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Hycamtin

Brand Name:Hycamtin Trade Name:topotecan
FDA Approved For:Hycamtin is indicated for the treatment of: metastatic carcinoma of the ovary after failure of initial or subsequent chemotherapy. small cell lung cancer sensitive disease after failure of first-line chemotherapy. In clinical studies submitted to support approval, sensitive disease was defined as disease responding to chemotherapy but subsequently progressing at least 60 days (in the phase 3 study) or at least 90 days (in the phase 2 studies) after chemotherapyPediatric Use:Safety and effectiveness in pediatric patients have not been established.
Carcinogen:Carcinogenicity testing of topotecan has not been performed. Topotecan, however, is known to be genotoxic to mammalian cells and is a probable carcinogen.Mutagen:Topotecan was mutagenic to L5178Y mouse lymphoma cells and clastogenic to cultured human lymphocytes with and without metabolic activation. It was also clastogenic to mouse bone marrow. Topotecan did not cause mutations in bacterial cells.
Manufacturer and/or Distributor:GlaxoSmithKline

Adverse Reactions:

Data in the following section are based on the combined experience of 453 patients with metastatic ovarian carcinoma, and 426 patients with small cell lung cancer treated with Hycamtin . Table 4 lists the principal hematologic toxicities and Table 5 lists non-hematologic toxicities occurring in at least 15% of patients. (See Tables) * Pain includes body pain, back pain and skeletal pain. ** Rash also includes pruritus, rash erythematous, urticaria, dermatitis, bullous eruption and rash maculopapular. Pre-medications were not routinely used in these clinical studies . Hematologic : (See WARNINGS) Gastrointestinal : The incidence of nausea was 64% (8% grade 3/4) and vomiting occurred in 45% (6% grade 3/4) of patients (see Table 5). The prophylactic use of antiemetics was not routine in patients treated with Hycamtin . Thirty-two percent of patients had diarrhea (4% grade 3/4), 29% constipation (2% grade 3/4) and 22% had abdominal pain (4% grade 3/4). Grade 3/4 abdominal pain was 6% in ovarian cancer patients and 2% in small cell lung cancer patients. Skin/Appendages: Total alopecia (grade 2) occurred in 31% of patients. Central and Peripheral Nervous System: Headache (18% of patients) was the most frequently reported neurologic toxicity. Paresthesia occurred in 7% of patients but was generally grade 1. Liver/Biliary : 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. Respiratory: The incidence of grade 3/4 dyspnea was 4% in ovarian cancer patients and 12% in small cell lung cancer patients. Table 6 shows the grade 3/4 hematologic and major non-hematologic adverse events in the topotecan/paclitaxel comparator trial in ovarian cancer. (See Table) *Pain includes body pain, skeletal pain, and back pain ** Rash also includes pruritus, rash erythematous, urticaria, dermatitis, bullous eruption, and rash maculopapular *** Increased hepatic enzymes includes increased SGOT/AST, increased SGPT/ALT and increased hepatic enzymes Premedications were not routinely used in patients randomized to Hycamtin , while patients receiving paclitaxel received routine pretreatment with corticosteroids, diphenhydramine, and histamine receptor type 2 blockers. Table 7 shows the grade 3/4 hematologic and major non-hematologic adverse events in the topotecan/CAV comparator trial in small cell lung cancer. (See Table) *Pain includes body pain, skeletal pain, and back pain ** Rash also includes pruritus, rash erythematous, urticaria, dermatitis, bullous eruption, and rash maculopapular *** Increased hepatic enzymes includes increased SGOT/AST, increased SGPT/ALT and increased hepatic enzymes Premedications were not routinely used in patients randomized to Hycamtin , while patients receiving CAV received routine pretreatment with corticosteroids, diphenhydramine, and histamine receptor type 2 blockers. Postmarketing Reports of Adverse Events Reports of adverse events in patients taking Hycamtin (topotecan hydrochloride) received after market introduction, which are not listed above, include the following: Hematologic: Rare - severe bleeding (in association with thrombocytopenia). Skin/Appendages: Rare - severe dermatitis, severe pruritis. Body As a Whole: Infrequent - allergic manifestations; rare - anaphylactoid reactions, angioedema. )

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