SIDE EFFECTS

Clinical Trials Experience

The safety of HYCAMTIN capsules (topotecan capsules) has been evaluated in 682 patients with thoracic cancer (3 recurrent small cell lung cancer [SCLC] studies and 1 recurrent non-small cell lung cancer [NSCLC] study) who received at least one dose of HYCAMTIN capsules (topotecan capsules) . Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Table 1 describes the hematologic and non-hematologic adverse reactions in recurrent SCLC patients treated with HYCAMTIN capsules (topotecan capsules) plus best supportive care (BSC) and in the overall thoracic cancer patient population.

Table 1: Incidence ( ≥ 5%) of Adverse Reactions in Small Cell Lung Cancer Patients Treated With HYCAMTIN Capsules (topotecan capsules) Plus BSC and in 4 Thoracic Cancer Studies

Diarrhea Adverse Reactions

Of the 70 patients who received HYCAMTIN capsules (topotecan capsules) plus BSC, the incidence of drug-related diarrhea was 14%, with 4% Grade 3 and 1% Grade 4.

In the 682 patients who received HYCAMTIN capsules (topotecan capsules) in the 4 thoracic cancer studies, the incidence of drug-related diarrhea was 22%, with 4% Grade 3 and 0.4% Grade 4. The overall incidence of drug-related diarrhea was more frequent in patients ≥ 65 years of age (28%, n = 225) with 10% Grade 1, 9% Grade 2, 7% Grade 3, and 1% Grade 4 compared to those < 65 years of age (19%, n = 457) with 7% Grade 1, 9% Grade 2, 3% Grade 3, and 0% Grade 4. The incidence of Grade 3 or 4 diarrhea proximate (within 5 days) to Grade 3 or 4 neutropenia events in the HYCAMTIN capsules (topotecan capsules) treatment group was 5%. The median time to onset of Grade 2 or worse diarrhea was 9 days in the HYCAMTIN capsules (topotecan capsules) group.

Deaths Occurring Within 30 Days Following the Last Dose of Study Medication

In the 682 patients who received HYCAMTIN capsules (topotecan capsules) in the 4 thoracic cancer studies, 39 deaths occurred within 30 days after the last dose of study medication for a reason other than progressive disease; 13 of these deaths were attributed to hematologic toxicity, 5 were attributed to non-hematologic toxicity, and 21 were attributed to other causes. One patient death (68 years of age) was attributed to treatment-related diarrhea and one death (68 years of age) attributed diarrhea as a contributory event; both patients received HYCAMTIN capsules (topotecan capsules) .

In addition to the adverse reactions listed previously, the following adverse reactions have been reported with HYCAMTIN for Injection:

• Incidence > 10%: Febrile neutropenia, abdominal pain, stomatitis, constipation.
• Incidence 1 to 10%: Sepsis, hypersensitivity (including rash), hyperbilirubinemia, malaise.

Postmarketing Experience

There is no postmarketing experience with HYCAMTIN capsules (topotecan capsules) . The following adverse reactions have been identified during post-approval use of HYCAMTIN for Injection. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Blood and lymphatic system disorders: Severe bleeding (in association with thrombocytopenia).

Immune system disorders: Allergic manifestations, anaphylactoid reactions.

Respiratory, thoracic, and mediastinal disorders: Interstitial lung disease.

Gastrointestinal disorders: Abdominal pain potentially associated with neutropenic colitis [see WARNINGS AND PRECAUTIONS].

Skin and subcutaneous tissue disorders: Angioedema, severe dermatitis, severe pruritus.

Read the entire FDA prescribing information for Hycamtin Capsules (Topotecan Capsules) »