Novel Technology :

Paclitaxel bulk for the formulation of Paxus injection in produced by the most advanced and the world's first ever industrialized plant cell culture technology.

High Quality and Hight Purity :

Highly reproducible production process operated under strict GMP guidelines allow production of bulk paclitaxel of highest and stable quality.

Efficacy :

Paxus given as a monotherapy showed anti-tumor efficacy of 37,5% response rate in patients with metastatic breast cancer who have failed to standard chemotherapy, and 40,0% response rate in patients with NSCLC in multi-centre, open label phase II clinical trials.

Safety :

Paxus showed safety profile similar to previously marketed paclitaxel formulation.

Composition

Each ml of Paxus injection contains 6 mg of paclitaxel, 527 mg of purified

Cremophor (polyoxyl 35 castor oil) and 49,7% (v/v) of dehydrated alcohol.

Indication
Each ml of Paxus injection contains 6 mg of paclitaxel, 527 mg of purified Cremophor (polyoxyl 35 castor oil) and 49,7% (v/v) of dehydrated alcohol.

Contra Indication
Paclitaxel is contraindicated in-patients who have a history of severe hypersensitivity reactions to paclitaxel or other drugs formulated in polyoxyl 35 castor oil. Paclitaxel should not be used in patients with baseline neutrophil count of less than 1,500 cells/mm3 or in patients with AIDS related Kaposi's sarcoma with baseline neutrophil counts of <1000 cells/mm3.

Adverse Reaction
Tertiary or more severe adverse events were observed in a total of 101 cycles or 15,2% out of a total of 666 treatment cycles. ADRs of severity less than tertiary adverse reactions, which are believed to be related with drug, totaled 35 (12,4%) out of a total of 282 cases.

Dosage
1) Premedication. Following sequence of premedication shall be done to prepare patient for infusion with Paxus injection. 12 hours before treatment .....Dexamethasone 20 mg P.O. 6 hours before treatment.....Dexamethasone 20 mg P.O. 30-60 minutes before treatment (Paxus Inj) .....Diphenhydramine 50 mg I.V. Cimetidine 300 mg or Ranitidine 50 mg I.V. 2) Preparation Prior to infusion to patients, Paxus injection shall be diluted in any of following injection solutions to get a final concentration of 0,3-1,2 mg of paclitaxel/ml. - 0,9% Sodium Chloride Injection - 5% Dextrose Injection - 5% Dextrose / 0,9% Sodium Chloride Injection - 5% Dextrose in Ringers Injection solution 3) Dose schedule. Intravenous (i.v.) infusion of a dose of 175 mg/m2 over a 3 hour period. The treatment may be repeated every 3 weeks. 4) Repeat dosage. Subsequent treatment shall not be given to patients until neutrophil count is at least 1,500 cells/mm3 and platelet count is at least 100,000 cells/mm3. For patients who experienced severe neutropenia (neutrophil <500 cells/mm3) for a week or longer or moderate to severe peripheral neuropathy during Paxus injection treatment, dosage shall be reduced by 20% for subsequent courses of Paxus therapy. 5) Stability of diluted solutions. Physically and chemically stable for up to 27 hours at ambient temperature (15-30ºC) 6) Infusion set. - Undiluted concentrate shall not come in contact with plasticized PVC equipments during preparation. To minimize patients exposure to the plasticizer DHEP, which may be leached from PVC infusion bags or sets, diluted Paxus solutions shall preferably be stored in bottles (glass, propylene) or plastic bags (polypropylene, polyolefin) and administered with polyethylene-lined administration sets. - Paxus shall be administered through an in-line filter with a microporous membrane not greater than 0,22 microns. Use of filter devices such as IVEX-2 filters which incorporate short inlet and outlet PVC-coated tubing has not resulted in significant leaching of DHEP.

Presentation
1 Box @ 1 vial (5 ml). Reg. No. DKL0303300143A1