Cancidas (previously Caspofungin MSD)
Authorised
This medicine is authorised for use in the European Union
caspofungin
MedicineHumanAuthorised
Overview
This is a summary of the European public assessment report (EPAR). It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the studies performed, to reach their recommendations on how to use the medicine.
If you need more information about your medical condition or your treatment, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. If you want more information on the basis of the CHMP recommendations, read the scientific discussion (also part of the EPAR).
Cancidas is an antifungal medicine used to treat the following fungal infections in adults and children:
- invasive candidiasis (an infection caused by Candida). ‘Invasive’ means that the infection has spread into the blood;
- invasive aspergillosis (an infection caused by Aspergillus) when the patient does not respond to or does not tolerate amphotericin B or itraconazole (other antifungal medicines);
- suspected fungal infections (such as due to Candida or Aspergillus) when the patient is feverish and has low white blood cell counts. This is known as ‘empirical treatment’, which means that the doctor starts treatment based on an observation of the patient before confirming that the patient has the infection.
Cancidas contains the active substance caspofungin
Cancidas treatment should be started by a doctor who has experience in the management of invasive fungal infections.
Cancidas is a powder that is made up into a solution for infusion (drip) into a vein. It is given once a day by infusion lasting about one hour. In adults, treatment starts with a 70 mg on the first day, followed by a daily dose of 50 mg, or 70 mg if the patient weighs more than 80 kg. A lower dose may be necessary in adults who have moderate problems with their liver.
In patients between 12 months and 17 years of age, the dose is calculated using the child’s height and weight. Cancidas should be used with care in children below 12 months of age, because it has not been studied sufficiently in this age group.
Treatment is continued for up to two weeks after the infection has been cured. The medicine can only be obtained with a prescription.
The active substance in Cancidas, caspofungin, belongs to a group of antifungal medicines known as ‘echinocandins’. It works by interfering with the production of a component of the fungal cell wall called ‘glucan polysaccharide’, which is necessary for the fungus to continue living and growing. Fungal cells treated with Cancidas have incomplete or defective cell walls, making them fragile and unable to grow. The list of fungi against which Cancidas is active can be found in the summary of product characteristics (also part of the EPAR).
Studies show that Cancidas treatment can lead to favourable responses in patients with fungal infections, including improvement of symptoms and the clearing of fungus from patient’s body.
In a study of 239 adults with invasive candidiasis, 73% of the adults treated with Cancidas who could be assessed had a favourable response (80 out of 109), compared with 62% of the adults treated with amphotericin B (71 out of 115).
In an invasive aspergillosis study involving 69 adults, 41% had a favourable response to Cancidas at the end of the study (26 out of 63). Of the adults who did not respond to other treatments, 36% responded to Cancidas (19 out of 53). Of those who did not tolerate other treatments, 70% responded to Cancidas (7 out of 10).
Similar responses were seen in a study in 49 children and adolescents with either invasive candidiasis or invasive aspergillosis: 50% of those with invasive candidiasis (5 out of 10) and 81% of those with invasive aspergillosis (30 out of 37) responded to Cancidas.
Finally, in 2 studies of patients with suspected fungal infection who were treated empirically, Cancidas was as effective as amphotericin B. In one of studies involving around 1,000 adults, 34% of patients had a favourable response with either Cancidas or amphotericin B Similar results were seen in the second study, which involved 82 children aged between two and 17 years.
The most common side effects with Cancidas in adults (which may affect up to 1 in 100 people) are reduced levels of haemoglobin or red blood cells, reduced white blood cell count, low levels of potassium in the blood, headache, inflammation of the veins, shortness of breath, nausea, diarrhoea, vomiting, raised levels of liver enzymes and bilirubin (which may indicate liver problems), rash, itching, redness of skin, excessive sweating, joint pain, fever, chills, itching at injection site, and reduced levels of albumin, a protein in the blood.
The most common side effect in children is fever and this occurs in more than 1 patient in 10. For the full list of all side effects reported with Cancidas in adults and children, see the package leaflet.
The CHMP decided that evidence form the studies with Cancidas show that the medicines benefits are greater than its risks for the treatment of invasive candidiasis or aspergillosis, and for empirical therapy for presumed fungal infections, in adults or children. The Committee therefore recommended that Cancidas be given marketing authorisation.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cancidas have been included in the summary of product characteristics and the package leaflet.
The European Commission granted a marketing authorisation valid throughout the European Union for Caspofungin MSD on 24 October 2001. The name of the medicine was changed to Cancidas on 9 April 2003.
For more information about treatment with Cancidas, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Product information
Latest procedure affecting product information: N/0084
08/04/2024
This medicine’s product information is available in all official EU languages.
Select 'available languages' to access the language you need.
Product information documents contain:
- summary of product characteristics (annex I);
- manufacturing authorisation holder responsible for batch release (annex IIA);
- conditions of the marketing authorisation (annex IIB);
- labelling (annex IIIA);
- package leaflet (annex IIIB).
Product details
- Name of medicine
- Cancidas (previously Caspofungin MSD)
- Active substance
- caspofungin (as acetate)
- International non-proprietary name (INN) or common name
- caspofungin
- Therapeutic area (MeSH)
- Candidiasis
- Aspergillosis
- Anatomical therapeutic chemical (ATC) code
- J02AX04
Pharmacotherapeutic group
Antimycotics for systemic useTherapeutic indication
- Treatment of invasive candidiasis in adult or paediatric patients;
- treatment of invasive aspergillosis in adult or paediatric patients who are refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B and / or itraconazole. Refractoriness is defined as progression of infection or failure to improve after a minimum of seven days of prior therapeutic doses of effective antifungal therapy;
- empirical therapy for presumed fungal infections (such as Candida or Aspergillus) in febrile, neutropaenic adult or paediatric patients.
Topics
This page was last updated on