ADRIBLASTINA RAPID DISSOLUTION 10mg/5ml Injection/Powder for

What is ADRIBLASTINA RAPID DISSOLUTION 10mg/5ml

ADRIBLASTINA RAPID DISSOLUTION 10mg/5ml is a chemotherapeutic agent containing doxorubicin hydrochloride, an anthracycline antibiotic used primarily in the treatment of various cancers. It is presented as a lyophilized powder for reconstitution with a solvent ampoule, forming a solution for intravenous injection.

• Therapeutic class: Antineoplastic agent (Anthracycline class)
• Formulation: 1 vial containing 10mg doxorubicin hydrochloride + 1 solvent ampoule (5ml)
• Primary indications: Breast cancer, bladder cancer, lymphomas, leukemias, sarcomas, and other solid tumors.
• Mechanism: Acts by interfering with DNA replication and RNA transcription in cancer cells.
• Administration: Intravenous injection under professional supervision.

This medication is typically used in combination chemotherapy regimens and must be administered in a hospital or oncology clinic with appropriate monitoring due to its potent effects and potential toxicities.

How to use ADRIBLASTINA RAPID DISSOLUTION 10mg/5ml

ADRIBLASTINA RAPID DISSOLUTION should only be administered by healthcare professionals trained in the use of cytotoxic agents. Correct handling, preparation, and administration are essential to ensure therapeutic efficacy and minimize risks.

• Reconstitution: The lyophilized powder should be dissolved using the provided solvent ampoule (5ml). Gently swirl until fully dissolved—do not shake vigorously.
• Route: Administered exclusively via intravenous (IV) injection, either as a bolus or continuous infusion, typically through a central line to avoid extravasation.
• Environment: Must be prepared in a certified cytotoxic laminar airflow cabinet with protective gear.
• Monitoring: Regular cardiac monitoring (ECG, echocardiogram) and blood counts are essential before, during, and after treatment.
• Handling precautions: This is a hazardous drug. Avoid skin or mucosal contact; use gloves, goggles, and gowns during preparation and administration.
• Disposal: Dispose of all unused medication and medical waste according to hospital cytotoxic waste procedures.

Patients should be advised about potential side effects and the importance of reporting symptoms such as chest pain, breathlessness, or signs of infection immediately.

Mode of Action ADRIBLASTINA RAPID DISSOLUTION 10mg/5ml

Doxorubicin hydrochloride, the active component in ADRIBLASTINA RAPID DISSOLUTION, is a potent anthracycline antibiotic that exerts its antineoplastic effects through multiple mechanisms that interfere with cell division and survival of cancer cells.

• DNA Intercalation: Doxorubicin intercalates between DNA base pairs, disrupting the helical structure and preventing replication and transcription.
• Topoisomerase II Inhibition: Inhibits topoisomerase II enzyme, causing DNA strand breaks and inhibiting repair—leading to apoptosis (programmed cell death).
• Free Radical Generation: Generates free radicals which cause oxidative damage to cellular components including DNA, lipids, and proteins.
• Cell Cycle Specificity: Acts predominantly during the S-phase and G2-phase of the cell cycle, targeting rapidly dividing tumor cells.
• Cytotoxic effects: Directly toxic to neoplastic cells, leading to growth arrest, DNA fragmentation, and cell lysis.

The broad antitumor activity makes it effective in treating various malignancies, but its cytotoxicity also affects rapidly dividing healthy cells (e.g., bone marrow, GI mucosa, hair follicles), contributing to its side effect profile.

ADRIBLASTINA RAPID DISSOLUTION 10mg/5ml Interactions ADRIBLASTINA RAPID DISSOLUTION 10mg/5ml

Doxorubicin has a wide range of potential drug interactions, which must be carefully managed to avoid increased toxicity or reduced efficacy. Physicians should always review the patient’s full medication list.

• Cardiotoxic Drugs: Increased risk of cardiotoxicity with cyclophosphamide, trastuzumab, paclitaxel, and radiation therapy to the chest.
• CYP450 Interactions: Doxorubicin is metabolized by CYP3A4; inducers (e.g., phenytoin, rifampicin) may reduce efficacy; inhibitors (e.g., ketoconazole) may increase toxicity.
• Nephrotoxic/ototoxic drugs: Increased risk of organ toxicity when combined with cisplatin or aminoglycosides.
• Live vaccines: Immunosuppression may reduce vaccine effectiveness and increase the risk of infection. Avoid during therapy.
• Anticoagulants: Doxorubicin may alter INR when given with warfarin. Monitor coagulation parameters closely.

