Onco Therapies Limited
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Onco Therapies Limited Drugs
Note: Contact of the undiluted concentrate with plasticized PVC equipment or devices used to prepare solutions for infusion is not recommended. In order to minimize patient exposure to the plasticizer DEHP [di-(2- ethylhexyl)phthalate], which may be leached from PVC infusion bags or sets, diluted paclitaxel injection solutions should be stored in bottles (glass, polypropylene) or plastic bags (polypropylene, polyolefin) and administered through polyethylene-lined administration sets.
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.
For patients with carcinoma of the ovary, the following regimens are recommended (see CLINICAL STUDIES: Ovarian Carcinoma):
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 (see TABLE 11in ADVERSE REACTIONS: Disease-Specific Adverse Event Experiences).
a. 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
b. Paclitaxel Injection administered intravenously over 24 hours at a dose of 135 mg/m2 followed by cisplatin at a dose of 75 mg/m2.
2) 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.
For patients with carcinoma of the breast, the following regimens are recommended (see CLINICAL STUDIES: Breast Carcinoma):
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 (see CLINICAL STUDIES: Breast Carcinoma).
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.
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.
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 (see CLINICAL STUDIES: AIDS-Related Kaposi’s Sarcoma), 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 immunosuppression in patients with advanced HIV disease, the following modifications are recommended in these patients:
Reduce the dose of dexamethasone as 1 of the 3 premedication drugs to 10 mg PO (instead of 20 mg PO);
Initiate or repeat treatment with paclitaxel injection only if the neutrophil count is
at least 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
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 platelet 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 neuropathy 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.
Patients with hepatic impairment may be at increased risk of toxicity, particularly grade III–IV myelosuppression (see CLINICAL PHARMACOLOGYand PRECAUTIONS: Hepatic). Recommendations for dosage adjustment for the first course of therapy are shown in TABLE 17 for both 3- and 24-hour infusions. Further dose reduction in subsequent courses should be based on individual tolerance. Patients should be monitored closely for the development of profound myelosuppression.TABLE 17 RECOMMENDATIONS FOR DOSING IN PATIENTS WITH HEPATICIMPAIRMENT BASED ON CLINICAL TRIAL DATAa
a These recommendations are based on dosages for patients without hepatic impairment of
135 mg/m2 over 24 hours or 175 mg/m2 over 3 hours; data are not available to make dose
adjustment recommendations for other regimens (eg, for AIDS-related Kaposi’s sarcoma).
b Differences in criteria for bilirubin levels between the 3- and 24-hour infusion are due to
differences in clinical trial design.
c Dosage recommendations are for the first course of therapy; further dose reduction in
subsequent courses should be based on individual tolerance.Degree of Hepatic Impairment Transaminase Levels Bilirubin Levelsb 24-hour infusion <2 × ULN and ≤1.5 mg/dL 135 mg/m2 2 to <10 × ULN and ≤1.5 mg/dL 100 mg/m2 <10 × ULN and 1.6–7.5 mg/dL 50 mg/m2 ≥10 × ULN or >7.5 mg/dL Not recommended 3-hour infusion <10 × ULN and ≤1.25 × ULN 175 mg/m2 <10 × ULN and 1.26–2.0 × ULN 135 mg/m2 <10 × ULN and 2.01–5.0 × ULN 90 mg/m2 ≥10 × ULN or >5.0 × ULN Not recommended
Preparation and Administration Precautions
Procedures for proper handling and disposal of anticancer drugs should be considered. Several guidelines on this subject have been published.1–4 To minimize the risk of dermal exposure, always wear impervious gloves when handling vials containing paclitaxel Injection. If paclitaxel injection solution contacts the skin, wash the skin immediately and thoroughly with soap and water. Following topical exposure, events have included tingling, burning, and redness. If paclitaxel injection contacts mucous membranes, the membranes should be flushed thoroughly with water. Upon inhalation, dyspnea, chest pain, burning eyes, sore throat, and nausea have been reported.
