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Cubicin 350 mg powder for solution for injection or infusion (Daptomycin)

What Cubicin is and what it is used for

The active substance in Cubicin powder for solution for injection or infusion is daptomycin. Daptomycin is an antibiotic that can stop the growth of certain bacteria. Cubicin is used in adults to treat infections of the skin and the tissues below the skin. It is also used in adults to treat infections in the tissues that line the inside of the heart (including heart valves) which are caused by a bacterium called Staphyloccocus aureus and to treat infections in the blood caused by the same bacterium when associated with skin or heart infection.

Depending on the type of infection(s) that you have, your doctor may also prescribe other antibiotics while you are receiving treatment with Cubicin.

Before you are given Cubicin

You should not be given Cubicin

  • If you are allergic (hypersensitive) to daptomycin or to sodium hydroxide.
  • If this applies to you, tell your doctor or nurse. If you think you may be allergic, ask your doctor or nurse for advice.

Take special care with Cubicin

If you have, or have previously had kidney problems. Your doctor may need to change the dose of Cubicin (see section 3 of this leaflet).

Occasionally, patients receiving Cubicin may develop tender or aching muscles or muscle weakness (see section 4 of this leaflet for more information). If this happens tell your doctor. Your doctor will make sure you have a blood test and will advise whether or not to continue with Cubicin. The symptoms generally go away within a few days of stopping Cubicin. If you are very overweight. There is a possibility that your blood levels of Cubicin could be higher than those found in persons of average weight and you may need careful monitoring in case of side effects. If any of these applies to you, tell your doctor or nurse before you are given Cubicin.

Tell your doctor straight away if you develop any of the following symptoms:

  • Serious, acute allergic reactions have been observed in patients treated with nearly all antibacterial agents, including Cubicin. Tell a doctor or a nurse straight away if you experience symptoms suggestive of allergic reaction, such as wheezing, difficulty breathing, rashes and hives, fever (see section 4 of this leaflet for more information).
  • Any unusual tingling or numbness of the hands or feet, loss of feeling or difficulties with movements. If this happens, tell your doctor who will decide whether you should continue the treatment.
  • Diarrhoea, especially if you notice blood or mucus, or if diarrhoea becomes severe or persistent.

Cubicin may interfere with laboratory tests that measure how well your blood is clotting. The results can suggest poor blood clotting when, in fact, there is no problem. Therefore it is important that your doctor takes into account that you are receiving Cubicin. Please inform your doctor that you are on treatment with Cubicin.

Your doctor will perform blood tests to monitor the health of your muscles both before you start treatment and frequently during treatment with Cubicin.

Use in children

The use of Cubicin in children has not been studied and is therefore not recommended.

Use in elderly

People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.

Taking other medicines

Please tell your doctor, nurse or pharmacist if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

It is particularly important that you mention the following:

Medicines called statins or fibrates (to lower cholesterol) or ciclosporin (a medicinal product used in transplantation to prevent organ rejection or for other conditions, e.g. rheumathoid arthritis or atopic dermatitis). It is possible that the risk of side effects affecting the muscles may be higher when any of these medicines (and some others that can affect muscles) is taken during treatment with Cubicin. Your doctor may decide not to give you Cubicin or to stop the other medicine for a while.

Pain killing medicines called non-steroidal anti-inflammatory drugs (NSAIDs) or COX-2 inhibitors (e.g. celecoxib). These could interfere with the effects of Cubicin in the kidney. Oral anti-coagulants (e.g. warfarin), which are medicines that prevent blood from clotting. It may be necessary for your doctor to monitor your blood clotting times.

Pregnancy and breast-feeding

Cubicin is not usually given to pregnant women. Tell your doctor if you are pregnant, think you may be pregnant, or are planning to become pregnant.

Do not breast-feed if you are receiving Cubicin, because it may pass into your breast milk and could affect the baby.

Driving and using machines

Cubicin has no known effects on the ability to drive or use machines.

How Cubicin is given

Cubicin will usually be given to you by a doctor or a nurse.

The dose will depend on how much you weigh and the type of infection being treated. The usual dose for adults is 4 mg for every kilogram (kg) of body weight once daily for skin infections or 6 mg for every kg of body weight once daily for a heart infection or a blood infection associated with skin or heart infection. This dose is given directly into your blood stream (into a vein), either as an infusion lasting about 30 minutes or as an injection lasting about 2 minutes. The same dose is recommended in people aged over 65 years provided their kidneys are working well.

