Oritavancin parenteral
- Drugs List
- Therapeutic Indications
- Dosage
- Administration
- Contraindications
- Precautions and Warnings
- Pregnancy and Lactation
- Side Effects
- Monograph
Presentation
Infusions of oritavancin.
Drugs List
Therapeutic Indications
Uses
Treatment of skin and skin structure infections
Dosage
Adults
1200mg administered as a single dose by intravenous infusion over 3 hours.
Administration
For intravenous infusion only.
Contraindications
Children under 18 years
Concomitant medication consider washout period, see prescribing information
Breastfeeding
Precautions and Warnings
Pregnancy
Severe hepatic impairment
Severe renal impairment
Advise ability to drive/operate machinery may be affected by side effects
Consult national/regional policy on the use of anti-infectives
Previous/Concurrent medicine consider washout period: See prescribing info
Suspend treatment or reduce rate until infusion reactions resolve
Monitor for signs and symptoms of osteomyelitis
Consider pseudomembranous colitis if patient presents with diarrhoea
Prolonged use may result in superinfection with non-susceptible organisms
May affect results of some laboratory tests
Consider alternative antibacterial therapy if osteomyelitis is suspected
Discontinue if hypersensitivity reactions occur
Infusion-associated reactions characterised by chest pain, chest discomfort, chills, tremor, back pain, neck pain, dyspnoea, hypoxia, abdominal pain and fever have been observed with the use of oritavancin including after the administration of more than one dose of oritavancin (1200mg) during a single course of therapy.
Oritavancin is active against Gram positive bacteria only. In mixed infections where Gram negative and/or certain types of anaerobic bacteria are suspected, oritavancin should be co-administered with appropriate antibacterial agent(s).
Pregnancy and Lactation
Pregnancy
Use oritavancin with caution during pregnancy.
The manufacturer advises, as a precautionary measure, that it is preferable to avoid the use of oritavancin during pregnancy unless the potential benefit justifies the potential risk to the fetus.
At the time of writing there are no or limited amount of data from the use of oritavancin in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Lactation
Oritavancin is contraindicated during breastfeeding.
The manufacturer advises that the patient either discontinues oritavancin or discontinues breastfeeding taking into account the benefit of breastfeeding for the child and the benefit of therapy for the women.
Available pharmacodynamic/toxicological data in animals have shown excretion of oritavancin in milk. It is unknown whether oritavancin/metabolites are excreted in human milk. A risk to newborns/infants cannot be excluded.
Side Effects
"Red man" syndrome (flushing of upper body)
Abdominal pain
Abnormal liver function tests
Abscess
Alanine aminotransferase increased
Anaemia
Anaphylactic reaction
Anaphylactic shock
Angioedema
Antibiotic-associated colitis
Aspartate aminotransferase increased
Back pain
Bronchospasm
Cellulitis
Chest discomfort
Chest pain
Chills
Constipation
Diarrhoea
Dizziness
Dyspnoea
Eosinophilia
Erythema at injection site
Erythema multiforme
Extravasation
Flushing
Headache
Hypersensitivity reactions
Hyperuricaemia
Hypoglycaemia
Hypoxia
Increased susceptibility to infection
Infusion related reaction
Infusion site induration
Infusion site reaction
Leukocytoclastic vasculitis
Myalgia
Nausea
Neck pain
Osteomyelitis
Peripheral oedema
Phlebitis (injection site)
Pruritus
Pseudomembranous colitis
Pyrexia
Rash
Respiratory disorders
Serum bilirubin increased
Skin reactions
Tachycardia
Tenosynovitis
Thrombocytopenia
Tremor
Urticaria
Vomiting
Wheezing
Effects on Laboratory Tests
Use of intravenous unfractionated heparin sodium is contraindicated for 120 hours (5 days) after oritavancin administration because the activated partial thromboplastin time (aPTT) test results may remain falsely elevated for up to 120 hours after oritavancin administration. For patients that require aPTT monitoring within 120 hours of oritavancin dosing, a non-phospholipid dependent coagulation test such as a Factor Xa (chromogenic) assay or an alternative anticoagulant not requiring aPTT monitoring may be considered.
Oritavancin has been shown to artificially prolong prothrombin time (PT) and international normalised ratio (INR) for up to 12 hours. Therefore the monitoring of the anticoagulation effect of warfarin is unreliable up to 12 hours after an oritavancin dose.
Oritavancin concentrations that are found in the blood of patients following administration of a single dose have shown to artificially prolong; Activated Clotting Time (ACT) for up to 24 hours, Silica Clot Time (SCT) for up to 18 hours, and Dilute Russell's Viper Venom Test (DRVVT) for up to 72 hours.
Overdosage
It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.
The following number will direct the caller to the relevant local centre (0844) 892 0111
Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( www.toxbase.org ) or if this is unavailable at the backup site ( www.toxbasebackup.org ).
Further Information
Last Full Review Date: July 2022
Reference Sources
Summary of Product Characteristics: Tenkasi 400mg powder for concentrate for solution for infusion. A. Menarini Farmaceutica Internazionale SRL. Revised July 2021.
NICE Evidence Services Available at: www.nice.org.uk Last accessed: 20 July 2022
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