Given the possibility of extravasation, it is advisable to closely monitor the infusion site for possible infiltration during drug administration (see PRECAUTIONS: Injection Site Reaction).
Preparation for Intravenous Administration
Paclitaxel Injection must be diluted prior to infusion. Paclitaxel Injection should be diluted in 0.9% Sodium Chloride Injection, USP; 5% Dextrose Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection, USP; or 5% Dextrose in Ringer’s Injection to a final concentration of 0.3 to 1.2 mg/mL. The solutions are physically and chemically stable for up to 27 hours at ambient temperature (approximately 25° C) and room lighting conditions. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Upon preparation, solutions may show haziness, which is attributed to the formulation vehicle. No significant losses in potency have been noted following simulated delivery of the solution through IV tubing containing an in-line (0.22 micron) filter.
Data collected for the presence of the extractable plasticizer DEHP [di-(2- ethylhexyl)phthalate] show that levels increase with time and concentration when dilutions are prepared in PVC containers. Consequently, the use of plasticized PVC containers and administration sets is not recommended. Paclitaxel Injection solutions should be prepared and stored in glass, polypropylene, or polyolefin containers. Non-PVC containing administration sets, such as those which are polyethylene-lined, should be used.
Paclitaxel Injection should 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 DEHP.
The Chemo Dispensing Pin™ device or similar devices with spikes should not be used with vials of paclitaxel injection since they can cause the stopper to collapse resulting in loss of sterile integrity of the paclitaxel injection solution.
Chemo Dispensing Pin™ is a trademark of B. Braun Medical Incorporated.
Unopened vials of paclitaxel injection are stable until the date indicated on the package when stored between 20°–25° C (68°–77° F), in the original package. Neither freezing nor refrigeration adversely affects the stability of the product. Upon refrigeration, components in the paclitaxel injection vial may precipitate, but will redissolve upon reaching room temperature with little or no agitation. There is no impact on product quality under these circumstances. If the solution remains cloudy or if an insoluble precipitate is noted, the vial should be discarded. Solutions for infusion prepared as recommended are stable at ambient temperature (approximately 25° C) and lighting conditions for up to 27 hours.
The recommended dose and schedule of Cladribine Injection for active Hairy Cell Leukemia is as a single course given by continuous infusion for 7 consecutive days at a dose of 0.09 mg/kg/day. Deviations from this dosage regimen are not advised. If the patient does not respond to the initial course of Cladribine Injection for Hairy Cell Leukemia, it is unlikely that they will benefit from additional courses. Physicians should consider delaying or discontinuing the drug if neurotoxicity or renal toxicity occurs (see WARNINGS).
Specific risk factors predisposing to increased toxicity from Cladribine have not been defined. In view of the known toxicities of agents of this class, it would be prudent to proceed carefully in patients with known or suspected renal insufficiency or severe bone marrow impairment of any etiology. Patients should be monitored closely for hematologic and non-hematologic toxicity (see WARNINGS and PRECAUTIONS).
Preparation and Administration of Intravenous Solutions:
Cladribine Injection must be diluted with the designated diluent prior to administration. Since the drug product does not contain any anti-microbial preservative or bacteriostatic agent, aseptic technique and proper environmental precautions must be observed in preparation of Cladribine Injection solutions.
