Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Lorlatinib
Drug ID BADD_D02504
Description Lorlatinib has been used in trials studying the basic science and treatment of Non-small Cell Lung Cancer and anaplastic lymphoma kinase (ALK)-positive Non-Small Cell Lung Cancer (NSCLC) and ROS1-positive NSCLC. Despite initial responses from the use of various ALK inhibitors, however, it is virtually almost guaranteed that all patients with the condition in question will develop tumour progression or resistance to the current therapy in use [A40086]. Considered a third-generation ALK tyrosine kinase inhibitor (TKI) for patients with ALK-positive metastatic NSCLC, lorlatinib's most optimal place in the treatment sequence of this condition has most recently been identified with its latest approval by the US FDA in November of 2018 for the indication of treating those patients' disease which has progressed even after the use of first and second-generation TKIs like crizotinib, alectinib, or ceritinib [L4848, FDA Label]. Loratinib's ability to move past the blood-brain barrier facilitates its ability to treat progressive or worsening brain metastases as well [L4848, A40078].
Indications and Usage Lorlatinib is a third-generation anaplastic lymphoma kinase (ALK) tyrosine kinase inhibitor (TKI) [L4848] indicated for the treatment of patients with ALK-positive metastatic non-small cell lung cancer (NSCLC) whose disease has progressed on a) the prior use of crizotinib and at least one other ALK inhibitor for metastatic disease, or b) the prior use of alectinib as the first ALK inhibitor therapy for metastatic disease, or c) the prior use of certinib as the first ALK inhibitor therapy for metastatic disease [L848, FDA Label].
Marketing Status Not Available
ATC Code L01ED05
DrugBank ID DB12130
KEGG ID D11012
MeSH ID C000590786
PubChem ID 71731823
NDC Product Code 53869-0131; 0069-0231; 0069-0227; 53869-1043
Synonyms lorlatinib | loratinib | (10R)-7-amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2H-8,4-(metheno)pyrazolo(4,3-H)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile | PF-06463922 | PF06463922 | Lorbrena | 7-amino-12-fluoro-2,10,16-trimethyl-15-oxo-10,15,16,17-tetrahydro-2H-8,4-(metheno)pyrazolo(4,3-h)(2,5,11)benzoxadiazacyclotetradecine-3-carbonitrile
Chemical Information
Molecular Formula C21H19FN6O2
CAS Registry Number 1454846-35-5
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal pain upper07.01.05.003--
Affective disorder19.04.04.0010.001066%Not Available
Alanine aminotransferase increased13.03.01.0030.000799%
Altered state of consciousness19.07.01.003; Available
Anger19.04.02.0010.000533%Not Available
Aspartate aminotransferase increased13.03.01.0060.000799%
Asthenia08.01.01.001--Not Available
Back pain15.03.04.005--
Blood bilirubin increased13.03.01.0080.000799%
Blood cholesterol increased13.12.01.0020.000625%
Blood glucose increased13.02.02.0020.000533%Not Available
Blood triglycerides increased13.12.03.0010.001598%Not Available
Bradycardia02.03.02.0020.000533%Not Available
Cardiac failure02.05.01.0010.000486%
Cellulitis11.02.01.001; Available
Cerebral infarction24.04.06.002; Available
Cerebrovascular accident24.03.05.001;
Chronic obstructive pulmonary disease22.03.01.0070.000139%Not Available
Confusional state19.13.01.001;
Dementia19.20.02.001; Available
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