PACLITAXEL Seacross 6mg/ml Concentrate for Solution for Infusion

What is PACLITAXEL Seacross 6mg/ml

PACITAXEL Seacross 6mg/ml is a medication used in the treatment of various cancers, including breast cancer, ovarian cancer, lung cancer, and Kaposi's sarcoma. It is a concentrated solution intended for intravenous infusion. The drug’s active ingredient, paclitaxel, is a chemotherapy agent that works by interfering with cell division, ultimately inhibiting the growth and spread of cancer cells.

• Generic Name: Paclitaxel
• Brand Name: PACLITAXEL Seacross
• Formulation: Concentrate for solution for infusion (IV)
• Strength: 6 mg/ml
• Size: 1 Glass vial (5 ml)

PACITAXEL is classified as a taxane chemotherapy drug and is typically used as part of a broader cancer treatment regimen, often in combination with other drugs. It can be administered either alone or alongside other chemotherapy agents to treat certain cancers.

The drug works by stabilizing the microtubules within cancer cells, preventing them from disassembling, a necessary process for cell division. This prevents the cancer cells from proliferating, which eventually leads to their death. Because of its mechanism, paclitaxel is considered an effective agent in cancer treatment, particularly when used as part of multi-drug chemotherapy regimens.

How to use PACLITAXEL Seacross 6mg/ml

PACITAXEL Seacross is intended for intravenous (IV) infusion and should only be administered by a healthcare professional, typically in a hospital or clinical setting. The administration process is critical to ensure the medication is delivered safely and effectively. Below are the general steps for using PACLITAXEL Seacross 6mg/ml:

• Preparation: PACLITAXEL Seacross comes in a concentrated form. It must be diluted with an appropriate diluent, such as 0.9% Sodium Chloride or Dextrose 5%, before it is infused. The solution should be prepared by a trained professional in sterile conditions to avoid contamination.
• Administration Method: The diluted solution is given as an IV infusion, typically over 1-3 hours, depending on the specific treatment protocol. The rate of infusion is adjusted to minimize side effects like hypersensitivity reactions.
• Dosage Adjustments: The exact dosage will depend on the type of cancer being treated, the patient’s overall health, and other factors such as their response to previous treatments. The standard dose for many cancer regimens is around 175 mg/m² of body surface area, given every three weeks. Your doctor will determine the appropriate dose for you based on these factors.
• Pre-treatment Measures: Prior to PACLITAXEL administration, premedication with corticosteroids, antihistamines, and H2 antagonists may be required to reduce the risk of hypersensitivity reactions.
• Post-Administration Monitoring: Patients should be closely monitored for signs of allergic reactions, infusion-related side effects, and any other adverse events that may occur during or after the infusion.

It is critical to follow the healthcare provider’s specific instructions for the administration of PACLITAXEL to minimize risks and ensure optimal efficacy. Patients should never attempt to administer PACLITAXEL Seacross themselves.

Mode of Action PACLITAXEL Seacross 6mg/ml

The mode of action of PACLITAXEL Seacross, like other taxane-based chemotherapy agents, involves disrupting the normal process of cell division, known as mitosis. Here's how PACLITAXEL works at the cellular level:

• Microtubule Stabilization: Paclitaxel binds to the microtubules, which are essential structures involved in cell division. Normally, microtubules can disassemble and reassemble as needed to ensure proper cell division. Paclitaxel, however, stabilizes the microtubules, preventing their disassembly. This halts the proper formation of the mitotic spindle, an essential structure for chromosome separation during cell division.
• Inhibition of Cell Cycle: By preventing microtubule disassembly, PACLITAXEL arrests cells in the G2/M phase of the cell cycle, thus inhibiting mitosis. This results in the inability of cancer cells to complete their division process, leading to cell death.
• Impact on Cancer Cells: Paclitaxel’s effect is particularly potent in rapidly dividing cancer cells, which rely on proper mitotic function to proliferate. By interfering with cell division, PACLITAXEL inhibits tumor growth and metastasis.
• Effect on Non-Cancerous Cells: While paclitaxel primarily targets rapidly dividing cancer cells, it may also affect normal, healthy cells that divide quickly, such as those in the bone marrow, digestive tract, and hair follicles. This is why some common side effects of chemotherapy, like hair loss and gastrointestinal symptoms, occur.

