Epirubicin

The drug Epirubicin (Epirubicin) is a cytotoxic antibiotic from the class of antineoplastic agents, which is used in chemotherapy to treat various types of cancer. It is widely used in the treatment of breast cancer, ovarian cancer, bladder cancer and other cancers.

Epirubicin is used as part of combination chemotherapy regimens or can sometimes be used in monotherapy. It is administered into the patient's body by intravenous injection under the supervision of a doctor or medical staff.

Like other anticancer drugs, Epirubicin may cause side effects, including nausea, vomiting, hair loss, decrease in the number of white blood cells and platelets in the blood and others. The dosage and regimen of the drug are determined by the doctor depending on the type and stage of cancer, as well as individual characteristics of the patient.

Indications Epirubicin

1. Breast Cancer: Epirubicin can be used in both adjuvant (postoperative) chemotherapy to prevent breast cancer recurrence and in the treatment of metastatic breast cancer.
2. Ovarian Cancer: Epirubicin can be used in combination with other anticancer drugs to treat ovarian cancer.
3. Bladder Cancer: The use of Epirubicin may be part of combination chemotherapy regimens for the treatment of bladder cancer.
4. Gastric and other cancers: Epirubicin may be used in combination with other chemotherapy drugs to treat a variety of cancers, including stomach cancer and other cancers of the digestive system.

Release form

1. Solution for Injection: Epirubicin is supplied as a concentrated solution for injection. This solution is usually given intravenously into the patient's body, usually in a medical setting under the supervision of medical personnel.

Epirubicin solution is commonly used to treat various types of cancer such as breast cancer, ovarian cancer, stomach cancer, leukemia and other tumors.

Pharmacodynamics

The mechanism of action of epirubicin is related to its ability to interact with the DNA of cells and disrupt their normal function. The main mechanism of action of epirubicin is binding to DNA and inhibiting topoisomerase II, an enzyme that is responsible for unwinding and cleaving DNA during its replication and repair. This leads to disruption of DNA copying and repair processes, which ultimately leads to tumor cell death.

Epirubicin also has cytotoxic effects on cancer cells through induction of apoptosis (programmed cell death) and other mechanisms, which also helps reduce tumor size.

Like other anthracycline drugs, epirubicin is highly affinity to cardiomyocytes (heart muscle cells), which may lead to cardiotoxicity. Therefore, its use is usually accompanied by monitoring of cardiac function during treatment.

Pharmacokinetics

1. Absorption: Epirubicin is usually given intravenously into the body. After intravenous administration, the drug is rapidly distributed throughout the body.
2. Distribution: Epirubicin is well distributed in body tissues, including tumor tissues. It can penetrate the plasma barrier and reach the tumor.
3. Metabolism: Epirubicin is metabolized in liver with formation of active metabolites and inactive products. The main active metabolite is epirubicin aglycone.
4. Excretion: The drug and its metabolites are eliminated from the body mainly through the kidneys, both unchanged and in the form of metabolites.
5. Concentration: Peak plasma concentrations of epirubicin are usually reached within 5-15 minutes after intravenous administration.
6. Duration of action: The duration of action of epirubicin may vary depending on its dose, regimen, and individual patient characteristics.
7. Interactions with other medicinal products: Epirubicin may interact with other medicinal products, which may lead to strengthening or weakening of its effect, as well as to the occurrence of undesirable side effects.

Dosing and administration

1. For the treatment of breast cancer:

   • Epirubicin is usually given in combination with other anticancer drugs such as cyclosfamide and taxanes.
   • The usual dose of epirubicin may be in the range of 60-90 mg/m² body surface area, with injections usually given every 21 days.

2. To treat other types of cancer:

   • For other cancers, such as ovarian cancer, stomach cancer, or some leukemias, the dosage and regimen may vary. They are usually determined by your doctor according to your treatment protocols.

3. Method of Application:

   • Epirubicin is given by slow intravenous infusion into a vein (usually in 5-15 minutes).
   • Injections are usually given in an inpatient setting under the supervision of medical staff, as epirubicin can have side effects and requires close monitoring.

4. Duration of the course of treatment:

   • The duration of treatment with epirubicin is also determined by your doctor and may vary depending on your response to treatment and other factors. The course is usually several months.

Use Epirubicin during pregnancy

The use of epirubicin during pregnancy may pose serious risks to both the mother and the developing fetus.

There are limited data on the safety of epirubicin during pregnancy and its use is generally not recommended during this period. The drug is FDA Category D for use during pregnancy. This means that there is evidence of risk to the fetus, but the potential benefits of its use in some cases may justify the risk.

The use of epirubicin during pregnancy may have various adverse effects, including the risk of toxic effects on the fetus, possible defects in fetal development, and the risk of premature birth or miscarriage.

If a woman is found to be pregnant or planning to become pregnant during treatment with epirubicin, it is important to discuss this with her doctor. The doctor can assess the benefit of continuing or stopping chemotherapy and suggest alternative treatments or management strategies that may be safer for the pregnancy.

