Immunoglobulin (Privigen) intravenous for adults

Who can administer

May be administered by registered competent doctor or nurse/midwife

Important information

• Use Online Dosage Calculator and Order Form
• For haematology and oncology patients please provide patient information leaflet BEFORE first-dose
• 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
• 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 (max weight to use for RATE calculations*)	30	60	120	240	480
Rates above are for most patients. Patients with Primary immunodeficiency may tolerate up to 7.2ml/kg/hour * max 100kg used to calculate dose RATE - based on requirement not to overload heavy patients with high rate of large volume infusions

Dose in adults

Important points (ref 2)

• Use Online Dosage Calculator and Order Form
• Using this adjusted weight dose may contribute to minimisation of side-effects and will also save significant quantities of immunoglobulin.

Measles prophylaxis (ref 3) (see NIAC Immunisation Guidelines, Chapter 12, Measles)

• Kiovig is our preferred first line brand to use for this indication (supply issues) - but Privigen may be used if necessary
• Give 0.4g per kg
• For example 0.4g per kg for patient who weighs 65Kg is 26g - give 25g (2x10g vials + 5g vial)

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
• 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
• 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
• Treatment may be repeated if relapse occurs

Guillain Barre syndrome

• 0.4g per kg daily for five days

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

3: NIAC immunisation guidelines Measles Prophylaxis - see page 19

Therapeutic classification

Intravenous immunoglobulin