Haemodialysis - LEO Pharma Sarath

1. How is Innohep® administered?
In standard haemodialysis, it is recommended that Innohep® is administered as a bolus dose at the arterial side of the dialyser before the filter.

2. Does the consumption of Innohep® vary with the type of dialysis?
In some centres, haemofiltration and haemodiafiltration are beginning to replace conventional standard haemodialysis in certain patients.

3. Does the consumption of Innohep® vary with filter type?
The growing use of high flux filters in many centres has increased focus on the outdialysation of molecules of varying size and structure.

4. How is the starting dose of Innohep® estimated?
The recommended starting dose of Innohep® is a bolus dose of 4500 anti-Xa IU.

5. Is there a connection between the Innohep® dose and the patient's weight?
A correlation between bodyweight and Innohep® dosage has been shown.

6. Is there any difference in dosage between Innohep® and other LMWHs?
In a comparative multicentre study, equivalent efficacy was achieved with a 10% lower dose of Innohep® than with dalteparin...

7. Should additional Innohep® be given if the dialysis lasts more than 4 hours?
One of the advantages of Innohep® compared with UFH is that only one dose is necessary and this is administered as a bolus dose at the beginning of dialysis.

8. How long is the bleeding time after dialysis when using Innohep® compared with UFH?
The post-dialysis bleeding time after using Innohep® is similar to that recorded after use of UFH.

9. How should Innohep® be stored?
* Innohep® must not be stored above 25oC. *Innohep® has a shelf-life of 2 years.

10. Is Innohep® still active int he body when the patient leaves the dialysis unit?
It is likely that some Innohep® will remain in the body after dialysis, but since the doses used are relatively small, the amount remaining will be very small and not clinically important.

11. Vials or syringes?
Innohep® is available both as vials and prefilled syringes, offering flexibility and ease in daily use.

12. What about Innohep® excretion?
The main route of elimination of Innohep® is via the kidneys so with impaired renal function, there is a possibility of Innohep® accumulating.

13. Can patients on NSAIDs be treated with Innohep®?
It is recommended that patients on haemodialysis receiving anticoagulation treatment should, if possible, use analgesics other than NSAIDs.

14. What should be done in the event of an overdose?
Severe bleeding that requires neutralisation is very rare.

15. Should patients on EPO-treatment receive a higher Innohep® dose?
Patients on erythropoietin (EPO) treatment tend to have elevated haematocrit values.

16. Which anticoagulation parameters should be monitored?
One of the advantages of Innohep® compared with UFH is that no anticoagulation parameters need to be monitored.

17. COAGULATION PARAMETERS TO BE OBSERVED IN CONNECTION WITH HAEMODIALYSIS
Unlike with unfractionated heparin, it is not necessary to monitor anticoagulation during dialysis when using Innohep®.

18. How can the patient get involved in the anticoagulation treatment?
Many dialysis patients feel a certain degree of ownership of their disease, and are often very well informed about their treatment.

19. How is clotting of the tubes managed?
Severe clotting is very rare.

20. How is the treatment switched from UFH to Ιnnohep®?
Most centres consider it simple and safe to switch from UFH to Ιnnohep®.

21. Should the dialysis machine be primed?
Priming is when the extracorporeal circuite (ECC) is flushed with saline and UFH or LMWH.

22. What about the heparin pump?
One of the advantages of Ιnnohep® compared with UFH is the ease of use and single bolus dose.

23. Can Ιnnohep® be used in the central venous catheter?
Between 20-30% of patients are normally dialysed through central venous catheters.

24. Can Ιnnohep® be used in home dialysis?
Patients on home dialysis can easily be taught to administer their own Ιnnohep® dose.

25. What are the costs of Innohep® compared to UFH?
A Canadian study (Lord, submitted 2001) shows that using Innohep® in dialysis was less costly than standard UFH due to savings in nursing time and costs for testing and equipment.

26. Hemolysis in Haemodialysis
Hematologic abnormalities

27. Indications and contraindications of alendronate and cholecalciferol in dialysis patients.
Generally, bisphosphonates including alendronate are contra indicated in patients with renal insufficiency (creatinine clearance <35 mL/min) as well as in renal failure patients receiving regular dialysis.

QUESTION
1. How is Innohep® administered?

