DIQTA 1.0: Drug-Induced QT Prolongation Atlas

RUCAPARIB

Classification:Ambiguous

Severity Score:1.0

ADVERSE REACTIONS
Clinical Trials Experience
Discontinuation due to adverse reactions occurred in 8% of patients receiving Rubraca. None of the adverse reactions leading to discontinuation of Rubraca (ECG QT prolonged, acute respiratory distress syndrome, anemia, balance disorder, cardiac failure, decreased appetite/fatigue/weight decreased, leukopenia/neutropenia, ALT/AST increased, and pneumonia) occurred in more than one patient (<1%).
CLINICAL PHARMACOLOGY
Cardiac Electrophysiology
The effect of multiple doses of Rubraca on QTc interval was evaluated in an open-label single-arm study in 56 patients with solid tumors who were administered continuous doses of Rubraca ranging from 40 mg once daily (0.03 times the approved recommended dose) to 840 mg twice daily (1.4 times the approved recommended dose). A positive concentration-QTc relationship was observed. The mean QTcF increase from baseline (90% confidence interval [CI]) in population pharmacokinetics estimated 95th percentile Cmax (3019 ng/mL) at steady state of 600 mg rucaparib twice daily was 14.9 msec (11.1-18.7 msec).

Current Drug

Other Drugs

QT Prolongation

24090

Other ADRs

27628

38353959

Odds Ratio = 0.116

ATC Code(s):

Active Ingredient:rucaparib camsylate

Active Ingredient UNII:41AX9SJ8KO

Drugbank ID:DB12332

PubChem Compound:9931954

CAS Number:283173-50-2

Dosage Form(s):tablet, film coated

Route(s) Of Administrator:oral

Daily Dose:

Chemical Structure:

SMILE Code:
CNCC1=CC=C(C=C1)C1=C2CCNC(=O)C3=C2C(N1)=CC(F)=C3

[Segan Louise,Beekman Ashley,Parfrey Shane,Perrin Mark]
Eur Heart J Case Rep,2019 Dec 31;4(1):1-5. PMID: 32128485