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Immunoglobulin (Privigen) intravenous for adults

Who can administer

May be administered by registered competent doctor or nurse/midwife

Important information

  • 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.
  • See below re using adjusted weight for calculation of doses
  • 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
  • Round doses to nearest vial size (ref 2)
  • Licensed doses vary with the brand of immunoglobulin employed. Discuss with your consultant or pharmacy if further information required
  • Contraindicated in individuals with known class specific antibody to Immunoglobulin A; patients with hyperprolinaemia
  • 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
  • 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

Privigen human normal Immunoglobulin 2.5g per 25mL vial

Privigen human normal Immunoglobulin 5g per 50mL vial

Privigen human normal Immunoglobulin 10g per 100mL vial

Privigen human normal Immunoglobulin 20g per 200mL vial

Privigen human normal Immunoglobulin 40g per 400mL vial

Reconstitution

Already in solution

Infusion fluids

Not required (product ready for infusion)

Methods of intravenous administration

Intermittent intravenous infusion (using an electronically controlled infusion device)

  • Initial rate: 0.3ml per kg per hour for 30 minutes
  • If well tolerated, the rate of administration may be gradually increased to a maximum of 4.8ml/kg/hour
  • Clinical data obtained from a limited number of patients also indicate that adult patients with Primary Immunodeficiency Syndromes may tolerate a rate of up to 7.2ml/kg/hour
  • If reaction occurs during infusion, see 'Further information' for guidance
  • When prescribed as a daily dose over 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 PRIVIGEN- 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) Maximum rate (ml/hour)
0.3ml/kg/hour 0.6ml/kg/hour 1.2ml/kg/hour 2.4ml/kg/hour 4.8ml/kg/hour
50 15 30 60 120 240
55 16.5 33 66 132 264
60 18 36 72 144 288
65 19.5 39 78 156 312
70 21 42 84 168 336
75 22.5 45 90 180 360
80 24 48 96 192 384
85 25.5 51 102 204 408
90 27 54 108 216 432
95 28.5 57 114 228 456
100 30 60 120 240 480
Rates above are for most patients. Patients with Primary immunodeficiency may tolerate up to 7.2ml/kg/hour
Table continues below
Infusion rates for PRIVIGEN- sample calculations CONTINUED. 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) Maximum rate (ml/hour)
0.3ml/kg/hour 0.6ml/kg/hour 1.2ml/kg/hour 2.4ml/kg/hour 4.8ml/kg/hour
105 31.5 63 126 252 504
110 33 66 132 264 528
115 34.5 69 138 276 552
120 36 72 144 288 576
125 37.5 75 150 300 600
130 39 78 156 312 624
135 40.5 81 162 324 648
140 42 84 168 336 672
Rates above are for most patients. Patients with Primary immunodeficiency may tolerate up to 7.2ml/kg/hour

Dose in adults

Important points (ref 2)

Replacement therapy in primary immunodeficiency syndromes

  • 0.4 to 0.8g per kg as starting dose, followed by 0.2 to 0.8g per kg every three to four weeks
  • Round dose down to nearest vial size
  • Three to six months are required after the initiation of therapy for equilibration to occur
  • Desired trough levels (taken before the next infusion) are at least 6g/L

Replacement therapy in secondary immunodeficiency

  • Usual dose 0.2 to 0.4g per kg every three to four weeks
  • 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)

  • Treatment: either 0.8g to 1g per kg on day one, which may be repeated once within three days,
  • or 0.4g/kg daily for two to five days
  • Round dose to nearest vial size, or adjust dose over the treatment course. For example 0.4g per 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
  • Treatment may be repeated if relapse occurs

Guillain Barre syndrome

  • 0.4g per kg daily for five days
  • Round dose to nearest vial size, or adjust dose over the treatment course. For example 0.4g per 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

Chronic Inflammatory Demyelinating Polyneuropathy (CIPD)

  • Starting dose: Give 2g/kg given over two to five days .(example 1g/kg daily for two days, or 0.4g/kg daily for five days)
  • Maintenance dose: Give 1g/kg given over one to two days, every three weeks

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)
  • 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 response to live vaccines - serological testing may be necessary - see SPC
  • At least 98% of Privigen is immunoglobulin G (IgG)
  • Maximum IgA content is 25 microgram per ml
  • If dilution to a lower concentration is required,Privigen may be diluted with Glucose 5% to a final concentration of 50mg/ml (5%). Example: Mix 50ml Privigen 10% solution with 50ml Glucose 5%

Storage

  • Store below 250C, do not freeze

References

SPC Privigen 100mg/ml solution November 2017

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

(2) Department of Health Clinical Guidelines on the use of Intravenous Immunoglobulins 2011- second edition update

Therapeutic classification

Intravenous immunoglobulin

IV Guide Type