PACLITAXEL Seacross 6mg/ml Concentrate for Solution for Infusion

What is PACLITAXEL Seacross 6mg/ml

PACLITAXEL Seacross 6mg/ml is a chemotherapeutic agent used to treat various forms of cancer. The active ingredient in this medication, paclitaxel, is a member of the taxane class of chemotherapy drugs. It is administered intravenously in the form of a concentrate for infusion. The concentration of paclitaxel in this solution is 6mg/ml, and it is typically supplied in a 16.7 ml glass vial, which provides the necessary dose for administration.

• Generic Name: Paclitaxel
• Brand Name: PACLITAXEL Seacross
• Formulation: Concentrate for Solution for Infusion (IV)
• Concentration: 6 mg/ml
• Vial Size: 1 Glass Vial (16.7 ml)

Paclitaxel is used to treat several types of cancer, including but not limited to breast cancer, ovarian cancer, non-small cell lung cancer, and Kaposi's sarcoma. It works by inhibiting the growth of cancer cells, helping to shrink tumors and prevent the spread of cancer to other areas of the body. It is often used in combination with other chemotherapy agents to improve overall treatment efficacy.

The mechanism of action of paclitaxel is related to its ability to stabilize microtubules, which are key components of the cell's structure and function during cell division. This inhibition prevents the cancer cells from properly dividing and replicating, ultimately leading to their death. Paclitaxel is considered effective in targeting rapidly dividing cancer cells, making it a potent drug in oncology treatment regimens.

How to use PACLITAXEL Seacross 6mg/ml

PACLITAXEL Seacross 6mg/ml is an intravenous (IV) chemotherapy drug that must be administered in a clinical setting, such as a hospital or specialized infusion center. The drug should only be prepared and infused by a trained healthcare professional to ensure proper handling and reduce the risk of complications.

• Preparation: PACLITAXEL Seacross is provided as a concentrate. Before administration, the concentrate must be diluted with an appropriate diluent, such as 0.9% sodium chloride or dextrose 5%. The solution should be mixed carefully to avoid contamination or improper dosing. The solution should not be frozen and should be prepared under sterile conditions.
• Administration: Once diluted, PACLITAXEL is administered intravenously, usually over a period of 1-3 hours, depending on the specific treatment protocol. The rate of infusion will be determined by the oncologist to minimize the risk of infusion-related reactions.
• Dosage Regimen: The dosage is generally based on the patient's body surface area (BSA). A common starting dose for many cancers is 175 mg/m² of body surface area, typically administered every three weeks. However, specific dosages may vary depending on the type of cancer being treated, the patient’s previous responses to therapy, and their overall health condition.
• Pre-medication: To prevent hypersensitivity reactions, pre-medication with corticosteroids (e.g., dexamethasone), antihistamines, and H2 blockers may be recommended by the treating physician. This pre-treatment helps reduce the chances of allergic reactions during or after the infusion.
• Post-Administration Care: After the infusion, patients should be closely monitored for any immediate reactions, including signs of allergic or hypersensitivity reactions, fever, and changes in blood pressure. Regular blood tests are necessary to check for signs of myelosuppression, liver function abnormalities, or other side effects.

Healthcare providers will carefully monitor patients during each infusion to ensure the treatment is well-tolerated. Adjustments to the dosage or treatment schedule may be made based on the patient's response to therapy and any adverse effects that arise.

Mode of Action PACLITAXEL Seacross 6mg/ml

The mode of action of PACLITAXEL Seacross is through its effect on microtubules, which are key components of the cell's cytoskeleton. Microtubules are essential for cell division, as they help form the mitotic spindle, a structure responsible for separating chromosomes during mitosis. Here's how PACLITAXEL works:

• Microtubule Stabilization: Paclitaxel binds to and stabilizes the microtubules, preventing them from disassembling. Normally, microtubules must disassemble and reassemble during cell division, but paclitaxel causes them to become hyper-stabilized, thus preventing the necessary changes that would allow the cell to divide properly.
• Arrest of Cell Cycle: This disruption in the microtubule dynamic results in a blockage at the G2/M phase of the cell cycle, where the cell prepares for division. As a result, the cancer cells are unable to progress through mitosis and are forced into a state of arrested development.
• Induction of Apoptosis: After the cells are unable to divide, they experience apoptosis (programmed cell death). This leads to the death of the cancerous cells, helping to reduce tumor size and slow or halt cancer progression.
• Selective Targeting of Cancer Cells: Paclitaxel is particularly effective against rapidly dividing cancer cells. Cancer cells, by nature, divide more frequently than normal cells, making them more susceptible to the disruptive effects of paclitaxel. However, some normal healthy cells that divide quickly, such as those in the bone marrow, hair follicles, and gastrointestinal tract, may also be affected, leading to side effects like hair loss and gastrointestinal symptoms.

