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.
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.
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