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TRAMETINIB
DIR Classification
Classification:Less-DIR concern
Severity Score:1
Description in Drug Labeling: View Full Labeling: SPL in DailyMed | PDF
- CLINICAL PHARMACOLOGY
- Pharmacodynamics
- Cardiac Electrophysiology
- The heart rate-corrected QT (QTc) prolongation potential of trametinib was assessed in a dedicated study in 32 patients who received placebo on day 1 and MEKINIST 2 mg once daily on days 2-14 followed by MEKINIST 3 mg on day 15. No clinically relevant QTc prolongation was detected in the study.
- In clinical trials in patients who received MEKINIST with dabrafenib, QTc prolongation > 500 ms occurred in 0.8% of patients and QTc increased by > 60 ms from baseline in 3.8% of patients.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
22
42890
Other ADRs
2454
14114825
Odds Ratio = 2.951
Drug Property Information
ATC Code(s):
- L01XE25 - trametinib
- L01XE - Protein kinase inhibitors
- L01X - OTHER ANTINEOPLASTIC AGENTS
- L01 - ANTINEOPLASTIC AGENTS
- L - ANTINEOPLASTIC AND IMMUNOMODULATING AGENTS
Active Ingredient:trametinib dimethyl sulfoxide
Active Ingredient UNII:BSB9VJ5TUT
Drugbank ID:DB08911
PubChem Compound:11707110
CAS Number:871700-17-3
Dosage Form(s):tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
Chemical Structure: 
SMILE Code:
CC1=C2C(=C(N(C1=O)C)NC3=C(C=C(C=C3)I)F)C(=O)N(C(=O)N2C4=CC(=CC=C4)NC(=O)C)C5CC5
CC1=C2C(=C(N(C1=O)C)NC3=C(C=C(C=C3)I)F)C(=O)N(C(=O)N2C4=CC(=CC=C4)NC(=O)C)C5CC5
Reference
COHORT STUDY:
N/AOTHER 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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