This mode of action makes paclitaxel an effective treatment for a wide variety of cancers, though it also means that some normal tissues can be affected during treatment. The ability to specifically target cell division is a cornerstone of its therapeutic use in oncology.

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

Drug interactions are a critical consideration when using PACLITAXEL Seacross. This chemotherapy agent can interact with several other medications, which may alter its effectiveness or increase the risk of side effects. Below are the most common drug interactions to be aware of:

• Myelosuppressive Agents: When combined with other myelosuppressive drugs, such as certain antibiotics, antivirals, or chemotherapy agents, the risk of bone marrow suppression is increased. This can lead to a higher likelihood of infection, anemia, or bleeding. Close monitoring of blood counts is necessary when using PACLITAXEL with these drugs.
• Anticoagulants: Paclitaxel can increase the risk of bleeding, and when used with anticoagulants like warfarin, there may be an enhanced risk of hemorrhage. It is important to monitor coagulation parameters and adjust anticoagulant doses accordingly.
• CYP450 Enzyme Inhibitors/Inducers: Paclitaxel is metabolized primarily by the liver enzyme CYP2C8. Medications that inhibit or induce this enzyme may alter paclitaxel metabolism, affecting its concentration in the bloodstream. Drugs such as ketoconazole (an inhibitor) or rifampin (an inducer) may require dose adjustments.
• Drugs That Affect Liver Function: Since paclitaxel is metabolized in the liver, liver enzyme-modifying drugs (e.g., hepatotoxic drugs, anticonvulsants, or antifungals) may affect its clearance, leading to toxicity or sub-therapeutic effects.
• Other Chemotherapy Agents: Combining paclitaxel with other chemotherapy drugs may increase the likelihood of severe side effects, such as neuropathy or cardiotoxicity, depending on the specific medications. Careful coordination of drug schedules and doses is necessary.

Patients should inform their healthcare provider about all medications, including over-the-counter drugs, supplements, and herbal products, to avoid adverse interactions during paclitaxel therapy. Drug interaction monitoring is vital throughout the course of treatment.

Dosage of PACLITAXEL Seacross 6mg/ml

The dosage of PACLITAXEL Seacross is highly individualized, depending on the type of cancer being treated, the patient’s health status, and their body surface area (BSA). The medication is administered intravenously, and the following guidelines represent general dosing regimens:

• Standard Dose for Solid Tumors: The recommended dose for most solid tumors is 175 mg/m² of body surface area. This is typically given every 3 weeks. Depending on the cancer type, this dosage may be adjusted or combined with other chemotherapeutic agents.
• Ovarian Cancer: For ovarian cancer, paclitaxel is often administered at a dose of 175 mg/m² every 3 weeks, though some regimens may vary.
• Breast Cancer: In breast cancer treatment, paclitaxel may be given as part of a combination therapy regimen, sometimes at doses as high as 250 mg/m², every 3 weeks, or at lower doses in more frequent cycles (e.g., weekly regimens).
• Pre-dosing and Dose Adjustments: Prior to treatment with paclitaxel, pre-medications such as corticosteroids, H1 antagonists, and H2 blockers may be used to prevent hypersensitivity reactions. Dose adjustments may be required if the patient experiences severe side effects, especially myelosuppression (low blood counts), peripheral neuropathy, or liver dysfunction.
• Monitoring During Treatment: Throughout treatment, frequent monitoring of blood counts, liver function, and kidney function is essential. Adjustments to dosage may be required based on these results.

It's essential that the dosage and administration schedule be closely followed as prescribed by the healthcare provider. The doctor will adjust the dose based on response to treatment and any side effects experienced.

