PACLITAXEL 6mg/ml (BIOLYSE PHARMA) Injection/Solution for

What is PACLITAXEL 6mg/ml (BIOLYSE PHARMA)

Paclitaxel (BIOLYSE PHARMA) is a chemotherapy agent used to treat a variety of cancers, including ovarian, breast, and non-small cell lung cancer. It belongs to a class of drugs known as taxanes, which work by interfering with cell division. Paclitaxel is primarily used in oncology to treat both solid tumors and certain hematologic cancers.

Formulation:

• Medicine Name: Paclitaxel (BIOLYSE PHARMA)
• Form: Injection/Solution for intravenous (IV) infusion.
• Concentration: 6mg/ml
• Volume: 16.7ml Glass Vial x 1 (100mg/16.7ml)

Paclitaxel is typically administered intravenously in a hospital or clinical setting. It is usually given in combination with other chemotherapy drugs to increase its efficacy. This drug is highly effective against rapidly dividing cancer cells, making it particularly useful for aggressive cancers. The active ingredient, paclitaxel, inhibits the division of cancer cells, preventing them from proliferating and causing tumor growth.

Indications:

• Ovarian Cancer
• Breast Cancer
• Non-Small Cell Lung Cancer (NSCLC)
• Kaposi’s Sarcoma
• Head and Neck Cancer

Paclitaxel is also sometimes used for cancers like pancreatic cancer, small cell lung cancer, and soft tissue sarcomas, depending on the specific treatment regimen prescribed by the oncologist.

How to use PACLITAXEL 6mg/ml (BIOLYSE PHARMA)

Paclitaxel is a potent chemotherapy drug and should only be administered under the supervision of a healthcare professional. It is typically administered intravenously (IV) in a hospital or clinical setting to ensure safe and accurate delivery.

Administration:

• Route: Intravenous (IV) Infusion
• Concentration: 6mg/ml
• Volume: 16.7ml Glass Vial (100mg/16.7ml)
• Infusion Duration: Paclitaxel is usually administered over a period of 3 to 24 hours, depending on the specific chemotherapy regimen.
• Frequency: The standard treatment cycle involves administration every three weeks for most cancers. However, regimens may vary depending on the patient's health, cancer type, and combination therapy used.

Preparation and Dilution:

• Paclitaxel should be diluted prior to administration. It is commonly mixed with 0.9% Sodium Chloride or Dextrose 5% in Water (D5W).
• Ensure that the IV bag used for dilution is non-PVC, as polyvinyl chloride (PVC) bags may interact with the drug.

Monitoring During Infusion:

• Allergic Reactions: Premedication with corticosteroids, antihistamines, and H2 blockers is often given before infusion to prevent hypersensitivity reactions.
• Vital Signs: Blood pressure, heart rate, and respiratory function should be monitored during the infusion, especially during the first dose.
• Infusion Reactions: If any signs of hypersensitivity occur (e.g., rash, fever, or shortness of breath), the infusion should be halted immediately, and appropriate management should be initiated.

Mode of Action PACLITAXEL 6mg/ml (BIOLYSE PHARMA)

The mechanism of action of Paclitaxel is centered around its ability to inhibit cell division, which is essential for the growth and spread of cancer cells. This is achieved through the stabilization of microtubules, a crucial component of the cell’s cytoskeleton.

Mechanism:

• Microtubule Stabilization: Paclitaxel binds to tubulin, a protein that forms microtubules. By binding to tubulin, paclitaxel stabilizes the microtubules, preventing them from disassembling. This disruption in the normal microtubule dynamics arrests the cell cycle during mitosis.
• Cell Cycle Arrest: When cells are unable to divide properly, they cannot complete mitosis, leading to cell death or apoptosis.
• Prevention of Tumor Growth: The stabilization of microtubules by paclitaxel prevents normal cellular processes like mitotic spindle formation, leading to the inhibition of tumor cell proliferation.

Effect on Cancer Cells:

• Apoptosis: Paclitaxel-induced mitotic arrest triggers apoptotic signaling pathways in cancer cells, resulting in cell death.
• Targeting Rapidly Dividing Cells: Because cancer cells divide much more rapidly than normal cells, paclitaxel is particularly effective against tumors that proliferate quickly.

This mechanism of action makes paclitaxel highly effective in the treatment of a variety of solid tumors, especially those that exhibit aggressive growth patterns.

PACLITAXEL 6mg/ml (BIOLYSE PHARMA) Interactions PACLITAXEL 6mg/ml (BIOLYSE PHARMA)

Paclitaxel is metabolized by liver enzymes and has several known drug interactions that can either increase its toxicity or decrease its effectiveness. It is essential to be aware of these interactions to avoid complications during treatment.

