Acalaside 100mg Capsule

Acalabrutinib is a kinase inhibitor indicated: - In combination with bendamustine and rituximab for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). - For the treatment of adult patients with MCL who have received at least one prior therapy. - For the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Previously Untreated Mantle Cell Lymphoma Acalabrutinib in combination with bendamustine and rituximab is indicated for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL) who are ineligible for autologous hematopoietic stem cell transplantation (HSCT). Previously Treated Mantle Cell Lymphoma Acalabrutinib is indicated for the treatment of adult patients with MCL who have received at least one prior therapy. Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma Acalabrutinib is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL).

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

• Serious and Opportunistic Infections: Monitor for signs and symptoms of infection and treat promptly. - Hemorrhage: Monitor for bleeding and manage appropriately. - Cytopenias: Monitor complete blood counts regularly. - Second Primary Malignancies: Other malignancies have occurred, including skin cancers and other solid tumors. Advise patients to use sun protection. - Cardiac Arrhythmias: Monitor for symptoms of arrhythmias and manage. - Hepatotoxicity, Including Drug Induced Liver Injury: Monitor hepatic function throughout treatment. Serious and Opportunistic Infections Fatal and serious infections, including opportunistic infections, have occurred in patients with hematologic malignancies treated with Acalabrutinib. Serious or Grade 3 or higher infections (bacterial, viral, or fungal) occurred in 29% of 2,055 patients exposed to Acalabrutinib in clinical trials, most often due to respiratory tract infections (18% of all patients, including pneumonia in 14%). These infections predominantly occurred in the absence of Grade 3 or 4 neutropenia, with neutropenic infection reported in 8% of all patients. Opportunistic infections in recipients of Acalabrutinib have included, but are not limited to, hepatitis B virus reactivation, fungal pneumonia, Pneumocystis jirovecii pneumonia, Epstein-Barr virus reactivation, cytomegalovirus, and progressive multifocal leukoencephalopathy (PML). Consider prophylaxis in patients who are at increased risk for opportunistic infections. Monitor patients for signs and symptoms of infection and treat promptly. In an additional cohort of patients receiving Acalabrutinib in combination with venetoclax with obinutuzumab (AVO) (an unapproved regimen for previously untreated CLL/SLL in AMPLIFY), serious or Grade 3 or higher infections occurred in 25% receiving AVO compared to 14% in patients receiving AV. Fatal infections occurred in 6% receiving AVO compared to 3.1% of patients receiving AV, most commonly due to COVID-19. The safety and effectiveness of AVO has not been established in patients with previously untreated CLL/SLL. Hemorrhage Fatal and serious hemorrhagic events have occurred in patients treated with Acalabrutinib. Major hemorrhage (serious or Grade 3 or higher bleeding or any central nervous system bleeding) occurred in 4.7% of patients, with fatal hemorrhage occurring in 0.1% of 2,055 patients exposed to Acalabrutinib in clinical trials. Bleeding events of any grade, excluding bruising and petechiae, occurred in 39% of patients. Use of antithrombotic agents concomitantly with Acalabrutinib may further increase the risk of hemorrhage. In clinical trials, major hemorrhage occurred in 5% of patients taking Acalabrutinib without antithrombotic agents and 3.2% of patients taking Acalabrutinib with antithrombotic agents. Abridged from the full prescribing information.

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: - Serious and Opportunistic Infections - Hemorrhage - Cytopenias - Second Primary Malignancies - Cardiac Arrhythmias - Hepatotoxicity, including DILI The most common adverse reactions (≥ 30%), excluding laboratory abnormalities, are upper respiratory tract infection, diarrhea, headache, and musculoskeletal pain. The most common Grade 3 or 4 laboratory abnormalities (≥ 10%) are absolute neutrophil count decreased, uric acid increased, absolute lymphocyte count decreased, and platelets decreased. 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 to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data in the Warnings and Precautions reflect exposure to Acalabrutinib 100 mg approximately every 12 hours in 2,055 patients with hematologic malignancies. Treatment includes Acalabrutinib monotherapy in 1258 patients in 9 trials, and Acalabrutinib combinations in 797 patients in 4 trials. Among these recipients of Acalabrutinib, 89% were exposed for at least 6 months and 82% were exposed for at least one year. In this pooled safety population, adverse reactions in ≥ 30% of 2,055 patients, excluding laboratory abnormalities, were upper respiratory tract infection (37%), diarrhea (36%), headache (35%), and musculoskeletal pain (32%). The most common Grade 3 or 4 laboratory abnormalities (≥ 10%) were absolute neutrophil count decreased (32%), uric acid increased (27%), absolute lymphocyte count decreased (21%) and platelets decreased (10%). Previously Untreated Mantle Cell Lymphoma The safety data described below reflect exposure to Acalabrutinib (100 mg approximately every 12 hours, with or without BR) in patients with MCL. ECHO The safety of Acalabrutinib in combination with bendamustine and rituximab (Acalabrutinib plus BR) was evaluated in 297 patients with previously untreated MCL in ECHO. The trial enrolled patients with previously untreated MCL, ≥ 65 years of age with no intention for transplant, total bilirubin ≤ 1.5 × ULN, AST or ALT ≤ 2.5 × ULN, and estimated creatinine clearance of > 50 mL/min. Patients received 6 cycles (as 28-day cycles) of Acalabrutinib 100 mg orally twice daily (n = 297) or placebo (n = 297) in combination with bendamustine and rituximab. Abridged from the full prescribing information.

---

Source: US FDA prescribing information, via openFDA. Provided for general information only — it is not a substitute for your doctor's or pharmacist's advice. Always follow your prescriber's instructions.