Single Vial Docetaxel Injection - ION Solutions

More documents

Recommendations

Info

Adverse Reaction <strong>Docetaxel</strong> 75 mg/m 2 n=176 % Best Supportive Care n=49 % Vinorelbine/Ifosfamide n=119 % Thrombocytopenia Any Grade 3/4 8 3 0 0 8 2 Anemia Any Grade 3/4 91 9 55 12 91 14 Febrile Neutropenia** 6 NA † 1 Infection Any Grade 3/4 34 10 Treatment Related Mortality 3 NA † 3 Hypersensitivity Reactions Any Grade 3/4 6 3 Fluid Retention Any 34 ND †† 23 Severe 3 3 Neurosensory Any 23 14 29 Grade 3/4 2 6 5 Neuromotor Any 16 8 10 Grade 3/4 5 6 3 Skin Any 20 6 17 Grade 3/4 1 2 1 Gastrointestinal Nausea Any 34 31 31 Grade 3/4 5 4 8 Vomiting Any 22 27 22 Grade 3/4 3 2 6 Diarrhea Any 23 6 12 Grade 3/4 3 0 4 Alopecia 56 35 50 29 6 0 0 30 9 1 0 Page 20 of 46
<strong>Docetaxel</strong> 75 mg/m 2 n=176 % Best Supportive Care n=49 % Vinorelbine/Ifosfamide n=119 % Adverse Reaction Asthenia Any 53 57 54 Severe*** 18 39 23 Stomatitis Any 26 6 8 Grade 3/4 2 0 1 Pulmonary Any 41 49 45 Grade 3/4 21 29 19 Nail Disorder Any 11 0 2 Severe*** 1 0 0 Myalgia Any 6 0 3 Severe*** 0 0 0 Arthralgia Any 3 2 2 Severe*** 0 0 1 Taste Perversion Any 6 0 0 Severe*** 1 0 0 *Normal Baseline LFTs: Transaminases ≤1.5 times ULN or alkaline phosphatase ≤2.5 times ULN or isolated elevations of transaminases or alkaline phosphatase up to 5 times ULN **Febrile Neutropenia: ANC grade 4 with fever >38°C with intravenous antibiotics and/or hospitalization † Not Applicable †† Not Done ***COSTART term and grading system Combination therapy with docetaxel in chemotherapy-naïve advanced unresectable or metastatic NSCLC Table 6 presents safety data from two arms of an open label, randomized controlled trial (TAX326) that enrolled patients with unresectable stage IIIB or IV non-small cell lung cancer and no history of prior chemotherapy. Adverse reactions were described using the NCI Common Toxicity Criteria except where otherwise noted. Page 21 of 46
Page 1 and 2: Frequently Asked Questions Hospira
Page 5 and 6: HIGHLIGHTS OF PRESCRIBING INFORMATI
Page 7 and 8: FULL PRESCRIBING INFORMATION WARNIN
Page 9 and 10: Injection administration in order t
Page 11 and 12: Please follow the preparation instr
Page 13 and 14: discontinuation of the Docetaxel In
Page 15 and 16: Docetaxel 100 mg/m 2 : Adverse drug
Page 17 and 18: Hematologic Reactions Reversible ma
Page 19 and 20: Table 2 - Hematologic Adverse React
Page 21 and 22: 60 mg/m 2 vs. 6.9% and 16.5% for pa
Page 23: Gastrointestinal Reactions In addit
Page 27 and 28: Adverse Reaction Skin Any Grade 3/4
Page 29 and 30: Table 7 - Clinically Important Trea
Page 31 and 32: In vivo studies showed that the exp
Page 33 and 34: observed in mice at 48 mg/kg (about
Page 35 and 36: however, includes a substantial ran
Page 37 and 38: Table 8 - Efficacy of Docetaxel in
Page 39 and 40: doxorubicin 50 mg/m 2 and cyclophos
Page 41 and 42: infections, and treatment-related m
Page 43 and 44: Combination Therapy with Docetaxel
Page 45 and 46: Figure 5 - TAX327 Survival K-M Curv
Page 47 and 48: If your white blood cells are too l
Page 49 and 50: General information about Docetaxel

Single Vial Docetaxel Injection - ION Solutions

Create successful ePaper yourself

Delete template?

Save as template?