Active Substance: daptomycin
Common Name: daptomycin
ATC Code: J01XX09
Marketing Authorisation Holder: Novartis Europharm Ltd.
Active Substance: daptomycin
Authorisation Date: 2006-01-19
Therapeutic Area: Gram-Positive Bacterial Infections Soft Tissue Infections Endocarditis, Bacterial Bacteremia
Pharmacotherapeutic Group: Antibacterials for systemic use
Cubicin is indicated for the treatment of the following infections in adults.
- complicated skin and soft-tissue infections (cSSTI);
- right-sided infective endocarditis (RIE) due to Staphylococcus aureus. It is recommended that the decision to use daptomycin should take into account the antibacterial susceptibility of the organism and should be based on expert advice;
- Staphylococcus aureus bacteraemia (SAB) when associated with RIE or with cSSTI.
Daptomycin is active against Gram-positive bacteria only. In mixed infections where Gram-negative and / or certain types of anaerobic bacteria are suspected, Cubicin should be co-administered with appropriate antibacterial agent(s).
Consideration should be given to official guidance on the appropriate use of antibacterial agents
What is Cubicin?
Cubicin is a powder that is made up into a solution for injection or infusion (drip into a vein). It contains the active substance daptomycin.
What is Cubicin used for?
Cubicin is used to treat adults (aged 18 years or over) with the following bacterial infections:
- complicated infections of the skin and the â€˜soft tissuesâ€™ below the skin. â€˜Complicatedâ€™ means that the infection is difficult to treat, because it has spread to the deep tissues below the skin, treatment with surgery might be needed, or the patient has other conditions that might affect the response to treatment;
- right-sided infective endocarditis (infection of the lining or the valves of the right side of the heart) caused by the bacterium Staphylococcus aureus (S. aureus). The decision to treat this type of infection with Cubicin should be based on the likelihood that the medicine will work against the infection and on advice from an expert;
- bacteraemia (infection of the blood) caused by S. aureus, associated with either of the two infections above.
Prescribers should consider official guidance on the use of antibiotics.
The medicine can only be obtained with a prescription.
How is Cubicin used?
Cubicin is given into a vein by a doctor or a nurse as an infusion lasting 30 minutes or as an injection lasting two minutes. For skin or soft-tissue infections without bacteraemia, Cubicin is given at a dose of 4 mg per kilogram body weight once every 24 hours for seven to 14 days or until the infection has cleared up. For endocarditis and for skin or soft-tissue infection with bacteraemia, the dose is 6 mg/kg every 24 hours. The duration of treatment depends on the risk of complications and official recommendations. Cubicin should not be given more than once a day.
Cubicin should only be used in patients who have problems with their kidneys if the benefit of treatment is greater than its potential risk, in which case it may need to be given less often. Depending on the type of infection being treated and whether a patient has more than one infection, other antibiotics may be given during treatment with Cubicin.
How does Cubicin work?
The active substance in Cubicin, daptomycin, is an antibiotic that belongs to the group â€˜lipopeptidesâ€™. It can stop the growth of certain types of bacteria by attaching to the membrane around each bacterial cell and upsetting the essential functions that keep the cell alive. A list of bacteria against which Cubicin is active can be found in the summary of product characteristics (also part of the EPAR).
How has Cubicin been studied?
Cubicin infusions have been studied in two large studies involving 1,118 adults with complicated skin and soft-tissue infections (mainly wound infections and major abscesses) and in one study involving 246 adults with bacteraemia caused by S. aureus, including 35 who also had right-sided infective endocarditis. In all three studies, Cubicin was compared with standard treatments for these infections (other antibiotics such as vancomycin or one of the penicillins, including oxacillin, cloxacillin, flucloxacillin and nafcillin). The studies looked at whether the infections had been cured or had improved.
Two further studies were carried out in a total of 40 healthy volunteers to show that Cubicin injections are as safe as the infusions, and that they produce similar levels of daptomycin in the blood.
What benefit has Cubicin shown during the studies?
Cubicin was as effective as the standard treatments.
In the studies of skin and soft-tissue infections, the success rates at seven to 12 days after the last injection of Cubicin were 67% in one study and 85% in the other. The difference in response rates between the two studies was due to differences in the types of patients and infections being treated.
For the treatment of bacteraemia in patients with right-sided infective endocarditis, 42% of the patients receiving Cubicin (8 out of 19) and 44% of the patients receiving standard treatment (7 out of 16) were treated successfully. However, there was insufficient evidence to support the use of Cubicin to treat bacteraemia in patients who did not have either right-sided infective endocarditis or complicated skin and soft-tissue infections.
What is the risk associated with Cubicin?
The most common side effects with Cubicin (seen in between 1 and 10 patients in 100) are infections caused by fungi (moulds and yeasts), urinary-tract infections (infection of the structures that carry urine), Candida infection (a fungal infection), anaemia (low red-blood-cell counts), anxiety, insomnia (difficulty sleeping), dizziness, headache, hypertension (high blood pressure), hypotension (low blood pressure), gastrointestinal and abdominal pain (stomach ache), nausea (feeling sick), vomiting, constipation, diarrhoea, flatulence (gas), bloating and distension (feeling as if the tummy is full), rash, pruritus (itching), pain in the limbs (arms or legs), infusion-site reactions, pyrexia (fever), asthenia (weakness), abnormal liver tests and raised levels in the blood of an enzyme called CPK (a marker of muscle damage). For the full list of all side effects reported with Cubicin, see the package leaflet.
Cubicin should not be used in people who may be hypersensitive (allergic) to daptomycin or the other ingredient (sodium hydroxide). Caution is needed when it is given to patients with kidney problems and the medicine may need to be given less often. All patients must have their CPK levels measured at the beginning of their treatment and at regular intervals, particularly if they have any known risk factors for muscle damage. For the full list of precautions, see the package leaflet.
Why has Cubicin been approved?
The CHMP decided that Cubicinâ€™s benefits are greater than its risks and recommended that it be given marketing authorisation.
Which measures are being taken to ensure the safe use of Cubicin?
The company that makes Cubicin will carry out further studies with Cubicin to investigate whether it has an effect on the muscle, and to look at its safety and effectiveness in patients with kidney disease and in the elderly.
Other information about Cubicin
The European Commission granted a marketing authorisation valid throughout the European Union for Cubicin on 19 January 2006. The marketing-authorisation holder is Novartis Europharm Limited. The marketing authorisation is valid for an unlimited period.
For more information about treatment with Cubicin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Source: European Medicines Agency
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