Nanoxel

Features

Paclitaxel is a novel antimicrotubule agent 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. In addition, paclitaxel induces abnormal arrays or "bundles" of microtubules through out the cell cycle and multiple asters of microtubules during mitosis.

Dosage

Breast Cancer:

a) For the adjuvant treatment of node-positive breast cancer, the recommended regimen is NANOXEL, at a dose of 220 mg/m2 intravenously over 1-hour every 3 weeks for four courses administered sequentially to doxorubicincontaining combination chemotherapy.

b) After failure of initial chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy, NANOXEL at a dose of 220 mg/m2 administered intravenously over 1-hour every 3 weeks.

Ovarian Cancer:

a) For previously untreated patients with carcinoma of the ovary following regimen may be given every 3 weeks. NANOXEL administered intravenously over 1-hour at a dose of 220 mg/m followed by cisplatin at a dose of 75 mg/m2;

b) In patients previously treated with chemotherapy for carcinoma of the ovary. The recommended regimen is NANOXEL 165 mg/m2 or 220 mg/m2 administered intravenously over 1-hour every 3 weeks.

Non-Small Cell Lung Cancer:

For patients with non-small cell lung carcinoma, the recommended regimen, given every 3 weeks, is NANOXEL administered intravenously over 1-hour at a dose of 220 mg/m2 followed by cisplatin, 75 mg/m2.

AIDS-related Kaposi's Sarcoma:

For patients with AIDS-related Kaposi's sarcoma, NANOXEL administered at a dose of 165 mg/m2 given intravenously over 1-hour every 3 weeks.

Indications

NANOXEL is indicated for the adjuvant treatment of node-positive breast cancer administered sequentially to standard doxorubicin-containing combination chemotherapy.

NANOXEL 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.

NANOXEL is indicated as first-line and subsequent therapy for the treatment of advanced carcinoma of the ovary. As firstline therapy, NANOXEL is indicated in combination with cisplatin.

NANOXEL, in combination with cisplatin, is indicated for the first-line treatment of non-small cell lung cancer in patients who are not candidates for potentially curative surgery and/or radiation therapy.

NANOXEL is indicated for the second-line treatment of AIDS-related Kaposi's sarcoma.

Product Information

NANOXEL is available as a combination pack containing one vial of “Paclitaxel Solution for Nanoparticle” and one vial of “Concentrate of excipients for NANOXEL”.

The Paclitaxel Solution for Nanoparticle is available in vials of 1.5 ml (30 mg), 5 ml (100 mg) & 15 ml (300 mg).

The “Concentrate of excipients for NANOXEL” is also available in vials of 1.5 ml, 5 ml and 15 ml.

 

For the use only of a Registered Medical Practitioner or a Hospital or a Laboratory