Who can administer
May be administered by registered competent doctor or nurse/midwife
Important information
- Use Online Dosage Calculator and Order Form
- 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
- 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 by 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 10% contains human normal immunoglobulin 5g in 50ml
Flebogamma DIF 10% contains human normal immunoglobulin 10g in 100ml
Flebogamma DIF 10% contains human normal immunoglobulin 20g in 200ml
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: 0.6ml/kg/hour
- If well tolerated, the rate may be increased every 30 minutes in the following step-wise fashion: 1.2ml/kg/hour, then 2.4ml/kg/hour, then 3.6ml/kg/hour, and finally the maximum rate of 4.8ml/kg/hour.
- It has been reported that the frequency of adverse reactions to IVIg increases with the infusion rate. For patients experiencing adverse reactions it is advisable to reduce the infusion rate in subsequent infusions and limit the maximum rate to 2.4ml/kg/hr or administer IVIG at a 5% concentration.
- 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 10%- 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) |
| |
0.6ml/kg/hour |
1.2ml/kg/hour |
2.4ml/kg/hour |
3.6ml/kg/hour |
4.8ml/kg/hour |
| 50 |
30 |
60 |
120 |
180 |
240 |
| 55 |
33 |
66 |
132 |
198 |
264 |
| 60 |
36 |
72 |
144 |
216 |
288 |
| 65 |
39 |
78 |
156 |
234 |
312 |
| 70 |
42 |
84 |
168 |
252 |
336 |
| 75 |
45 |
90 |
180 |
270 |
360 |
| 80 |
48 |
96 |
192 |
288 |
384 |
| 85 |
51 |
102 |
204 |
306 |
408 |
| 90 |
54 |
108 |
216 |
324 |
432 |
| 95 |
57 |
114 |
228 |
342 |
456 |
| 100 (max weight to use for RATE calculations*) |
60 |
120 |
240 |
360 |
480 |
* 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)
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.
- 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
- 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
Guillain Barre syndrome
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)
- For patients who experience adverse reactions, it is advisable to reduce the rate of subsequent infusions to a maximum rate of 2.4ml/kg/hour, or administer the 5% concentration
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 100 microgam per ml
- IgG content is at least 97%
Storage
Store below 250C
Do not freeze
References
Summary of Product Characteristics Flebogamma Dif 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 update
Therapeutic classification
Intravenous immunoglobulin
