Tenkasi 400 mg powder for concentrate for solution for infusion

• 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.

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

• 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.

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.

Tenkasi should not to be used in children below the age of 3 months. The use of Tenkasi has not yet been studied in this age group.

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.

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.

Tenkasi make you feel dizzy, which can influence your ability to drive or operate machines.

Your doctor will decide how to treat you, including stopping the treatment and monitoring for signs of ill effects.

• 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.

Side effects in paediatric patients are similar to those seen in adults. The side effects seen only in paediatric patients are: irritability, changes in ECG heart tracing (transitory, asymptomatic and not associated to other changes in heart tracing), infection of the bowel (Clostridioides difficile colitis).

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.

• The active substance is oritavancin. Each vial contains oritavancin diphosphate equivalent to 400 mg oritavancin.
• The other ingredients are mannitol and phosphoric acid (for pH-adjustment).

• Tenkasi is a powder for concentrate for solution for infusion.
• Tenkasi is a white to off white powder, supplied in a 50 ml glass vial.
• Tenkasi is available in cartons containing 3 vials.

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