HYCAMTIN

Following administration of HYCAMTIN capsules at doses of 1.2 to 3.1 mg/m 2 (0.52 to 1.35 times the recommended dose) administered daily for 5 days, the area under the curve (AUC) increased proportionally with dose.

AbsorptionThe time to the peak plasma concentrations is between 1 to 2 hours following oral administration. The oral bioavailability of topotecan is approximately 40%. Food Effect Following a high-fat meal, the AUC was similar in the fed and fasted states, while T max was delayed fr...

14.1 Small Cell Lung Cancer (SCLC) The efficacy of HYCAMTIN capsules was studied in 141 patients with relapsed SCLC in a randomized, controlled, open-label trial (Study 478). The patients were prior responders (complete or partial) to first-line chemotherapy, were not considered candidates for standard intravenous chemotherapy and had relapsed at least 45 days from the end of first-line chemotherapy. Patients were randomized 1:1 to HYCAMTIN capsules (2.3 mg/m 2 orally once daily for 5 consecutive days, starting on Day 1 of a 21-day cycle) with best supportive care (BSC) or BSC alone. The major...

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, a...

HYCAMTIN is contraindicated in patients who have a history of severe hypersensitivity reactions to topotecan. Reactions have included anaphylactoid reactions [see Adverse Reactions (6.2)] .

• History of severe hypersensitivity reactions to topotecan ( 4 )

• Diarrhea: Severe diarrhea can occur. Withhold and reduce dose as recommended. ( 2.2 , 5.2 )
• Interstitial Lung Disease (ILD): Fatal cases have occurred. Permanently discontinue if confirmed ILD. ( 5.3 )
• Embryo-Fetal Toxicity: Can cause fetal harm. Advise patients of potential risk to the fetus and to use effective contraception. ( 5.4 , 8.1 , 8.3 ) 5.1 Myelosuppression HYCAMTIN can cause severe myelosuppression. The following safety data are based on an integrated safety database from four ...

7 DRUG INTERACTIONS

• Avoid concomitant use of P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitors with HYCAMTIN capsules. ( 7.1 , 12.3 ) 7.1 Effect of Other Drugs on HYCAMTIN P-glycoprotein or Breast Cancer Resistance Protein Inhibitor Concomitant use of a P-glycoprotein (P-gp) or breast cancer resistance protein (BCRP) inhibitor increases topotecan AUC [see Clinical Pharm...