Patient leaflet - Tenkasi 1200 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 only.

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 be used in children or adolescents below the age of 18.

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.

Tenkasi contains cyclodextrin

Tenkasi 1 200 mg contains 2 400 mg of hydroxypropylbetadex in each vial which is equivalent to 9.6 mg/ml.

3. How you will be given Tenkasi

Tenkasi is available as Tenkasi 1 200 mg and Tenkasi 400 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 1 200 mg by infusion (drip) into a vein.

The recommended dose for Tenkasi is one single infusion of 1 200 mg administered into a vein over 1 hour.

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;
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.

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.

This medicine does not require any special storage conditions.

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 4 hours at 25 °C and 12 hours at 2 °C -8 °C for Tenkasi diluted in glucose 5% or 0.9% sodium chloride 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. The vial contains oritavancin diphosphate equivalent to
1 200 mg oritavancin.
The other ingredients are hydroxypropylbetadex (see section 2 “Tenkasi contains cyclodextrin”), mannitol, phosphoric acid (for pH-adjustment) and sodium hydroxide (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 to pink powder, supplied in a 50 ml glass vial.
Tenkasi is available in cartons containing 1 vial.

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

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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.

Tenkasi 1 200 mg vial needs 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% or sodium chloride 9 mg/mL (0.9%) intravenous infusion bag prior to use. Both the reconstituted solution and the diluted solution for infusion should be clear, colourless to pink solution. Parenteral medicinal products should be inspected visually for particulate matter after reconstitution.

Aseptic procedures should be used for the preparation of Tenkasi.

Reconstitution:

40 mL of sterile water for injections (WFI) should be added using a sterile syringe to reconstitute the vial to provide a 30 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.
The vial should be swirled gently to avoid foaming and ensure that all of the powder is completely reconstituted in solution.

Dilution: Glucose 5% (D5W) or sodium chloride 9 mg/mL (0.9%) intravenous bag should be used for dilution.

To dilute:

Withdraw and discard 40 mL from a 250 mL D5W or 0.9% sodium chloride intravenous bag.
Withdraw 40 mL of the reconstituted vial and add to D5W or 0.9% sodium chloride intravenous bag to bring the bag volume to 250 mL. This yields a concentration of 4.8 mg/mL of oritavancin. PP (Polypropylene) or PVC (Polyvinyl chloride) bags should be used for administration preparation.