Possible side effects of PACLITAXEL Seacross 6mg/ml

Like most chemotherapy agents, PACLITAXEL Seacross can cause a range of side effects. These may vary depending on the individual, the dosage, and the type of cancer being treated. Below are some common and severe side effects:

• Common Side Effects:
  • Hair Loss (Alopecia): One of the most common and visible side effects of paclitaxel treatment is hair loss, as the drug targets rapidly dividing cells, including hair follicle cells.
  • Fatigue: Many patients report feeling unusually tired or fatigued during treatment with paclitaxel, as chemotherapy affects the overall energy levels.
  • Nausea and Vomiting: Gastrointestinal disturbances like nausea and vomiting are common but can be managed with anti-nausea medications.
  • Peripheral Neuropathy: Numbness, tingling, or pain in the hands and feet is another frequent side effect, which may occur due to the drug's impact on nerve function.
  • Low Blood Counts: Myelosuppression, or a decrease in blood cells, can result in anemia, thrombocytopenia, and neutropenia, leading to an increased risk of infection, bleeding, and fatigue.
• Serious Side Effects:
  • Hypersensitivity Reactions: Severe allergic reactions, including anaphylaxis, can occur. Symptoms include difficulty breathing, swelling, and rash. Immediate medical attention is required.
  • Cardiovascular Effects: PACLITAXEL may cause changes in heart function, including arrhythmias or bradycardia. Patients with pre-existing heart conditions should be closely monitored.
  • Infection Risk: Due to the drug's impact on the immune system, the risk of infections increases. Patients may need additional medications to prevent or treat infections.

Patients should contact their healthcare provider immediately if they experience any severe reactions, and side effects should be discussed thoroughly before starting treatment. Not all patients will experience all of these side effects, and some may not experience any of them.

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

There are certain contraindications associated with the use of PACLITAXEL Seacross. Patients who have specific conditions or are taking certain medications may not be suitable candidates for this treatment. Below are the key contraindications:

• Hypersensitivity: PACLITAXEL should not be used in patients who have a known hypersensitivity to paclitaxel or any of its components. This includes allergic reactions or severe reactions to other taxane medications.
• Severe Bone Marrow Suppression: Paclitaxel should not be administered to patients with severe neutropenia (low white blood cell count), thrombocytopenia (low platelets), or anemia (low red blood cells) due to the increased risk of severe complications.
• Severe Liver Dysfunction: Patients with severe liver impairment (e.g., cirrhosis or active liver disease) should avoid paclitaxel, as it is metabolized by the liver, and compromised liver function may lead to increased toxicity.
• Pregnancy and Breastfeeding: PACLITAXEL is contraindicated during pregnancy due to potential teratogenic effects. It is also not recommended for breastfeeding mothers, as it can be excreted in breast milk.
• Severe Infection: Patients with an active or severe infection should not receive PACLITAXEL due to the risk of further compromising their immune system.

Before starting treatment, healthcare providers must assess a patient's overall health and medical history to ensure PACLITAXEL is appropriate for them. If any of the above conditions are present, alternative treatments may be considered.

Storage of PACLITAXEL Seacross 6mg/ml

Proper storage of PACLITAXEL Seacross is critical to maintaining its efficacy and safety. The following guidelines should be followed:

• Storage Temperature: PACLITAXEL Seacross should be stored at a temperature between 2°C to 8°C (36°F to 46°F). Do not freeze the medication. Freezing can damage the vial and render the drug ineffective.
• Storage Before Dilution: The medicine should be kept in its original packaging, away from direct light, until it is ready to be diluted and administered. Keep it out of reach of children.
• Storage After Dilution: Once PACLITAXEL has been diluted for infusion, it can be stored at room temperature (20°C to 25°C or 68°F to 77°F) for up to 24 hours. It should be discarded if not used within this time frame.
• Check for Visible Particles: Before use, check the vial for any visible particles or discoloration. If any are found, discard the vial.

Proper storage ensures that PACLITAXEL maintains its effectiveness throughout the treatment course, minimizing the risk of adverse reactions associated with degradation.