***
Xu QA, Trissel LA. Compatibility of palonosetron with cyclophosphamide and with ifosfamide during simulated Y-site administration. Am J Health Syst Pharm. 2005 Oct 1;62(19):1998-2000.
Division of Pharmacy, The University of Texas M. D. Anderson Cancer Center, 1515 Holcombe Boulevard, Houston, TX 77030, USA.
PURPOSE: The physical and chemical compatibility of palonosetron with cyclophosphamide and with ifosfamide during simulated Y-site administration was studied.
METHODS: Test samples were prepared in triplicate by mixing 7.5 mL of palonosetron hydrochloride 50 microg (of palonosetron) per milliliter with 7.5 mL of cyclophosphamide 10 mg/mL and with ifosfamide 20 mg/mL. Physical stability was assessed by turbidimetry, particle sizing, and visual inspection. Chemical stability was assessed by stability-indicating high-performance liquid chromatography. Evaluations were performed immediately and one and four hours after mixing.
RESULTS: The samples were clear and colorless when viewed in normal fluorescent room light and when viewed with a high-intensity monodirectional light. Turbidity remained unchanged, and particulate content was low and exhibited little change. Palonosetron, cyclophosphamide, and ifosfamide remained chemically stable throughout the four-hour test period.
CONCLUSION: Palonosetron hydrochloride was physically compatible with cyclophosphamide or ifosfamide during simulated Y-site administration.
REFERENCES: Xu QA, Trissel LA. Compatibility of palonosetron with cyclophosphamide and with ifosfamide during simulated Y-site administration. Am J Health Syst Pharm. 2005 Oct 1;62(19):1998-2000.
27 dezembro 2008
18 dezembro 2008
Fentanil intranasal em pacientes oncológicos
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TOLERABILITY AND SAFETY OF INTRANASAL FENTANYL TREATMENT FOR BREAKTHROUGH PAIN IN PATIENTS WITH CANCER: FOUR-MONTH FOLLOW-UP
S. Kaasa, C. Marchesini, Z. Kaczmarek, A. Oronska, H. Kress, T. Nolte
Purpose of the study: To confirm the long-term tolerability and safety of treatment with intranasal fentanyl titrated to doses of 50, 100, and 200 mcg, for the treatment of breakthrough pain in patients with cancer, during an open-label follow-up safety period.
***
Methods: This was a randomised double-blind, placebo-controlled, cross-over, multicentre trial involving 120 adult in/out patients with cancer, receiving stable, chronic opioid therapy and experiencing ‡3 BTP episodes per week and £4 per day. Patients were titrated to an effective dose (providing pain relief within 10 min) of 50, 100, or 200 mcg of intranasal fentanyl per administration. Subsequently, they received their successful treatment dose of intranasal fentanyl (in a randomised, double blinded sequence), for six of eight breakthrough pain episodes (maximum four per day), and placebo for one breakthrough pain episode each of episodes 1–4 and 5–8, respectively. Rescue analgesic after 20 minutes of treatment was permitted for patients with no or inadequate pain relief. Patients were monitored for safety for 4 months after inclusion of the last patient in the trial.
***
Results: In 108 patients, the mean number of days of exposure was 106.4. Sixty-five patients experienced adverse events (AEs) during this period: 52 had serious AEs, 42 died and 44 patients discontinued trial due to AEs, mainly due to progression of malignant neoplasm and unrelated to study medication.
Only five patients experienced AEs considered to be related to trial drug (4.6% of all patients): five had nausea; four had constipation; two experienced vomiting, and one had epistaxis, all of which were graded mild or moderate, and one patient experienced severe dysgeusia (taste disturbance) who discontinued participation in the trial.
***
Conclusions: All doses of intranasal fentanyl were shown to be safe and well tolerated. The majority of those AEs considered related to study drug were mild to moderate, and most reported AEs were considered to be related to progression of patients’ underlying disease.
Referências: Annals of Oncology 19 (Supplement 8): viii254–viii258, 2008
TOLERABILITY AND SAFETY OF INTRANASAL FENTANYL TREATMENT FOR BREAKTHROUGH PAIN IN PATIENTS WITH CANCER: FOUR-MONTH FOLLOW-UP
S. Kaasa, C. Marchesini, Z. Kaczmarek, A. Oronska, H. Kress, T. Nolte
Purpose of the study: To confirm the long-term tolerability and safety of treatment with intranasal fentanyl titrated to doses of 50, 100, and 200 mcg, for the treatment of breakthrough pain in patients with cancer, during an open-label follow-up safety period.
***
Methods: This was a randomised double-blind, placebo-controlled, cross-over, multicentre trial involving 120 adult in/out patients with cancer, receiving stable, chronic opioid therapy and experiencing ‡3 BTP episodes per week and £4 per day. Patients were titrated to an effective dose (providing pain relief within 10 min) of 50, 100, or 200 mcg of intranasal fentanyl per administration. Subsequently, they received their successful treatment dose of intranasal fentanyl (in a randomised, double blinded sequence), for six of eight breakthrough pain episodes (maximum four per day), and placebo for one breakthrough pain episode each of episodes 1–4 and 5–8, respectively. Rescue analgesic after 20 minutes of treatment was permitted for patients with no or inadequate pain relief. Patients were monitored for safety for 4 months after inclusion of the last patient in the trial.
***
Results: In 108 patients, the mean number of days of exposure was 106.4. Sixty-five patients experienced adverse events (AEs) during this period: 52 had serious AEs, 42 died and 44 patients discontinued trial due to AEs, mainly due to progression of malignant neoplasm and unrelated to study medication.
Only five patients experienced AEs considered to be related to trial drug (4.6% of all patients): five had nausea; four had constipation; two experienced vomiting, and one had epistaxis, all of which were graded mild or moderate, and one patient experienced severe dysgeusia (taste disturbance) who discontinued participation in the trial.
***
Conclusions: All doses of intranasal fentanyl were shown to be safe and well tolerated. The majority of those AEs considered related to study drug were mild to moderate, and most reported AEs were considered to be related to progression of patients’ underlying disease.
Referências: Annals of Oncology 19 (Supplement 8): viii254–viii258, 2008
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