Finished product reference

Paclitaxel (Albumin Band) Nano

Injection, Powder, for Suspension · Parenteral · 100 mg

List code
13879
Pharmacologic class
Antineoplastic; taxane (albumin-bound paclitaxel nanoparticles)

What it is and how it works

Paclitaxel promotes assembly and stabilisation of microtubules, preventing their depolymerisation and arresting cell division in mitosis. In this formulation paclitaxel is bound to human albumin nanoparticles (about 130 nm), avoiding solvent-based vehicles such as polyoxyl castor oil.

Indications

Metastatic breast cancer after failure of first-line therapy where anthracyclines are not indicated; first-line metastatic adenocarcinoma of the pancreas with gemcitabine; first-line non-small cell lung cancer with carboplatin.

Dosage and administration (summary)

Intravenous infusion over 30 minutes: breast cancer 260 mg/m² every 3 weeks; pancreatic cancer 125 mg/m² on days 1, 8 and 15 of a 28-day cycle; NSCLC 100 mg/m² on days 1, 8 and 15 of a 21-day cycle; doses adjusted for toxicity.

Contraindications

Baseline neutrophil count below 1.5 × 10⁹/L, breast-feeding and hypersensitivity to paclitaxel or albumin.

Warnings and precautions

Not interchangeable with solvent-based paclitaxel or other paclitaxel formulations. Myelosuppression (especially neutropenia), sensory neuropathy, pneumonitis and sepsis may occur; monitor blood counts before each dose. Contains human albumin, so a remote risk of transmission of viral diseases cannot be excluded.

Pregnancy

Contraindicated or to be avoided because of embryotoxicity; effective contraception is required during and after treatment.

Storage and supply

Store unopened vials below 25 °C in the original carton to protect from light; reconstituted suspension may be refrigerated for a limited period according to the product information.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.

Reference information for professional sourcing and registration enquiries, not medical advice or a promotion. Drug information is condensed from US FDA prescribing information (public domain, via openFDA and DailyMed) and does not replace the product’s approved labelling in Iran. Availability, origin and documentation are confirmed per enquiry.

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