Prospecto: information for the patient

Tenkasi 1200mg powder for concentrate for solution for infusion

oritavancina

Read this prospect carefully beforethey administerthis medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.
• If you experience adverse effects, consult your doctor or nurse, even if they are not listed in this prospect. See section4.

1.What is Tenkasi and for what it is used

2.What you need to know before they administer Tenkasi

3.How they will administer Tenkasi

4.Possible adverse effects

5.Storage of Tenkasi

6.Contents of the package and additional information

Tenkasi is an antibiotic that contains the active ingredient oritavancina. Oritavancina 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 of the skin.

It is used solely for the treatment of adult patients.

Tenkasi may be used only to treat infections caused by known bacteria called gram-positive bacteria. In cases of mixed infections where the presence of other types of bacteria is suspected, your doctor will provide other appropriate antibiotics along with Tenkasi.

Do not administerTenkasi:

-if you are allergic to oritavancin or any of the other components of this medication (listed in section6).

-if you are expected to receive a medication that makes your blood less thick (sodium heparin nonfractionated) in the 5días (120horas) following the Tenkasi dose.

Warnings and precautions

Consult your doctor or nurse before receiving Tenkasi if:

• You have ever had an allergic reaction to another glucopeptidic antibiotic (such as vancomycin and telavancin)
• You have had intense diarrhea during or after a previous antibiotic treatment.
• You have or suspect you have a bone infection caused by bacteria (osteomyelitis). Your doctor will treat you accordingly
• You have or suspect you have a painful accumulation of pus in the skin (abscess). Your doctor will treat you accordingly.

Intravenous infusions of Tenkasi may cause redness of the upper body, urticaria, itching, and/or rashes. Reactions related to infusion have also been observed, such as chest pain, chest discomfort, chills, tremors, back pain, neck pain, shortness of breath, abdominal pain, fever, and headache, fatigue, drowsiness, which could be symptoms of hypoxia. If you experience such reactions, 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, so they may continue to grow. This is called overgrowth. Your doctor will monitor you for this and treat you if necessary.

After receiving Tenkasi, you may develop a new skin infection in another area. Your doctor should monitor you for this and treat you accordingly.

Children and adolescents

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

Use of Tenkasi with other medications

Inform your doctorif you are using,have usedrecentlyor may need to use any other medication.

If you are to receive a medication to make your blood less thick called nonfractionated heparin, inform your doctor if you have received Tenkasi in the last 5 days (120 hours).

It is especially important to inform your doctor if you are using medications that prevent blood from clotting (oral anticoagulants, e.g., coumarinic 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, or think you may be pregnant, or plan to become pregnant, consult your doctor before using this medication.

You should not receive this medication during pregnancy unless it is considered that the benefits outweigh the risks for the baby.

Driving and operating machines

Tenkasi makes you feel dizzy, so it may affect your ability to drive or operate machines.

Tenkasi contains cyclodextrins

Tenkasi 1200 mg contains 2,400 mg of hydroxypropylbetadex in each vial, equivalent to 9.6 mg/ml.

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

Your doctor or nurse will carefully administer Tenkasi 1200 mg through an intravenous infusion (drip) in a vein.

The recommended dose of Tenkasi is a single infusion of 1,200 mg administered through a vein over 1 hour.

If You Take More Tenkasi Than You Should

Your doctor will decide how to treat you, as well as when to stop treatment and monitor for signs of adverse effects.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

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

Said reactions may put your life in danger.

Other side effects occur with the following frequencies:

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

• lower than normal red blood cell count or hemoglobin;
• dizziness;
• headache;
• nausea or vomiting;
• diarrhea;
• constipation;
• pain or irritation at the injection site;
• itching, skin rash;
• muscle pain;
• increased liver enzyme production (according to blood test results);
• rapid heart rate;
• worsening of an infection or new infection in another skin area;
• swollen and red area of the skin or under the skin with a sensation of heat and pain to the touch;
• accumulation of pus under the skin.

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus.You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the box and on the vial label after CAD.The expiration date is the last day of the month indicated.

This medication does not require special conservation conditions.

The diluted solutionmust be used immediately.

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

Medications should not be disposed of through drains.Ask your pharmacist how to dispose ofthe containers and medications that you no longerneed.This will help protect the environment.

Composition ofTenkasi

• The active ingredient isoritavancina. The vial containsdifosfato de oritavancina equivalent to 1 200mg of oritavancina.
• The other componentsare hidroxipropilbetadex (see section 2 “Tenkasi contains cyclodextrins”, manitol, ácido fosfórico(to adjust the pH) and hidróxido de sodio (to adjust the pH).

Appearance of the product and contents of the pack

• Tenkasi is a powder for concentrate for solution for infusion
• Tenkasi is a white to off-white to pinkish powder, supplied in a 50ml glass vial.

Tenkasi is marketed in boxes of 1 vial.

Marketing Authorization Holder

Menarini International Operations Luxembourg S.A.

1, Avenue de la Gare

L-1611, Luxembourg

Luxembourg

Responsible for manufacturing

Biologici Italia Laboratories S.r.l

Via Filippo Serpero 2

20060 Masate (MI)

Italy

For more information about this medicinal product, please contact the local representative of the marketing authorization holder:

Last update of this leaflet:09/2023

Other sources of information

Further information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

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This information is intended for healthcare professionals only:

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

Tenkasimust beprepared using aseptic techniques.

There are two medicinal products containing oritavancina (Tenkasi 400 mg and Tenkasi 1200 mg) that:

- Are supplied in different doses of oritavancina.

- Have a different recommended infusion duration.

- Have different preparation instructions, including differences in reconstitution, dilution, and compatible diluents.

Follow the recommended instructions for each medicinal product carefully.

Tenkasi 1200 mg vialmust be reconstituted and diluted to prepare a single intravenous dose of 1 200 mg.The powder must be reconstituted with sterile water for injectionsand the resulting concentrate must 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 must be transparent and colourless to pinkish. Parenteral medicines must be visually inspected for the presence of particles after reconstitution.For the preparationof Tenkasiaseptic techniquesmust beused.

Reconstitution:

• 40ml ofsterile water for injectionsmust be added to the vial using a sterile syringe to reconstitute the vial to provide 30mg/ml of solution per vial.
• To avoid excessive foam formation, it is recommended to add the sterile water for injections carefully, along the sides of the vials.
• The vial must be gently moved to avoid foam formation and to ensure that all the Tenkasi powder has been completely reconstituted in the solution.

Dilution: Glucose 5% (D5W) or sodium chloride 9 mg/ml (0.9%) in an intravenous infusion bag must be used for dilution.

To dilute:

•Remove and discard 40 ml from a 250 ml glucose 5% or sodium chloride 0.9% intravenous infusion bag.

•Remove 40 ml from the reconstituted vial and add to a glucose 5% or sodium chloride 0.9% intravenous infusion bag to bring the bag volume to 250 ml. This provides an oritavancina concentration of 4.8 mg/ml. For the preparation of the administration, PP (polypropylene) or PVC (polyvinyl chloride) bags must be used.

The diluted solutionmust beused immediately.

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