DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

COBIMETINIB

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Moderate-DIR concern

Severity Score:2

Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF

CLINICAL PHARMACOLOGY
Pharmacodynamics
Cardiac Electrophysiology
Clinically relevant QT prolongation has been reported with vemurafenib, further QTc prolongation was not observed when cobimetinib 60 mg daily was co-administered with vemurafenib. Monitor ECG and electrolytes before initiating treatment and routinely during treatment with cobimetinib, when administered with vemurafenib. Review the Full Prescribing Information for vemurafenib for details.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

42900

Other ADRs

506

14116773

Odds Ratio = 7.804

Drug Property Information

ATC Code(s): N/A

Active Ingredient:cobimetinib fumarate

Active Ingredient UNII:6EXI96H8SV

Drugbank ID:DB05239

PubChem Compound:16222096

CAS Number:934660-93-2

Dosage Form(s):tablet, film coated

Route(s) Of Administrator:oral

Daily Dose:

Chemical Structure:

SMILE Code:
C1CCN[C@@H](C1)C2(CN(C2)C(=O)C3=C(C(=C(C=C3)F)F)NC4=C(C=C(C=C4)I)F)O

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: Success of rechallenging dabrafenib and trametinib combination therapy after trametinib-induced rhabdomyolysis: a case report.

[Muto Yusuke,Ng William,Namikawa Kenjiro,Takahashi Akira,Tsutsumida Arata,Nishida Makiko,Yamazaki Naoya]
Melanoma Res.2018 Apr;28(2):151-154. doi: 10.1097/CMR.0000000000000424. PMID: 29356791

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