Cubicin 350 mg powder for solution for injection or infusion
daptomycin
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor, nurse or pharmacist.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- 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.
In this leaflet:
- 1. What Cubicin is and what it is used for
- 2. Before you are given Cubicin
- 3. How Cubicin is given
- 4. Possible side effects
- 5. How to store Cubicin
- 6. Further information
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 if you develop any of the following symptoms:
- 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.
- 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.
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 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,
- Headache,
- Diarrhoea, feeling sick (nausea) or being sick (vomiting),
- Skin rash,
- Pain, itchiness or redness at the site of infusion,
- Blood testing showing higher levels of liver enzymes or creatine phosphokinase (CPK).
Some side effects are uncommon
Urinary tract infection,
- Blood disorders (e.g increased number of small blood particles called platelets, which may increase the tendency for blood clotting, decreased number of red blood cells, known as anaemia, or higher levels of certain types of white blood cells),
- Decreased appetite,
- Dizziness, anxiety, difficulty in sleeping, tingling or numbness of the hands or feet, taste disturbance,
- Changes in heart rhythm, flushes, high or low blood pressure,
- Constipation, abdominal pain, indigestion, inflammation of the tongue,
- Yellowing of the skin and eyes,
- Itchy rash of skin,
- Muscle pain or weakness, joint pain,
- kidney problems,
- Inflammation and irritation of the vagina,
- General pain or weakness, fever, tiredness,
- Blood test showing increased levels of blood sugar, serum creatinine, myoglobin, or lactic dehydrogenase (LDH), or imbalance of salts.
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.
Marketing Authorisation Holder
Manufacturer
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder.
United Kingdom
This leaflet was last approved in 07/2009.
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