ANSWER
In standard haemodialysis, it is recommended that Innohep® is administered as a bolus dose at the arterial side of the dialyser before the filter.

Innohep® can be administered just prior to the start of the dialysis in the artery cannula.

Alternatively, Innohep® can be administered in the artery stub when the blood first reaches this.

Some centres prefer to administer Innohep® in the vein cannula or the vein pipe stub after the filter for patients using very large filters, and for those on haemofiltration and haemodiafiltration. This procedure is chosen in order to prvent possible outdialysation of Innohep®.

QUESTION
2. Does the consumption of Innohep® vary with the type of dialysis?

ANSWER
In some centres, haemofiltration and haemodiafiltration are beginning to replace conventional standard haemodialysis in certain patients. Haemofiltration and haemodiafiltration are advantageous as they use principles such as convective mass transfer, substitution fluid and a higher flow rate, so therefore filter larger molecules.

The higher flow rate could indicate a reduced need for anticoagulation. However, experience shows that the consumption of Innohep® may be slightly higher with haemofiltration and haemodiafiltration than with conventional haemodialysis. This is because haemofiltration and haemodiafiltration is often performed with very large filters, thus leading to a slight increase in the use of Innohep®.

QUESTION
3. Does the consumption of Innohep® vary with filter type?

ANSWER
The growing use of high flux filters in many centres has increased focus on the outdialysation of molecules of varying size and structure.

The average molecular weight Innohep® is 6500 Da. It takes very large filters to dialyse out Innohep®. Experience shows that there seems to be a tendency towards higher consumption of Innohep® when very large filters are used.

When shifting between various filter types the recommendation is to start with the same dose as previously given, and to observe any changes that may indicate the need for a dose adjustment.

QUESTION
4. How is the starting dose of Innohep® estimated?

ANSWER
The recommended starting dose of Innohep® is a bolus dose of 4500 anti-Xa IU. This dose may need to be adjusted over a number of dialysis sessions and must take into account certain factors such as patient characteristics and dialysis conditions.

Evidence from different clinical trials and practical experience from several centres have shown that patients switched from unfractionated heparin (UFH) to Innohep® will required approximately 50% of the previous UFH dose. This can be used as the starting dose when switching from UFH to Innohep® (Akiba, 1992; Egfjord, 1998; Elisaf, 1997).

For patients switched from dalteparin, the dose of Innohep® required is approximately 10% less than the dalteparin dose (Beijering, submitted 2001).

Optimisation of dosage is required for each individual patient and can be made in steps of 500 anti-Xa IU between subsequent dialysis sessions, until a satisfactory dose is obtained.

The first couple of dialysis sessions are often shorter than 4 hours for new patients. The Innohep® dose should thus be adjusted accordingly.

QUESTION
5. Is there a connection between the Innohep® dose and the patient's weight?

ANSWER
A correlation between bodyweight and Innohep® dosage has been shown. As well as using the recommended starting dose of 4500 anti-Xa IU or 50% of the UFH dose previously given, the Innohep® dose may be calculated by bodyweight.

A typical dose based on bodyweight is between 40-60 anti-Xa IU/kg, as observed in a number of clinical trials (Akiba, 1992; Beijering, submitted 2001; Egfjord, 1998).

QUESTION
6. Is there any difference in dosage between Innohep® and other LMWHs?

ANSWER
In a comparative multicentre study, equivalent efficacy was achieved with a 10% lower dose of Innohep® than with dalteparin (Beijering, submitted 2001).

QUESTION
7. Should additional Innohep® be given if the dialysis lasts more than 4 hours?

ANSWER
One of the advantages of Innohep® compared with UFH is that only one dose is necessary and this is administered as a bolus dose at the beginning of dialysis. The initial dose should thus reflect the expected duration of dialysis.

A dose titration study found that an Innohep® dose of 5000 anti-Xa IU was effective in preventing clot formation in dialysis for up to 6 hours (Ryan, 1991). It should, however, always be kept in mind that numerous factors influence the dose of Innohep®.

If the dialysis time is prolonged, an additional 500 anti-Xa IU may be added to the machine. If less than one hour remains before the end of dialysis, it may be preferable to give an UFH that has a shorter half-life than Innohep®.

