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Cubicin 500 mg powder for concentrate for solution for injection or infusion
Cubicin® 500 mg powder for solution for injection or infusion
1. What Cubicin is and what it is used for
2. What you need to know before you are given Cubicin
3. How Cubicin is given
4. Possible side effects
5. How to store Cubicin
6. Contents of the pack and other information
The active substance in Cubicin powder for solution for injection or infusion is daptomycin. Daptomycin is an antibacterial that can stop the growth of certain bacteria. Cubicin is used in adults and in children and adolescents (age from 1 to 17 years) to treat infections of the skin and the tissues below the skin. It is also used to treat infections in the blood when associated with skin infection.
Cubicin 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 type of bacteria called Staphylococcus aureus. It is also used to treat infections in the blood caused by the same type of bacteria when associated with heart infection. Depending on the type of infection(s) that you have, your doctor may also prescribe other antibacterials while you are receiving treatment with Cubicin.
If you are allergic to daptomycin or to sodium hydroxide or to any of the other ingredients of this medicine (listed in section 6).
If this applies to you, tell your doctor or nurse. If you think you may be allergic, ask your doctor or nurse for advice.
Talk to your doctor or nurse before you are given Cubicin:
If any of these applies to you, tell your doctor or nurse before you are given Cubicin.
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.
Cubicin should not be administered to children below one year of age as studies in animals have indicated that this age group may experience severe side effects.
People over the age of 65 can be given the same dose as other adults, provided their kidneys are working well.
Tell your doctor or nurse if you are taking, have recently taken or might take any other medicines.
It is particularly important that you mention the following:
Cubicin is not usually given to pregnant women. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
Do not breast-feed if you are receiving Cubicin, because it may pass into your breast milk and could affect the baby.
Cubicin has no known effects on the ability to drive or use machines.
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-free’.
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. In adult patients, 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.
The dose for children and adolescents (1 to 17 years of age) will depend on the age of patient and the type of infection being treated. This dose is given directly into the blood stream (into a vein), as an infusion lasting about 30-60 minutes.
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.
Detailed instructions for use and handling are given at the end of the leaflet.
Like all medicines, this medicine can cause side effects, although not everybody gets them.
The most serious side effects are described below:
Serious side effects with frequency not known (frequency cannot be estimated from the available data)
Other serious side effects that have been reported with the use of Cubicin are:
If you experience these symptoms, tell your doctor or nurse straight away. Your doctor will perform additional tests to make a diagnosis.
The most frequently reported side effects are described below:
Common side effects (may affect up to 1 in 10 people)
Other side effects which may occur following Cubicin treatment are described below:
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Frequency not known (frequency cannot be estimated from the available data)
Antibacterial-associated colitis, including pseudomembranous colitis (severe or persistent diarrhoea containing blood and/or mucus, associated with abdominal pain or fever), easy bruising, bleeding gums, or nosebleeds.
If you get any side effects, talk to your doctor, pharmacist 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 at: 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.
Cubicin powder for solution for injection or infusion is supplied as a pale yellow to light brown cake or 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.
Marketing Authorisation Holder:
For any information about this medicine, please contact:
This leaflet was last revised in June 2022.
Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
© 2022 Merck & Co., Inc., Rahway, NJ, USA and its affiliates. All rights reserved.