Buy Epirubicin-Ebeve solution concentrate 2 mg/ml vial 5 ml package
  • Buy Epirubicin-Ebeve solution concentrate 2 mg/ml vial 5 ml package

Epirubicin

Ebeve Pharma
1642 Items
2019-09-19
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Clinical Pharmacology

At the molecular level, forms a complex with DNA through the intercalation of epirubicin between the main nucleotide pairs, as a result of which the synthesis of DNA, RNA and proteins is disrupted. In addition, the intercalation of vDNA is the trigger of DNA cleavage under the action of topoisomerase II, which leads to serious violations in the tertiary structure of DNA. Epirubicin can be involved in redox reactions with the formation of highly active and highly toxic free radicals.

Pharmacokinetics

After IV injection is rapidly distributed in the tissues. Does not penetrate the BBB. Communication with proteins (mainly with albumin) - 77%.
Metabolized by oxidation in the liver to form the major metabolite of epirubicin (13-hydroxyepirubicin) and glucuronic acid conjugates. Removal of the drug from the body is three-phase in nature with a slow final phase lasting 30–40 hours. It is mainly excreted in the bile and partly in the urine in unchanged form and in the form of metabolites. After 72 hours, approximately 43% of the drug is determined in bile and approximately 16% in urine.

Indications

breast cancer, ovarian cancer, non-small cell and small cell lung cancer, cancer of the stomach and esophagus, primary hepatocellular carcinoma, transitional cell bladder cancer, soft tissue sarcoma, osteosarcoma, non-Hodgkin's lymphoma, Hodgkin's disease, acute leukemia, multiple myeloma, pancreatic cancer , rectal cancer, head and neck cancer.

Composition

1 ml of concentrate contains:

Active ingredient: epirubicin hydrochloride 2 mg;

Excipients: sodium chloride, hydrochloric acid diluted, water for injection

Epirubicin is marketed under different brands and generic names, and comes in different dosage forms:

Brand nameManufacturerCountryDosage form
Epirubicin-Ebeve Ebeve Pharma Austria solution concentrate
Vero-Epirubicin Veropharm Russia bottle
Epirubicin-Ebeve Lance farm Russia solution

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Epirubicin

Dosage and Administration

IV, in the cavity, in / a. Epirubicin can be used both as monotherapy and in combination with other cytotoxic drugs in various doses, depending on the regimen of therapy. When individual dose should be guided by the data of special literature.

IV the introduction. As a monotherapy, the recommended standard dose per cycle for adults is 60–90 mg / m2every 3-4 weeks The total dose of the drug per cycle can be administered both simultaneously, and divided into several injections, within 2-3 days.

When combined with other anticancer drugs, the recommended dose per cycle should be reduced accordingly. In some cases, can be used high doses - 90-120 mg / m2 once with an interval of 3-4 weeks. Repeated administrations are possible only with the disappearance of all signs of toxicity (especially gastro and hemotoxicity).

Renal impairment:

- In patients with severe impaired renal function (serum creatinine> 5 mg / dL), lower doses of Epirubicin should be used.

Liver dysfunction:
- when the concentration of bilirubin in the serum is in the range of 1.2–3 mg / dL or the AST level is 2–4 times higher than the upper limit of normal (VGN), the administered dose of the drug should be reduced by 50% of the recommended dose;

- when the concentration of bilirubin in the serum of more than 3 mg / dL or AST value is more than 4 times higher than VGN, the dose should be reduced by 75% from the recommended.

It is recommended to assign lower doses or increase the intervals between cycles in patients who have previously received massive antitumor therapy, as well as in patients with bone marrow tumor infiltration. In elderly patients, during initial therapy, standard doses and regimens can be used.

To reduce the risk of thrombosis and extravasation, Epirubicin is recommended to be administered through the tube of the system for intravenous infusion, during the infusion of 0.9% sodium chloride solution or 5% dextrose solution. The duration of the infusion is 3–20 min, depending on the dose of the drug and the volume of the infusion solution.

Introduction to the bladder. For the treatment of superficial bladder tumors, 8 weekly instillations of 50 mg each are recommended (in 25–50 ml of 0.9% sodium chloride solution). If symptoms of local toxicity (chemical cystitis) appear, the dose should be reduced to 30 mg.

When treating bladder cancer in situ, depending on individual tolerance, the dose of the drug can be increased to 80 mg.

To prevent recurrence after transurethral resection of superficial tumors, it is recommended to perform 4 weekly instillations of 50 mg each followed by 11 monthly instillations at the same dose.

