PACLINAB

Generic Name: Nano-albumin bond paclitaxel

Paclinab is a solvent-free colloidal suspension of paclitaxel initially developed to avoid the toxicities associated with conventional paclitaxel. It contains human serum albumin-paclitaxel nanoparticles of approximately 130 nm in size, which can be infused into a vein. Upon intravenous administration, the nanoparticles dissociate rapidly into soluble albumin bound paclitaxel complexes of approximately 10 nm in size and would be transported across endothelial cells by the specific albumin receptors.

This novel formulation provided some advantages over standard paclitaxel therapy:
• Safe infusion of significantly higher doses of paclitaxel
• Shorter infusion schedules (30 minutes vs 3 hours)
• No need for premedication

Mechanism of Action:
Paclinab 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.

Indications:
• 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.
Dosage Form and Strength:
For injectable suspension: white to yellow, sterile, lyophilized powder containing 100 mg of paclitaxel formulated as albumin-bound particles in single-dose vial for reconstitution

Administration:
Intravenous infusion over 30 minutes following dilution with 20ml sterile, pyrogen free, 0.9% sodium chloride
The reconstituted Paclinab shall be administered over 30 minutes of IV infusion.