Ontaxel-30

Paclitaxel USP

Composition:

Ontaxel-30 IV Injection: Each vial contains 16.7ml solution containing Paclitaxel USP 30 mg (6 mg/ml).

Ontaxel-100 IV Injection: Each vial contains 16.7ml solution containing Paclitaxel USP 100 mg (6 mg/ml).

Ontaxel-300 IV Injection: Each vial contains 50ml solution containing Paclitaxel USP 300 mg (6 mg/ml).

Indications: Ovarian Carcinoma: Ontaxel is indicated as first line and subsequent therapy for the treatment of advanced carcinoma of the ovary.As first line therapy,Ontaxel is indicated in combination with cisplatin.

Breast carcinoma: Ontaxel is indicated for the adjuvant treatment of node positive breast cancer administered sequentially to standard doxorubicincontaining combination chemotherapy. Ontaxel 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 anthracline unless clinically contraindicated. Ontaxel is indicated for the first line therapy of advanced or metastatic breast cancer either in combination with an anthracycline in patients for whom anthracline therapy is suitable or in combination with trastuzumab in patients who over express HER-2 at a 2+ or 3+ level as determined by immunohistochemistry. Gemoxen, in combination of Ontaxel .is indicated in the treatment of patients with unresectable,locally recurrent or metastatic breast cancer who have relapsed following adjuvant/neoadjuvant chemotherapy. Prior chemotherapy should have included an anthracycline unless clinically contraindicated. Ontaxel is indicated for the treatment of metastatic cancer of the breast,in combination with trastuzumab (Herceptin), in patients who have tumors that over-express HER-2 and who have not received previous chemotherapy for their metastatic disease.

Non Small Cell Lung Carcinoma: Ontaxel, in combination with cisplatin, is indicated for the first line treatment of non small cell lung cancer in patients who are not candidates for potential curative surgery and/or radiation therapy.

Kaposi's Saocoma: Ontaxel is indicated for the second line treatment of AIDS related Kaposi's Sarcoma.

Gastric Carcinoma: Ontaxel is indicated for the treatment of Gastric Carcinoma.

Dosage & Administration: All patients should be premedicated prior to paclitaxel injection administration in order to prevent severe hypersensitivity reactions. Such premedication may consist of dexamethasone 20 mg PO administered approximately 12 and 6 hours before paclitaxel injection, diphenhydramine (or its equivalent) 50 mg IV 30 to 60 minutes prior to paclitaxel injection, and cimetidine (300 mg) or ranitidine (50 mg) IV 30 to 60 minutes before paclitaxel injection.

Ovarian Carcinoma: For patients with carcinoma of the ovary, the following regimens are recommended:

1. For previously untreated patients with carcinoma of the ovary, one of the following recommended regimens may be given every 3 weeks. In selecting the appropriate regimen, differences in toxicities should be considered.

· Paclitaxel Injection administered intravenously over 3 hours at a dose of 175 mg/m² followed by cisplatin at a dose of 75 mg/m²; or

· Paclitaxel Injection administered intravenously over 24 hours at a dose of 135 mg/m² followed by cisplatin at a dose of 75 mg/m².

1. In patients previously treated with chemotherapy for carcinoma of the ovary, paclitaxel injection has been used at several doses and schedules; however, the optimal regimen is not yet clear. The recommended regimen is paclitaxel injection 135 mg/m² or 175 mg/m² administered intravenously over 3 hours every 3 weeks.

Breast Carcinoma: For patients with carcinoma of the breast, the following regimens are recommended:

1. For the adjuvant treatment of node-positive breast cancer, the recommended regimen is paclitaxel injection, at a dose of 175 mg/m² intravenously over 3 hours every 3 weeks for 4 courses administered sequentially to doxorubicin-containing combination chemotherapy. The clinical trial used 4 courses of doxorubicin and cyclophosphamide.

2. After failure of initial chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy, paclitaxel injection at a dose of 175 mg/m² administered intravenously over 3 hours every 3 weeks has been shown to be effective.

Non-small cell lung carcinoma: For patients with non-small cell lung carcinoma, the recommended regimen, given every 3 weeks, is paclitaxel injection administered intravenously over 24 hours at a dose of 135 mg/m² followed by cisplatin, 75 mg/m².