Epirubicin is injected into the bladder through a catheter and left inside the bladder for 1 hour. During the instillation, the patient should roll over from side to side to ensure a uniform effect of the solution on the bladder mucosa. In order to prevent excessive dilution of the drug with urine, patients should be warned to refrain from drinking for 12 hours before instillation. At the end of the instillation procedure, the patient should empty the bladder.

Special care should be taken when bladder catheterization occurs during urethral obstruction due to massive intravesical tumors.

In / a introduction. Patients with hepatocellular carcinoma can be injected into the main hepatic artery at a dose of 60–90 mg / m to provide intensive local exposure while reducing the overall toxic effect of epirubicin.2 with an interval of 3 weeks to 3 months or at a dose of 40-60 mg / m2 with an interval of 4 weeks.

Adverse reactions

On the part of the blood system: leukopenia, neutropenia, possible thrombocytopenia and anemia.Cytopenia usually reaches its maximum value 10–14 days after drug administration; recovery of the blood picture is usually observed on day 21.

Since the cardiovascular system: manifestations of early (acute) cardiotoxicity of epirubicin is mainly sinus tachycardia and / or abnormality on the ECG (non-specific change of ST-T waves). Tachyarrhythmia is also possible, including ventricular extrasystoles and tachycardias, as well as bradycardia, atrioventricular block, and His blockade. The occurrence of these phenomena is not always a prognostic factor for the development of subsequently delayed cardiotoxicity, they are rarely clinically significant, and usually do not require discontinuation of the drug. Late (delayed) cardiomyopathy is manifested by a decrease in the left ventricular ejection fraction (LVEF) and / or such symptoms of congestive heart failure (CHF), such as shortness of breath, pulmonary edema, orthostatic edema, cardio-and hepatomegaly, oliguria, ascites, exudative pleurisy, gallop rhythm Subacute events such as pericarditis / myocarditis may also occur. The most severe form caused by anthracyclines of cardiomyopathy is life-threatening CHF, which is toxicity that limits the total dose of the drug.

On the part of the gastrointestinal tract organs: anorexia, nausea, vomiting, stomatitis, hyperpigmentation of the oral mucosa, esophagitis, pain or a burning sensation in the abdomen, erosion of the stomach, bleeding from the gastrointestinal tract, diarrhea, colitis, an increase in total bilirubin and liver transaminase activity in serum.

On the part of the urinary system: urine staining in red for 1-2 days after drug administration. Possible hyperuricemia.

On the part of the organs of vision: conjunctivitis, keratitis.

On the part of the endocrine system: amenorrhea (after the end of therapy, ovulation is restored, however, premature menopause is possible); oligospermia, azoospermia (in some cases the number of spermatozoa is restored to a normal level; this can happen after several years after the end of therapy); flushing of the face.

On the part of the skin and skin appendages: alopecia, rash, itching, sudden reddening of the skin, hyperpigmentation of the skin and nails, photosensitivity, hypersensitivity of the irradiated skin.

On the part of the vascular system: thromboembolic complications, including pulmonary embolism (in some cases with a fatal outcome).

Local reactions: erythematous striation along the vein in which the infusion was performed, local phlebitis or thrombophlebitis, phlebosclerosis (more often with repeated injections into the veins of small diameter). If the drug gets into the surrounding tissues - pain, suppuration and necrosis of the surrounding tissues.

When intra-arterial administration, gastric and duodenal ulcers may be observed in addition to systemic toxicity (probably due to reflux of the drug into the gastric artery); narrowing of the bile duct due to drug-induced sclerosing cholangitis.

When administered to the bladder: the development of chemical cystitis (dysuria, polyuria, nocturia, painful urination, hematuria, discomfort in the bladder area), necrosis of the walls and wrinkling of the bladder.

Others: general malaise, asthenia, fever, chills, anaphylaxis, the addition of secondary infections, the development of secondary acute lymphocytic leukemia or myeloid leukemia.

Contraindications

General: hypersensitivity to epirubicin and components of the drug, as well as to other anthracyclines or anthracendiones; pregnancy and breastfeeding; children's age (efficacy and safety have not been established).

Contraindications for intravenous administration: severe myelosuppression, severe liver dysfunction, severe heart failure and arrhythmias, recent myocardial infarction, prior therapy with other anthracyclines or anthracendiones in limiting total doses.

Contraindications for introduction into the bladder: invasive tumors with penetration into the bladder wall, urinary tract infections, cystitis.

Drug interactions

Epirubicin can increase the toxicity of other antitumor agents, especially myelotoxicity and toxic effects on the gastrointestinal tract.When using epirubicin as part of combination chemotherapy with other potentially cardiotoxic drugs, as well as when it is used simultaneously with other cardio-active drugs (for example, CCR), it is necessary to monitor cardiac activity during the entire period of treatment. Cimetidine increases T1/2 epirubicin (should be canceled at the time of last therapy).

