What is Daptomycin Hospira and what is it used for?
Daptomycin Hospira is an antibiotic medicine used to treat the following bacterial infections:
- complicated skin and soft tissue infections underlying the skin in adults and children aged 1 to 17 years. The term "complicated" indicates that the infection is difficult to treat because it has spread to the deep tissues underlying the skin, because it may be necessary to resort to surgical treatment or because the patient is subject to other conditions that could affect treatment;
- Infective endocarditis of the right heart (infection of the lining or valves of the right side of the heart) caused by the bacterium Staphylococcus aureus (S. aureus) in adults. The decision to treat this infection with Daptomycin Hospira must take into account the degree of probability that the medicine effectively counteracts the infection and the advice of an expert;
- bacteremia (blood infection) caused by S. aureus, associated with one of the two infections mentioned above, in adults.
Daptomycin Hospira contains the active substance daptomycin.
Daptomycin Hospira is a "generic medicine". This means that Daptomycin Hospira contains the same active substance and acts in the same way as a 'reference medicine' already authorized in the European Union (EU) called Cubicin. For more information on generic medicines, see the questions and answers by clicking here.
How is Daptomycin Hospira used?
Daptomycin Hospira is available as a powder for the preparation of a solution for injection or infusion (drip) into a vein. In adults, Daptomycin Hospira should be given by a doctor or nurse as a 30-minute infusion or as a two-minute injection. In the case of skin or soft tissue infections without bacteremia, Daptomycin Hospira should be administered at a dose of 4 mg per kilogram of body weight, once every 24 hours for 7-14 days or until the infection has disappeared. For endocarditis and infection of the skin or soft tissues with bacteremia, the dose is 6 mg / kg every 24 hours.
In children between 7 and 17 years of age with complicated skin or soft tissue infections, Daptomycin Hospira is given as a 30-minute infusion, while in infants aged 1 to 6 the infusion should last 60 minutes. In children, the dose changes with age, varying between 5 and 10 mg / kg every 24 hours for a maximum of 14 days.
The duration of treatment depends on the risk of complications and official recommendations. Depending on the infection treated and the number of infections present in the patient, it is possible to combine other antibiotics with Daptomycin Hospira.
The medicine can only be obtained with a prescription. For more information, see the package leaflet.
How does Daptomycin Hospira work?
The active substance in Daptomycin Hospira, daptomycin, is an antibiotic that belongs to the category of "lipopeptides". It is able to stop the growth of certain types of bacteria by binding to the membrane around each bacterial cell and altering the primary functions that allow the cell to survive. The list of bacteria for which Daptomycin Hospira is active is given in the summary of product characteristics (included with EPAR).
What benefit has Daptomycin Hospira shown during the studies?
Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Cubicin, and should not be repeated for Daptomycin Hospira.
As with any medicine, the company has provided quality studies of Daptomycin Hospira. No "bioequivalence" studies were needed to verify whether Daptomycin Hospira was absorbed similarly to the reference medicine to produce the same level of active ingredient in the blood. This is because Daptomycin Hospira is administered by infusion into a vein or by injection, so the active ingredient enters the bloodstream directly.
Because Daptomycin Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
What are the risks associated with Daptomycin Hospira?
Because Daptomycin Hospira is a generic medicine, its benefits and risks are taken as being the same as the reference medicine's.
Why has Daptomycin Hospira been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that, in accordance with EU requirements, Daptomycin Hospira has been shown to be comparable to Cubicin. Therefore, the CHMP considered that, as in the case of Cubicin, the benefits outweigh the identified risks and recommended to approve the use of Daptomycin Hospira in the EU.
What measures are being taken to ensure the safe and effective use of Daptomycin Hospira?
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Daptomycin Hospira have been included in the summary of product characteristics and the package leaflet.
More information on Daptomycin Hospira
On 22 March 2017, the European Commission issued a marketing authorization for Daptomycin Hospira, valid throughout the European Union.
For the full EPAR of Daptomycin Hospira, see the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Daptomycin Hospira, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
The full EPAR for the reference medicine can also be found on the Agency's website. Last update of this summary: 02-2017.