Major Drug Interactions:

• CYP450 Enzyme Inhibitors: Drugs that inhibit the CYP3A4 enzyme (e.g., ketoconazole, ritonavir, clarithromycin) can increase paclitaxel levels, raising the risk of adverse effects such as neutropenia, peripheral neuropathy, and liver toxicity.
• CYP450 Enzyme Inducers: Medications that induce CYP3A4 (e.g., rifampin, phenytoin) may lower paclitaxel levels, potentially reducing its effectiveness in treating cancer.
• Other Chemotherapy Drugs: Co-administration with myelosuppressive agents (e.g., doxorubicin, cyclophosphamide) can increase the risk of hematologic toxicity, particularly neutropenia and thrombocytopenia.
• Anticoagulants: Warfarin and other blood thinners may increase the risk of bleeding, especially if combined with paclitaxel’s side effects on platelet function.
• Grapefruit Juice: Grapefruit juice may inhibit CYP3A4, increasing paclitaxel concentrations and potentially leading to increased toxicity.

Other Considerations:

• Herbal Supplements: Certain herbs (e.g., St. John’s Wort) can affect paclitaxel metabolism and reduce its effectiveness, so they should be avoided unless approved by the oncologist.
• Drug Metabolism: Patients should be monitored closely when starting or discontinuing any medications that affect paclitaxel metabolism.

Dosage of PACLITAXEL 6mg/ml (BIOLYSE PHARMA)

The dosage of Paclitaxel varies depending on the type of cancer, the patient’s body surface area (BSA), and whether it is being used alone or in combination with other chemotherapy agents.

General Dosage Recommendations:

• Ovarian Cancer: Typically administered at a dose of 175 mg/m² intravenously every three weeks, often in combination with carboplatin.
• Breast Cancer: The standard dose is also 175 mg/m² every 3 weeks, used either alone or in combination with other chemotherapeutic agents.
• Non-Small Cell Lung Cancer: The typical dose is 200 mg/m² administered every 3 weeks.
• Kaposi’s Sarcoma: The recommended dose is 100 mg/m², given weekly over several weeks.

Adjustments for Toxicity:

• If a patient experiences significant side effects (e.g., neutropenia or hypersensitivity reactions), the dose may need to be reduced or delayed until the patient has recovered.
• For patients with liver impairment, dose adjustments should be made to minimize the risk of hepatotoxicity.

Possible side effects of PACLITAXEL 6mg/ml (BIOLYSE PHARMA)

Paclitaxel is associated with several potential side effects, some of which can be severe. Monitoring for these side effects is essential to prevent complications during treatment.

Common Side Effects:

• Hematologic Toxicity: Includes neutropenia (low white blood cell count), anemia (low red blood cell count), and thrombocytopenia (low platelet count), which can lead to fatigue, increased risk of infection, and bleeding.
• Gastrointestinal Effects: Nausea, vomiting, diarrhea, and constipation are common. These can often be managed with antiemetics and other supportive therapies.
• Peripheral Neuropathy: Numbness, tingling, and pain in the hands and feet are frequent, particularly with prolonged use.
• Hypersensitivity Reactions: Rash, fever, and chills are common, especially during the first few infusions. Severe reactions such as anaphylaxis, though rare, can occur.

Serious Side Effects:

• Liver Toxicity: Paclitaxel can cause liver dysfunction, especially in patients with pre-existing liver disease.
• Cardiovascular Issues: Rare but possible, including arrhythmias and hypotension.
• Severe Infection: Due to its effects on white blood cells, paclitaxel can increase susceptibility to infections.

PACLITAXEL 6mg/ml (BIOLYSE PHARMA) Contraindications PACLITAXEL 6mg/ml (BIOLYSE PHARMA)

Paclitaxel should not be administered in certain patient populations due to the risk of severe complications.

Key Contraindications:

• Hypersensitivity: Contraindicated in patients with a known hypersensitivity to paclitaxel or its formulation components (including polyoxyl 35 castor oil).
• Bone Marrow Suppression: Not recommended for patients with pre-existing bone marrow suppression, as paclitaxel can exacerbate hematologic toxicity.
• Liver Impairment: Contraindicated in patients with severe hepatic dysfunction due to the drug’s hepatic metabolism.
• Pregnancy: Paclitaxel is classified as a Category D drug and is contraindicated during pregnancy.
• Breastfeeding: Contraindicated in breastfeeding mothers as paclitaxel is excreted into breast milk.

Storage of PACLITAXEL 6mg/ml (BIOLYSE PHARMA)

Paclitaxel should be stored under specific conditions to maintain its stability and potency.

Storage Recommendations:

• Unopened Vials: Store at 2°C to 8°C (36°F to 46°F). Do not freeze.
• Diluted Solutions: After dilution, paclitaxel should be used within 24 hours when stored at room temperature or refrigerated at 2°C to 8°C.
• Avoid Light: Both unopened vials and diluted solutions should be kept away from light to prevent degradation of the drug.