This mechanism of action is why paclitaxel is effective in the treatment of several types of cancer, including breast cancer, ovarian cancer, non-small cell lung cancer, and Kaposi’s sarcoma. By halting the cell division process, paclitaxel prevents cancer cells from spreading and proliferating.

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

As with any chemotherapy drug, PACLITAXEL Seacross can interact with a variety of other medications, which may influence its effectiveness, side effect profile, or cause other complications. It's important to inform your healthcare provider about all other drugs you are taking, including prescription, over-the-counter, and herbal supplements.

• Myelosuppressive Drugs: Paclitaxel can cause myelosuppression, or suppression of bone marrow activity. When used in combination with other myelosuppressive drugs, such as other chemotherapy agents or certain antibiotics, the risk of neutropenia (low white blood cell count), thrombocytopenia (low platelet count), and anemia (low red blood cell count) is heightened. Careful monitoring of blood counts is essential during treatment.
• Anticoagulants: Paclitaxel can increase the risk of bleeding. When taken alongside anticoagulant medications like warfarin or heparin, this bleeding risk is further amplified. Close monitoring of INR (International Normalized Ratio) and other coagulation parameters is essential to prevent excessive bleeding or clotting complications.
• CYP450 Enzyme Inhibitors: Paclitaxel is metabolized by the liver enzyme CYP2C8. Drugs that inhibit this enzyme (e.g., ketoconazole or gemfibrozil) can increase paclitaxel concentrations in the blood, potentially leading to toxicity. Conversely, inducers of CYP2C8 (e.g., rifampin) can decrease paclitaxel levels, reducing its effectiveness.
• HIV Medications: Antiretroviral drugs used to treat HIV, particularly protease inhibitors, can interact with paclitaxel, affecting its metabolism and increasing the risk of side effects.
• Drugs Affecting Liver Function: Since paclitaxel is metabolized in the liver, any drug that affects liver function (such as anticonvulsants, antifungals, or other hepatotoxic agents) may alter the pharmacokinetics of paclitaxel, requiring adjustments in the dose or monitoring of liver enzymes.
• Other Chemotherapy Drugs: Combining paclitaxel with other chemotherapy agents, especially those that also target microtubules, can lead to cumulative toxic effects, including neuropathy or cardiotoxicity. Careful management of these combinations is necessary to minimize harmful interactions.

As always, patients should discuss any other medications they are taking with their healthcare team to avoid interactions and ensure the safety and efficacy of their chemotherapy regimen.

Dosage of PACLITAXEL Seacross 6mg/ml

The dosage of PACLITAXEL Seacross 6mg/ml depends on several factors, including the type of cancer being treated, the patient's body surface area (BSA), and their overall health status. Below are general guidelines for dosing, though adjustments may be necessary based on individual responses and tolerability:

• Standard Dosage for Breast Cancer: The typical recommended dose for breast cancer is 175 mg/m², administered as an intravenous infusion every 3 weeks.
• Ovarian Cancer: The usual dose for ovarian cancer is 175 mg/m² every 3 weeks, though this may vary depending on the individual patient's response.
• Non-Small Cell Lung Cancer (NSCLC): For NSCLC, paclitaxel is often given at 200 mg/m² on a 3-week cycle, although this can vary.
• Dosage Adjustments: Dosage may need to be reduced or delayed in patients who experience severe side effects, especially myelosuppression (low blood counts). Liver function tests and blood counts should be monitored regularly to ensure safe dosing.
• Pre-medication: To minimize infusion reactions, patients typically receive pre-medications, including corticosteroids, antihistamines, and H2 blockers, before each infusion of paclitaxel.
• Infusion Time: Paclitaxel is usually administered as an IV infusion over a period of 1 to 3 hours. The rate of infusion may be adjusted to reduce the likelihood of hypersensitivity reactions.

