TENKASI 1200 MG POWDER FOR CONCENTRATE FOR PERFUSION SOLUTION

Introduction

Package Leaflet: Information for the Patient

Tenkasi 1200mg powder for concentrate for solution for infusion

oritavancin

Read all of this leaflet carefully before you are giventhis medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Tenkasi and what is it used for
2. What you need to know before you are given Tenkasi
3. How Tenkasi is given
4. Possible side effects
5. Storage of Tenkasi
6. Contents of the pack and other information

1. What is Tenkasi and what is it 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 skin and soft tissue infections.

It is only used to treat adult patients.

Tenkasi can only be used to treat infections caused by bacteria known as Gram-positive bacteria. In the case of mixed infections where the presence of other types of bacteria is suspected, your doctor will provide you with other appropriate antibiotics along with Tenkasi.

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

You should not be givenTenkasi:

• if you are allergic to oritavancin or any of the other ingredients of this medicine (listed in section 6).
• if you are expected to need to be given a medicine to make your blood less thick (unfractionated heparin sodium) in the 5 days (120 hours) following 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)
• you have had severe diarrhea during or after antibiotic treatment in the past.
• you have or are suspected to have a bone infection caused by bacteria (osteomyelitis). Your doctor will treat you as necessary
• You have or are suspected to have a painful accumulation of pus in the skin (abscess). Your doctor will treat you as necessary.

Intravenous infusions of Tenkasi can cause redness of the upper body, hives, itching and/or rash. Infusion-related reactions such as chest pain, chest discomfort, chills, shivers, back pain, neck pain, shortness of breath, abdominal pain, fever, and headache, fatigue, drowsiness that could be symptoms of hypoxia have also been observed. If you experience reactions of this type, your doctor may decide to stop or slow down the infusion.

Tenkasi may interfere with laboratory tests that measure blood clotting and may produce a false reading.

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

After you are given Tenkasi, you may develop a new infection in another area of the skin. Your doctor should monitor you for this and treat you as necessary.

Children and adolescents

Tenkasi should not be used in children or adolescents under 18 years of age.

Using Tenkasi with other medicines

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

If you are going to be given a medicine to make your blood less thick called unfractionated heparin, tell your doctor if you have received Tenkasi in the last 5 days (120 hours).

It is especially important that you 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-tests that measure blood clotting (INR), and may cause a false reading up to 12 hours after infusion.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.

You should not be given this medicine during pregnancy unless your doctor considers that the benefit is greater than the risk to the baby.

Driving and using machines

Tenkasi can make you feel dizzy, so it may affect your ability to drive or use machines.

Tenkasi contains cyclodextrins

Tenkasi 1200 mg contains 2400 mg of hydroxypropylbetadex in each vial, equivalent to 9.6 mg/ml.

3. How Tenkasi is given

Tenkasi is available as Tenkasi 1200 mg and Tenkasi 400 mg. The two medicines differ in the amount of oritavancin per vial, the duration of infusion, and the preparation instructions for administration.

Your doctor or nurse will carefully administer Tenkasi 1200 mg by infusion (drip) into a vein.

The recommended dose of Tenkasi is a single infusion of 1200 mg administered into a vein over 1 hour.

If you use more Tenkasithan you should

Your doctor will decide how to treat you, as well as when to stop treatment and monitor for signs of side 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 an infusion reaction, including any of the following symptoms:

• redness of the face and upper body, hives, itching and/or rash;
• wheezing (high-pitched sound when breathing);
• shortness of breath;
• swelling around the throat or under the skin that appears in a short period of time;
• chills or shivers;
• rapid or weak pulse;
• chest pain or tightness;
• Decreased blood pressure (may make you feel weak or dizzy).

Such reactions can be life-threatening.

Other side effects occur with the following frequencies:

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

• fewer red blood cells or less hemoglobin than normal;
• dizziness;
• headache;
• feeling sick (nausea) or vomiting;
• diarrhea;
• constipation;
• pain or irritation at the injection site;
• itching, skin rash;
• muscle pain;
• higher amount of liver enzymes (according to blood test results);
• rapid heartbeat;
• worsening of an infection or new infection in another area of the skin;
• swollen and red area of the skin or under the skin with a feeling of heat and pain to the touch;
• accumulation of pus under the skin.

