Tenkasi 1200 mg powder for concentrate for solution for infusion

Package leaflet: Information for the user

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 given this medicine, because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you get any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

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 skin and soft tissue skin infections.

It is used only to treat adult patients.

Tenkasi may be used alone to treat infections caused by bacteria known as Gram-positive bacteria. In cases of mixed infections where other types of bacteria are suspected, your doctor will provide additional appropriate antibiotics along with Tenkasi.

2. What you need to know before Tenkasi is administered to you

Do not receive Tenkasi:

• if you are allergic to oritavancin or to any of the other ingredients of this medicine (listed in section 6).
• if it is expected that you may need to be administered a medicine used to make the blood less thick (unfractionated sodium heparin) within the next 5 days (120 hours) following your 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 previously had severe diarrhoea during or after antibiotic treatment.
• you have or it is suspected that you have a bone infection caused by bacteria (osteomyelitis). Your doctor will treat you as appropriate.
• you have or it is suspected that you have a painful collection of pus under the skin (abscess). Your doctor will treat you as appropriate.

Intravenous infusions of Tenkasi may cause redness of the upper body, hives, itching and/or rashes. Infusion-related reactions such as chest pain, chest discomfort, chills, shivering, back pain, neck pain, shortness of breath, abdominal pain, fever and headache, fatigue, drowsiness may also occur, 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 measuring blood coagulation and may produce a false reading.

Although antibiotics, including Tenkasi, fight certain bacteria, they may not be effective against other bacteria or fungi, allowing them to grow unchecked. This is known as overgrowth. Your doctor will monitor you for this and treat you if necessary.

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

Children and adolescents

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

Use of Tenkasi with other medicines

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

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

It is especially important that you inform your doctor if you are taking medicines that prevent blood from clotting (oral anticoagulants, e.g., coumarin anticoagulants). Tenkasi may interfere with laboratory or self-testing used to measure blood coagulation (INR), and may cause a false reading for up to 12 hours after infusion.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to become pregnant, consult your doctor before using this medicine.

You must not receive this medicine during pregnancy unless it is considered that the benefit outweighs the risk to the unborn baby.

Driving and using machines

Tenkasi may cause dizziness, which could affect your ability to drive or operate machinery.

Tenkasi contains cyclodextrins

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

3. How Tenkasi will be administered to you

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 to you by intravenous infusion (drip).

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

If you receive more Tenkasi than you should

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

• flushing of the face and upper body, hives, itching and/or rashes;
• wheezing (a high-pitched whistling sound when breathing);
• shortness of breath;
• swelling around the throat or under the skin that develops rapidly;
• chills or shivering;
• rapid or weak pulse;
• chest pain or tightness;
• drop in blood pressure (which may make you feel weak or dizzy).

These reactions may be life-threatening.

Other adverse effects occur with the following frequencies:

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

• lower than normal red blood cells or hemoglobin;
• dizziness;
• headache;
• nausea or vomiting;
• diarrhea;
• constipation;
• pain or irritation at the injection site;
• itching, skin rash;
• muscle pain;
• increased levels of liver enzymes (as shown by blood tests);
• rapid heartbeat;
• worsening of an infection or new infection at another site on the skin;
• swollen, red area of skin or under the skin with a sensation of warmth and pain on palpation;
• accumulation of pus under the skin.

Uncommon adverse 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;
• increased levels of bilirubin in the blood;
• severe skin rash;
• hot flashes;
• inflammation around a tendon (known as tenosynovitis);
• bone infection caused by bacteria (known as osteomyelitis);
• reduced platelet count in the blood below the lower limit of normal (known as thrombocytopenia);
• abdominal pain;
• chest pain;
• fever;
• shortness of breath.

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

• headache, fatigue, drowsiness, which may be symptoms of low oxygen levels in body tissues (hypoxia);
• back pain;
• neck pain;
• chills;
• tremors.

Reporting of adverse effects

If you experience any kind of adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse 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 stated on the carton and on the label of the vial after EXP. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

The diluted solution must be used immediately.

From a microbiological standpoint, the medicine should be used immediately. If not used immediately, the storage times and conditions prior to 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 5 % glucose or 0.9 % sodium chloride.

Medicines must not be disposed of via wastewater. Ask your pharmacist how to dispose of medicines and packaging you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Tenkasi

• The active substance is oritavancin. The vial contains oritavancin difosphate equivalent to 1,200 mg of oritavancin.
• The other components are hydroxypropylbetadex (see section 2 “Tenkasi contains cyclodextrins”), mannitol, phosphoric acid (to adjust pH), and sodium hydroxide (to adjust pH).

Nature 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 or pinkish powder supplied in a 50 ml glass vial.

Tenkasi is marketed in packs of 1 vial.

Marketing Authorization 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

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet: 09/2023

Other sources of information

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

This information is intended for healthcare professionals only:

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

Tenkasi must be prepared using aseptic techniques.

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

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

Carefully follow the recommended instructions for each medicinal product.

Tenkasi 1200 mg vial must be reconstituted and diluted to prepare a single intravenous dose of 1,200 mg. The powder must be reconstituted with sterile water for injections, and the resulting concentrate must be diluted in an intravenous infusion bag with 5% glucose or 9 mg/ml (0.9%) sodium chloride prior to use. Both the reconstituted solution and the diluted infusion solution should be clear and colourless to pink. Parenteral medicines should be inspected visually for particulate matter after reconstitution. Aseptic techniques must be used when preparing Tenkasi.

Reconstitution:

• Add 40 ml of sterile water for injections using a sterile syringe to reconstitute the vial, providing a solution of 30 mg/ml per vial.
• To avoid excessive foaming, it is recommended to add the sterile water for injections carefully, along the vial wall.
• Gently swirl the vial to avoid foaming and ensure complete reconstitution of all Tenkasi powder into solution.

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

To dilute:

• Withdraw and discard 40 ml from a 250 ml intravenous bag of 5% glucose or 0.9% sodium chloride.
• Withdraw 40 ml from the reconstituted vial and add it to an intravenous bag of 5% glucose or 0.9% sodium chloride to achieve a final bag volume of 250 ml. This results in an oritavancin concentration of 4.8 mg/ml. Polypropylene (PP) or polyvinyl chloride (PVC) bags must be used for preparation and administration.

The diluted solution should be used immediately.

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