hcp.aliqopa-us.comAliqopa US HCP

For US Healthcare Professionals Only | Full Prescribing Information | Important Safety Information | For Patients & Caregivers IMPORTANT SAFETY INFORMATION Infections: Serious, including fatal, infections occurred in 19% of 317 patients treated with ALIQOPA monotherapy. The most common serious infection was pneumonia. Monitor patients for signs and symptoms of infection and withhold ALIQOPA for Grade 3 and higher infection. Continue reading below Toggle burger menu Close burger menu Relapsed Follicular Lymphoma MOA Clinical Trials Study Background Patient Characteristics Efficacy Overall Response Rate Duration of Response Safety Safety Profile Follow-up Safety Data Dosing & Administration Recommended Dosing Dose Modification & Toxicity Management Considerations for Use Preparation & Administration Patient Profiles Access, Support & Resources ARC™ Program Ordering Storing & Handling Resources Request a Bayer Consultant Toggle country select Country select Country 1 Country 2 SPC Bayer Global Relapsed Follicular Lymphoma MOA Clinical Trials Study Background Patient Characteristics Efficacy Overall Response Rate Duration of Response Safety Safety Profile Follow-up Safety Data Dosing & Administration Recommended Dosing Dose Modification & Toxicity Management Considerations for Use Preparation & Administration Patient Profiles Access, Support & Resources ARC™ Program Ordering Storing & Handling Resources Request a Bayer Consultant Request a Bayer Consultant Fill out the fields below to share a link to this page All fields required Subject: I thought this website might be of interest to you Message: I thought you might be interested in this information about Aliqopa™ (copanlisib). Click here to learn more. Name: From: To: Leave this field blank HCP Patient HCP Patient For US Healthcare Professionals Only | Full Prescribing Information | Important Safety Information | For Patients & Caregivers IMPORTANT SAFETY INFORMATION Infections: Serious, including fatal, infections occurred in 19% of 317 patients treated with ALIQOPA monotherapy. The most common serious infection was pneumonia. Monitor patients for signs and symptoms of infection and withhold ALIQOPA for Grade 3 and higher infection. Continue reading below Toggle burger menu Close burger menu Relapsed Follicular Lymphoma MOA Clinical Trials Study Background Patient Characteristics Efficacy Overall Response Rate Duration of Response Safety Safety Profile Follow-up Safety Data Dosing & Administration Recommended Dosing Dose Modification & Toxicity Management Considerations for Use Preparation & Administration Patient Profiles Access, Support & Resources ARC™ Program Ordering Storing & Handling Resources Request a Bayer Consultant Toggle country select Country select Country 1 Country 2 SPC Bayer Global Relapsed Follicular Lymphoma MOA Clinical Trials Study Background Patient Characteristics Efficacy Overall Response Rate Duration of Response Safety Safety Profile Follow-up Safety Data Dosing & Administration Recommended Dosing Dose Modification & Toxicity Management Considerations for Use Preparation & Administration Patient Profiles Access, Support & Resources ARC™ Program Ordering Storing & Handling Resources Request a Bayer Consultant Request a Bayer Consultant Fill out the fields below to share a link to this page All fields required Subject: I thought this website might be of interest to you Message: I thought you might be interested in this information about Aliqopa™ (copanlisib). Click here to learn more. Name: From: To: Leave this field blank EFFICACY Clinical efficacy as a chemo-free single agent for third-line follicular lymphoma 1 2-year ‡ follow-up efficacy data available. Aliqopa was evaluated in a single-arm, multicenter, phase II clinical trial, CHRONOS-1, in a total of 142 subjects, which included 104 subjects with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least 2 prior treatments. 1 CI, confidence interval; CR, complete response; mDoR, median duration of response; ORR, overall response rate; PR, partial response. *Tumor response was assessed according to the International Working Group response criteria for malignant lymphoma. Efficacy based on overall response rate (ORR) was assessed by an Independent Review Committee. 1 1 Kaplan-Meier estimate. ‡ Primary analysis was conducted on data until 16 weeks after the last patient eligible for full analysis started treatment. Clinical efficacy as a chemo-free single agent for third-line follicular lymphoma 1 Aliqopa was evaluated in a single-arm, multicenter, phase II clinical trial, CHRONOS-1, in a total of 142 subjects, which included 104 subjects with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least 2 prior treatments. 1 *Tumor response was assessed according to the International Working Group response criteria for malignant lymphoma. Efficacy based on overall response rate (ORR) was assessed by an Independent Review Committee. 1 2-year ‡ follow-up efficacy data available. CI, confidence interval; CR, complete response; mDoR, median duration of response; ORR, overall response rate; PR, partial response. 1 Kaplan-Meier estimate. ‡ Primary analysis was conducted on data until 16 weeks after the last patient eligible for full analysis started treatment. EFFICACY Clinical efficacy as a chemo-free single agent for third-line follicular lymphoma 1 Aliqopa was evaluated in a single-arm, multicenter, phase II clinical trial, CHRONOS-1, in a total of 142 subjects, which included 104 subjects with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least 2 prior treatments. 1 *Tumor response was assessed according to the International Working Group response criteria for malignant lymphoma. Efficacy based on overall response rate (ORR) was assessed by an Independent Review Committee. 1 2-year ‡ follow-up efficacy data available. CI, confidence interval; CR, complete response; mDoR, median duration of response; ORR, overall response rate; PR, partial response. 1 Kaplan-Meier estimate. ‡ Primary analysis was conducted on data until 16 weeks after the last patient eligible for full analysis started treatment. SELECTED SAFETY Demonstrated a low incidence (10%) of serious gastrointestinal and hepatic toxicity 1,2 Serious adverse reactions were reported in 44 (26%) patients. The most frequent serious adverse reactions that occurred were pneumonia (8%), pneumonitis (5%), and hyperglycemia (5%) 1 Adverse reactions resulted in dose reduction in 36 (21%) and discontinuation in 27 (16%) patients. The most common reasons for dose reduction were hyperglycemia (7%), neutropenia (5%), and hypertension (5%). The most common reasons for drug discontinuation were pneumonitis (2%) and hyperglycemia (2%) 1 2-year ‡ follow-up efficacy data available. ALT, alanine aminotransferase; AST, aspartate aminotransferase. a Based on 142 subjects in a single-arm, multicenter, phase II clinical trial, CHRONOS-1, which included 104 subjects with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least 2 prior treatments. 1 b One patient missing. 3 c Primary analysis was conducted on data until 16 weeks after the last patient eligible for full analysis started treatment. SELECTED SAFETY Demonstrated a low incidence (10%) of serious gastrointestinal and hepatic toxicity 1,2 ALT, alanine aminotransferase; AST, aspartate aminotransferase. a Based on 142 subjects in a single-arm, multicenter, phase II clinical trial, CHRONOS-1, which included 104 subjects with follicular B-cell non-Hodgkin lymphoma who had relapsed disease following at least 2 prior treatments. 1 b One patient missing. 3 c Primary analysis was conducted on data until 16 weeks after the last patient eligible for full analysis started treatment. Serious adverse reactions were reported in 44 (26%) patients. The most frequent serious adverse reactions that occurred were pneumonia (8%), pneumonitis (5%),...