregnancy and during breastfeeding.
Tell your doctor about all medicines you have recently taken, including those that are over the counter.
Parallel use of cytotoxic, anti-cancer, myelosuppressant or irradiation drugs increases cardiotoxicity, gastrointestinal toxicity and bone marrow depression effects of doxorubicin. Doxorubicin intensifies the action of radiotherapy and may cause severe symptoms of the irradiated area, even if it is used longer than the end of radiotherapy. Doxorubicin may increase the toxic effects of medicines used to treat cancer (streptozocin, Methotrexate , cyclophosphamide). Parallel use of drugs that are toxic to the liver (eg methotrexate) may exacerbate the toxic effects of doxorubicin.
Verapamil (and other Calcium antagonists) may increase the cytotoxic effect of the preparation. Doxorubicin may exacerbate hemorrhagic cystitis caused by cyclophosphamide.
Parallel use with ciclosporin may result in increased levels of both drugs in the blood and have an adverse effect on the immune system and increase the toxic effects of the drug on the bone marrow.
Cimetidine and Ranitidine (cytochrome P450 inhibitors) may reduce the metabolism and increase the toxic effect of the drug, and rifampicin and barbiturates may stimulate the metabolism of doxorubicin and reduce its effectiveness.
Paclitaxel taken before doxorubicin may cause an increase in its concentration in the blood (probably the effect is weaker if doxorubicin is taken before Paclitaxel ).
Like all medicines, Adriblastina PFS can cause side effects, although they will not occur in all patients using this product. Remember that the expected benefits of using the drug are usually greater than the damage resulting from the occurrence of side effects. Adverse reactions depend on the dose and may increase with the cumulative dose. In the treatment of benign and malignant tumors (including cysts and polyps) doxorubicin in combination with other drugs that damage DNA increases the risk of secondary leukemia.
Very often, possible bone marrow suppression including (mostly transient) hematological disorders: anemia, thrombocytopenia, leukopenia (decrease in the number of leukocytes in blood counts), neutropenia (decrease in neutrophil counts in blood counts). Cardiotoxic effects of the preparation are common: cardiac arrhythmia, ECG changes, cardiomyopathy, irreversible congestive heart failure. Cardiotoxic effects may occur immediately after taking the preparation or with delay, a few months and years after the end of treatment. Common: nausea, vomiting, mucositis (burning sensation, ulceration), diarrhea, anorexia, dehydration, malaise, weakness, chills, fever. Possible: reversible abnormal liver function (increased AST liver enzymes, ALT), reversible alopecia, nail diseases, conjunctivitis, tearing, thrombophlebitis, hyperuricemia, amenorrhea, decreased number or lack of sperm in semen, skin hypersensitivity reactions (rash, pruritus, urticaria, reaction at the injection site), and, occasionally, possible dangerous Anaphylactic reactions (angioneurotic edema that may impede breathing, bronchospasm, anaphylactic shock). Doxorubicin intensifies tissue reaction to irradiation; after some time possible secondary reactions (so-called reminder reactions). Doxorubicin causes a red urine.
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