DIRA 1.0: Atlas of Drug-induced Rhabdomyolysis

RITONAVIR

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
Established and Other Potentially Significant Drug Interactions
figure
CLINICAL PHARMACOLOGY
Pharmacodynamics
Cardiac Electrophysiology
QTcF interval was evaluated in a randomized, placebo and active (moxifloxacin 400 mg once-daily) controlled crossover study in 45 healthy adults, with 10 measurements over 12 hours on Day 3. The maximum mean (95% upper confidence bound) time-matched difference in QTcF from placebo after baseline correction was 5.5 (7.6) milliseconds (msec) for 400 mg twice-daily ritonavir. Ritonavir 400 mg twice daily resulted in Day 3 ritonavir exposure that was approximately 1.5 fold higher than observed with ritonavir 600 mg twice-daily dose at steady state.

Postmarketing Surveillance

Contingency Table:

Current Drug

Other Drugs

Rhabdomyolysis

42870

Other ADRs

8568

14108711

Odds Ratio = 1.614

Drug Property Information

ATC Code(s):

J05AX67 - ritonavir

J05AX - Other antivirals
J05A - DIRECT ACTING ANTIVIRALS
J05 - ANTIVIRALS FOR SYSTEMIC USE
J - ANTIINFECTIVES FOR SYSTEMIC USE

J05AR10 - ritonavir

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

J05AE03 - ritonavir

J05AE - Protease inhibitors
J05A - DIRECT ACTING ANTIVIRALS
J05 - ANTIVIRALS FOR SYSTEMIC USE
J - ANTIINFECTIVES FOR SYSTEMIC USE

J05AX66 - ritonavir

J05AX - Other antivirals
J05A - DIRECT ACTING ANTIVIRALS
J05 - ANTIVIRALS FOR SYSTEMIC USE
J - ANTIINFECTIVES FOR SYSTEMIC USE

Active Ingredient:ritonavir

Active Ingredient UNII:O3J8G9O825

Drugbank ID:DB00503

PubChem Compound:392622

CAS Number:155213-67-5

Dosage Form(s):capsule

Route(s) Of Administrator:oral

Daily Dose:

1200.0 mg/day J05AE03

Chemical Structure:

SMILE Code:
CC(C)C1=NC(=CS1)CN(C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CC2=CC=CC=C2)C[C@@H]([C@H](CC3=CC=CC=C3)NC(=O)OCC4=CN=CS4)O

Reference

COHORT STUDY:

N/A

OTHER REFERENCE(S):

1: [Rhabdomyolysis and severe hepatotoxicity due to a drug-drug interaction between ritonavir and simvastatin. Could we use the most cost-effective statin in all human immunodeficiency virus-infected patients?].

[Bastida Carla,Also Maria Antonia,Pericas Juan Manuel,Letang Emili,Tuset Montse,Miró Josep Maria]
Enferm Infecc Microbiol Clin.2014 Nov;32(9):579-82. doi: 10.1016/j.eimc.2014.03.014. Epub 2014 Jun 7. PMID: 24913991

2: 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

3: Rhabdomyolysis in an HIV-infected patient with impaired renal function concomitantly treated with rosuvastatin and lopinavir/ritonavir.

[de Kanter Clara T M M,Keuter Monique,van der Lee Manon J,Koopmans Peter P,Burger David M]
Antivir Ther.2011;16(3):435-7. doi: 10.3851/IMP1747. PMID: 21555828

4: Severe rhabdomyolysis due to rosuvastatin in a liver transplant subject with human immunodeficiency virus and immunosuppressive therapy-related dyslipidemia.

[Moreno Ana,Fortún Jesús,Graus Javier,Rodriguez-Gandía Miguel A,Quereda Carmen,Pérez-Elías María J,Nuño Javier,Wikman Philip,Moreno Santiago,Bárcena Rafael]
Liver Transpl.2011 Mar;17(3):331-3. doi: 10.1002/lt.22225. PMID: 21384516

5: Tolerability of HIV postexposure prophylaxis with tenofovir/emtricitabine and lopinavir/ritonavir tablet formulation.

[Tosini William,Muller Philippe,Prazuck Thierry,Benabdelmoumen Ghania,Peyrouse Eric,Christian Bernard,Quertainmont Yann,Bouvet Elisabeth,Rabaud Christian]
AIDS.2010 Sep 24;24(15):2375-80. doi: 10.1097/QAD.0b013e32833dfad1. PMID: 20729709

6: Short term treatment with clarithromycin resulting in colchicine-induced rhabdomyolysis.

[McKinnell James,Tayek John A]
J Clin Rheumatol.2009 Sep;15(6):303-5. doi: 10.1097/RHU.0b013e3181bbbcd7. PMID: 19734738

7: Rhabdomyolysis in an HIV-infected patient on anti-retroviral therapy precipitated by high-dose pravastatin.

[Mikhail Nasser,Iskander Elizabeth,Cope Dennis]
Curr Drug Saf.2009 May;4(2):121-2. PMID: 19442105

8: Drug interactions with lipid-lowering drugs: mechanisms and clinical relevance.

[Neuvonen Pertti J,Niemi Mikko,Backman Janne T]
Clin Pharmacol Ther.2006 Dec;80(6):565-81. PMID: 17178259

9: Clinical pharmacokinetics of atorvastatin.

[Lennernäs Hans]
Clin Pharmacokinet.2003;42(13):1141-60. PMID: 14531725

10: Drug-induced rhabdomyolysis after concomitant use of clarithromycin, atorvastatin, and lopinavir/ritonavir in a patient with HIV.

[Mah Ming Jinell B,Gill M John]
AIDS Patient Care STDS.2003 May;17(5):207-10. PMID: 12816614

11: Rhabdomyolysis due to probable interaction between simvastatin and ritonavir.

[Cheng Cindy H,Miller Christine,Lowe Christopher,Pearson Vincent Earl]
Am J Health Syst Pharm.2002 Apr 15;59(8):728-30. PMID: 11977859

12: Pharmacokinetic-pharmacodynamic consequences and clinical relevance of cytochrome P450 3A4 inhibition.

[Dresser G K,Spence J D,Bailey D G]
Clin Pharmacokinet.2000 Jan;38(1):41-57. PMID: 10668858

13: Two episodes of acute renal failure, rhabdomyolysis, and severe hepatitis in an AIDS patient successively treated with ritonavir and indinavir.

[Benveniste O,Longuet P,Duval X,Le Moing V,Leport C,Vildé J L]
Clin Infect Dis.1999 May;28(5):1180-1. PMID: 10452668

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