Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Oritavancin
Drug ID BADD_D01623
Description Oritavancin is a glycopeptide antibiotic used for the treatment of skin infections. It was developed by The Medicines Company (acquired by Novartis).[L12858] Oritavancin was initially approved by the FDA in 2014 and formulated to combat susceptible gram-positive bacteria that cause skin and skin structure infections. It boasts the option of single-dose administration and has been proven as non-inferior to a full course of [vancomycin] therapy.[A39384,A193482,L8492] On March 12, 2021 the FDA approved Kimyrsa, a complete course of therapy in a single, 1 hour 1200 mg infusion.[L32634] Orbactiv, the other FDA approved oritavancin product, is administered over a 3 hour infusion and contains a lower dose of 400 mg. Marketed by Melinta Therapeutics, Kimyrsa offers effective and time-efficient treatment for skin and skin structure infections.[L32629]
Indications and Usage Oritavancin is indicated for the treatment of adult patients with acute bacterial skin and skin structure (including subcutaneous) infection. It is used for confirmed/suspected infections with designated and susceptible gram-positive organisms.[L8492] There are two preparations of oritavancin; the 400 mg dose that is administered over 3 hours, and the 1200 mg dose administered over 1 hour. Both are indicated for susceptible gram-positive skin and skin structure infections in adults.[L8492,L32629] As antimicrobial susceptibility patterns are geographically distinct, local antibiograms should be consulted to ensure adequate coverage of relevant pathogens prior to use.
Marketing Status approved; investigational
ATC Code J01XA05
DrugBank ID DB04911
KEGG ID D05271
MeSH ID C100708
PubChem ID 16136912
TTD Drug ID D02IBU
NDC Product Code 70842-140; 68225-051
UNII PUG62FRZ2E
Synonyms oritavancin | LY 333328 | LY-333328 | LY333328 | Orbactiv
Chemical Information
Molecular Formula C86H97Cl3N10O26
CAS Registry Number 171099-57-3
SMILES CC1C(C(CC(O1)OC2C3C(=O)NC(C4=C(C(=CC(=C4)O)O)C5=C(C=CC(=C5)C(C(=O)N3)NC(=O)C6C7= CC(=C(C(=C7)OC8=C(C=C2C=C8)Cl)OC9C(C(C(C(O9)CO)O)O)OC1CC(C(C(O1)C)O)(C)NCC1=CC=C (C=C1)C1=CC=C(C=C1)Cl)OC1=C(C=C(C=C1)C(C(C(=O)NC(C(=O)N6)CC(=O)N)NC(=O)C(CC(C)C) NC)O)Cl)O)C(=O)O)(C)N)O
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice..
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abscess11.01.08.001--Not Available
Acute myocardial infarction24.04.04.001; 02.02.02.0010.000049%Not Available
Alanine aminotransferase increased13.03.04.005--
Anaemia01.03.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.0010.000486%
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Anxiety19.06.02.0020.000544%
Arthralgia15.01.02.0010.000462%
Aspartate aminotransferase increased13.03.04.011--
Back pain15.03.04.0050.003130%
Blister23.03.01.001; 12.01.06.0020.000107%Not Available
Blood bilirubin increased13.03.04.018--
Blood uric acid increased13.02.04.001--Not Available
Bronchospasm22.03.01.004; 10.01.03.012--
Burning sensation17.02.06.001; 08.01.09.0290.000355%Not Available
Cardiac failure congestive02.05.01.0020.000097%Not Available
Cellulitis23.11.02.004; 11.02.01.001--Not Available
Chest discomfort02.02.02.009; 22.12.02.002; 08.01.08.0190.000889%Not Available
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.0110.001949%Not Available
Chills08.01.09.001; 15.05.03.0160.003844%
Clostridium difficile colitis11.02.02.004; 07.19.01.004--Not Available
Cyanosis02.11.04.004; 24.03.01.007; 22.02.02.007; 23.06.04.0050.000107%
Dermatitis23.03.04.002--Not Available
Diarrhoea07.02.01.001--
Discomfort08.01.08.0030.000330%Not Available
Dizziness02.11.04.006; 24.06.02.007; 17.02.05.0030.000914%
Dyspnoea02.11.05.003; 22.02.01.0040.002104%
Eosinophilia01.02.04.001--
Erythema23.03.06.0010.002897%Not Available
Erythema multiforme23.03.01.003; 10.01.03.015--
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