If your kidneys do not work well, you may receive Cubicin less often, e.g. once every other day. If you are receiving dialysis, and your next dose of Cubicin is due on a dialysis day, you will be usually given Cubicin after the dialysis session.

A course of treatment usually lasts for 1 to 2 weeks for skin infections. For blood or heart infections and skin infections your doctor will decide how long you should be treated.

Possible side effects

Like all medicines, Cubicin can cause side effects, although not everybody gets them.

The frequency of possible side effects listed below is defined using the following convention:

  • very common (affects more than 1 user in 10)
  • common (affects 1 to 10 users in 100)
  • uncommon (affects 1 to 10 users in 1,000)
  • rare (affects 1 to 10 users in 10,000)
  • very rare (affects less than 1 user in 10,000)
  • not known (frequency cannot be estimated from the available data).

Some side effects are very rare

A hypersensitivity reaction (serious allergic reaction including anaphylaxis) has been reported, in some cases during administration of Cubicin. This serious allergic reaction needs immediate medical attention. Tell your doctor or nurse straight away if you experience any of the following symptoms:

  • Chest pain or tightness
  • Rash with blistering, sometimes affecting the mouth and genitals
  • Swelling around throat
  • Rapid or weak pulse
  • Wheezing
  • Fever
  • Shivering or trembling
  • Hot flushes
  • Dizziness
  • Fainting
  • Metallic taste

Tell your doctor straight away if you experience unexplained muscle pain, tenderness, or weakness. In very rare cases (reported in less than 1 in every 10,000 patients), muscle problems can be serious, including muscle breakdown (rhabdomyolysis), which can result in kidney damage.

Cubicin may also cause other side effects:

Some side effects are common

  • Fungal infections such as thrush,
  • Urinary tract infection,
  • Decreased number of red blood cells (anaemia),
  • Dizziness, anxiety, difficulty in sleeping,
  • Headache,
  • Fever, weakness (asthenia),
  • High or low blood pressure,
  • Constipation, abdominal pain,
  • Diarrhoea, feeling sick (nausea) or being sick (vomiting),
  • Flatulence,
  • Abdominal swelling or bloating,
  • Skin rash or itching,
  • Pain, itchiness or redness at the site of infusion,
  • Pain in arms or legs,
  • Blood testing showing higher levels of liver enzymes or creatine phosphokinase (CPK).

Some side effects are uncommon

  • Blood disorders (e.g increased number of small blood particles called platelets, which may increase the tendency for blood clotting, or higher levels of certain types of white blood cells),
  • Decreased appetite,
  • Tingling or numbness of the hands or feet, taste disturbance,
  • Trembling,
  • Changes in heart rhythm, flushes,
  • Indigestion (dyspepsia), inflammation of the tongue,
  • Itchy rash of skin,
  • Muscle pain or weakness, inflammation of the muscles (myositis), joint pain,
  • kidney problems,
  • Inflammation and irritation of the vagina,
  • General pain or weakness, tiredness (fatigue),
  • Blood test showing increased levels of blood sugar, serum creatinine, myoglobin, or lactate
  • dehydrogenase (LDH), prolonged blood clotting time or imbalance of salts.

Some side effects are rare

  • Yellowing of the skin and eyes, Prothrombin time prolonged.

Frequency not known

  • Antibiotic-associated colitis, including pseudomembranous colitis (severe or persistent diarrhoea containing blood and/or mucus, associated with abdominal pain or fever).

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist.

How to store Cubicin

Keep out of the reach and sight of children.

Do not use after the expiry date which is stated on the carton and label. The expiry date refers to the last day of that month.

Store in a refrigerator (2°C – 8°C).

Dispose of in accordance with local requirements.

Further information

What Cubicin contains

The active substance is daptomycin. The other ingredient is sodium hydroxide.

What Cubicin looks like and contents of the pack

Cubicin powder for solution for injection or infusion is supplied as a pale yellow to light brown powder in a glass vial. It is mixed with a solvent to form a liquid before it is administered.

Cubicin is available in packs containing 1 vial or 5 vials.

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