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Ensuring the Safety of IVIgG: Protocols and Clinical Use in Neonates

This document outlines the comprehensive protocols and safety measures regarding the sourcing and processing of IVIgG at SNBTS. It details the auditing processes for non-UK plasma suppliers, stringent testing for viral contamination, and the methods employed to ensure the highest levels of product traceability and safety. Additionally, it covers the clinical applications of IVIgG in treating various conditions, with a specific focus on neonatal use. The findings reveal a low risk of adverse reactions and effective management of potential infections, supporting the utility of IVIgG in clinical settings.

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Ensuring the Safety of IVIgG: Protocols and Clinical Use in Neonates

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  1. Safetyof IVIgG Elspeth McIntosh SNBTS Medical Information and Pharmacovigilance Manager

  2. Plasma • “Non-UK” Plasma - USA or Germany • All suppliers audited by SNBTS and approved by the MHRA • Unpaid donors wherever possible • Meet Red Book/EU Blood Directive and/or FDA requirements • Donor selection as per the UK • Epidemiological data satisfactory

  3. Plasma tested for HBsAg Anti- HCV Anti-HIV ALT PCR for HCV, HBV, HIV, Parvovirus B19 Plasma pools tested for HBsAg Anti- HCV Anti-HIV PCR for HCV, HBV, HIV, Parvovirus B19 Plasma Testing

  4. Product Safety • Full Traceability From Donor To Final Product • Notification System For Advising Of Post Donation Infections • Validated Virus Elimination Step(s) • Control Of Process To Prevent Re-contamination After Virus Elimination Step • Clinical Trial Data • Post Marketing Surveillance

  5. Virus Inactivation and Removal • Devise methods that will selectively inactivate and/or remove viruses without undue product damage/loss. • Study relevant test viruses in scaled-down process. • Ensure that method is capable of giving the degree of virus inactivation/removal required.

  6. Virus Inactivation and Removal • Scale-up the process to ensure that the small-scale results can be fully reproduced at production scale. • Validate the production scale operation to ensure that this has been achieved. • Monitor and control the operations to prove that the procedure has been accomplished correctly on every occasion.

  7. Virus Safety • Cold ethanol fractionation • pH4/pepsin virus inactivation • effective against • enveloped viruses e.g. HIV, Hep B and C • and non-enveloped viruses e.g. Hep A

  8. vCJD Precautions • All PFC plasma imported from countries with no vCJD cases and little or no BSE. • Donors selection processes designed to exclude those who may represent a risk. • Decontamination of UK fractionation facilities before processing of non-UK plasma in 1998.

  9. vCJD Precautions • Very low level of infectivity in plasma pool should an infective donation be processed. • Research work identifies the potential for prion reduction during manufacturing. • So • Very low risk of vCJD being transmitted via PFC products.

  10. SNBTS IVIgG Clinical Use • SNBTS IVIgG supplied since 1985 • 270kgs used every year • Licensed for use in • 1o and 2o Hypogammaglobulinaemia • Children with HIV • Bone Marrow Transplant • Kawasaki Disease • ITP • Guillain Barre Syndrome

  11. Adenovirus Chlamydia CMV Coxsackie B2 Epstein Barr Herpes Simplex Influenza A + B Measles Mumps Mycoplasma Q fever RSV Rotavirus Varicella Zoster Antibody Profile

  12. Serious ADRs • Serious Reactions to IVIgG are rare but the follwing are well described. • Acute Renal Failure • Anaphylaxis/Anaphylactoid Reactions • Aseptic Meningitis • Hypertension • Haemolytic Reactions

  13. Non Serious ADRs • Idiosyncratic batch related reactions - • One or more of the following symptoms: pyrexia, rigors, backache, nausea/vomiting, malaise, breathlessness, rash, hyper or hypotension, headache.

  14. IVIgG for Neonatal Use • ~ 6000 patients, 32 studies. • Cochrane Review - Prevention of infection in pre-term/LBW infants • Cochrane Review - Treatment of infection in neonates. • Cochrane Reviews - Isoimmune haemolytic jaundice in neonates

  15. Neonatal Use - SNBTS IVIgG • Small trial early 1990s • Randomised to IVIgG or 5% Dextrose • Study to small to produce significant results • No product related adverse events • AND • No reports of neonatal reactions in routine use.

  16. Neonatal ADRs • Cochrane Reports • No Serious Adverse Reactions. • Non-serious Adverse Reactions transient, included hypotension, tachycardia, and haemolysis • related to too rapid infusion of placebo or immunoglobulins. • One study - increase in respiratory rate following the first infusion of IVIG

  17. Causality • Temporal relationship • Pharmacological plausibility • Recognised class effect • Dechallenge/rechallenge • Underlying illness and medications • Irreversible events • Transient/episodic events

  18. Topics covered • Plasma selection • Virus safety • vCJD • Clinical use of SNBTS IVIgG • Neonatal experience • Adverse reactions

  19. Conclusion • SNBTS IVIgG is a well established product. • Steps in place to reduce risk of virus transmission/vCJD. • Low overall risk of adverse reactions.

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