Many factors interplay in the dose determination of Innohep® for each patient, and it is therefore recommended to monitor the dose by visual examination of the bubble chamber, the fistula bleeding time and the colour of the filter at the end of the dialysis session. If needed, the dose can then be adjusted at the start of the next session.

QUESTION
8. How long is the bleeding time after dialysis when using Innohep® compared with UFH?

ANSWER
The post-dialysis bleeding time after using Innohep® is similar to that recorded after use of UFH. There is therefore no difference in the bleeding time whether Innohep® or UFH is used.

In a study by Simpson (1996) using Innohep®, the mean duration of post-dialysis bleeding ranged from 4-7.5 minutes throughout the study period.

QUESTION
9. How should Innohep® be stored?

ANSWER
Innohep® must not be stored above 25oC.
Innohep® has a shelf-life of 2 years.
The contents of the Innohep® vials should be used within 14 days after the first perforation of the septum, provided the vial was handled correctly when drawing the solution into a syringe.

QUESTION
10. Is Innohep® still active int he body when the patient leaves the dialysis unit?

ANSWER
It is likely that some Innohep® will remain in the body after dialysis, but since the doses used are relatively small, the amount remaining will be very small and not clinically important.

QUESTION
11. Vials or syringes?

ANSWER
Innohep® is available both as vials and prefilled syringes, offering flexibility and ease in daily use. A 2ml vial is available with 10,000 anti-Xa IU/ml and can thus be used for a number of dialysis sessions. Some centres prefer to save one vial for additional use in the same patient; others prefer to split the vial between patients. Use of the vial offers the greatest flexibility with individual dose titration.

Simple hygiene procedures should be followed when using a multidose vial. The correct procedure is always to change syringes and needle when a new dose is drawn from the vial, even if it is for the same patient.

Innohep® is available in three sizes of prefilled syringes for haemodialysis: 0.25ml, 0.35ml and 0.45ml in 10,000 anti-Xa IU/ml strength. The syringes are easy and safe to use and easily disposed of. The three sizes offer a practical advantage compared with the multidose vial for patients requiring 2500 anti-Xa IU, 3500 anti-Xa IU or 4500 anti-Xa IU of Innohep® per dialysis session.

QUESTION
12. What about Innohep® excretion?

ANSWER
The main route of elimination of Innohep® is via the kidneys so with impaired renal function, there is a possibility of Innohep® accumulating. However, this is only important when patients are treated with very large doses of Innohep® as in the treatment of deep vein thrombosis or pulmonary embolism. When following the recommended dosages in patients undergoing dialysis Innohep® will not accumulate. The haemodialysis studies done by LEO® is show that long-term use with haemodialysis does not present problems with regards to accumulation.

QUESTION
13. Can patients on NSAIDs be treated with Innohep®?

ANSWER
It is recommended that patients on haemodialysis receiving anticoagulation treatment should, if possible, use analgesics other than NSAIDs.

Innohep® can be used in patients taking NSAIDs, but the Innohep® dose may need to be reduced slightly.

QUESTION
14. What should be done in the event of an overdose?

ANSWER
Severe bleeding that requires neutralisation is very rare.

In case prolonged fistula bleeding, the dose of Innohep® can be reduced in steps of 500 anti-Xa IU at the beginning of the next dialysis until a satisfactory dose is obtained.

In case of severe bleeding Innohep® can be neutralised with protamine sulphate.

The half-life of Innohep® in haemodialysis is 2 hours.
Protamine sulphate neutralises approximately 80% of Innohep® (and 100% of UFH).
1mg of protamine sulphate neutralises 100 anti-Xa IU of Innohep®.

QUESTION
15. Should patients on EPO-treatment receive a higher Innohep® dose?

ANSWER
Patients on erythropoietin (EPO) treatment tend to have elevated haematocrit values. It could be assumed that this correlation would mean higher anticoagulant doses for patients on EPO treatment. However, the correlation is rarely observed in practice because most dialysis patients are treated with EPO.

It is advisable not to adjust the Innohep® dose directly in relation to changes in EPO treatment, but to observe and adjust if necessary.

QUESTION
16. Which anticoagulation parameters should be monitored?

ANSWER
One of the advantages of Innohep® compared with UFH is that no anticoagulation parameters need t

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