Cubicin

daptomycin

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This is a summary of the European public assessment report (EPAR) for Cubicin. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Cubicin.

For practical information about using Cubicin, patients should read the package leaflet or contact their doctor or pharmacist.

What is Cubicin and what is it used for?

Cubicin is an antibiotic medicine, which is used to treat the following bacterial infections:

  • complicated infections of the skin and soft tissue below the skin in patients from 1 year of age. ‘Complicated’ 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 how well treatment works;
  • 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) in adults. 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. It is used in adults when the bacteraemia is associated with either of the two infections above, or in adolescents and children from 1 year of age when the bacteraemia is associated with complicated infections of the skin and soft tissue.

Prescribers should consider official guidance on the use of antibiotics.

Cubicin contains the active substance daptomycin.

How is Cubicin used?

Cubicin is available as a powder that is made up into a solution for injection or infusion (drip) into a vein.

In adults, for skin or soft tissue infections without bacteraemia, Cubicin is given at a dose of 4 mg/kg body weight once a day. For endocarditis and for skin or soft tissue infection with bacteraemia, the dose is 6 mg/kg once a day. Cubicin is given into a vein as an infusion lasting 30 minutes or as an injection lasting 2 minutes.

In children the dose of Cubicin for skin or soft tissue infection without bacteraemia depends on the child’s age and ranges between 5 and 10 mg/kg once a day. Higher doses (between 7 and 12 mg/kg once a day) are used if the skin or soft tissue infection is associated with bacteraemia. Cubicin is given by infusion lasting 60 minutes in children aged 1 to 6 years and 30 minutes in those aged above 7 years.

The duration of treatment with Cubicin depends on the risk of complications and official recommendations. The medicine can only be obtained with a prescription. For further information, see the package leaflet.

How does Cubicin work?

The active substance in Cubicin, daptomycin, is an antibiotic that belongs to the group ‘lipopeptides’. It can stop the growth of certain types of bacteria by attaching to the membrane surrounding the bacterial cell and upsetting the essential functions that keep the cell alive.

What benefits of Cubicin have been shown in studies?

Three main studies in adults and two in children aged between 1 and 17 years found that Cubicin was as effective as standard treatments at curing or improving infection. Standard treatments comprised use of antibiotics such as vancomycin, a penicillin (including oxacillin, cloxacillin, flucloxacillin and nafcillin) or a cephalosporin.

In the first two studies involving 1,118 adults with complicated skin and soft tissue infections (mainly wound infections and major abscesses), Cubicin was effective in 67% of patients in one study and in 85% in the other. Effectiveness varied between the two studies because of differences in the types of patients and infections being treated.

The third study involved 246 adults with bacteraemia caused by S. aureus, including 35 who also had right-sided infective endocarditis. In the group with endocarditis, treatment was successful in 42% (8 out of 19) of the patients receiving Cubicin compared with 44% (7 out of 16) of the patients receiving standard treatment. 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.

The first study in children and adolescents involved 396 patients with complicated skin and soft tissue infections without bacteraemia. Treatment was successful in 88% (227 out of 257) of the patients receiving Cubicin compared with 86% (114 out of 132) receiving standard treatment.

The second study in children and adolescents involved 73 patients with bacteraemia caused by S. aureus. Treatment was successful in 88% (45 out of 51) of the patients receiving Cubicin compared with 77% (17 out of 22) receiving standard treatment.

What are the risks 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 (belly 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).

Serious side effects include hypersensitivity (allergic) reactions, eosinophilic pneumonia (infection of the lungs), drug rash with eosinophilia and systemic symptoms (DRESS, a severe reaction affecting the skin, blood and internal organs), angioedema (rapid swelling of deeper skin tissues) and rhabdomyolysis (breakdown of muscle fibres).

For the full list of side effects and restrictions with Cubicin, see the package leaflet.

Why is Cubicin approved?

The European Medicines Agency decided that Cubicin’s benefits are greater than its risks and recommended that it be given marketing authorisation.

What measures are being taken to ensure the safe and effective use of Cubicin?

The company that markets Cubicin will provide all doctors who are expected to use Cubicin with a dosage card to ensure the safe use of the medicine.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cubicin have also been included in the summary of product characteristics and the package leaflet.

Other information about Cubicin

The European Commission granted a marketing authorisation valid throughout the European Union for Cubicin on 19 January 2006.

For more information about treatment with Cubicin, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Cubicin : EPAR - Summary for the public BG = bălgarski 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public ES = español 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public CS = čeština 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public DA = dansk 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public DE = Deutsch 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public ET = eesti keel 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public EL = elliniká 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public EN = English 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public FR = français 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public IT = italiano 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public LV = latviešu valoda 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public LT = lietuvių kalba 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public HU = magyar 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public MT = Malti 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public NL = Nederlands 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public PL = polski 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public PT = português 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public RO = română 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public SK = slovenčina 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public SL = slovenščina 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public FI = suomi 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public SV = svenska 2009-09-09 2018-01-04
Cubicin : EPAR - Summary for the public HR = Hrvatski 2009-09-09 2018-01-04

This EPAR was last updated on 20/08/2018 .

Authorisation details

Product details

Product details for Cubicin
NameCubicin
Agency product numberEMEA/H/C/000637
Active substance

daptomycin

International non-proprietary name (INN) or common name

daptomycin

Therapeutic area Gram-Positive Bacterial InfectionsSoft Tissue InfectionsEndocarditis, BacterialBacteremia
Anatomical therapeutic chemical (ATC) code J01XX09

Publication details

Publication details for Cubicin
Marketing-authorisation holder

Merck Sharp & Dohme Ltd

Revision30
Date of issue of marketing authorisation valid throughout the European Union19/01/2006

Contact address:

Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Harlem
The Netherlands

Product information

Product information

08/08/2018  Cubicin -EMEA/H/C/000637 -T/0069

Name Language First published Last updated
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20
Cubicin : EPAR - Product Information HR = Hrvatski 2009-09-09 2018-08-20

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22
Cubicin : EPAR - All Authorised presentations HR = Hrvatski 2009-09-09 2010-09-22

Pharmacotherapeutic group

Antibacterials for systemic use

Therapeutic indication

Cubicin is indicated for the treatment of the following infections.

  • Adult and paediatric (1 to 17 years of age) patients with complicated skin and soft-tissue infections (cSSTI).
  • Adult patients with 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.

  • Adult and paediatric (1 to 17 years of age) patients with Staphylococcus aureus bacteraemia (SAB). In adults, use in bacteraemia should be associated with RIE or with cSSTI, while in paediatric patients, use in bacteraemia should be associated 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.

Assessment History

Changes since initial authorisation of medicine

Initial marketing-authorisation documents

Name Language First published Last updated
Cubicin : EPAR - Procedural steps taken before authorisation HR = Hrvatski 2006-08-11  
Cubicin : EPAR - Scientific Discussion HR = Hrvatski 2006-08-11  

Authorised

This medicine is approved for use in the European Union

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