1 INDICATIONS AND USAGE HYCAMTIN ® capsules are indicated for the treatment of relapsed small cell lung cancer (SCLC) in patients with a prior complete or partial response and who are at least 45 days from the end of first-line chemotherapy.

HYCAMTIN capsules is a topoisomerase inhibitor indicated for treatment of patients with relapsed small cell lung cancer (SCLC).

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6 ADVERSE REACTIONS The following serious adverse reactions are described elsewhere in the labeling: • Myelosuppression [see Warnings and Precautions (5.1)] • Diarrhea [see Warnings and Precautions (5.2)] • Interstitial Lung Disease (ILD) [see Warnings and Precautions (5.3)] • The most common Grade 3 or 4 hematologic adverse reactions (incidence > 20%) were neutropenia, anemia, and thrombocytopenia.

• The most common (incidence > 10%) non-hematologic adverse reactions (all Grades) were nausea, diarrhea, vomiting, alopecia, fatigue, and anorexia.

( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Sandoz Inc.

at 1-800-525-8747 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.

The data in the Warnings and Precautions and below reflects exposure to HYCAMTIN capsules in 682 patients with recurrent lung cancer enrolled in four randomized, open label trials, including 275 patients with small lung cell lung cancer (SCLC) (Studies 478, 065 and 396), and 407 patients with non-small cell lung cancer (NSCLC) (Study 387), who received at least one dose of HYCAMTIN capsules.

Patients in these trials had advanced lung cancer and received prior chemotherapy in the first-line setting.

Patients received HYCAMTIN capsules 2.3 mg/m 2 orally once daily for 5 consecutive days, starting on Day 1 of a 21-day cycle.

The median number of cycles was 3 (range: 1 to 20).

The safety of HYCAMTIN capsules was evaluated in a randomized trial (Study 478) conducted in 70 patients with recurrent SCLC [see Clinical Studies (14)] .

In the 682 patients who received HYCAMTIN capsules in the four lung cancer trials, 39 deaths (6%) occurred within 30 days after the last dose for a reason other than progressive disease: 13 due to hematologic toxicity, 5 due to non-hematologic toxicity (2 from diarrhea), and 21 due to other causes.

Table 1 describes the hematologic and non-hematologic adverse reactions that occurred in greater than 5% of patients treated with HYCAMTIN capsules in these trials.

Table 1.

Adverse Reactions Occurring in Greater than or Equal to 5% of Patients With Lung Cancer Adverse Reactions Adverse reactions were graded using National Cancer Institute (NCI) Common Toxicity Criteria (CTC) Version 2.0.

HYCAMTIN Capsules With Best Supportive Care (Study 478) HYCAMTIN Capsules Lung Cancer Population (Studies 478, 065, 396 and 387) N = 70 N = 682 All Grades (%) Grade 3 (%) Grade 4 (%) All Grades (%) Grade 3 (%) Grade 4 (%) Hematologic Anemia 94 15 10 98 18 7 Neutropenia 91 28 33 83 24 32 Thrombocytopenia 81 30 7 81 29 6 Non-hematologic Nausea 27 1 0 33 3 0 Vomiting 19 1 0 21 3 0.4 Diarrhea 14 4 1 22 4 0.4 Fatigue 11 0 0 19 4 0.1 Alopecia 10 0 0 20 0.1 0 Pyrexia 7 1 0 5 1 1 Anorexia 7 0 0 14 2 0 Asthenia 3 0 0 7 2 0 6.2 Postmarketing Experience The following reactions have been identified during post approval use of HYCAMTIN.

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.

Gastrointestinal: Gastrointestinal perforation General and Administration Site Conditions: Mucosal inflammation Hypersensitivity: Allergic manifestations, anaphylactoid reactions, angioedema