Contraindications

1. Hypersensitivity or allergic reaction to epirubicin or other anthracycline antibiotics (e.g., doxorubicin, daunorubicin, and others).
2. Severe cardiovascular insufficiency: The use of Epirubicin is contraindicated in patients with severe cardiac dysfunction, including heart failure, heart rhythm disorders and other cardiovascular diseases.
3. Severe hepatic and renal impairment: The drug should be used with caution in patients with hepatic and/or renal impairment and dosage adjustment may be required in these cases.
4. Severe hematopoietic disorders: The use of Epirubicin may be contraindicated in patients with severe anemia, leukopenia, thrombocytopenia or other disorders of hematopoiesis.
5. Pregnancy and breastfeeding: The use of Epirubicin is contraindicated during pregnancy, as the drug may cause harm to the fetus. It is also not recommended to use the drug during breastfeeding.
6. Pediatric age: Epirubicin may be contraindicated in children depending on their age, general condition and treatment.

Side effects Epirubicin

1. Cardiac Toxicity: Epirubicin may cause cardiotoxicity, manifested by an increased risk of heart failure, heart rhythm disturbances, or even the development of cardiac dystrophy. This is one of the most serious side effects of this drug.
2. Skin Toxicity: Skin reactions such as redness, rash, itching, dryness or flaking of the skin may occur.
3. Bone marrow toxicity: Epirubicin may decrease the number of hematopoietic cells in the bone marrow, resulting in anemia, thrombocytopenia (decreased platelet count), and leukopenia (decreased white blood cell count).
4. Gastrointestinal Toxicity: Nausea, vomiting, diarrhea, anorexia (loss of appetite), mucous characteristic of the mouth may occur.
5. Hair and nails: There may be problems with hair (hair loss) and nails (changes in structure).
6. Systemic reactions: Including fever, generalized weakness, fatigue.
7. Allergic reactions: In rare cases, allergic reactions such as urticaria, pruritus, angioedema may occur.
8. Increased risk of infections: Due to a decrease in the number of white blood cells, there is an increased risk of infections.

Overdose

1. Toxic effects on hematopoiesis: Epirubicin may cause toxic effects on the hematopoiesis, including decreased numbers of white blood cells (leukopenia), platelets (thrombocytopenia), and red blood cells (anemia). This can lead to an increased risk of infections, bleeding, and anemia.
2. Cardiac toxic effects: Epirubicin may cause cardiotoxicity, including cardiomyopathy and heart failure. The increased risk of cardiotoxicity is dose-related.
3. Other toxic effects: Epirubicin overdose can also lead to unwanted effects such as nausea, vomiting, oral ulcers, diarrhea, and hypersensitivity to infections.
4. Medical intervention: In case of suspected overdose of epirubicin, immediate medical attention should be sought. Treatment of overdose may include measures to reduce the toxic effects of the drug, maintenance of vital functions, and symptomatic therapy.
5. Preventionof overdose: To prevent overdose it is important to strictly follow the doctor's recommendations regarding the dosage and regimen of epirubicin. Before starting treatment, the doctor should assess the patient's condition and choose the optimal dose of the drug.

Interactions with other drugs

1. Drugs that may increase cardiotoxicity: Certain drugs, such as other anticancer drugs (e.g., doxorubicin, tretiosirubin), cardiotoxic antibiotics (e.g., ampicillin), or drugs that increase cardiotoxicity (e.g., cyclosporine), may increase the risk of cardiac complications with epirubicin.
2. Drugs that decrease hematopoiesis: Epirubicin may increase the hematologic side effects of other drugs that also inhibit hematopoiesis, such as aspirin, some antibiotics, and some anticoagulants.
3. Drugs that increase hypersensitivity: Epirubicin may increase skin hypersensitivity when combined with drugs such as photosensitizing antibiotics (e.g., tetracyclines), certain antifungal drugs (e.g., ketoconazole), or drugs that increase photosensitivity (e.g., ammonia).
4. Drugs affecting liver function: Epirubicin is metabolized in the liver, therefore drugs that affect liver function may alter its metabolism and increase its toxic effects.
5. Drugs affecting renal function: Epirubicin and its metabolites can be excreted through the kidneys, therefore drugs affecting renal function may alter its excretion and increase the risk of toxic effects.

Storage conditions

1. Temperature: Epirubicin should normally be stored at a controlled temperature of 20 to 25°C. Avoid extreme temperatures and temperature fluctuations.
2. Light: It is best to store epirubicin in its original packaging protected from direct sunlight. Light may adversely affect the stability of the drug.
3. Humidity: Humid storage conditions should be avoided. Epirubicin should not come in contact with moisture or be stored in areas with high humidity.
4. Packaging: Follow the storage instructions on the drug package. It is important to store the drug in a closed package or container to prevent contamination or contamination.
5. Children and pets: Keep Epirubicin out of the reach of children and pets to prevent accidental use.
6. Shelf life: The expiration date of the drug should be observed. Do not use epirubicin after the expiration date as this may result in loss of efficacy or undesirable effects.
7. Disposal: Unused or expired epirubicin should be disposed of in accordance with local regulatory requirements or hazardous chemical disposal guidelines.