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Immunoglobulin (Flebogamma DIF 5%) Intravenous for Adults

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Who can administer

May be administered by registered competent doctor or nurse/midwife

Important information

  • Please ensure you are using correct monograph- separate monographs for both Flebogamma DIF 5% and 10% are available
  • Use 10% Flebogamma DIF unless instructed by Dr V Tormey and supply of the 5% can be arranged by pharmacy
  • See below re using adjusted weight for calculation of doses
  • An In-patient Authorisation form or Out-patient prescription form MUST be completed prior to the first dose of immunoglobulin in GUH. Supply will ONLY be arranged when this form is completed correctly.
  • Round dose to nearest vial size (ref 2)
  • Contraindicated in individuals with known class specific antibody to Immunoglobulin A
  • Thromboembolism: Use caution with IVIg in obese patients and in patients with pre-existing risk factors for thrombotic events. In patients at risk for thromboembolic adverse reactions, IVIg products should be administered at the minimum rate of infusion and dose practicable
  • See overleaf for monitoring requirements
  • This is a blood product, therefore batch and expiry information should be recorded in the patient's notes. This is facilitated by putting the dispensing label from each vial into the patient's notes.
  • Licensed doses vary with the brand of immunoglobulin employed. Discuss with your consultant or pharmacy if further information required.
  • Glass bottle precautions as follows:
  • Precautions need to be taken during administration to prevent possible air embolism - particularly in central line administration. Bottles must be vented in one of two ways:
    • Directly by means of a filter needle into the bottle which goes through the rubber stopper and opens into the air,
    • or Direct air vent on the air inlet of the administration set, located between the drip chamber and piercing pin, it is covered with a bacterial retentive filter to reduce the chance of contamination

Available preparations

Flebogamma DIF Human normal immunoglobulin 5% 2.5g in 50ml

Flebogamma DIF Human normal immunoglobulin 5% 5g in 100ml

Flebogamma DIF Human normal immunoglobulin 5% 10g in 200ml

Flebogamma DIF Human normal immunoglobulin 5% 20g in 400ml

Reconstitution

Already in solution

Infusion fluids

Not required (product ready for infusion)

Methods of intravenous administration

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

  • First 30 minutes: 0.6 to 1.2ml/kg/hour
  • If well tolerated, the rate may then be gradually increased to a maximum of 6ml/kg/hour for the remainder of the infusion. For example, if started at 0.6ml/kg/hour for first 30 minutes, then increase after 30 minutes to 1.2ml/kg/hour, then increase after a further 30 minutes to 2.4ml/kg/hour, and so on, to a maximum rate of 6ml/kg/hour
  • If reaction occurs during infusion, see 'Further information' for guidance
  • When prescribed as a daily dose for several days, the rate will need to be titrated again on each day. However, if it was well tolerated the previous day, the rate may be increased more quickly on subsequent days. (ref 1)
  • If prescribed as a daily dose, and on day one it is first administered late in the day, on subsequent days the starting time for administration may be brought back to earlier in the day if required. Gradual titration of the rate will be needed on each day, as before.

Infusion rates for FLEBOGAMMA 5%- sample calculations. See above for exceptions to rate increases
If a patient's weight falls between two values below, use the lower infusion rate- e.g. patient weight 59kg- use rates for 55kg rather than for 60kg

Increase rate as per table below, every 30 minutes as tolerated - until the full dose has been administered

