Abbreviated Prescribing Information:  Tenkasi 400 mg  powder for concentrate for solution for infusion (oritavancin).

Please consult the Summary of Product Characteristics (SmPC) for full prescribing information.

Presentation:

Powder for concentrate for solution for infusion (powder for concentrate) in a vial.

Use:

Adults: Treatment of acute bacterial skin and skin structure infections (ABSSSI).

Dosage and administration:

Adult dose: 1200 mg administered as a single dose by intravenous infusion over 3 hours. No adjustment for age required, nor for mild to moderate hepatic impairment. No dosage adjustment for mild to moderate renal impairment. The pharmacokinetics of oritavancin in patients with severe renal impairment has not been evaluated. Oritavancin is not removed from blood by haemodialysis procedures. The pharmacokinetics of oritavancin in patients with severe hepatic impairment has not been evaluated, however based on pharmacokinetic parameters, severe hepatic impairment is not expected to have an impact on oritavancin exposure. Children: No data.

Contraindications:

Hypersensitivity to the active substance, any of the excipients. 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.

Warnings and Precautions:

Discontinue use if an acute hypersensitivity reaction occurs during oritavancin infusion. Careful monitoring of patients with any history of glycopeptide hypersensitivity during and after the infusion. If infusion-related reactions occur, stopping or slowing the infusion may result in cessation of these symptoms. 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). Monitoring of the anticoagulation effect of warfarin is unreliable up to 12 hours after an oritavancin dose. Oritavancin has been shown to interfere with certain laboratory coagulation tests. Antibacterial-associated colitis and pseudomembranous colitis have been reported for oritavancin and may range in severity from mild to life threatening diarrhoea. In such a circumstance, the use of supportive measures together with the adminnistration of specific treatment for Clostridioides difficile should be considered. The use of antibacterial medicinal products may increase the risk of overgrowth of non-susceptible micro-organisms. Patients should be monitored for signs and symptoms of osteomyelitis after administration of oritavancin, and if suspected or diagnosed, appropriate alternative antibacterial therapy should be instituted. If newly emergent abscesses occur, appropriate measures should be taken. Limited data in patients with bacteraemia, peripheral vascular disease or neutropenia, in immunocompromised patients, in patients aged > 65 years and in infections due to S. pyogenes. 

Interactions:

Substances metabolised by cytochrome P450: Caution should be used when administering oritavancin concomitantly with medicinal products with a narrow therapeutic window that are predominantly metabolised by one of the affected CYP450 enzymes (e.g. warfarin), as co-administration may increase or decrease concentrations of the narrow therapeutic range medicinal product. Patients should be closely monitored for signs of toxicity or lack of efficacy if they have been given oritavancin while on a potentially affected compound. Drug-laboratory test interactions: Oritavancin binds to and prevents the action of the phospholipid reagents which activate coagulation in commonly used laboratory coagulation tests. Oritavancin concentrations in the blood after 1200 mg doses may produce falsely elevated results from certain laboratory tests.

Pregnancy and lactation:

Avoid use unless the potential benefit justifies the potential risk to the foetus. Pharmacodynamic/ toxicological data in animals have shown excretion in milk. A risk to the newborn/infants cannot be excluded.

Side-effects:

Most common adverse drug reactions in Phase 3 ABSSSI clinical trials: nausea, hypersensitivity reactions, infusion site reactions, and headache. The most commonly reported serious adverse reaction was cellulitis (1.1%).  The most common reported reasons for discontinuation were cellulitis (0.4%) and osteomyelitis (0.3%). Adverse reactions for oritavancin from pooled Phase 3 ABSSSI clinical trials with single dose oritavancin: Common: cellulitis, abscess (limb and subcutaneous), anaemia, headache, dizziness, tachycardia, nausea, vomiting, diarrhoea, constipation, liver function test abnormal, urticaria, rash, pruritus, myalgia, infusion site reactions. Uncommon: osteomyelitis, eosinophilia, thrombocytopenia, hypersensitivity, anaphylactic reactions, hypoglycaemia, hyperuricaemia, bronchospasm, wheezing, dyspnoea, abdominal pain, blood bilirubin increased, leucocyte vasculitis, angioedema, erythema multiforme, flushing, tenosynovitis, chest pain, pyrexia. Rare: tremor, hypoxia, back pain, neck pain, red man syndrome, chest discomfort, chills. Frequency unknown: anaphylactic shock.

Pack size:

400 mg powder for concentrate for solution for infusion: 3 vials.

Legal category:

POM.

Marketing Authorisation Holder:

Menarini International Operations Luxembourg S.A., 1, Avenue de la Gare, L-1611, Luxembourg.

Marketing Authorisation Number:

EU/1/15/989/001

Marketed by:

A. Menarini Pharmaceuticals Ireland Ltd., Castlecourt, Monkstown Farm, Monkstown, Glenageary, Co. Dublin A96 T924.

Further information is available on request to A. Menarini Pharmaceuticals Ireland Ltd or may be found in the SmPC.

Last updated:

July 2021