Prospect: information for the patient

Tenkasi 400mg 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 to treat adult patients and pediatric patients aged 3 months or older.

Tenkasi may be used alone 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 in addition to 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) within 5días (120hours) after 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.

Tenkasi intravenous infusions 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 coagulation 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 under 3 months of age. The use of Tenkasi has not yet been studied in this age group.

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 sodium heparin nonfractionated, 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 coagulation (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 benefit outweighs the risk for the baby.

Driving and operating machinery

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

Your doctor or nurse will administer Tenkasi to you through an intravenous infusion (drip).

In adults, the recommended dose of Tenkasi is a single infusion of 1,200 mg administered through a vein over 3 hours.

For pediatric patients aged 3 months or older, the recommended dose of Tenkasi will be calculated based on weight and age: a single infusion of 15 mg per kilogram of body weight administered through a vein over 3 hours (maximum 1,200 mg). See section 6 for more details.

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 can 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;
• whistling (a 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 shivering;
• rapid or weak pulse;
• chest pain or tightness;
• Decreased blood pressure (may make you feel weak or dizzy).

Said reactions can put your life in danger.

Other side effects occur with the following frequencies:

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

• fewer red blood cells or lower than normal hemoglobin;
• dizziness;
• headache;
• nausea (feeling like vomiting) or vomiting;
• diarrhea;
• constipation;
• pain or irritation at the injection site;
• itching, skin rash;
• muscle pain;
• higher levels of liver enzymes (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.

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 levels;
• high levels of uric acid in the blood;
• high levels of bilirubin in the blood;
• severe skin rash;
• seizures;
• inflammation around a tendon (known as tenosynovitis);
• bone infection caused by bacteria (known as osteomyelitis);
• reduction of 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 1000 patients):

• Headache, fatigue, drowsiness that may be symptoms of hypoxia;
• Back pain
• Neck pain
• Chills
• Shivering

Additional side effects in children and adolescents

Side effects in pediatric patients are similar to those observed in adults. Side effects observed only in pediatric patients are: irritability, changes in the ECG tracing (transient, asymptomatic, and not associated with other changes in the ECG tracing), intestinal infection (colitis caused byClostridioides difficile).

Reporting of side effects

If you experienceany type of side effect, consult your doctor or nurse, even if it is apossibleside effect that does not appear in this prospectus.You can also report them directly through thenational notification system included in theAppendix V. 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 label.The expiration date is the last day of the month indicated.

Do not store at a temperature above 25 °C.

Medicines should not be disposed of through drains.Ask your pharmacist how to dispose ofthe packaging and the medications that you no longerneed.By doing so, you will help protect the environment.

Composition ofTenkasi

• The active principle isoritavancina.Each vial containsdifosfate of oritavancina equivalent to 400mg of oritavancina.
• The other componentsare mannitol and phosphoric acid.

Aspect of the product and content of the package

• Tenkasi is a powder for concentrate for solution for infusion
• Tenkasi is a white to off-white powder, supplied in a 50ml glass vial.
• Tenkasi is marketed in boxes of 3vials.

Holder of the marketing authorization

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 medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:07/2021

Other sources of information

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

--------------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals:

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

Tenkasimust beprepared using aseptic techniques in a pharmacy.

The powder must be reconstituted with water for injectionand the resulting concentrate must be diluted in an intravenous infusion bag with glucose 5% before use. Both the reconstituted solution and the diluted infusion solution must be transparent and colorless or pale yellow. Parenteral drugs must be visually inspected for the presence of particles after reconstitution.For the preparationof Tenkasiaseptic techniquesmust beused.

Adults

It is necessary to reconstitute and dilute three vials of Tenkasi 400mg to prepare a single IV dose of 1.200mg of a single use.

Reconstitution: aseptic technique must be used to reconstitute three vials of 400mg of Tenkasi.

• 40ml ofwater for injectionmust be added to each vial using a sterile syringe to reconstitute each vial to provide a 10mg/ml solution per vial.
• To avoid excessive foam formation, it is recommended to add the water for injection carefully, along the walls of the vials.
• Each vial must be gently shaken to avoid foam formation and to ensure that all the Tenkasi powder is completely reconstituted in the solution.

The reconstituted solution must be diluted immediately.

Dilution: three reconstituted vials are needed for dilution for the administration of a single IV infusion of 1.200mg. For dilution, only a glucose 5% intravenous infusion bag (D5W) must be used.

To dilute:

• 120ml of a 1000ml glucose 5% intravenous infusion bag must be removed and discarded.
• 40ml of each of the three reconstituted vials must be removed and added to a glucose 5% intravenous infusion bag to bring the bag volume to 1000ml. This provides a concentration of oritavancina of 1.2mg/ml. For the preparation of administration, PP (polypropylene) or PVC (polyvinyl chloride) bags must be used.

Use in pediatric population (3 months to <18

Calculate the dose of oritavancina needed based on the patient's weight (a single infusion of 15 mg/kg administered intravenously over 3 hours).

Determine the number of vials of oritavancina needed for the patient (each vial contains 400 mg).

Reconstitution:

• 40ml ofwater for injectionmust be added to each vial using a sterile syringe to reconstitute each vial and obtain a 10 mg/ml solution per vial.
• • To avoid excessive foam formation, it is recommended to add the water for injection carefully, along the walls of the vials.

• Each vial must be gently shaken to avoid foam formation and to ensure that all the powder is completely reconstituted in the solution.

Dilution:Only a glucose 5% intravenous infusion bag (D5W) must be used for dilution. The sodium chloride solution must not be used for dilution (see section 6.2).

Dilution:

The necessary volume of oritavancina must be removed with a sterile syringe and added to a glucose 5% intravenous infusion bag containing sterile D5W (see the corresponding example in Table 1). The size of the intravenous infusion bag will depend on the total volume administered. For small volumes, a syringe pump may be used.

Table 1: 15 mg/kg of Oritavancina: Infusion of 3 hours (Concentration of 1.2 mg/ml)

Cálculos

1) Use the patient's actual weight - ROUND ONLY TO THE NEAREST WHOLE NUMBER

2) Dose: Patient weight (kg) x 15 mg/kg = ______ mg (Maximum dose 1200 mg)

3) Total infusion volume: Dose (mg) ÷ 1.2 mg/ml = _______ ml

4) Volume of reconstituted Oritavancina: Dose (mg) ÷ 10 =______ ml

5) Volume of D5W to add to the IV bag: Total infusion volume (C) - Volume of reconstituted Oritavancina (D) = _______ ml

The diluted solutionmust beused immediately.

From a microbiological point of view, the drug must be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not normally exceed 12hours at 25 °C and 24hours at 2 ºC to 8 ºC for Tenkasi diluted in an intravenous infusion bag with glucose 5%, unless reconstitution and dilution have taken place in controlled and validated aseptic conditions.