Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
ACALABRUTINIB (UNII: I42748ELQW) (ACALABRUTINIB - UNII:I42748ELQW)
AstraZeneca Pharmaceuticals LP
ORAL
PRESCRIPTION DRUG
CALQUENCE is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy. This indication is approved under accelerated approval based on overall response rate [see Clinical Studies (14.1)] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. CALQUENCE is indicated for the treatment of adult patients with chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). None. Risk Summary Based on findings in animals, CALQUENCE may cause fetal harm and dystocia when administered to a pregnant woman. There are no available data in pregnant women to inform the drug-associated risk. In animal reproduction studies, administration of acalabrutinib to animals during organogenesis resulted in dystocia in rats and reduced fetal growth in rabbits at maternal exposures (AUC) 2 times exposures in patients at the recommended dose of 100 mg approximately every 12 hours (s
How Supplied Pack Size Contents NDC Number 60-count bottle Bottle containing 60 tablets with a child-resistant closure 100 mg, orange, oval, biconvex tablet, with debossment ‘ACA100’ on one side and plain on the reverse 0310-3512-60 Storage Store at 20°C-25°C (68°F-77°F); excursions permitted to 15°C-30°C (59°F-86°F) [see USP Controlled Room Temperature].
New Drug Application
CALQUENCE- ACALABRUTINIB TABLET, FILM COATED ASTRAZENECA PHARMACEUTICALS LP ---------- HIGHLIGHTS OF PRESCRIBING INFORMATION THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE CALQUENCE SAFELY AND EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CALQUENCE. CALQUENCE (ACALABRUTINIB) TABLETS, FOR ORAL USE INITIAL U.S. APPROVAL: 2017 INDICATIONS AND USAGE CALQUENCE is a kinase inhibitor indicated for the treatment of adult patients with: • • DOSAGE AND ADMINISTRATION • • • • DOSAGE FORMS AND STRENGTHS Tablets: 100 mg. (3) CONTRAINDICATIONS None. (4) WARNINGS AND PRECAUTIONS • • • • • ADVERSE REACTIONS Most common adverse reactions (incidence ≥ 30%) are: anemia, neutropenia, upper respiratory tract infection, thrombocytopenia, headache, diarrhea, and musculoskeletal pain. (6.1) TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT ASTRAZENECA AT 1-800-236-9933 OR FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH. DRUG INTERACTIONS • • • USE IN SPECIFIC POPULATIONS • • • SEE 17 FOR PATIENT COUNSELING INFORMATION AND FDA-APPROVED PATIENT LABELING. REVISED: 8/2022 ® Mantle cell lymphoma (MCL) who have received at least one prior therapy. (1.1) This indication is approved under accelerated approval based on overall response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. (1.1, 14.1) Chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). (1.2) Recommended dose is 100 mg orally approximately every 12 hours; swallow whole with water and with or without food. (2.1) Advise patients not to chew, crush, dissolve, or cut tablets. (2.1) Manage toxicities using treatment interruption, dose reduction, or discontinuation. (2.2) Avoid CALQUENCE in patients with severe hepatic impairment. (8.6) Serious and Opportunistic Infections: Monitor for signs and symptoms of infection and treat promptly. (5.1) Hemorrhage: Monitor for bleeding and manage appropriately. (5.2) Cytopenias: Monitor c Прочетете целия документ