Interaction risk increases with polychemotherapy regimens; thus, clinical decisions must be guided by a qualified oncologist, including dose adjustments or monitoring strategies.

Dosage of ADRIBLASTINA RAPID DISSOLUTION 10mg/5ml

The dosage of ADRIBLASTINA (Doxorubicin) depends on the type of cancer, treatment regimen, patient’s weight, organ function (especially cardiac and hepatic), and prior therapy. It must be individualized and administered under strict oncological supervision.

• Standard adult dose (IV): 60–75 mg/m² once every 21 days when used alone; or 40–60 mg/m² when used in combination chemotherapy, divided over 2–3 days.
• Cumulative lifetime dose: Should not exceed 450–550 mg/m² due to the risk of irreversible cardiomyopathy.
• Hepatic impairment: Reduce dose based on serum bilirubin levels.
• Renal impairment: May require dose adjustment if severe, although not primarily renally excreted.
• Pediatric use: Adjust according to body surface area and organ maturity. Use with caution due to potential cardiac risks.

Important: Close monitoring of CBC, liver function, and cardiac function is essential. Dose modification may be needed based on toxicity levels (e.g., neutropenia, mucositis, cardiac events).

Possible side effects of ADRIBLASTINA RAPID DISSOLUTION 10mg/5ml

Doxorubicin, while effective, has a well-documented profile of adverse effects, some of which may be serious or dose-limiting. Patients must be monitored closely during treatment.

• Common Side Effects:
  • Nausea, vomiting, and diarrhea
  • Alopecia (hair loss)
  • Mucositis and stomatitis
  • Myelosuppression (anemia, leukopenia, thrombocytopenia)
  • Fatigue and weakness
• Serious Side Effects:
  • Cardiotoxicity: Arrhythmias, cardiomyopathy, congestive heart failure
  • Extravasation: Can cause severe tissue necrosis if drug leaks outside the vein
  • Secondary malignancies: Risk of therapy-related leukemia
  • Hepatotoxicity
• Allergic reactions: Rare but may include rash, fever, or anaphylaxis.

Most side effects are reversible with dose adjustments or treatment interruptions. Early recognition and supportive care are key to minimizing long-term complications.

ADRIBLASTINA RAPID DISSOLUTION 10mg/5ml Contraindications ADRIBLASTINA RAPID DISSOLUTION 10mg/5ml

ADRIBLASTINA is contraindicated in certain populations and clinical settings due to its potent toxic profile. The decision to initiate therapy must always balance the expected benefit against potential harm.

• Hypersensitivity: Known allergy to doxorubicin or any excipients.
• Severe cardiac impairment: Including recent myocardial infarction, uncontrolled heart failure, or arrhythmias.
• Cumulative anthracycline dose: Patients who have received the maximum allowable lifetime dose of anthracyclines.
• Severe hepatic dysfunction: High bilirubin or liver enzyme levels contraindicate use.
• Persistent myelosuppression: Low neutrophil/platelet count not caused by malignancy.
• Pregnancy and lactation: Contraindicated unless benefits outweigh risks—teratogenic potential is high.

Use with extreme caution in elderly patients or those with pre-existing organ dysfunction. Oncological consultation is essential in borderline cases.

Storage of ADRIBLASTINA RAPID DISSOLUTION 10mg/5ml

Proper storage of cytotoxic medications like ADRIBLASTINA is crucial to maintain stability and ensure safety for both healthcare workers and patients.

• Before reconstitution:
  • Store vials at a temperature between 2°C to 8°C (refrigerated).
  • Protect from light and moisture.
• After reconstitution:
  • Use the solution immediately after preparation to avoid microbial contamination and maintain potency.
  • If not used immediately, the reconstituted solution may be stored at 2–8°C for a limited time (refer to local guidelines, usually no longer than 24 hours).
• Disposal: Follow institutional protocols for cytotoxic waste disposal. Do not discard in household or general waste.

Keep the medication out of reach of children. Handle with caution during transportation and preparation to avoid breakage or accidental exposure.