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

• higher than normal levels of eosinophils, a type of white blood cell (eosinophilia);
• low blood sugar levels;
• high levels of uric acid in the blood;
• increased levels of bilirubin in the blood;
• severe skin rash;
• hot flushes;
• inflammation around a tendon (known as tenosynovitis);
• bone infection caused by bacteria (known as osteomyelitis);
• low platelet count in the blood below the lower limit of normal (known as thrombocytopenia);
• Abdominal pain;
• Chest pain;
• Fever;
• Shortness of breath.

Rare side effects (may affect up to 1 in 1,000 people)

• Headache, fatigue, drowsiness that can be symptoms of low oxygen levels in body tissues (hypoxia);
• Back pain;
• Neck pain;
• Chills;
• Shivers.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of 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 on the vial label after EXP. The expiry date is the last day of the month shown.

This medicine does not require any special storage conditions.

The diluted solution should be used immediately.

From a microbiological point of view, the medicine should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and normally should not exceed 4 hours at a temperature of 25 °C and 12 hours at a temperature between 2 °C and 8 °C for Tenkasi diluted in an intravenous infusion bag with glucose 5% or sodium chloride 0.9%.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What is in Tenkasi

• The active substance is oritavancin. The vial contains oritavancin diphosphate equivalent to 1200 mg of oritavancin.
• The other ingredients are hydroxypropylbetadex (see section 2 “Tenkasi contains cyclodextrins”), mannitol, phosphoric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).

Appearance and pack contents

• 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 marketed in packs of 1 vial.

Marketing authorisation holder

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare

L-1611, Luxembourg

Luxembourg

Manufacturer

Biologici Italia Laboratories S.r.l

Via Filippo Serpero 2

20060 Masate (MI)

Italy

You can obtain further information on this medicine from the local representative of the marketing authorisation holder:

Date of last revision of this leaflet:09/2023

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu.

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This information is intended only for healthcare professionals:

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

Tenkasi should be prepared using aseptic techniques.

There are two medicines that contain oritavancin (Tenkasi 400 mg and Tenkasi 1200 mg) that:

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

Follow the recommended instructions for each medicine carefully.

The Tenkasi 1200 mg vial should be reconstituted and diluted to prepare a single intravenous dose of 1200 mg. The powder should be reconstituted with sterile water for injection and the resulting concentrate should be diluted in an intravenous infusion bag with glucose 5% or sodium chloride 9 mg/ml (0.9%) before use. Both the reconstituted solution and the diluted infusion solution should be clear and colorless to pink. Parenteral medicines should be inspected visually for particulate matter after reconstitution. Aseptic techniques should be used for the preparation of Tenkasi.

Reconstitution:

• 40 ml of sterile water for injection should be added using a sterile syringe to reconstitute the vial to provide a 30 mg/ml solution per vial.
• To avoid excessive foam formation, it is recommended to add the sterile water for injection carefully, along the wall of the vials.
• The vial should be gently swirled to avoid foam formation and to ensure that all the Tenkasi powder is completely reconstituted in the solution.

Dilution: For dilution, glucose 5% (D5W) or sodium chloride 9 mg/ml (0.9%) in an intravenous infusion bag should be used.

To dilute:

• 40 ml should be withdrawn and discarded from a 250 ml intravenous infusion bag of glucose 5% or sodium chloride 0.9%.
• 40 ml should be withdrawn from the reconstituted vial and added to a 250 ml intravenous infusion bag of glucose 5% or sodium chloride 0.9% to achieve a volume of 250 ml. This provides a concentration of oritavancin of 4.8 mg/ml. For preparation of administration, PP (polypropylene) or PVC (polyvinyl chloride) bags should be used.

The diluted solution should be used immediately.

From a microbiological point of view, the medicine should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and normally should not exceed 4 hours at a temperature of 25 °C and 12 hours at a temperature between 2 °C and 8 °C for Tenkasi diluted in an intravenous infusion bag with glucose 5% or sodium chloride 0.9%.