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adverse reactions
6 ADVERSE REACTIONS Small cell lung cancer: The most common hematologic adverse reactions were: neutropenia (97%), leukopenia (97%), anemia (89%), and thrombocytopenia (69%). (6.1) The most common (>25%) non-hematologic adverse reactions (all grades) were: nausea, alopecia, vomiting, sepsis or pyrexia/infection with neutropenia, diarrhea, constipation, fatigue, and pyrexia. (6.1) Cervical cancer (topotecan hydrochloride for injection plus cisplatin): The most common hematologic adverse reactions (all grades) were: anemia (94%), leukopenia (91%), neutropenia (89%), and thrombocytopenia (74%). (6.1) The most common (>25%) non-hematologic adverse reactions (all grades) were: pain, nausea, vomiting, and infection/febrile neutropenia. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories Limited Inc., at 1-888-375-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice. Small Cell Lung Cancer: Data in the following section are based on the 426 patients with small cell lung cancer treated with topotecan hydrochloride for injection. Table 1 lists the principal hematologic adverse reactions and Table 2 lists non-hematologic adverse reactions occurring in at least 15% of patients. Table 1. Hematologic Adverse Reactions Experienced in ≥ 15% Small Cell Lung Cancer Patients Receiving Topotecan Hydrochloride For Injection Hematologic Adverse Reaction Patients (n = 879) % Incidence Neutropenia <1,500 cells/mm 3 <500 cells/mm 3 97 78 Leukopenia <3,000 cells/mm 3 <1,000 cells/mm 3 97 32 Thrombocytopenia <75,000/mm 3 <25,000/mm 3 69 27 Anemia <10 g/dL <8 g/dL 89 37 Table 2. Non-hematologic Adverse Reactions Experienced by ≥ 15% of Small Cell Lung Cancer Patients Receiving Topotecan Hydrochloride For Injection Non-hematologic Adverse Reaction Percentage of Patients with Adverse Reaction (879 Patients) All Grades Grade 3 Grade 4 Infections and infestations Sepsis or pyrexia/infection with neutropenia a 43 NR 23 Metabolism and nutrition disorders Anorexia 19 2 <1 Nervous system disorders Headache 18 1 <1 Respiratory, thoracic, and mediastinal disorders Dyspnea Coughing 22 15 5 1 3 0 Gastrointestinal disorders Nausea Vomiting Diarrhea Constipation Abdominal pain Stomatitis 64 45 32 29 22 18 7 4 3 2 2 1 1 1 1 1 2 <1 Skin and subcutaneous tissue disorders Alopecia Rash b 49 16 NA 1 NA 0 General disorders and administrative site conditions Fatigue Pyrexia Pain c Asthenia 29 28 23 25 5 1 2 4 0 <1 1 2 NA = Not applicable NR = Not reported separately a Does not include Grade 1 sepsis or pyrexia. b Rash also includes pruritus, rash erythematous, urticaria, dermatitis, bullous eruption, and maculopapular rash. c Pain includes body pain, back pain, and skeletal pain. Nervous System Disorders: Paresthesia occurred in 7% of patients but was generally Grade 1. Hepatobiliary Disorders: Grade 1 transient elevations in hepatic enzymes occurred in 8% of patients. Greater elevations, Grade 3/4, occurred in 4%. Grade 3/4 elevated bilirubin occurred in <2% of patients. Table 3 shows the Grade 3/4 hematologic and major non-hematologic adverse reactions in the topotecan/CAV (cyclophosphamide-doxorubicin-vincristine) comparator trial in small cell lung cancer. Table 3. Adverse Reactions Experienced by ≥ 5 % of Small Cell Lung Cancer Patients Randomized to Receive Topotecan Hydrochloride For Injection or CAV Adverse Reaction Topotecan Hydrochloride For Injection (n = 107) CAV (n = 104) Hematologic Grade 3/4 % % Grade 4 neutropenia (<500 cells/mm 3 ) 70 72 Grade 3/4 anemia (Hgb <8 g/dL) 42 20 Grade 4 thrombocytopenia (<25,000 plts/mm 3 ) 29 5 Pyrexia/Grade 4 neutropenia 28 26 Non-hematologic Grade 3/4 % % Infections and infestationsDocumented sepsis a 5 5 Respiratory, thoracic, and mediastinal disorders Dyspnea Pneumonia 9 8 14 6 Gastrointestinal disorders Abdominal pain Nausea 6 8 4 6 General disorders and administrative site conditions Fatigue Asthenia Pain b 6 9 5 10 7 7 a Death related to sepsis occurred in 3% of patients receiving topotecan hydrochloride for injection , and 1% of patients receiving CAV. b Pain includes body pain, skeletal pain, and back pain. Cervical Cancer: In the comparative trial with topotecan hydrochloride for injection plus cisplatin versus cisplatin in patients with cervical cancer, the most common dose-limiting adverse reaction was myelosuppression. Table 4 shows the hematologic adverse reactions and Table 5 shows the non-hematologic adverse reactions in patients with cervical cancer. Table 4. Hematologic Adverse Reactions in Patients with Cervical Cancer Treated with Topotecan Hydrochloride For Injection Plus Cisplatin or Cisplatin