It's crucial that the exact dosing regimen be followed as prescribed by the oncologist, based on the patient's condition and response to treatment. Regular monitoring is needed to detect any adverse effects early and adjust the dose if necessary.

Possible side effects of PACLITAXEL Seacross 6mg/ml

Like most chemotherapy drugs, PACLITAXEL Seacross 6mg/ml can cause a wide range of side effects, some of which may be serious. These side effects may vary based on individual factors such as the patient's overall health, the dose used, and the specific cancer being treated. Below are some common and serious side effects:

• Common Side Effects:
  • Hair Loss (Alopecia): One of the most noticeable side effects of paclitaxel is hair loss. This occurs because paclitaxel targets rapidly dividing cells, including hair follicle cells.
  • Fatigue: Many patients report feeling unusually tired during treatment. This is a common symptom associated with chemotherapy.
  • Nausea and Vomiting: Gastrointestinal disturbances such as nausea and vomiting are common. Anti-nausea medications can help alleviate these symptoms.
  • Peripheral Neuropathy: Numbness, tingling, or pain in the hands and feet may occur as a result of nerve damage. This can be managed by dose adjustments or medication.
  • Low Blood Counts: Myelosuppression is a common side effect of paclitaxel, leading to a reduction in red blood cells, white blood cells, and platelets, which increases the risk of infections, anemia, and bleeding.
• Serious Side Effects:
  • Hypersensitivity Reactions: Severe allergic reactions, including anaphylaxis, can occur. Symptoms may include difficulty breathing, swelling, or a rash, and require immediate medical attention.
  • Cardiac Effects: Paclitaxel may cause arrhythmias or other heart-related issues. Patients with existing heart conditions should be monitored closely during treatment.
  • Infections: Paclitaxel suppresses the immune system, making patients more vulnerable to infections.

If any of these symptoms occur, patients should contact their healthcare provider immediately. Some side effects may resolve with dose adjustment or discontinuation of treatment, while others may require additional supportive care.

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

There are several contraindications for PACLITAXEL Seacross 6mg/ml, and patients with specific conditions should avoid its use. Before starting treatment, a thorough evaluation of the patient's medical history is necessary to determine if paclitaxel is appropriate for them. The following conditions are considered contraindications:

• Hypersensitivity to Paclitaxel: Patients who have a known allergy or hypersensitivity to paclitaxel or any of the components of the formulation should not receive this medication.
• Severe Bone Marrow Suppression: Paclitaxel is contraindicated in patients with severe neutropenia (low white blood cell count), thrombocytopenia (low platelet count), or anemia due to the increased risk of severe infections, bleeding, and other complications.
• Severe Liver Dysfunction: Patients with severe liver impairment (such as active liver disease or cirrhosis) should not receive paclitaxel, as it is metabolized by the liver, and impaired liver function can result in increased toxicity.
• Pregnancy and Breastfeeding: PACLITAXEL should not be used during pregnancy due to its teratogenic effects. It is also contraindicated during breastfeeding, as it may be excreted in breast milk.
• Active Infections: Patients with severe or active infections should not receive PACLITAXEL, as it can further suppress the immune system and worsen the infection.

A thorough assessment of each patient's medical history and current health condition is essential before administering PACLITAXEL. If any contraindications are present, alternative treatment options should be considered.

Storage of PACLITAXEL Seacross 6mg/ml

Proper storage of PACLITAXEL Seacross is essential to maintain its effectiveness and safety. The following guidelines should be followed:

• Storage Temperature: PACLITAXEL Seacross should be stored in a refrigerator at temperatures between 2°C and 8°C (36°F to 46°F). It should not be frozen, as freezing can damage the drug and render it ineffective.
• Storage Before Dilution: The vial should be kept in its original packaging to protect it from light. It should also be kept out of reach of children.
• Storage After Dilution: Once diluted, PACLITAXEL Seacross can be stored at room temperature (20°C to 25°C, or 68°F to 77°F) for up to 24 hours. The solution must be discarded if not used within this timeframe.
• Inspection: Before use, inspect the vial for any visible particles, discoloration, or damage. If any irregularities are present, the vial should be discarded.

Storing PACLITAXEL correctly is essential to ensure its efficacy and to reduce the risk of complications during treatment. Always follow storage instructions as outlined by the manufacturer and healthcare provider.