Paclitaxel

What it is and how it works

Mechanism of Action Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) is a microtubule inhibitor that promotes the assembly of microtubules from tubulin dimers and stabilizes microtubules by preventing depolymerization. This stability results in the inhibition of the normal dynamic reorganization of the microtubule network that is essential for vital interphase and mitotic cellular functions. Paclitaxel induces abnormal arrays or “bundles” of microtubules throughout the cell cycle and multiple asters of microtubules during mitosis.

Indications

Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) is a microtubule inhibitor indicated for the treatment of: Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine. Metastatic Breast Cancer Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) is indicated for the treatment of breast cancer after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated.

Dosage and administration (summary)

Do not substitute Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) for other paclitaxel products. Extravasation: Closely monitor the infusion site for extravasation and infiltration. Metastatic Breast Cancer (MBC) : Recommended dosage of Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) is 260 mg/m 2 intravenously over 30 minutes every 3 weeks. Non-Small Cell Lung Cancer (NSCLC) : Recommended dosage of Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) is 100 mg/m 2 intravenously over 30 minutes on Days 1, 8, and 15 of each 21-day cycle.

Contraindications

Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) is contraindicated in patients with: Baseline neutrophil counts of <1,500 cells/mm 3 A history of severe hypersensitivity reactions to protein bound paclitaxel Neutrophil counts of <1,500 cells/mm 3 . Severe hypersensitivity reactions to protein bound paclitaxel.

Warnings and precautions

Sensory neuropathy occurs frequently and may require dose reduction or treatment interruption. Sepsis occurred in patients who received Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound); interrupt Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) until sepsis resolves, and if neutropenia, until neutrophils are at least 1500 cells/mm 3 , then resume treatment at reduced dose levels. Pneumonitis occurred with the use of protein bound paclitaxel in combination with gemcitabine.

Pregnancy

Pregnancy Risk Summary Based on its mechanism of action and findings in animals, Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) can cause fetal harm when administered to a pregnant woman .

Storage and supply

Paclitaxel Protein-Bound Particles for Injectable Suspension (albumin-bound) is supplied as a white to yellow, sterile, lyophilized powder for reconstitution and is available as follows: NDC 0480-3290-01 100 mg of paclitaxel in a single-dose vial, individually packaged in a carton. Store vial in original carton at 20°C to 25°C (68°F to 77°F) .

Source: Paclitaxel (Paclitaxel) — US FDA prescribing information, 2023-11-01, DailyMed. Summarised and shortened; the full label governs. Iranian registration, indications and labelling may differ.