Patient leaflet - Orbactiv 400 mg powder for concentrate for solution for infusion

1. What Tenkasi is and what it is used for

Tenkasi is an antibiotic that contains the active substance oritavancin. Oritavancin is a type of antibiotic (a lipoglycopeptide antibiotic) that can kill or stop the growth of certain bacteria.

Tenkasi is used to treat infections of the skin and underlying tissues. It is for use in adults and paediatric patients aged 3 months and older.

Tenkasi can only be used to treat infections caused by bacteria known as Gram-positive bacteria. In mixed infections where other types of bacteria are suspected, your doctor will give you other appropriate antibiotics together with Tenkasi.

2. What you need to know before you are given Tenkasi

You must not be given Tenkasi

if you are allergic to oritavancin or any of the other ingredients of this medicine
(listed in section 6).
if it is expected that you may need to be given a blood thinning medicine
(unfractionated heparin sodium) within 5 days (120 hours) of the dose of Tenkasi.

Warnings and precautions

Talk to your doctor or nurse before receiving Tenkasi if you:

have ever had an allergic reaction to another glycopeptide antibiotic (such as
vancomycin and telavancin)
have developed severe diarrhoea during or following antibiotic treatment in
the past
have or are suspected to have a bone infection caused by bacteria
(osteomyelitis). Your doctor will treat you as necessary
have or are suspected to have a painful collection of pus on your skin
(abscess). Your doctor will treat you as necessary

Intravenous infusions of Tenkasi can cause flushing of the upper body, hives, itching and/or rashes. Infusion-associated reactions characterized by chest pain, chest discomfort, chills, tremor, back pain, neck pain, shortness of breath, abdominal pain, fever and headache, fatigue, somnolence that might be symptoms of hypoxia, have also been observed. If you experience these types of reactions, your doctor may decide to stop or slow the infusion.

Tenkasi may interfere with laboratory tests that measure how well your blood is clotting and may cause a false reading.

While antibiotics, including Tenkasi, fight certain bacteria, they may not be active against other bacteria or fungi, which may, therefore, continue to grow. This is called overgrowth. Your doctor will monitor you in case this happens and treat you if necessary.

After being given Tenkasi, you may get a new infection at another site on your skin. Your doctor should monitor you in case this happens and treat you as necessary.

Children and adolescents

Tenkasi should not to be used in children below the age of 3 months. The use of Tenkasi has not yet been studied in this age group.

Other medicines and Tenkasi

Tell your doctor if you are using, have recently used or might use any other medicines.

If you are going to be given a blood thinner called unfractionated heparin, then tell your doctor if you have received Tenkasi within the last 5 days (120 hours).

It is particularly important to tell your doctor if you are using medicines that prevent blood from clotting (oral anticoagulants, e.g.coumarin anticoagulants). Tenkasi may interfere with laboratory tests or self-test that measure how well your blood is clotting (INR) and may cause a false reading up to 12 hours after the infusion.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before you are given this medicine.

You should not be given this medicine during pregnancy unless the benefit is considered to be greater than the risk to the baby.

Driving and using machines

Tenkasi make you feel dizzy, which can influence your ability to drive or operate machines.

3. How you will be given Tenkasi

Tenkasi is available as Tenkasi 400 mg and Tenkasi 1 200 mg. The two products differ in oritavancin quantity per vial, duration of infusion and preparation instructions for the administration.

Your doctor or nurse will carefully give you Tenkasi 400 mg by infusion (drip) into a vein.

In adults, the recommended dose for Tenkasi is one single infusion of 1 200 mg (equivalent to 3 vials of 400 mg) administered into a vein over 3 hours.

For paediatric patients aged 3 months and over the recommended dose for Tenkasi will be calculated based on the weight and age: one single infusion of 15 mg for each kg of body weight administered into a vein over 3 hours (maximum 1 200 mg). Please refer to section 6 for further details.

If you are given more Tenkasi than you should

Your doctor will decide how to treat you, including stopping the treatment and monitoring for signs of ill effects.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Tell your doctor or nurse immediately if you experience a reaction to the infusion including any of the following symptoms:

Flushing of the face and upper body, hives, itching and/or rashes
Wheezing;
Shortness of breath;
Swelling around throat or under the skin that develops over a short period of time;
Shivering or trembling;
Rapid or weak pulse;
Chest pain or tightness;
Decrease in blood pressure (which could make you feel faint or dizzy).