Maintain low rate of infusion throughout if patient has acute renal disease, or thromboembolic disorders
Weight (kg) First 30 minutes (ml/hour) Second 30 minutes (ml/hour) Third 30 minutes (ml/hour) Fourth 30 minutes (ml/hour) Fifth 30 minutes (ml/hour) Maximum rate (ml/hour)
0.6ml/kg/hour 1.2ml/kg/hour 2.4ml/kg/hour 3.6ml/kg/hour 4.8ml/kg/hour 6ml/kg/hour
50 30 60 120 180 240 300
55 33 66 132 198 264 330
60 36 72 144 216 288 360
65 39 78 156 234 312 390
70 42 84 168 252 336 420
75 45 90 180 270 360 450
80 48 96 192 288 384 480
85 51 102 204 306 408 510
90 54 108 216 324 432 540
95 57 114 228 342 456 570
100 60 120 240 360 480 600
105 63 126 252 378 504 630
110 66 132 264 396 528 660
115 69 138 276 414 552 690
120 72 144 288 432 576 720
125 75 150 300 450 600 750
130 78 156 312 468 624 780
135 81 162 324 486 648 810
140 84 168 336 504 672 840

Dose in adults

Important points (ref 2)

Replacement therapy in primary immunodeficiency

  • 0.4g to 0.8g/kg initially, followed by 0.2g to 0.8g/kg every three to four weeks thereafter, depending on the clinical response and on the IgG trough level.
  • Round dose down to nearest vial size
  • Desired trough levels (taken before the next infusion) are at least 6g/L
  • Three to six months are required after initiation of therapy for equilibration to occur

Replacement therapy in secondary immunodeficiency

  • 0.2g to 0.4g/kg every three to four weeks thereafter, depending on the clinical response
  • Round dose down to nearest vial size
  • IgG trough levels should be measured and assessed in conjunction with the incidence of infection.
    Dose should be adjusted as necessary to achieve optimal protection against infections, an increase
    may be necessary in patients with persisting infection; a dose decrease can be considered when the
    patient remains infection free.

Idiopathic thrombocytopenia (ITP)

  • 0.4g/kg daily for two to five days
  • Alternative regimen: 0.8g/kg to 1g/kg on day 1, which may be repeated once within three days if relapse occurs
  • Round dose to nearest vial size, or adjust dose over the treatment course
  • For example 0.4g/kg for 5 days for patient who weighs 65kg is 26g daily for up to 5 days - give 25g daily for four days, then give 30g on day 5

Guillain Barre syndrome

  • 0.4g/kg daily for 5 days
  • Round dose or adjust dose over the treatment course e.g. 0.4g/kg for 5 days for patient who weighs 65kg is 26g daily for up to 5 days - give 25g daily for four days, then give 30g on day 5

It is common practice for neurology patients to be prescribed enoxaparin 40mg od subcutaneously due to the increased risk of thromboembolism. Consider prescribing but check dose etc with Registrar first. See also under Important information re thromboembolism

See SPC for other indications

Monitoring

  • Patients must be closely monitored and carefully observed for any adverse reactions throughout the infusion period and for at least twenty minutes after administration
  • Monitoring should be extended to one hour for immunoglobulin naive patients, those switched from another product, or when there has been a long interval since previous infusion.
  • If adverse reactions occur, slow or stop the infusion - see under 'Further information'. Please also consult Medication Protocol: Management of Infusion Related patient reactions in nurse led infusion settings in GUH -available on Q pulse (CLN-NM-0118)

Further information

  • Management of infusion related reactions: depending on the severity of the reactions, the infusion rate may either be slowed or stopped
  • Some cases of acute renal failure have been reported in patients receiving IVIG (particularly those containing sucrose as an excipient).
  • Contains 50mg/ml sorbitol as an excipient. Should not be administered to patients with rare hereditary problems of fructose intolerance
  • Adequate hydration prior to infusion of IVIG is essential, urinary output and creatinine must be monitored, and the concomitant use of loop diuretics should be avoided where possible.
  • IVIG may interfere with responses to live vaccines - serological testing may be necessary- see SPC for details
  • IgA content is less than or equal to 50 microgam per ml
  • IgG content is at least 97%

Storage

Store below 250C

References

Flebogamma Dif 50mg/ml SPC 24/4/2017

(1) Communication with Dr Tormey, Immunologist, email March 2011

(2) Department of Health UK 2011 Clinical guidelines for the use of intravenous immunoglobulins 2nd edition

Therapeutic classification

Intravenous immunoglobulin