DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

COBICISTAT

DIR Classification Postmarketing Surveillance Drug Property Information Reference

DIR Classification

Classification:Moderate-DIR concern

Severity Score:3

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

DRUG INTERACTIONS
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CLINICAL PHARMACOLOGY
Pharmacodynamics
Cardiac Electrophysiology
In a thorough QT/QTc study in 48 healthy subjects, a single dose of cobicistat 250 mg and 400 mg (1.67 and 2.67 times the dose in TYBOST) did not affect the QT/QTc interval. Prolongation of the PR interval was noted in subjects receiving cobicistat. The maximum mean (95% upper confidence bound) difference in PR from placebo after baseline-correction was 9.5 (12.1) msec for the 250 mg cobicistat dose and 20.2 (22.8) for the 400 mg cobicistat dose.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

42912

Other ADRs

14117266

Odds Ratio = N/A

Drug Property Information

ATC Code(s):

J05AR14 - cobicistat

J05AR - "Antivirals for treatment of HIV infections, combinations"
J05A - DIRECT ACTING ANTIVIRALS
J05 - ANTIVIRALS FOR SYSTEMIC USE
J - ANTIINFECTIVES FOR SYSTEMIC USE

V03AX03 - cobicistat

V03AX - Other therapeutic products
V03A - ALL OTHER THERAPEUTIC PRODUCTS
V03 - ALL OTHER THERAPEUTIC PRODUCTS
V - VARIOUS

J05AR18 - cobicistat

J05AR - "Antivirals for treatment of HIV infections, combinations"
J05A - DIRECT ACTING ANTIVIRALS
J05 - ANTIVIRALS FOR SYSTEMIC USE
J - ANTIINFECTIVES FOR SYSTEMIC USE

J05AR15 - cobicistat

J05AR - "Antivirals for treatment of HIV infections, combinations"
J05A - DIRECT ACTING ANTIVIRALS
J05 - ANTIVIRALS FOR SYSTEMIC USE
J - ANTIINFECTIVES FOR SYSTEMIC USE

J05AR09 - cobicistat

J05AR - "Antivirals for treatment of HIV infections, combinations"
J05A - DIRECT ACTING ANTIVIRALS
J05 - ANTIVIRALS FOR SYSTEMIC USE
J - ANTIINFECTIVES FOR SYSTEMIC USE

Active Ingredient:cobicistat

Active Ingredient UNII:LW2E03M5PG

Drugbank ID:DB09065

PubChem Compound:25151504

CAS Number:1004316-88-4

Dosage Form(s):tablet, film coated

Route(s) Of Administrator:oral

Daily Dose:

150.0 mg/day V03AX03

Chemical Structure:

SMILE Code:
CC(C)C1=NC(=CS1)CN(C)C(=O)N[C@@H](CCN2CCOCC2)C(=O)N[C@H](CC[C@H](CC3=CC=CC=C3)NC(=O)OCC4=CN=CS4)CC5=CC=CC=C5

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: Fewer pills do not mean fewer drug-drug interactions: severe rhabdomyolysis on Elvitegravir/Cobicistat and statin treatment.

[Perrone Carlo,Rauch Andri,Furrer Hansjakob,Hug Markus,Wandeler Gilles]
AIDS.2018 Mar 13;32(5):676-678. doi: 10.1097/QAD.0000000000001746. PMID: 29494427

2: A 68-year old male presenting with rhabdomyolysis-associated acute kidney injury following concomitant use of elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate and pravastatin/fenofibrate: a case report.

[Suttels Veronique,Florence Eric,Leys John,Vekemans Marc,Van den Ende Jef,Vlieghe Erika,Kenyon Chris]
J Med Case Rep.2015 Sep 8;9:190. doi: 10.1186/s13256-015-0671-z. PMID: 26347243

3: A Review of the Toxicity of HIV Medications II: Interactions with Drugs and Complementary and Alternative Medicine Products.

[Stolbach Andrew,Paziana Karolina,Heverling Harry,Pham Paul]
J Med Toxicol.2015 Sep;11(3):326-41. doi: 10.1007/s13181-015-0465-0. PMID: 26036354

4: Drug-drug interactions between HMG-CoA reductase inhibitors (statins) and antiviral protease inhibitors.

[Chauvin Benoit,Drouot Sylvain,Barrail-Tran Aurélie,Taburet Anne-Marie]
Clin Pharmacokinet.2013 Oct;52(10):815-31. doi: 10.1007/s40262-013-0075-4. PMID: 23703578

5: Tolerability of HIV integrase inhibitors.

[Lee Frederick J,Carr Andrew]
Curr Opin HIV AIDS.2012 Sep;7(5):422-8. doi: 10.1097/COH.0b013e328356682a. PMID: 22886031

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