Epirubicin should not be mixed with other drugs, with alkaline solutions (hydrolysis of epirubicin is possible), with heparin (a precipitate is formed).

Pregnancy and Lactation

Contraindicated

Overdosage

Symptoms: marked myelosuppression (mainly leukopenia and thrombocytopenia), toxic effects on the gastrointestinal tract (mainly mucositis), acute complications of the heart.

Treatment: symptomatic, antidote not known.

  • Brand name: Epirubicin-Ebeve
  • Active ingredient: Epirubicin
  • Dosage form: Concentrate for infusion
  • Manufacturer: Ebeve Pharma
  • Country of Origin: Austria

Studies and clinical trials of Epirubicin (Click to expand)

  1. High incidence of treatment failure with vincristine, etoposide, epirubicin, and prednisolone chemotherapy with successful salvage in childhood Hodgkin disease
  2. Cisplatin, epirubicin, and vindesine with or without lonidamine in the treatment of inoperable nonsmall cell lung carcinoma: A multicenter randomized clinical trial
  3. Mobilization, collection, and characterization of peripheral blood hemopoietic progenitors after chemotherapy with epirubicin, paclitaxel, and granulocyte-colony stimulating factor administered to patients with metastatic breast carcinoma
  4. Multimodality treatment of 128 patients with locally advanced breast carcinoma in the era of mammography screening using standard polychemotherapy with 5-fluorouracil, epirubicin, and cyclophosphamide : Prognostic and therapeutic implications
  5. Preliminary report of the asian-oceanian clinical oncology association randomized trial comparing cisplatin and epirubicin followed by radiotherapy versus radiotherapy alone in the treatment of patients with locoregionally advanced nasopharyngeal carcinoma
  6. A randomized Phase III trial of etoposide, epirubicin, and cisplatin versus 5-fluorouracil, epirubicin, and cisplatin in the treatment of patients with advanced gastric carcinoma
  7. High rate of clinical complete response to weekly outpatient neoadjuvant chemotherapy in oral carcinoma patients using a new regimen of cisplatin, 5-fluorouracil, and bleomycin alternating with methotrexate and epirubicin
  8. Mobilization, collection, and characterization of peripheral blood hemopoietic progenitors after chemotherapy with epirubicin, paclitaxel, and granulocyte-colony stimulating factor administered to patients with metastatic breast carcinoma
  9. Suramin in combination with weekly epirubicin for patients with advanced hormone-refractory prostate carcinoma
  10. Phase II trial of chemotherapy with 5-fluorouracil, bleomycin, epirubicin, and cisplatin for patients with locally advanced, metastatic, or recurrent undifferentiated carcinoma of the nasopharyngeal type
  11. A Phase II trial of high dose epirubicin in patients with advanced breast carcinoma
  12. Response to epirubicin in patients with superficial bladder cancer and expression of the topoisomerase II α and β genes
  13. Activated cell cycle checkpoints in epirubicin-treated breast cancer cells studied by BrdUrd-flow cytometry
  14. A phase I–II study of epirubicin, 5-fluorouracil, and leucovorin in advanced adenocarcinoma of the stomach
  15. Intravesical 4′-epi-doxorubicin(epirubicin) versus bacillus calmette—guérin. A controlled prospective study on the prophylaxis of superficial bladder cancer
  16. Alternated approach with local irradiation and combination chemotherapy including cisplatin or carboplatin plus epirubicin and etoposide in intermediate stage non-small cell lung cancer
  17. Alternated approach with local irradiation and combination chemotherapy including cisplatin or carboplatin plus epirubicin and etoposide in intermediate stage non-small cell lung cancer
  18. Phase I/II trial of dexverapamil, epirubicin, and granulocyte-macrophage–colony stimulating factor in patients with advanced pancreatic adenocarcinoma
  19. Epirubicin-lipiodol chemotherapy versus 131iodine-lipiodol radiotherapy in the treatment of unresectable hepatocellular carcinoma
  20. Phase II study of paclitaxel and epirubicin as first-line treatment in patients with metastatic nonsmall cell lung carcinoma
  21. Paclitaxel, cisplatin, and epirubicin first-line chemotherapy in Stage III and IV ovarian carcinoma : Long term results of a Phase II study
  22. Phase II trial of epirubicin, cisplatin, oral uracil and tegafur, and leucovorin in patients with advanced gastric carcinoma
  23. Randomized study comparing 4′-epi-doxorubicin (Epirubicin) versus doxorubicin as a part of induction treatment in adult acute lymphoblastic leukemia

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