What is Respreeza and what is it used for?
Respreeza is a medicine used in adults with human alpha1-proteinase inhibitor deficiency, an inherited disorder which can cause lung problems including increasing breathing difficulties and which can also affect the liver. Respreeza is used to slow lung damage in patients with severe deficit.
Respreeza contains the active substance human alpha1-proteinase inhibitor.
How is Respreeza used?
Respreeza is available as a powder and solvent that are made up into a solution for infusion (drip into a vein). The first infusion should be administered under the supervision of a healthcare professional experienced in the treatment of human alpha1-proteinase inhibitor deficiency. Subsequent infusions may be administered by the caregiver or by the patient himself.
The recommended dose of Respreeza is 60 mg / kg body weight given once a week. The infusion should last about 15 minutes.
The medicine can only be obtained with a prescription. For more information, see the package leaflet.
How does Respreeza work?
The active substance in Respreeza, the human alpha1-proteinase inhibitor, is a natural component of the blood whose function is to protect lung tissue. It is obtained from human blood and works by replacing the protein that patients with human alpha1-proteinase inhibitor deficiency lack.
What benefit has Respreeza shown during the studies?
Respreeza was shown to slow lung damage in one main study involving 180 patients with lung damage due to human alpha1-proteinase inhibitor deficiency. In this study, Respreeza was compared with placebo (a dummy treatment) and the main one. the measure of effectiveness was the decrease in lung density. Lung density is an indicator of the extent of lung damage: the greater the decrease in lung density, the greater the injury to the lungs. The reduction in lung density after 24 months was about 2.6 g / l in Respreeza-treated patients compared to approximately 4.2 g / l in placebo-treated subjects.
What is the risk associated with Respreeza?
The most common side effects with Respreeza (which may affect up to 1 in 10 people) are dizziness and headache. Allergic reactions, some of them severe, have been observed during treatment.
In view of the risk of severe allergic reactions, Respreeza should not be used in patients who are deficient in a protein called IgA and who have developed antibodies against it, as these people are more prone to allergic reactions. For the full list of restrictions and side effects of Respreeza, see the package leaflet.
Why has Respreeza been approved?
The main study conducted with Respreeza showed that the medicine was effective in slowing lung damage in patients with human alpha1-proteinase inhibitor deficiency and this effect was considered significant in those with severe deficiency. the main concern related to the use of Respreeza is represented by allergic reactions; however, guidance on how to manage this risk has been provided in the product information. There were no other major concerns related to the safety of the medicine.
Therefore, the Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Respreeza'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 Respreeza?
A risk management plan has been developed to ensure that Respreeza is used as safely as possible. Based on this plan, safety information has been added to the summary of product characteristics and package leaflet for Respreeza, including the appropriate precautions to be followed by healthcare professionals and patients.
In addition, the company that markets Respreeza will carry out a new study to investigate whether a higher dose (120 mg / kg body weight) may offer more benefits than the currently recommended dose.
Other information about Respreeza
For more information about Respreeza therapy, read the package leaflet (included with the EPAR) or contact your doctor or pharmacist.
Respreeza information published on this page may be out of date or incomplete. For a correct use of this information, see the Disclaimer and useful information page.
