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RALTEGRAVIR
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
- At a dose 1.33 times the maximum approved recommended dose (and peak concentrations 1.25-fold higher than the maximum approved dose), raltegravir does not prolong the QT interval or PR interval to any clinically relevant extent.
Postmarketing Surveillance
Contingency Table:
Current Drug
Other Drugs
Rhabdomyolysis
55
42857
Other ADRs
4918
14112361
Odds Ratio = 3.683
Drug Property Information
ATC Code(s):
- J05AX08 - raltegravir
- J05AX - Other antivirals
- J05A - DIRECT ACTING ANTIVIRALS
- J05 - ANTIVIRALS FOR SYSTEMIC USE
- J - ANTIINFECTIVES FOR SYSTEMIC USE
- J05AR16 - raltegravir
- J05AR - "Antivirals for treatment of HIV infections, combinations"
- J05A - DIRECT ACTING ANTIVIRALS
- J05 - ANTIVIRALS FOR SYSTEMIC USE
- J - ANTIINFECTIVES FOR SYSTEMIC USE
Active Ingredient:raltegravir potassium
Active Ingredient UNII:43Y000U234
Drugbank ID:DB06817
PubChem Compound:54671008
CAS Number:518048-05-0
Dosage Form(s):granule, for suspension; tablet, chewable; tablet, film coated
Route(s) Of Administrator:oral
Daily Dose:
- 800.0 mg/day J05AX08
Chemical Structure: 
SMILE Code:
CC1=NN=C(O1)C(=O)NC(C)(C)C2=NC(=C(C(=O)N2C)O)C(=O)NCC3=CC=C(C=C3)F
CC1=NN=C(O1)C(=O)NC(C)(C)C2=NC(=C(C(=O)N2C)O)C(=O)NCC3=CC=C(C=C3)F
Reference
COHORT STUDY:
N/AOTHER REFERENCE(S):
1: Muscle symptoms and creatine phosphokinase elevations in patients receiving raltegravir in clinical practice: Results from the SCOLTA project long-term surveillance.
[Madeddu Giordano,De Socio Giuseppe V L,Ricci Elena,Quirino Tiziana,Orofino Giancarlo,Carenzi Laura,Franzetti Marco,Parruti Giustino,Martinelli Canio,Vichi Francesca,Penco Giovanni,Dentone Chiara,Celesia Benedetto Maurizio,Maggi Paolo,Libertone Raffaella,Bagella Paola,Di Biagio Antonio,Bonfanti Paolo,C.I.S.A.I. Group, Italy]Int J Antimicrob Agents.2015 Mar;45(3):289-94. doi: 10.1016/j.ijantimicag.2014.10.013. Epub 2014 Nov 13. PMID: 25476452
2: Skeletal muscle toxicity in HIV-1-infected patients treated with a raltegravir-containing antiretroviral therapy: a cohort study.
[Calza Leonardo,Danese Ilaria,Colangeli Vincenzo,Vandi Giacomo,Manfredi Roberto,Girometti Nicolò,Borderi Marco,Appolloni Lucia,Puggioli Cristina,Viale Pierluigi]AIDS Res Hum Retroviruses.2014 Dec;30(12):1162-9. doi: 10.1089/aid.2014.0113. PMID: 25369244
3: No evident association between efavirenz use and suicidality was identified from a disproportionality analysis using the FAERS database.
[Napoli Andrew A,Wood Jennifer J,Coumbis John J,Soitkar Amit M,Seekins Daniel W,Tilson Hugh H]J Int AIDS Soc.2014 Sep 4;17:19214. doi: 10.7448/IAS.17.1.19214. eCollection 2014. PMID: 25192857
4: [Severe or life-threatening interactions between antiretrovirals and non-HIV drugs].
[Manzardo Christian,Tuset Montserrat,Miró Jose M,Gatell Jose M]Enferm Infecc Microbiol Clin.2015 Aug-Sep;33(7):e15-30. doi: 10.1016/j.eimc.2014.02.020. Epub 2014 Jun 7. PMID: 24913990
5: Long-term efficacy and safety of raltegravir in the management of HIV infection.
[Liedtke Michelle D,Tomlin C Ryan,Lockhart Staci M,Miller Misty M,Rathbun R Chris]Infect Drug Resist.2014 Mar 18;7:73-84. doi: 10.2147/IDR.S40168. eCollection 2014. PMID: 24672249
6: Rapid onset of rhabdomyolysis after switching to a raltegravir-based antiretroviral regimen.
[Tsai Wan-Jung,Lee Susan Shin-Jung,Tsai Hung-Chin,Sy Cheng-Len,Chen Jui-Kuang,Wu Kuang-Sheng,Wang Yung-Hsin,Chen Yao-Shen]J Microbiol Immunol Infect.2016 Apr;49(2):286-8. doi: 10.1016/j.jmii.2013.02.008. Epub 2013 Apr 21. PMID: 23612027
7: Skeletal muscle toxicity associated with raltegravir-based combination antiretroviral therapy in HIV-infected adults.
[Lee Frederick J,Amin Janaki,Bloch Mark,Pett Sarah L,Marriott Debbie,Carr Andrew]J Acquir Immune Defic Syndr.2013 Apr 15;62(5):525-33. PMID: 23274936
8: 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
9: Common adverse effects of antiretroviral therapy for HIV disease.
[Reust Carin E]Am Fam Physician.2011 Jun 15;83(12):1443-51. PMID: 21671545
10: Severe raltegravir-associated rhabdomyolysis: a case report and review of the literature.
[Croce F,Vitello P,Dalla Pria A,Riva A,Galli M,Antinori S]Int J STD AIDS.2010 Nov;21(11):783-5. doi: 10.1258/ijsa.2010.010246. PMID: 21187364
11: Severe acute renal failure associated with rhabdomyolysis during treatment with raltegravir. A call for caution.
[Masiá Mar,Enríquez Ricardo,Sirvent Ana,Gutiérrez Félix]J Infect.2010 Jul;61(2):189-90. doi: 10.1016/j.jinf.2010.04.011. Epub 2010 May 4. PMID: 20447415
12: A case of rhabdomiolysis associated with raltegravir use.
[Dori Luca,Buonomini Anna R,Viscione Magda,Sarmati Loredana,Andreoni Massimo]AIDS.2010 Jan 28;24(3):473-5. doi: 10.1097/QAD.0b013e328334cc4a. PMID: 20087078
13: Severe rhabdomyolysis associated with raltegravir use.
[Zembower Teresa R,Gerzenshtein Lana,Coleman Karen,Palella Frank J]AIDS.2008 Jul 11;22(11):1382-4. doi: 10.1097/QAD.0b013e328303be40. PMID: 18580624
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