What is Neofordex - Dexamethasone used for?
Neofordex is a medicine used in combination with anticancer medicines to treat adults with multiple myeloma who have developed symptoms. Multiple myeloma is a type of white blood cell cancer called plasma cells, which are part of the immune system (the body's natural defenses).
Neofordex contains the active substance dexamethasone and is a "hybrid medicine". This means that it is similar to a 'reference medicine' which contains the same active ingredient, but Neofordex is available at a higher dose. The reference medicine for Neofordex is Dectancyl.
How is Neofordex - Dexamethasone used?
Neofordex can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating multiple myeloma.
Neofordex is available as 40 mg tablets. The usual dose is 40 mg once a day, preferably taken in the morning. However, the dose and frequency with which Neofordex should be taken varies depending on the medicines with which it is given and the patient's condition. For more information, see the package leaflet.
How does Neofordex - Dexamethasone work?
The active substance in Neofordex, dexamethasone, belongs to a group of medicines known as corticosteroids. In multiple myeloma, Neofordex is used in combination with anticancer medicines to destroy tumor plasma cells. This action interacts with different proteins (the nuclear factor κB and caspase 9) that regulate cell death. Neofordex may also reduce some undesirable effects of anticancer treatment, such as nausea (feeling sick) and vomiting.
What benefit has Neofordex - Dexamethasone shown during the studies?
Since the effects of high doses of dexamethasone in multiple myeloma are well established, the company presented some studies in the literature on the use of dexamethasone for the treatment of multiple myeloma.
Furthermore, a bioequivalence study conducted on 24 healthy volunteers showed that Neofordex has qualities comparable to Dectancyl, the reference medicine.
What is the risk associated with Neofordex - Dexamethasone?
The most common side effects with Neofordex (which may affect more than 1 in 10 people) include hyperglycaemia (high blood glucose levels), insomnia (difficulty sleeping), muscle pain and weakness, asthenia (weakness), fatigue, edema ( swelling) and weight gain. Less common and yet serious side effects include pneumonia (lung infection) and other infections and psychiatric disorders such as depression. For the full list of all side effects reported with Neofordex, see the package leaflet.
Neofordex should not be used in patients with an active viral disease (especially hepatitis, cold sores, shingles or chickenpox) or with uncontrolled psychosis (an altered sense of reality). For the full list of limitations, see the package leaflet.
Why has Neofordex - Dexamethasone been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) concluded that Neofordex has been shown to have comparable quality to Dectancyl and that the use of high doses of dexamethasone in multiple myeloma is well established. The CHMP therefore decided that Neofordex's benefits are greater than its risks and recommended that it be approved for use in the EU.
What measures are being taken to ensure the safe and effective use of Neofordex - Dexamethasone?
A risk management plan has been developed to ensure that Neofordex is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Neofordex, including the appropriate precautions to be followed by healthcare professionals and patients. Further information is available in the summary of the risk management plan.
More information on Neofordex - Dexamethasone
For the full EPAR and the summary of the Neofordex risk management plan, consult the Agency's website: ema.europa.eu/Find medicine / Human medicines / European public assessment reports. For more information about treatment with Neofordex, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
