topotecan injection Adverse Reactions

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6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

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.

Table 1. Adverse Reactions Occurring in ≥5% of Patients with Small Cell Lung Cancer in Study 090
Adverse ReactionsTopotecan
(n = 107)
CAV*
(n = 104)
Grade 3–4 (%)Grade 3–4 (%)
*
CAV = cyclophosphamide, doxorubicin and vincristine.
Pain includes body pain, skeletal pain, and back pain.
Death related to sepsis occurred in 3% of patients receiving topotecan and 1% of patients receiving CAV.
Hematologic
Grade 4 neutropenia (< 500/mm3)7072
Grade 3 or 4 anemia (Hgb < 8 g/dL)4220
Grade 4 thrombocytopenia (< 25,000/mm3)295
Febrile neutropenia2826
Non-Hematologic
Respiratory, thoracic, and mediastinal
  Dyspnea914
  Pneumonia86
General and administrative site conditions
  Asthenia97
  Fatigue610
  Pain57
Gastrointestinal
  Nausea86
  Abdominal pain64
Infections
  Sepsis55

Hepatobiliary Disorders

Based on 879 patients with small cell lung cancer or another solid tumor who were treated with topotecan, Grade 3 or 4 elevated aspartate (AST) or alanine transaminase (ALT) occurred in 4% and Grade 3 or 4 elevated bilirubin occurred in less than 2% of patients.

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.

Blood and Lymphatic System

Severe bleeding (in association with thrombocytopenia)

Hypersensitivity

Allergic manifestations, anaphylactoid reactions, angioedema

Gastrointestinal

Abdominal pain potentially associated with neutropenic enterocolitis, gastrointestinal perforation

Pulmonary

Interstitial lung disease

Skin and Subcutaneous Tissue

Severe dermatitis, severe pruritus

General and Administration Site Conditions

Extravasation, mucosal inflammation

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Adverse Reactions

6 ADVERSE REACTIONS

The following serious adverse reactions are described elsewhere in the labeling:

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.

Table 1. Adverse Reactions Occurring in ≥5% of Patients with Small Cell Lung Cancer in Study 090
Adverse ReactionsTopotecan
(n = 107)
CAV*
(n = 104)
Grade 3–4 (%)Grade 3–4 (%)
*
CAV = cyclophosphamide, doxorubicin and vincristine.
Pain includes body pain, skeletal pain, and back pain.
Death related to sepsis occurred in 3% of patients receiving topotecan and 1% of patients receiving CAV.
Hematologic
Grade 4 neutropenia (< 500/mm3)7072
Grade 3 or 4 anemia (Hgb < 8 g/dL)4220
Grade 4 thrombocytopenia (< 25,000/mm3)295
Febrile neutropenia2826
Non-Hematologic
Respiratory, thoracic, and mediastinal
  Dyspnea914
  Pneumonia86
General and administrative site conditions
  Asthenia97
  Fatigue610
  Pain57
Gastrointestinal
  Nausea86
  Abdominal pain64
Infections
  Sepsis55

Hepatobiliary Disorders

Based on 879 patients with small cell lung cancer or another solid tumor who were treated with topotecan, Grade 3 or 4 elevated aspartate (AST) or alanine transaminase (ALT) occurred in 4% and Grade 3 or 4 elevated bilirubin occurred in less than 2% of patients.

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.

Blood and Lymphatic System

Severe bleeding (in association with thrombocytopenia)

Hypersensitivity

Allergic manifestations, anaphylactoid reactions, angioedema

Gastrointestinal

Abdominal pain potentially associated with neutropenic enterocolitis, gastrointestinal perforation

Pulmonary

Interstitial lung disease

Skin and Subcutaneous Tissue

Severe dermatitis, severe pruritus

General and Administration Site Conditions

Extravasation, mucosal inflammation

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