Such reactions may be life-threatening.

Other side effects occur with the following frequencies:

Common side effects (may affect up to 1 in 10 patients)

Fewer red blood cells or less haemoglobin than normal;
Feeling dizzy;
Headache;
Feeling sick (nausea) or being sick (vomiting);
Diarrhoea;

The following information is intended for healthcare professionals only:

Tenkasi is intended for intravenous (IV) administration, only after reconstitution and dilution.

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. Aseptic procedures should be used for the preparation of Tenkasi.

Adults

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

Reconstitution: Aseptic technique should be used to reconstitute three Tenkasi 400 mg vials.

40 mL of sterile 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 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 Tenkasi powder is completely reconstituted in solution.

The reconstituted solution should be further diluted in glucose 5% intravenous infusion bag immediately.

Dilution: Three reconstituted vials are needed for dilution for administration of a single 1 200 mg IV infusion. Only glucose 5% intravenous bag (D5W) should be used for dilution.

To dilute:

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 is 400 mg).

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.
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Constipation;
Pain or irritation where the injection was given;
Itching, skin rash;
Muscle pain;
More enzymes produced by your liver (as shown in blood tests);
Heart racing or beating fast;
Infection getting worse or new infection at another site on your skin;
Swollen, red area of skin or underneath skin that feels hot and tender;
Accumulation of pus underneath the skin.

Uncommon side effects (may affect up to 1 in 100 patients)

Higher than normal levels of eosinophils, a type of white blood cell
(eosinophilia);
Low blood sugar;
High uric acid levels in the blood;
Increased blood bilirubin levels;
Severe rash;
Flushing;
Inflammation surrounding a tendon (known as tenosynovitis);
Bone infection caused by bacteria (known as osteomyelitis);
Reduced blood platelet count below the normal lower limit (known as
thrombocytopenia);
Abdominal pain;
Chest pain;
Fever;
Shortness of breath.

Rare side effects (may affect up to 1 in 1000 patients)

Headache, fatigue, somnolence that might be symptoms of low levels of
oxygen in your body tissues (hypoxia);
Back pain;
Neck pain;
Chills;
Tremor.

Additional side effects in children and adolescents

Side effects in paediatric patients are similar to those seen in adults. The side effects seen only in paediatric patients are: irritability, changes in ECG heart tracing (transitory, asymptomatic and not associated to other changes in heart tracing), infection of the bowel (Clostridioides difficile colitis).

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Tenkasi

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and vial label after EXP. The expiry date refers to the last day of that month. Do not store above 25 °C.

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 for Tenkasi diluted in glucose 5% intravenous infusion bag.

Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information

What Tenkasi contains

The active substance is oritavancin. Each vial contains oritavancin diphosphate
equivalent to 400 mg oritavancin.
- The other ingredients are mannitol and phosphoric acid (for pH-adjustment).

What Tenkasi looks like and contents of the pack

Tenkasi is a powder for concentrate for solution for infusion.
Tenkasi is a white to off white powder, supplied in a 50 ml glass vial.
Tenkasi is available in cartons containing 3 vials.

Marketing Authorisation Holder

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare

L-1611, Luxembourg

Luxembourg

Manufacturer

Falorni S.r.l.

Via dei Frilli 25

50019 Sesto Fiorentino (FI)

Italy

This leaflet was last revised in: November 2024

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.

To dilute:

Withdraw the necessary volume of oritavancin with a sterile syringe and add to the IV bag containing sterile D5W (please refer to table 1 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 1: 15 mg/kg Oritavancin: 3-Hour Infusion (Concentration of 1.2 mg/ml)

Patient’s

Weight (kg)

Calculated Oritavancin Dose (mg)

Total

Infusion

Volume (ml)

Volume of Reconstituted Oritavancin (ml)

Volume of D5W to add to IV Bag (ml)

5 75 62.5 7.5 55

10 150 125 15 110

15 225 187.5 22.5 165

20 300 250 30 220

25 375 312.5 37.5 275

30 450 375 45 330

35 525 437.5 52.5 385

40 600 500 60 440

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