"Jan. 13, 2015 -- Drug-maker Bristol-Myers Squibb says a trial of nivolumab (Opdivo) has been stopped early because the drug improves how long people with a type of advanced lung cancer live compared to chemotherapy.
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The following serious adverse reactions are described below and elsewhere in the labeling:
- Bone Marrow Suppression [see WARNINGS AND PRECAUTIONS]
- Diarrhea [see WARNINGS AND PRECAUTIONS]
- Interstitial Lung Disease [see WARNINGS AND PRECAUTIONS]
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 safety of HYCAMTIN capsules was evaluated in 682 patients with lung cancer (3 recurrent small cell lung cancer [SCLC] trials and 1 recurrent non-small cell lung cancer [NSCLC] trial) who received at least one dose of HYCAMTIN capsules. Patients in all four trials had advanced lung malignancies and received prior chemotherapy in the first-line setting. The dose regimen for HYCAMTIN capsules was 2.3 mg/m²/day for five consecutive days every 21 days. The median number of courses was 3 (range: 1 to 20) in these four trials. Table 2 describes the hematologic and non-hematologic adverse reactions in recurrent SCLC patients treated with HYCAMTIN capsules in the overall lung cancer patient population. | HYCAMTIN [see Use in Specific Populations].
Table 2: Incidence ( ≥ 5%) of Adverse Reactions in
Small Cell Lung Cancer Patients Treated With HYCAMTIN Capsules Plus BSC and in
Four Lung Cancer Trials
|Adverse Reaction||HYCAMTIN Capsules + BSC
(N = 70)
|HYCAMTIN Capsules Lung Cancer Population
[N = 682)
|All Grades (%)||Grade 3 (%)||Grade 4 (%)||All Grades (%)||Grade 3 (%)||Grade 4 (%)|
|Thromb ocy topenia||81||30||7||81||29||6|
|BSC = Best Supportive Care.
N = Total number of patients treated.
Adverse reactions were graded using NCI Common Toxicity Criteria Version 2.0.
On-Study Death Due to Toxicity of HYCAMTIN
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.
Read the Hycamtin Capsules (topotecan capsules) Side Effects Center for a complete guide to possible side effects
Topotecan is a substrate for both P-glycoprotein (P-gp) and breast cancer resistance protein (BCRP). Inhibitors of these transporters increase the systemic exposure to oral topotecan. Avoid concomitant use of P-gp inhibitors (e.g., amiodarone, azithromycin, captopril, carvedilol, clarithromycin, conivaptan, cyclosporine, diltiazem, dronedarone, erythromycin, felodipine, itraconazole, ketoconazole, lopinavir, ritonavir, quercetin, quinidine, ranolazine, ticagrelor, verapamil) and BCRP inhibitors (e.g., cyclosporine, eltrombopag) with HYCAMTIN capsules [see CLINICAL PHARMACOLOGY].
Read the Hycamtin Capsules Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 12/8/2016
Additional Hycamtin Capsules Information
- Hycamtin Capsules Drug Interactions Center: topotecan oral
- Hycamtin Capsules Side Effects Center
- Hycamtin Capsules in detail including Side Effects and Drug Images
- Hycamtin Capsules FDA Approved Prescribing Information including Dosage
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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