AIDS-related Kaposi's Sarcoma: For patients with AIDS-related Kaposi's sarcoma, paclitaxel injection administered at a dose of 135 mg/m² given intravenously over 3 hours every 3 weeks or at a dose of 100 mg/m² given intravenously over 3 hours every 2 weeks is recommended (dose intensity 45-50 mg/m²/week). In the 2 clinical trials evaluating these schedules, the former schedule (135 mg/m² every 3 weeks) was more toxic than the latter. In addition, all patients with low performance status were treated with the latter schedule (100 mg/m² every 2 weeks).

Based upon the immunosupreesion in patients with advanced HIV disease, the following modifications are recommended in these patients:

1. Reduce the dose of dexamethasone as 1 of the 3 premedication drugs to 10 mg PO (instead of 20 mg PO);

2. Initiate or repeat treatment with paclitaxel injection only if the neutrophil count is atleast 1000 cells/mm³;

3. Reduce the dose of subsequent courses of paclitaxel injection by 20% for patients who experience severe neutropenia (neutrophil < 500 cells/mm³ for a week or longer); and

4. Initiate concomitant hematopoietic growth factor (G-CSF) as clinically indicated.

For the therapy of patients with solid tumors (ovary, breast, and NSCLC), courses of paclitaxel injection should not be repeated until the neutrophil count is at least 1500 cells/mm³ and the platlet count is at least 100,000 cells/mm³. Paclitaxel Injection should not be given to patients with AIDS-related Kaposi's sarcoma if the baseline or subsequent neutrophil count is less than 1000 cells/mm³. Patients who experience severe neutropenia (neutrophil < 500 cells/mm³ for a week or longer) or severe peripheral neutropathy during paclitaxel injection therapy should have dosage reduced by 20% for subsequent courses of paclitaxel injection. The incidence of neurotoxicity and the severity of neutropenia increase with dose.Ovarian Cancer First line treatment in combination with cisplatin : Ontaxel administered intravenously over 3 hours at a dose of 175 mg/m2 followed by cisplatin at a dose of 75 mg/m2 every 3 weeks Ontaxel administered intravenously over 24 hours at a dose of 135 mg/m2 followed by cisplatin at a dose of 75 mg/m2 every 3 weeks In patients previously treated with chemotherapy for carcinoma of the ovary, Ontaxel has been use at several doses and schedules; however,the optimal regimem is not yet clear.The recommended regimen is Ontaxel (paclitaxel) 135 mg/m2 or 175 mg/m2 administered intravenously over 3 hours every 3 weeks. Breast Cancer : - 175 mg/m2 administered IV over 3 hours every 3 weeks has been shown to be effective after failure of chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. AIDS-related Kaposi's sarcoma : - 135 mg/m2 given IV over 3 hours every 3 weeks or at a dose of 100 mg/m2 given IV. over 3 hours every 2 weeks is recommended (dose intensity 45-50 mg/ m2 /week) Lung cancer : - For the first-line treatment of NSCLC, in combination with cisplatin, in patients who are not candidates for potentially curative surgery and/or radiation therapy. -135 mg/m2 IV administered over 24 hours followed by cisplatin. The regimen to be repeated every 3 weeks based on the clinical status of the patient. Gastric Cancer : - Once daily 210 mg/m2 (Body surface area) by 3 hours intravenous infusion for adults. At least 3 week of dosing interval is of absolute necessity. Dosage modification for toxicity (solid tumors, including ovary, breast, and lung carcinoma) : Courses of Paclitaxel should not be repeated until the neutrophil count is> 1500 cells/mm3 and the platelet count is> 100,000 cells/mm3; reduce dosage by 20% for patients experiencing severe peripheral neuropathy or severe neutropenia (neutrophil <500>

Use in Pregnancy and Lactation: Pregnancy Category D. There is no adequate and well- controlled clinical studies in pregnant or breastfeeding women. It should only be used in pregnant women if the potential benefit justifies the potential risk to the foetus. Since it is not known if Paclitaxel is distributed into milk,the drug should be used with caution in nursing women.

Packaging:

Ontaxel 30 injection: Each box contains 1 vial (5 ml) Paclitaxel.

Ontaxel 100 injection: Each box contains 1 vial (16.7ml) Paclitaxel.

Ontaxel 300 injection: Each box contains 1 vial (50ml) Paclitaxel.

Prescribing Description

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