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Safety of IVIgG

Safety of IVIgG. Elspeth McIntosh SNBTS Medical Information and Pharmacovigilance Manager. 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

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Safety of IVIgG

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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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