Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Acalabrutinib
Drug ID BADD_D02482
Description To date, acalabrutinib has been used in trials studying the treatment of B-All, Myelofibrosis, Ovarian Cancer, Multiple Myeloma, and Hodgkin Lymphoma, among others. As of October 31, 2017 the FDA approved Astra Zeneca's orally administered Calquence (acalabrutinib). This Bruton Tyrosine Kinase (BTK) inhibitor indicated for the treatment of chronic lymphocytic leukemia, small lymphocytic lymphoma, and in adult patients with Mantle Cell Lymphoma (MCL) who have already received at least one prior therapy. Also known as ACP-196, acalabrutinib is also considered a second generation BTK inhibitor because it was rationally designed to be more potent and selective than ibrutinib, theoretically expected to demonstrate fewer adverse effects owing to minimized bystander effects on targets other than BTK. Nevertheless, acalabrutinib was approved under the FDA's accelerated approval pathway, which is based upon overall response rate and faciliates earlier approval of medicines that treat serious conditions or/and that fill an unmet medical need based on a surrogate endpoint. Continued approval for acalabrutinib's currently accepted indication may subsequently be contingent upon ongoing verification and description of clinical benefit in confimatory trials. Furthermore, the FDA granted this medication Priority Review and Breakthrough Therapy designations. It also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. At this time, more than 35 clinical trials across 40 countries with more than 2500 patients are underway or have been completed with regards to further research into better understanding and expanding the therapeutic uses of acalabrutinib [L1009].
Indications and Usage Acalabrutinib is currently indicated for the treatment of adult patients with Mantle Cell Lymphoma (MCL) who have received at least one prior therapy.[L10241] It has also been recently approved for chronic lymphocytic leukemia and small lymphocytic lymphoma.[L10241]
Marketing Status approved; investigational
ATC Code L01EL02
DrugBank ID DB11703
KEGG ID D10893
MeSH ID C000604908
PubChem ID 71226662
TTD Drug ID D09PQZ
NDC Product Code 0310-5512; 54864-600; 43744-024; 0310-0512; 0310-3512; 60440-0512; 17228-0512; 17228-4512; 54893-0108
UNII I42748ELQW
Synonyms acalabrutinib | Calquence | ACP-196
Chemical Information
Molecular Formula C26H23N7O2
CAS Registry Number 1420477-60-6
SMILES CC#CC(=O)N1CCCC1C2=NC(=C3N2C=CN=C3N)C4=CC=C(C=C4)C(=O)NC5=CC=CC=N5
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Lymphadenopathy01.09.01.0020.000336%-
Lymphocytosis01.02.01.0030.000448%-
Lymphoma01.12.01.001; 16.20.01.0010.000112%-
Malaise08.01.01.003--
Migraine17.14.02.001; 24.03.05.0030.000168%-
Mucosal inflammation08.01.06.0020.000381%-
Muscle spasms15.05.03.004--
Myalgia15.05.02.0010.002339%
Myelodysplastic syndrome01.10.04.001; 16.01.04.0010.000112%
Myocardial infarction02.02.02.007; 24.04.04.0090.000392%
Neutropenia01.02.03.0040.002227%-
Oedema08.01.07.006; 14.05.06.0100.000470%-
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.0110.000604%
Orthostatic hypotension17.05.01.020; 24.06.03.0040.000112%-
Osteonecrosis15.02.04.007; 24.04.05.0040.000112%
Pain in extremity15.03.04.010--
Pancytopenia01.03.03.0030.000728%-
Pericardial effusion02.06.01.0020.000112%
Petechiae01.01.03.002; 23.06.01.003; 24.07.06.0040.000112%-
Platelet disorder01.08.03.0010.000112%-
Pleural effusion22.05.02.0020.000582%
Pneumonitis22.01.01.0060.000280%
Polyneuropathy17.09.03.0120.000112%-
Pulmonary haemorrhage22.12.01.009; 24.07.01.0160.000112%
Pulmonary hypertension22.06.01.001; 24.08.03.002--
Pyrexia08.05.02.003--
Rash23.03.13.0010.002877%-
Rash maculo-papular23.03.13.0040.000112%
Retching07.01.07.0020.000381%-
Retroperitoneal haemorrhage07.07.02.002; 12.01.17.018; 24.07.01.017--
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