ORBACTIV is a weak inhibitor of CYP2C9. Co-administration may increase or decrease concentrations; close monitoring for toxicity or lack of efficacy is advised.
Source: NLP:oritavancin
Brand names: Orbactiv
Lipoglycopeptide Antibacterial · Cytochrome P450 2C19 Inhibitors · Cytochrome P450 2C9 Inhibitors · Cytochrome P450 3A4 Inducers · Cytochrome P450 2D6 Inducers
Route: Intravenous
Contraindications
4 CONTRAINDICATIONS Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after ORBACTIV administration. ( 4.1 , 5.1 ) Known hypersensitivity to oritavancin products. ( 4.2 , 5.2 ) 4.1 Intravenous Unfractionated Heparin Sodium Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after ORBACTIV administration because the activated partial thromboplastin time (aPTT) test results may remain falsely elevated for up to 120 hours (5 days) after ORBACTIV administration [see Warnings and Precautions (5.1) and Drug Interactions (7.2) ]. 4.2 Hypersensitivity ORBACTIV is contraindicated in patients with known hypersensitivity to oritavancin products.
Pregnancy & Breastfeeding
8.1 Pregnancy Risk Summary There are no available data on ORBACTIV use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, no effects on embryo-fetal development or survival were observed in pregnant rats or rabbits treated at the highest doses throughout organogenesis with intravenous oritavancin, at doses equivalent to 25% of the single clinical dose of 1,200 mg (see Data ) . The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data Reproduction studies performed in rats and rabbits have revealed no evidence of harm to the fetus due to oritavancin at the highest doses administered throughout organogenesis, 30 mg/kg/day (gestation days 6-17) and 15 mg/kg/day (gestation days 7-19), respectively. Those doses would be equivalent to a human dose of 300 mg, or 25% of the single clinical dose of 1,200 mg. Higher doses were not evaluated in nonclinical developmental and reproductive toxicology studies.
2 interactions on record
ORBACTIV is a weak inhibitor of CYP2C9. Co-administration may increase or decrease concentrations; close monitoring for toxicity or lack of efficacy is advised.
Source: NLP:oritavancin
ORBACTIV may affect warfarin concentrations as it inhibits CYP2C9. Patients should be monitored for bleeding signs; however, a drug-drug interaction study showed no effect on S-warfarin Cmax or AUC.
Source: NLP:oritavancin