TENKASI Powder for solution for infusion Ref.[50255] Active ingredients: Oritavancin

Posology

Adults

1 200 mg administered as a single dose by intravenous infusion over 3 hours.

Paediatric patients aged 3 months to <18 years

15 mg/kg administered as a single dose by intravenous infusion over 3 hours (maximum 1 200 mg). Please refer to Table 1 for relevant example, and to section 6.6 for further details.

Table 1. 15 mg/kg Body Weight Dose of Oritavancin: 3-Hour Infusion (Concentration of 1.2 mg/ml):

Special populations

Elderly (≥65 years)

No dose adjustment is required for patients ≥65 years of age (see section 5.2).

Renal impairment

No dose adjustment is needed in patients with mild or moderate renal impairment. Very limited data are available in patients with severe renal impairment. Renal impairment had no clinically relevant effect on the exposure of oritavancin (see section 5.2), however caution should be exercised when prescribing oritavancin in patients with severe renal impairment. Oritavancin is not removed from blood by haemodialysis procedures.

Hepatic impairment

No dose adjustment is required for patients with mild to moderate hepatic impairment (Child-Pugh Class B) (see section 5.2). The pharmacokinetics of oritavancin in patients with severe hepatic impairment (Child-Pugh Class C) has not been evaluated, however based on pharmacokinetic parameters, severe hepatic impairment is not expected to have an impact on oritavancin exposure. Therefore, no dose adjustment is required, even if caution should be exercised when prescribing oritavancin to patients with severe hepatic impairment (Child-Pugh Class C).

Paediatric population

The safety and efficacy of oritavancin in paediatric patients < 3 months of age have not yet been established.

Method of administration

Intravenous use.

There are two oritavancin medicinal products (Tenkasi 400 mg and Tenkasi 1 200 mg) that:

• Are supplied in different dose strengths of oritavancin.
• Have different recommended duration of infusion.
• Have different preparation instructions, including differences in reconstitution, dilution, and compatible diluents.

Carefully follow the recommended posology (see section 4.2) and the instructions on reconstitution and dilution for Tenkasi 400 mg before administration (see section 6.6).

Each of the three 400 mg vials should first be reconstituted with 40 mL of sterile water for injection (WFI). The reconstituted solutions should be withdrawn and added to a 1 000 mL glucose 5% intravenous bag (D5W) for an intravenous infusion over 3 hours (see section 6.6).

Only D5W should be used for dilution. Sodium chloride solution should not be used for dilution (see section 6.2)

Refer to Tenkasi 1 200 mg for relevant information on the other oritavancin medicinal product.

In the clinical programme of 3017 oritavancin-treated subjects, there was no incidence of accidental overdose of oritavancin.

Oritavancin is not removed from blood by haemodialysis procedures. In the event of overdose, supportive measures should be taken.

4 years.

After reconstitution:

The reconstituted solution should be further diluted in glucose 50 mg/ml (5%) intravenous infusion bag immediately.

After dilution:

The diluted solution should be used immediately.

From a microbiological point of view, the product should be used immediately. If not used immediately storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 12 hours at 25°C and 24 hours at 2°C-8°C following dilution in a glucose 5% intravenous infusion bag.

Do not store above 25°C.

For storage conditions after reconstitution and dilution of the medicinal product, see section 6.3.

Single-use 50 ml Type 1 glass vials with rubber stoppers and aluminium flip off cap.

3 individual vials are packaged in a carton.

For single use only. Tenkasi should be prepared under aseptic techniques.

There are two oritavancin medicinal products (Tenkasi 400 mg and Tenkasi 1 200 mg) that:

• Are supplied in different dose strengths of oritavancin.
• Have different recommended duration of infusion.
• Have different preparation instructions, including differences in reconstitution, dilution, and compatible diluents.

Carefully follow the recommended instructions for each medicinal product.

Three Tenkasi 400 mg vials need to be reconstituted and diluted to prepare a single once-only 1 200 mg IV dose.

The powder must be reconstituted with sterile water for injection and the resulting concentrate must be diluted in a glucose 5% intravenous infusion bag prior to use. Both the reconstituted solution and the diluted solution for infusion should be clear, colourless to pale yellow solution. Parenteral medicinal products should be inspected visually for particulate matter after reconstitution.

Adults

Reconstitution:

• 40 mL of sterile water for injection (WFI) should be added using a sterile syringe to reconstitute each vial to provide a 10 mg/mL solution per vial.
• To avoid excessive foaming, it is recommended that sterile WFI should be added carefully, along the walls of the vials.
• Each vial should be swirled gently to avoid foaming and ensure that all of the powder is completely reconstituted in solution.

Dilution: Three reconstituted vials are needed for dilution for administration of a single 1 200 mg intravenous infusion. Only glucose 5% intravenous bag (D5W) should be used for dilution. Sodium chloride solution should not be used for dilution (see section 6.2).

Dilution:

• Withdraw and discard 120 mL from a 1 000 mL D5W intravenous bag.

• Withdraw 40 mL from each of the three reconstituted vials and add to D5W intravenous bag to bring the bag volume to 1 000 mL. This yields a concentration of 1.2 mg/mL of oritavancin. PP (Polypropylene) or PVC (Polyvinyl chloride) bags should be used for administration preparation.

Use in the paediatric population (aged 3 months to <18 years)

Calculate the dose of oritavancin required based on patient’s weight (one single infusion of 15 mg/kg administered intravenously over 3 hours).

Determine the number of oritavancin vials that are required for the patient (each vial contains oritavancin diphosphate equivalent to 400 mg oritavancin)

Reconstitution:

• 40 mL of water for injections (WFI) should be added using a sterile syringe to reconstitute each vial to provide a 10 mg/mL solution per vial.

• To avoid excessive foaming, it is recommended that WFI should be added carefully, along the walls of the vials.

• Each vial should be swirled gently to avoid foaming and ensure that all of the powder is completely reconstituted in solution.

Dilution: Only glucose 5% intravenous bag (D5W) should be used for dilution. Sodium chloride solution should not be used for dilution (see section 6.2).

Dilution:

Withdraw the necessary volume of oritavancin with a sterile syringe and add to the IV bag containing sterile D5W (please refer to table 6 for relevant example). The size of the IV bag will be based on the total volume administered. For small volumes a syringe pump may be used.

Table 6. 15 mg/kg Oritavancin: 3-Hour Infusion (Concentration of 1.2 mg/ml):

Calculations

1) Use Patient’s Actual Weight—ROUND ONLY TO THE NEAREST WHOLE NUMBER

2) Dose: Weight (kg) x 15 mg/kg = ______ mg (Maximum Dose 1 200 mg)

3) Total Infusion Volume: Dose (mg) ÷1.2 mg/ml = _______ ml

4) Volume of Reconstituted Oritavancin: Dose (mg) ÷ 10 =______ ml

5) Volume of D5W to add to IV bag: Total Infusion Volume (C) – Volume of Reconstituted Oritavancin (D) = _______ ml

Any unused medicinal product or waste material should be disposed of in accordance with local requirements.

Refer to Tenkasi 1 200 mg for relevant information on the other oritavancin medicinal product.