Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Voclosporin
Drug ID BADD_D02608
Description Lupus nephritis (LN) is a type of glomerulonephritis occurring in patients with systemic lupus erythematosus (SLE). LN is a significant cause of renal failure, morbidity, and death in patients with SLE. Within 10 years of being diagnosed with SLE, 5-20% of those suffering from LN develop end-stage kidney disease, a fatal condition. Early and accurate intervention for LN is important in improving clinical outcomes.[A227683] Voclosporin, marketed as Lupkynis, is a calcineurin-inhibitor immunosuppressant for the treatment of LN.[L31218] This [cyclosporine] A analog was approved by the FDA on January 22, 2021 following promising results in clinical trials. Early intervention with voclosporin coupled with a kidney response is believed to prevent irreversible damage to the kidney and lead to better long-term clinical outcomes for patients with LN.[L31208] Voclosporin has demonstrated a more stable pharmacokinetic and pharmacodynamic relationship than cyclosporine, a higher potency than cyclosporine, and an improved metabolic profile when compared to older calcineurin inhibitors.[L31253]
Indications and Usage Voclosporin is used in combination with a background immunosuppressive regimen for the treatment of lupus nephritis. Safety has not been established in combination with cyclophosphamide.[L31218]
Marketing Status approved; investigational
ATC Code L04AD03
DrugBank ID DB11693
KEGG ID D09033
MeSH ID C484071
PubChem ID 6918486
TTD Drug ID D0L9HX
NDC Product Code 47848-059; 11014-0480; 75626-001; 11014-0436; 49187-0803
UNII 2PN063X6B1
Synonyms voclosporin | ISATX247 | ISA 247 | ISA-247 | ISA(TX)247 | lupkynis
Chemical Information
Molecular Formula C63H111N11O12
CAS Registry Number 515814-00-3
SMILES CCC1C(=O)N(CC(=O)N(C(C(=O)NC(C(=O)N(C(C(=O)NC(C(=O)NC(C(=O)N(C(C(=O)N(C(C(=O)N(C (C(=O)N(C(C(=O)N1)C(C(C)CC=CC=C)O)C)C(C)C)C)CC(C)C)C)CC(C)C)C)C)C)CC(C)C)C)C(C)C )CC(C)C)C)C
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 discomfort07.01.06.0010.002869%Not Available
Abdominal distension07.01.04.0010.000820%
Abdominal pain upper07.01.05.0030.000940%
Alopecia23.02.02.0010.004099%
Anaemia01.03.02.0010.000651%
Arthralgia15.01.02.0010.002291%
Asthenia08.01.01.0010.000940%Not Available
Back pain15.03.04.0050.000530%
Condition aggravated08.01.03.0040.000940%Not Available
Cough22.02.03.0010.000820%
Epistaxis24.07.01.005; 22.04.03.0010.001230%
Eye swelling06.08.03.0030.000530%Not Available
Fatigue08.01.01.0020.002170%
Feeling abnormal08.01.09.0140.000820%Not Available
Gastrointestinal disorder07.11.01.0010.000530%Not Available
Gout14.09.01.001; 15.01.06.0010.000651%Not Available
Haematuria21.10.01.018; 24.07.01.047; 20.02.01.0060.000820%
Headache17.14.01.0010.006968%
Hyperkalaemia14.05.03.0010.000241%
Hypersensitivity10.01.03.0030.000820%
Hypertension24.08.02.0010.006245%
Joint swelling15.01.02.0040.000820%Not Available
Lip swelling07.05.04.005; 23.04.01.007; 10.01.05.0050.000530%Not Available
Malaise08.01.01.0030.000940%
Memory impairment19.20.01.003; 17.03.02.0030.001230%
Muscle spasms15.05.03.0040.000530%
Myalgia15.05.02.0010.000820%
Nausea07.01.07.0010.005329%
Neuralgia17.02.07.0050.000241%
Oedema14.05.06.010; 08.01.07.0060.000530%Not Available
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