Remaxol® in Patients with Drug-induced Liver Injuries During Cancer Chemotherapy

Inclusion Criteria:

• The study can include all patients who are scheduled, at a physician's discretion,to receive the therapy with the drug Remaxol®, solution for infusions, orAdemethionine, lyophilizate for solution for intravenous and intramuscularinjection, according to the approved instruction for the medical use of the drug andestablished clinical practice of a healthcare facility, and who meet all thefollowing criteria:

1. Males and females aged from 40 to 70 years inclusive.

2. Verified diagnosis of neoplasm (morphologically proven).

3. Receiving the course polychemotherapy (PCT).

4. PCT regimens with pronounced hepatotoxic effects, which use drugs from thefollowing pharmacologic classes:

5. Competitive antagonists (5-Fluorouracil, Methotrexate etc.);

6. Alkylating agents (Cyclophosphamide, Oxaliplatin etc.);

7. Antitumor antibiotics (Doxorubicin, Bleomycin etc.);

8. Drugs influencing tubulin (Trabectedin, Paclitaxel etc.);

9. Topoisomerase inhibitors (Irinotecan, Etoposide etc.).

10. Contraindications for the continuation of PCT at the time of a visit to aphysician for its continuation, because of developed hepatotoxicity.

11. Stage of the treatment: supporting, hepatoprotective and detoxication therapyto correct hepatotoxicity developed during PCT, to remove it and continue thechemotherapeutic treatment.

12. A patient is scheduled to receive one of the following infusion therapies withthe following regimen, as part of the routine clinical practice:

13. It is planned to administer the drug Remaxol®, solution for infusions, byintravenous drop infusion in the dose of 400 ml/day, on everyday basis for 12days.

14. It is planned to administer the drug Ademethionine, lyophilisate for solutionfor intravenous and intramuscular injection, by intravenous drop infusion inthe dose of 800 mg/day, on everyday basis for 14 days. ECOG performance statusscore: 1-2 inclusive (Karnofsky score: 50-80 %).

15. Hepatotoxicity grade according to the classification of the US National CancerInstitute (NCCN, CTC) - 2 and 3.

16. Scores by selected parameters of CTCAE (National Cancer Institute CommonToxicity Criteria for Adverse Events) scale - I and II.

17. Patient's written consent for participation in the study according to thecurrent legislation.

Exclusion Criteria:

1. Pregnancy, breast-feeding.

2. Mental disorders requiring psychiatric observation.

3. Chronic alcohol abuse and/or substance abuse.

4. HIV-infection, syphilis, virus hepatitis, autoimmune hepatitis, storage diseases,tuberculosis.

5. Administration of monoclonal antibodies, (multi)kinase inhibitors during the PCTsession immediately preceding this study.

6. Administration of methionine-, Ademetionine-, malate- and/or succinate-containingmedicines during the last month.

7. Prescription of other malate-, succinate, or methionine-containing medicines (mexidol, cytoflavin, etc.).

8. Decompensation of any severe/clinically apparent somatic diseases of the kidneys,liver, cardiovascular system, respiratory system, endocrine system, etc., as decidedby the investigating physician.

9. Contraindications mentioned in the approved instructions for use of medicinesapplied in the study (idiosyncrasy to the product components).

10. Disease or use of medicines, which, in the doctor's opinion, can influence safety,tolerability and efficiency of the study medicines.