PACLITAXEL Seacross 6mg/ml Concentrate for Solution for Infusion

What is PACLITAXEL Seacross 6mg/ml

PACLITAXEL Seacross 6mg/ml is a cytotoxic chemotherapy agent used primarily in the treatment of various types of cancer. It contains the active ingredient Paclitaxel, a natural product derived from the bark of the Pacific yew tree (Taxus brevifolia), and is formulated as a concentrate for solution for infusion.

• Therapeutic Class: Antineoplastic agent, taxane derivative
• Formulation: Concentrate for intravenous infusion
• Strength: 6 mg/ml
• Packaging: 1 glass vial containing 50 ml (total of 300 mg paclitaxel)

Paclitaxel is commonly used in combination or as monotherapy for cancers such as:

• Ovarian cancer
• Breast cancer
• Non-small cell lung cancer (NSCLC)
• Kaposi’s sarcoma (associated with AIDS)
• Pancreatic cancer

It is administered under close medical supervision in hospital or oncology centers due to its potential toxicity and requirement for premedication to avoid hypersensitivity reactions.

How to use PACLITAXEL Seacross 6mg/ml

PACLITAXEL Seacross must be administered by a healthcare professional with experience in the use of chemotherapy. It is given via intravenous (IV) infusion and must be diluted before administration.

• Route of Administration: Intravenous infusion (over 1 to 3 hours)
• Preparation: The concentrate should be diluted with a suitable IV fluid (e.g., 0.9% sodium chloride or 5% dextrose) to achieve the desired final concentration (typically 0.3 to 1.2 mg/mL)
• Premedication: Patients must receive premedication with corticosteroids (e.g., dexamethasone), H1 and H2 antagonists (e.g., diphenhydramine and ranitidine) to reduce the risk of hypersensitivity reactions
• Infusion Time: Usually administered over 3 hours; however, shorter durations (1 hour) may be used depending on the indication

Infusion should be closely monitored for adverse effects such as hypersensitivity, hypotension, or anaphylaxis. Infusion must be stopped immediately if severe reactions occur.

Extravasation should be avoided as it can cause severe local reactions. Use of a central venous catheter may be preferred for repeated or high-dose administration.

Mode of Action PACLITAXEL Seacross 6mg/ml

Paclitaxel acts by disrupting the normal function of microtubules during cell division, effectively inhibiting cancer cell proliferation.

• Microtubule Stabilization: Paclitaxel promotes the assembly of microtubules from tubulin dimers and stabilizes them by preventing depolymerization. This results in the formation of stable but dysfunctional microtubules.
• Inhibition of Mitosis: By stabilizing microtubules, paclitaxel halts the cell cycle at the G2/M phase, effectively preventing the cell from undergoing mitosis.
• Apoptosis Induction: The disruption of mitosis leads to programmed cell death (apoptosis), particularly in rapidly dividing cancer cells.

Unlike many chemotherapeutic agents that target DNA, paclitaxel works on the structural components of the cell division machinery, making it useful in drug combinations and in cases resistant to DNA-targeting agents.

PACLITAXEL Seacross 6mg/ml Interactions PACLITAXEL Seacross 6mg/ml

Paclitaxel has several clinically significant drug interactions that can affect efficacy or increase toxicity.

• CYP3A4 and CYP2C8 Substrates: Paclitaxel is metabolized by CYP3A4 and CYP2C8. Inhibitors (e.g., ketoconazole, erythromycin) may increase paclitaxel levels, while inducers (e.g., rifampin, phenytoin) may reduce efficacy.
• Cisplatin: When used with cisplatin, the risk of nephrotoxicity and bone marrow suppression increases. Paclitaxel should be administered before cisplatin to reduce toxicity.
• Doxorubicin: Concurrent use can increase the risk of cardiac toxicity; appropriate interval and monitoring are required.
• Live Vaccines: Avoid live vaccines during treatment due to immunosuppression.
• Other Chemotherapeutic Agents: Additive toxicity, especially on the bone marrow, requires close monitoring of blood counts and supportive care.

Always inform the healthcare provider about all medications, supplements, or herbal products before starting paclitaxel.

Dosage of PACLITAXEL Seacross 6mg/ml

Dosage of Paclitaxel is highly individualized based on indication, body surface area (BSA), organ function, and prior treatments.

• Standard Dosing (for Ovarian/Breast Cancer): 175 mg/m² IV over 3 hours every 3 weeks
• Weekly Regimens: 80–100 mg/m² administered weekly in some protocols
• Combination Regimens: Dose may vary depending on concomitant chemotherapeutic agents
• Renal/Hepatic Impairment: Dose adjustments are necessary; paclitaxel is metabolized hepatically and should be used with caution in liver dysfunction

Premedication is essential to minimize allergic reactions. Blood counts should be checked before each dose. Dosage should be delayed or reduced in cases of significant neutropenia or thrombocytopenia.

Possible side effects of PACLITAXEL Seacross 6mg/ml

Paclitaxel is associated with a wide range of side effects, many of which are dose-dependent and reversible upon discontinuation.

• Common Side Effects:
  • Hair loss (alopecia)
  • Nausea and vomiting
  • Peripheral neuropathy (numbness or tingling)
  • Fatigue and weakness
  • Myelosuppression (neutropenia, anemia, thrombocytopenia)
• Serious Side Effects:
  • Severe hypersensitivity reactions (e.g., rash, bronchospasm, hypotension, anaphylaxis)
  • Cardiac toxicity (bradycardia, arrhythmia)
  • Liver enzyme elevations
  • Gastrointestinal complications (mucositis, diarrhea)
• Long-Term Effects: Prolonged neuropathy and myelosuppression can persist beyond treatment.

Close monitoring of complete blood count (CBC), liver enzymes, and patient-reported symptoms is essential during therapy.

PACLITAXEL Seacross 6mg/ml Contraindications PACLITAXEL Seacross 6mg/ml

Paclitaxel should not be used in certain medical conditions due to the risk of serious adverse effects.

• Known hypersensitivity to paclitaxel, polyoxyethylated castor oil (Cremophor EL), or other formulation components
• Baseline neutrophil count < 1500/mm³ (for solid tumors)
• Severe hepatic impairment due to increased risk of toxicity
• Pregnancy and lactation: Contraindicated as it is teratogenic and excreted in breast milk
• Severe uncontrolled infections or concurrent illness compromising treatment tolerance

Use with caution in patients with pre-existing peripheral neuropathy or cardiac conditions.

Storage of PACLITAXEL Seacross 6mg/ml

Proper storage of paclitaxel is essential to ensure stability and effectiveness.

• Unopened Vials: Store below 25°C; protect from light
• Do Not Freeze: Freezing may cause precipitation of the contents
• After Dilution: Diluted solution is stable for up to 24 hours at room temperature and 7 days when refrigerated (2°C–8°C), depending on the diluent used
• Inspect visually: Discard if there is cloudiness or particulate matter

Keep out of reach of children. Follow hospital protocols for handling cytotoxic agents, including disposal of vials, IV tubing, and personal protective equipment (PPE).