Farmorubicin RD (10mg/5ml) 1 Ampoule Injection

Epirubicin HCl, a potent anthracycline antibiotic, exerts its cytotoxic effects primarily through DNA intercalation and inhibition of topoisomerase II. Upon entering the cell, epirubicin intercalates between DNA base pairs, leading to DNA strand breakage and interference with the replication process. This intercalation also stabilizes the topoisomerase II-DNA complex, preventing the enzyme from resealing broken DNA strands, further contributing to DNA damage. By disrupting DNA synthesis and repair mechanisms, epirubicin triggers cell cycle arrest and induces apoptosis in rapidly dividing cancer cells, ultimately leading to tumor regression.

Epirubicin HCl 10mg

Anthracycline antibiotic

Injection

The following are the uses of Epirubicin HCl 10mg injection:

• Used for treating early and advanced breast cancer, often as part of a chemotherapy regimen.
• Used for neoadjuvant treatment before surgery to shrink tumors.
• Used for adjuvant therapy to reduce the risk of cancer recurrence after surgery.
• Used in combination with other drugs to treat advanced stomach cancer.
• Used as a treatment option for soft tissue sarcomas.
• Used to manage certain types of ovarian cancer, sometimes in combination with other medications.
• Used in clinical trials for various cancers to evaluate its effectiveness and safety.
• Used in tailored chemotherapy approaches based on individual patient needs.

In the case of an overdose of Epirubicin HCl 10mg injection, prompt medical intervention is necessary. Symptoms may include severe bone marrow suppression, leading to decreased blood cell counts and an increased risk of infection. Gastrointestinal issues such as nausea, vomiting, and diarrhea can also occur. Medical professionals should be contacted immediately to initiate supportive care, manage symptoms, and prevent potential long-term complications associated with this potent medication.

In the case of a missed dose of Epirubicin HCl 10mg injection, it is important to contact your healthcare provider for guidance. Do not attempt to double the dose or take an extra dose to make up for the missed one. Your healthcare provider will likely advise you to continue with the next scheduled dose and may adjust the remaining doses accordingly. It is crucial to follow their instructions carefully to ensure the effectiveness of the treatment and minimize potential side effects.

To administer Epirubicin HCl 10mg injection, reconstitute the vial with the provided diluent, gently swirl to dissolve, and then inject the prepared solution intravenously over a period of 3-5 minutes, ensuring the infusion is completed within 30 minutes to minimize toxicity risks.

Here are the conditions or situations when Epirubicin HCl 10mg injection should not be administered:

• Must not be used in patients with a known allergy or hypersensitivity to Epirubicin HCl or any other anthracycline drugs.
• Contraindicated in patients with severe liver impairment or liver disease, as it can lead to increased toxicity.
• Should not be used in patients with a low white blood cell count (neutropenia) or a history of severe neutropenia.
• Not recommended for patients with severe heart disease or those who have previously received high cumulative doses of anthracyclines.
• Avoid in patients with active infections until the infection is controlled.
• Do not administer to breastfeeding mothers, as it can pass into breast milk and harm the nursing infant.
• Not suitable for patients with a history of severe bleeding disorders.

The side effects of Epirubicin HCl 10mg injection may include:

• Nausea and vomiting
• Hair loss (alopecia)
• Mouth sores
• Fatigue and weakness
• Diarrhea
• Low white blood cell count (increasing infection risk)
• Skin reactions (redness, peeling, or swelling at the injection site)
• Heart problems (cardiotoxicity), which may lead to irregular heartbeat or congestive heart failure

Following are the precautions and warnings for Epirubicin HCl 10mg injection:

• This medication is a potent cancer chemotherapy drug and should be handled with extreme care by healthcare professionals only.
• Epirubicin HCl can cause severe myelosuppression, leading to decreased white blood cells, red blood cells, and platelets. Regular blood tests are required to monitor blood cell counts.
• May cause severe nausea and vomiting. Antiemetic medications may be prescribed to manage these side effects.
• Cardiovascular toxicity is a serious concern, including the risk of congestive heart failure. Patients should be monitored for any signs of cardiac dysfunction.
• Avoid using in patients with a history of prior anthracycline therapy, as it may increase the risk of cardiac toxicity.
• Patients with liver or kidney impairment may require dose adjustments and should be closely monitored.
• Not recommended for use in pregnant or breastfeeding women due to potential harm to the fetus or infant.
• Extreme caution is necessary when handling and preparing the injection to prevent exposure and ensure proper disposal.

Following are the drug interactions for Epirubicin HCl 10mg injection:

• Avoid concurrent use with other cardiotoxic medications, such as other anthracyclines or trastuzumab, as it may increase the risk of cardiotoxicity and heart failure.
• Epirubicin may enhance the effects of other chemotherapy drugs, leading to increased toxicity and side effects.
• The use of bone marrow suppressants alongside Epirubicin can result in severe myelosuppression and increased infection risk.
• Concomitant administration with live vaccines should be avoided due to potential vaccine inactivation and possible infection.
• Drugs that induce or inhibit CYP3A4 enzymes may alter the metabolism of Epirubicin, affecting its efficacy and toxicity.
• Anticonvulsants like phenytoin or carbamazepine may reduce Epirubicin's effectiveness by increasing its clearance.
• Concurrent use with radiation therapy can increase the risk of radiation recall, a skin reaction at previous radiation sites.

Following are the food interactions to be aware of when taking Epirubicin HCl 10mg injection:

• Avoid consuming grapefruit or grapefruit juice as they may alter the drug's metabolism, potentially leading to increased toxicity.
• Alcohol consumption should be limited as it may increase the risk of certain side effects and negatively impact the effectiveness of the medication.
• Avoid eating cruciferous vegetables like broccoli, cauliflower, and cabbage, as they can affect the way this drug is broken down by the body.
• Dairy products should be consumed in moderation as they may interfere with the absorption of Epirubicin.
• Spicy foods might increase gastrointestinal discomfort and should be consumed sparingly.
• Limit the intake of foods rich in Vitamin K, such as leafy green vegetables, as they can impact the medication's anticoagulant effects.
• Ensure adequate hydration, but avoid excessive fluid intake, especially before and after the injection.
• Always consult your healthcare provider for personalized advice regarding dietary restrictions and interactions.

Epirubicin HCl 10mg injection should be stored in a controlled environment, specifically in a cool and dry place, maintaining a temperature range between 20°C and 25°C (68°F to 77°F). Protect the injection from direct sunlight and moisture to ensure its stability. Always keep the medication in its original packaging, tightly sealed, to prevent contamination. When disposing of Epirubicin HCl, it is crucial to follow safe disposal practices. Do not dispose of it in household garbage or pour it down the drain. Contact your healthcare provider or pharmacist for guidance on proper disposal methods to minimize environmental impact. Keep this medication securely locked away from children and pets to prevent accidental exposure.

Following are the quick tips for Epirubicin HCl 10mg injection:

• Ensure the injection is administered by a trained healthcare professional.
• Confirm the correct dosage and injection site as prescribed.
• Epirubicin should be handled with care; avoid contact with skin and eyes.
• Do not reuse needles or syringes; dispose of them safely.
• Store the injection as directed; protect it from light and moisture.
• Inform your doctor about all medications you are taking.
• Report any unusual symptoms or side effects promptly.
• Regularly monitor blood counts and liver function during treatment.