To prepare a single daily dose:
Add the calculated dose (0.09 mg/kg or 0.09 mL/kg) of Cladribine Injection to an infusion bag containing 500 mL of 0.9% Sodium Chloride Injection, USP. Infuse continuously over 24 hours. Repeat daily for a total of 7 consecutive days. The use of 5% dextrose as a diluent is not recommended because of increased degradation of cladribine. Admixtures of Cladribine Injection are chemically and physically stable for at least 24 hours at room temperature under normal room fluorescent light in Baxter Viaflex®† PVC infusion containers. Since limited compatibility data are available, adherence to the recommended diluents and infusion systems is advised.Dose of Recommended Quantity of Diluent Cladribine Injection Diluent 24-hour infusion 1(day) x 0.09 mg/kg 0.9% Sodium Chloride 500 mL method Injection, USP
To prepare a 7-day infusion:
The 7-day infusion solution should only be prepared with Bacteriostatic 0.9% Sodium Chloride Injection, USP (0.9% benzyl alcohol preserved). In order to minimize the risk of microbial contamination, both Cladribine Injection and the diluent should be passed through a sterile 0.22μ disposable hydrophilic syringe filter as each solution is being introduced into the infusion reservoir. First add the calculated dose of Cladribine Injection (7 days x 0.09 mg/kg or mL/kg) to the infusion reservoir through the sterile filter.
Then add a calculated amount of Bacteriostatic 0.9% Sodium Chloride Injection, USP (0.9% benzyl alcohol preserved) also through the filter to bring the total volume of the solution to 100 mL. After completing solution preparation, clamp off the line, disconnect and discard the filter. Aseptically aspirate air bubbles from the reservoir as necessary using the syringe and a dry second sterile filter or a sterile vent filter assembly. Reclamp the line and discard the syringe and filter assembly. Infuse continuously over 7 days. Solutions prepared with Bacteriostatic Sodium Chloride Injection for individuals weighing more than 85 kg may have reduced preservative effectiveness due to greater dilution of the benzyl alcohol preservative. Admixtures for the 7-day infusion have demonstrated acceptable chemical and physical stability for at least 7 days in the SIMS Deltec MEDICATION CASSETTE™ Reservoir‡.Dose of Cladribine Injection Recommended Diluent Quantity of Diluent 7-day infusion method 7 (days) x 0.09 mg/kg Bacteriostatic 0.9% Sodium q.s. to 100 mL (use sterile 0.22μ filter Chloride Injection, USP when preparing infusion (0.9% benzyl alcohol) solution)
Since limited compatibility data are available, adherence to the recommended diluents and infusion systems is advised. Solutions containing Cladribine Injection should not be mixed with other intravenous drugs or additives or infused simultaneously via a common intravenous line, since compatibility testing has not been performed. Preparations containing benzyl alcohol should not be used in neonates (see WARNINGS).
Care must be taken to assure the sterility of prepared solutions. Once diluted, solutions of Cladribine Injection should be administered promptly or stored in the refrigerator (2° to 8° C) for no more than 8 hours prior to start of administration. Vials of Cladribine Injection are for single-use only. Any unused portion should be discarded in an appropriate manner (see Handling and Disposal).
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. A precipitate may occur during the exposure of Cladribine Injection to low temperatures; it may be resolubilized by allowing the solution to warm naturally to room temperature and by shaking vigorously. DO NOT HEAT OR MICROWAVE.
Chemical Stability of Vials:
When stored in refrigerated conditions between 2° to 8°C (36° to 46°F) protected from light, unopened vials of Cladribine Injection are stable until the expiration date indicated on the package. Freezing does not adversely affect the solution. If freezing occurs, thaw naturally to room temperature. DO NOT heat or microwave. Once thawed, the vial of Cladribine Injection is stable until expiry if refrigerated. DO NOT refreeze. Once diluted, solutions containing Cladribine Injection should be administered promptly or stored in the refrigerator (2° to 8°C) for no more than 8 hours prior to administration.
Handling and Disposal:
The potential hazards associated with cytotoxic agents are well established and proper precautions should be taken when handling, preparing, and administering Cladribine Injection. The use of disposable gloves and protective garments is recommended. If Cladribine Injection contacts the skin or mucous membranes, wash the involved surface immediately with copious amounts of water. Several guidelines on this subject have been published.(2-8) There is no general agreement that all of the procedures recommended in the guidelines are necessary or appropriate. Refer to your Institution's guidelines and all applicable state/local regulations for disposal of cytotoxic waste.
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