Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Oprelvekin
Drug ID BADD_D01620
Description Oprelvekin, the active ingredient in Neumega®, is recombinant Interleukin-11 (IL-11), which is produced in Escherichia coli (E. coli) by recombinant DNA technology. With a molecular mass of approximately 19,000 daltons, the non-glycosylated protein is 177 amino acids in length in comparison to the natural IL-11, which is 178 amino acid long. However, it displays comparable biological activity compared to the natural IL-11 _in vitro_ and _in vivo_. Oprelvekin works by stimulating megakaryocytopoiesis and thrombopoiesis. In mice and nonhuman primate studies of animals with moderate and severe myelosuppression, in addition to compromised hematopoiesis, oprelvekin was shown to potently induce thrombopoiesis and improve platelet nadirs and accelerated platelet recoveries compared to controls. In animal studies, oprelvekin was also shown to regulate intestinal epithelium growth by enhancing healing of gastrointestinal lesions, inhibit adiopegenesis and macrophageal released pro-inflammatory cytokines, and induce acute phase protein synthesis.
Indications and Usage Indicated for the prevention of severe thrombocytopenia and the reduction of the need for platelet transfusions following myelosuppressive chemotherapy in adult patients with nonmyeloid malignancies who are at high risk of severe thrombocytopenia.[Label]
Marketing Status approved; investigational
ATC Code L03AC02
DrugBank ID DB00038
KEGG ID D05266
MeSH ID C105308
PubChem ID Not Available
TTD Drug ID D0T1IJ
NDC Product Code Not Available
UNII HM5641GA6F
Synonyms oprelvekin | interleukin-11 (2-178) | rhIL-11 | Neumega
Chemical Information
Molecular Formula Not Available
CAS Registry Number 145941-26-0
SMILES Not Available
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)
Abdominal pain07.01.05.002--
Alopecia23.02.02.001--
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Anaphylactoid reaction10.01.07.003; 24.06.03.007---
Arrhythmia supraventricular02.03.03.001---
Asthenia08.01.01.001---
Atrial fibrillation02.03.03.002--
Atrial flutter02.03.03.003--
Blindness06.02.10.003; 17.17.01.003---
Blood albumin decreased13.09.01.001---
Blood calcium decreased13.11.01.002---
Bone pain15.02.01.001--
Capillary leak syndrome08.01.07.012; 24.06.03.001--
Cerebrovascular accident17.08.01.007; 24.03.05.001--
Chills08.01.09.001; 15.05.03.016--
Constipation07.02.02.001--
Cough22.02.03.001--
Dehydration14.05.05.001--
Dermatitis exfoliative10.01.01.004; 23.03.07.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dyspepsia07.01.02.001--
Dyspnoea02.11.05.003; 22.02.01.004--
Ecchymosis01.01.03.001; 23.06.01.001; 24.07.06.002---
Eye haemorrhage06.07.02.001; 12.02.02.012; 24.07.05.002---
Febrile neutropenia01.02.03.002; 08.05.02.004--
Haemoglobin decreased13.01.05.003---
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Infection11.01.08.002---
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