6 ADVERSE REACTIONS
The following serious adverse reactions are described elsewhere in the labeling:
- Myelosuppression [see Warnings and Precautions (5.1)]
- Interstitial Lung Disease [see Warnings and Precautions (5.2)]
- Extravasation and Tissue Injury [see Warnings and Precautions (5.3)]
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.
The data in Warnings and Precautions reflect exposure to topotecan from 8 trials in which 879 patients with small cell lung cancer (SCLC) and other solid tumors received topotecan 1.5 mg/m2 by intravenous infusion daily for 5 consecutive days, starting on Day 1 of a 21-day cycle.
Small Cell Lung Cancer (SCLC)
The safety of topotecan was evaluated in randomized, comparative trial in patients with recurrent or progressive SCLC (Study 090) [see Clinical Studies (14.1)]. Table 1 shows the Grade 3 or 4 hematologic and non-hematologic adverse reactions in patients with SCLC.
| Adverse Reactions | Topotecan (n = 107) | CAV* (n = 104) |
|---|---|---|
| Grade 3–4 (%) | Grade 3–4 (%) | |
| Hematologic | ||
| Grade 4 neutropenia (< 500/mm3) | 70 | 72 |
| Grade 3 or 4 anemia (Hgb < 8 g/dL) | 42 | 20 |
| Grade 4 thrombocytopenia (< 25,000/mm3) | 29 | 5 |
| Febrile neutropenia | 28 | 26 |
| Non-Hematologic | ||
| Respiratory, thoracic, and mediastinal | ||
| Dyspnea | 9 | 14 |
| Pneumonia | 8 | 6 |
| General and administrative site conditions | ||
| Asthenia | 9 | 7 |
| Fatigue | 6 | 10 |
| Pain† | 5 | 7 |
| Gastrointestinal | ||
| Nausea | 8 | 6 |
| Abdominal pain | 6 | 4 |
| Infections | ||
| Sepsis‡ | 5 | 5 |
6.2 Postmarketing Experience
The following reactions have been identified during postapproval use of topotecan. Because these reactions are reported voluntarily from a population of unknown size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.