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Alpha 1 antitrypsin (Prolastin) Intravenous Infusion for Adults

Who can administer

May be administered by registered competent doctor or nurse/midwife

Important information

  • Should be prepared by an experienced member of staff (very expensive)
  • Contraindicated in individuals with selective IgA deficiency who are known to have antibodies against IgA, as allergic reactions to the point of anaphylactic shock may occur in such cases
  • Blood product- record batch number and expiry date in patient's notes

Available preparations

Prolastin 1g powder and solvent for Solution for Infusion

Reconstitution

Water for injection

  • Bring vials to room temperature before reconstitution. Add 40ml per 1g vial (solvent supplied)
  • Use a Mix2Vial device supplied with the product to reconstitute the vial
  • Push the blue end of the Mix2Vial device into the solvent bottle first
  • Place the vial containing the drug on to a flat surface and invert the solvent bottle with the Mix2Vial device still attached
  • While holding the Prolastin Vial securely, push the clear end of the Mix2Vial straight down until the spike penetrates the stopper.  The solvent will flow down into the Prolastin vial
  • Note: If the Mix2Vial is connected at an angle, the vacuum may be released from the product vial and the solvent will not transfer- in which case, a needle and syringe will be needed to make the transfer
  • Gently swirl the concentrate bottle until powder is completely dissolved
  • Do not shake- to avoid foaming 
  • Visually inspect for particulate matter and discolouration

Infusion fluids

Not applicable

Methods of intravenous administration

  • The reconstituted solution is added to an empty infusion bag (provided by pharmacy)
  • Use a 16Gauge needle (ref BD 300637 - supplied from pharmacy) to draw up the drug solution
  • Add the total dose to the empty infusion bag

Intermittent intravenous infusion (administer using an electronically controlled infusion device)

  • Use a 500ml empty bag for doses up to 12g and a 1000ml empty bag for doses greater than this
  • Administer at a rate of 4.8ml/kg/hour

Dose in adults

Usual dose

  • Give 60mg/kg every week
  • The dose can be rounded down to the nearest gram
  • See 'Further information' for dosage guidance on longer intervals

Further information

  • Vaccination against Hepatitis A and B is recommended before starting treatment
  • Because it is a blood derived product, interruptions to supply can occur
  • Consultant signed protocol for Prolastin® on file in Pharmacy, MPH, as required by nursing intravenous policy
  • Because this product is made from human blood, it may carry a risk of transmitting infectious agents, e.g. viruses. There is also the possibility that unknown infectious agents many be present in such products. Any suspicion of such infection should be reported to the manufacturers
  • May cause a transient increase in blood volume - use with caution in patients with severe heart failure and in patients at risk of circulatory overload

Order code numbers for empty bags are:

500ml bag (Baxter E3MC-3802),

1000ml bag (Baxter E3MC-3803) 

Items required:

BD 16g needles ref 300637- available from surgical stores

Extended dose intervals (unlicensed)

  • The manufacturers advise a weekly dosage regimen
  • There is very limited evidence for administration on a fortnightly or monthly basis
  • If this is required, the dose should be instituted as follows
    • 60mg/kg every week for six months, then..
    • 120mg/kg every fortnight for six months, then..
    • 250mg/kg every 28 days
  • However, it has been shown that adequate levels may not be maintained using this approach. One reference concludes that a dose of 120mg/kg every fortnight was not sufficient to maintain serum levels above the target trough for 14 days and that a higher dose of 200mg/kg every fortnight, or decreased interval between infusions (8 to 10 days) would need to be considered (ref 1)
  • However, monthly infusions of 250mg/kg (i.e four times the weekly infusion dose) effectively raised plasma and epithelial lining fluid AAT levels as well as anti-neutrophil elastase activity above the protective thresholds.  This effect was maintained until the next dose and over the long term. Further study would be needed to determine the efficacy of monthly dosing. (ref 1)
  • The expense of the drug means that increasing the dose has significant cost implications. Optimising the dosing interval is preferable to increasing the dose

Storage

  • Store below 25°C, do not freeze
  • Prepare infusion immediately before administration
  • Administration must be complete within 3 hours of reconstitution and do not refrigerate after reconstitution

References

SPC August 2017,

1: Uptodate-downloaded 10th Oct 2018

Therapeutic classification

Proteinase inhibitor