Monotherapy a Hematologic Adverse Reaction Topotecan Hydrochloride For Injection Plus Cisplatin (n = 140) Cisplatin(n = 144) Anemia All Grades (Hgb <12 g/dL) 131 (94%) 130 (90%) Grade 3 (Hgb <8-6.5 g/dL) 47 (34%) 28 (19%) Grade 4 (Hgb <6.5 g/dL) 9 (6%) 5 (3%) Leukopenia All Grades (<3,800 cells/mm3) 128 (91%) 43 (30%) Grade 3 (<2,000-1,000 cells/mm3) 58 (41%) 1 (1%) Grade 4 (<1,000 cells/mm3) 35 (25%) 0 (0%) Neutropenia All Grades (<2,000 cells/mm3) 125 (89%) 28 (19%) Grade 3 (<1,000-500 cells/mm3) 36 (26%) 1 (1%) Grade 4 (<500 cells/mm3) 67 (48%) 1 (1%) Thrombocytopenia All Grades (<130,000 cells/mm3) 104 (74%) 21 (15%) Grade 3 (<50,000-10,000 cells/mm3) 36 (26%) 5 (3%) Grade 4 (<10,000 cells/mm3) 10 (7%) 0 (0%) a Includes patients who were eligible and treated. Table 5. Non-hematologic Adverse Reactions Experienced by ≥5% of Patients with Cervical Cancer Treated with Topotecan Hydrochloride For Injection Plus Cisplatin or Cisplatin Monotherapya Topotecan Hydrochloride For Injection Plus Cisplatin Cisplatin (n = 140) (n = 144) Adverse Reaction All Gradesb Grade 3 Grade 4 All Gradesb Grade 3 Grade 4 General disorders and administrative site conditions Constitutional c 96 (69%) 11 (8%) 0 89 (62%) 17 (12%) 0 Pain d 82 (59%) 28 (20%) 3 (2%) 72 (50%) 18 (13%) 5 (3%) Gastrointestinal disorders Vomiting 56 (40%) 20 (14%) 2 (1%) 53 (37%) 13 (9%) 0 Nausea 77 (55%) 18 (13%) 2 (1%) 79 (55%) 13 (9%) 0 Stomatitis-pharyngitis 8 (6%) 1 (<1%) 0 0 0 0 Other 88 (63%) 16 (11%) 4 (3%) 80 (56%) 12 (8%) 3 (2%) Dermatology 67 (48%) 1 (<1%) 0 29 (20%) 0 0 Metabolic-Laboratory 55 (39%) 13 (9%) 7 (5%) 44 (31%) 14 (10%) 1 (<1%) Genitourinary 51 (36%) 9 (6%) 9 (6%) 49 (34%) 7 (5%) 7 (5%) Nervous system disorders Neuropathy 4 (3%) 1 (<1%) 0 3 (2%) 1 (<1%) 0 Other 49 (35%) 3 (2%) 1 (<1%) 43 (30%) 7 (5%) 2 (1%) Infection-febrile neutropenia 39 (28%) 21 (15%) 5 (4%) 26 (18%) 11 (8%) 0 Cardiovascular 35 (25%) 7 (5%) 6 (4%) 22 (15%) 8 (6%) 3 (2%) Hepatic 34 (24%) 5 (4%) 2 (1%) 23 (16%) 2 (1%) 0 Pulmonary 24 (17%) 4 (3%) 0 23 (16%) 5 (3%) 3 (2%) Vascular disorders Hemorrhage 21 (15%) 8 (6%) 1 (<1%) 20 (14%) 3 (2%) 1 (<1%) Coagulation 8 (6%) 4 (3%) 3 (2%) 10 (7%) 7 (5%) 0 Musculoskeletal 19 (14%) 3 (2%) 0 7 (5%) 1 (<1%) 1 (<1%) Allergy-Immunology 8 (6%) 2 (1%) 1 (<1%) 4 (3%) 0 1 (<1%) Endocrine 8 (6%) 0 0 4 (3%) 2 (1%) 0 Sexual reproduction function 7 (5%) 0 0 10 (7%) 1 (<1%) 0 Ocular-visual 7 (5%) 0 0 7 (5%) 1 (<1%) 0 Data were collected using NCI Common Toxicity Criteria, v. 2.0. a Includes patients who were eligible and treated. b Grades 1 through 4 only. There were 3 patients who experienced Grade 5 deaths with investigator designated attribution. One was a Grade 5 hemorrhage in which the drug-related thrombocytopenia aggravated the event. A second patient experienced bowel obstruction, cardiac arrest, pleural effusion and respiratory failure which were not treatment related but probably aggravated by treatment. A third patient experienced a pulmonary embolism and adult respiratory distress syndrome, the latter was indirectly treatment-related. c Constitutional includes fatigue (lethargy, malaise, asthenia), fever (in the absence of neutropenia), rigors, chills, sweating, and weight gain or loss. d Pain includes abdominal pain or cramping, arthralgia, bone pain, chest pain (non-cardiac and non pleuritic), dysmenorrhea, dyspareunia, earache, headache, hepatic pain, myalgia, neuropathic pain, pain due to radiation, pelvic pain, pleuritic pain, rectal or perirectal pain, and tumor pain. 6.2 Postmarketing Experience In addition to adverse reactions reported from clinical trials or listed in other sections of the prescribing information, the following reactions have been identified during postmarketing use of topotecan hydrochloride for injection. Because they are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. These reactions have been chosen for inclusion due to a combination of their seriousness, frequency of reporting, or potential causal connection to topotecan hydrochloride for injection. Blood and Lymphatic System Disorders: Severe bleeding (in association with thrombocytopenia) [see Warnings and Precautions ( 5.1) ]. Immune System Disorders: Allergic manifestations; anaphylactoid reactions. Gastrointestinal Disorders: Abdominal pain potentially associated with neutropenic colitis [see Warnings and Precautions ( 5.2) ]. Pulmonary Disorders: Interstitial lung disease [see Warnings and Precautions (5.3 ) ]. Skin and Subcutaneous Tissue Disorders: Angioedema, severe dermatitis, severe pruritus. General Disorders and Administration Site Conditions: Inadvertent extravasation [see Warnings and Precautions (5.5) ].