Source: European Medicines Agency (EU) Revision Year: 2019 Publisher: CSL Behring GmbH, Emil-von-Behring-Strasse 76, D-35041, Marburg, Germany
The recommended infusion rate given under section 4.2 should be adhered. During the first infusions, patient’s clinical state, including vital signs, should be closely monitored throughout the infusion period. If any reaction takes place that might be related to the administration of Respreeza, the rate of infusion should be decreased or the administration should be stopped, as required by the clinical condition of the patient. If symptoms subside promptly after stopping, the infusion may be resumed at a lower rate that is comfortable for the patient.
Hypersensitivity reactions may occur, including in patients who have tolerated previous treatment with human alpha1-proteinase inhibitor.
Respreeza may contain trace amounts of IgA. Patients with selective or severe IgA deficiency can develop antibodies to IgA and, therefore, have a greater risk of developing potentially severe hypersensitivity and anaphylactic reactions.
Suspected allergic or anaphylactic type reactions may require immediate discontinuation of the infusion, depending on the nature and severity of the reaction. In case of shock, emergency medical treatment should be administered.
There are limited data regarding the use of this medicinal product in home-treatment/selfadministration.
Potential risks associated with home-treatment/self-administration are related to the handling and administration of the medicinal product as well as to the handling of adverse reactions, particularly hypersensitivity. Patients should be informed of signs of hypersensitivity reactions.
The decision of whether a patient is suitable for home-treatment/self-administration is made by the treating doctor, who should ensure appropriate training is provided (e.g. regarding reconstitution, use of Mix2Vial set, assembly of intravenous tubing, infusion techniques, maintenance of a treatment diary, identification of adverse reactions and measures to be taken in case such reactions occur) and the use is reviewed at regular intervals.
Standard measures to prevent infections resulting from the use of medicinal products prepared from human blood or plasma include selection of donors, screening of individual donations and plasma pools for specific markers of infection and the inclusion of effective manufacturing steps for the inactivation/removal of viruses. Despite this, when medicinal products prepared from human blood or plasma are administered, the possibility of transmitting infective agents cannot be totally excluded.
This also applies to unknown or emerging viruses and other pathogens.
The measures taken are considered effective for enveloped viruses such as human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) and for the non-enveloped hepatitis A (HAV) and parvovirus B19 virus.
Appropriate vaccination (hepatitis A and B) should be considered for patients in regular/repeated receipt of human plasma-derived proteinase inhibitors.
It is strongly recommended that every time that Respreeza is administered to a patient, the name and batch number of the product are recorded in order to maintain a link between the patient and the batch of the product.
Tobacco smoke is an important risk factor for the development and progression of emphysema. Therefore cessation of smoking and the avoidance of environmental tobacco smoke are strongly recommended.
Respreeza contains approximately 1.9 mg (<1 mmol) sodium per ml of reconstituted solution. That should be taken into consideration for patients on a controlled sodium diet.
No interaction studies have been performed.
No animal reproduction studies have been conducted with Respreeza and its safety for use in human pregnancy has not been established in controlled clinical trials. Since alpha1-proteinase inhibitor is an endogenous human protein, it is considered unlikely that Respreeza will cause harm to the foetus when given at recommended doses. However, Respreeza should be given with caution to pregnant women.
It is unknown whether Respreeza/metabolites are excreted in human milk. The excretion of human alpha1-proteinase inhibitor in milk has not been studied in animals. A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Respreeza should be made, taking into account the benefit of breast-feeding to the child and the benefit of human alpha1-proteinase inhibitor therapy to the woman.
No animal fertility studies have been conducted with Respreeza and its effect on human fertility has not been established in controlled clinical trials. Since human alpha1-proteinase inhibitor is an endogenous human protein, no adverse effects on fertility are expected when given at recommended doses
Dizziness may occur following the administration of Respreeza (see section 4.8). Therefore, Respreeza may have a minor influence on the ability to drive and use machines.
Hypersensitivity or allergic reactions have been observed during the treatment. In the most serious cases, allergic reactions may progress to severe anaphylactic reactions even when the patient has shown no hypersensitivity to previous administrations (see section 4.4).
The adverse reactions (ARs) collected from six clinical studies in 221 patients and post-marketing experience are presented in the table below according to the MedDRA System organ classification (SOC and Preferred Term (PT) Level). Frequency per patient (based on six months of exposure during clinical trials) has been evaluated according to the following convention: common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000) and very rare (<1/10,000). The frequency of ARs during post marketing only is considered as “not known (cannot be estimated from the available data)”.
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness.
Frequency of Adverse Reactions (ARs) in clinical studies and post-marketing experience with Respreeza:
Not known: Lymph node pain
Uncommon: Hypersensitivity reactions (including tachycardia, hypotension, confusion, syncope, oxygen consumption decreased and pharyngeal oedema)
Very rare: Anaphylactic reactions
Common: Dizziness, headache
Uncommon: Paraesthesia
Very rare: Hypoaesthesia
Not known: Eye swelling
Uncommon: Flushing
Common: Dyspnoea
Common: Nausea
Not known: Lip swelling
Uncommon: Urticaria, rash (including exfoliative and generalized)
Very rare: Hyperhidrosis, pruritus
Not known: Face swelling
Uncommon: Asthenia, infusion-site reactions (including infusion site hematoma)
Very rare: Chest pain, chills, pyrexia
Safety and effectiveness in the paediatric population have not been established. No data are available.
The safety and efficacy of Respreeza in elderly patients (65 years of age or older) have not been established in clinical trials.
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
This medicinal product must not be mixed with other medicinal products, except those mentioned in section 6.6.
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