Please
be noted that currently our PCC, brand Prothrombinex-VF (From National Blood
Centre, Malaysia), is 3-factor PCC, which contains very low (non-therapeutic levels)
of factor VII.
For each
500 units vial :
Component
|
Kcentra / Beriplex
P/N (Canada)
|
Prothrombinex-VF (From
National Blood Centre, Malaysia)
|
Factor II
|
380-800 IU
|
500 IU
|
Factor VII
|
200-500 IU
|
Low level ( ≤ 500 mg ≈ ≤ 0.01 IU )
|
Factor IX
|
400-620 IU
|
~ 500 IU
|
Factor X
|
500-1020 IU
|
~ 500 IU
|
Factor V
|
No info
|
Low level ( ≤ 500 mg )
|
Protein C
|
420-820 IU
|
No info
|
Protein S
|
240-680 IU
|
No info
|
*Factor VII = 50,000 units/mg
Dosing Guide
The dose
for the same indication may be different by brand. Kindly double check product
leaflet
Indication
|
Kcentra / Beriplex
P/N (Canada)
|
Prothrombinex-VF
(From National Blood Centre, Malaysia)
|
||||||||||||||||||||||
Vitamin K antagonist
(VKA) reversal
|
|
From product leaflet
**May not fully
correct INR, higher or repeat doses NOT recommended.
|
||||||||||||||||||||||
Life-threatening
hemorrhage associated with warfarin
(off-label use)
|
With the correction
of vitamin K antagonist-induced impairment of hemostasis in patients who have
been treated concomitantly with an appropriate vitamin K dose, repeat dosing
with PCC is usually not necessary.
|
From UptoDate
Products contain low
or nontherapeutic levels of factor VII component; therefore, additional fresh
frozen plasma (FFP) or factor VIIa may be considered
When immediate INR
reversal is required, concomitant use of 1 to 2 units of FFP should be
considered to ensure acute INR reversal.
Co-administer
vitamin K (phytonadione) 5-10 mg by slow IV infusion; vitamin K may be
repeated every 12 hours if INR is persistently elevated.
|
||||||||||||||||||||||
Intracranial
hemorrhage associated with warfarin
(off-label use)
|
Oral direct factor
Xa inhibitor-mediated (api/rivaro-xaban):
50 IU/kg if ICH occurred within 3-5 terminal
half-lives of drug exposure or when liver failure co-exists.
Direct thrombin
inhibitor-mediated (dabigatran [if idarucizumab unavailable], bivalirudin):
50 IU/kg if direct thrombin inhibitor was administered within a period of 3-5
half-lives prior and there is no evidence of renal failure
OR
there is renal
impairment leading to drug exposure beyond 3-5 half-lives.
|
From UptoDate
Four-factor PCC is
preferred.
Administer with
vitamin K IV
Fixed-dose regimen,
weight based:
·
INR ≥1.4: 50 units/kg; repeat INR
within 15 to 60 minutes and serially every 6 to 8 hours for the next 24 to 48
hours.
·
If INR remains ≥1.4 within the first 24 to 48
hours after initial dose, use FFP (alone) for further correction.
·
For initial reversal, it is suggested to administer PCC alone rather
than combined with FFP or recombinant factor VIIa
|
||||||||||||||||||||||
Life-threatening
hemorrhage associated with NON-vitamin K antagonist anticoagulation
(off-label use)
|
No recommendation as most studies
use 4-factor PCC
However, Eikelboom & Merli
(2016) 3 suggested (for Rivaro/Api-xaban):
|
# From Ref 7
|
Dosage
Guideline of Prothrombinex-VF for Hemophilia B (congenital deficiency of factor
IX)
Indication
|
Desired plasma concentration of factor IX (IU/dL)
|
Dose (IU/kg)
|
Frequency of dosing (per day)
|
Duration of treatment (day)
|
Minor haemorrhage
|
20-30
|
20-30
|
1
|
1-2
|
Moderate-Severe
haemorrhage
|
30-50
|
30-50
|
1-2
|
1-5
|
Minor surgery
*Loading dose
*Maintenance
|
40-60
20-50
|
40-60
15-40
|
-
1-2
|
-
7-10
|
References:
1. Product leaflet: Prothrombinex-VF [ CSL Behring (Australia)
/ National Blood Centre (KL, Malaysia) ]. Revised on 05 March 2015.
2. UptoDate: Drug information: Prothrombin complex
concentrate, 4-factor, unactivated, from human plasma
3. UptoDate: Drug information: Prothrombin complex
concentrate, 3-factor, unactivated, from human plasma
4. Eikelboom J. & Merli G.M. Bleeding with direct
oral anticoagulants vs warfarin: clinical experience. American Journal of Emergency Medicine 34 (2016) 3–8. Accessed
online at: https://www.ajemjournal.com/article/S0735-6757(16)30647-7/pdf
5. Dabi A. & Koutrouvelis A.P. Reversal Strategies
for Intracranial Hemorrhage Related to Direct Oral Anticoagulant Medications. Critical Care Research and Practice,
vol. 2018, Article ID 4907164, 11 pages, 2018. Accessed online at: https://www.hindawi.com/journals/ccrp/2018/4907164/#B51
6. Steiner T et al. Anticoagulant-Associated Intracranial
Hemorrhage in the Era of Reversal Agents. Stroke.
2017;48:1432-1437. DOI: 10.1161/STROKEAHA.116.013343. Accessed online at: https://www.ahajournals.org/doi/pdf/10.1161/STROKEAHA.116.013343
7. Tomaselli GF et al. 2017 ACC Expert Consensus Decision
Pathway on Management of Bleeding in Patients on Oral Anticoagulants: A Report
of the American College of Cardiology Task Force on Expert Consensus Decision
Pathways. J Am Coll Cardiol 2017;Dec 1:[Epub ahead of print]. Accessed online
at: http://www.onlinejacc.org/content/early/2017/11/10/j.jacc.2017.09.1085?_ga=2.153937912.1348582126.1564395594-1295211746.1554257012
8. Tomaselli GF et al. SUMMARY OF 2017 ACC Expert
Consensus Decision Pathway on Management of Bleeding in Patients on Oral Anticoagulants:
A Report of the American College of Cardiology Task Force on Expert Consensus
Decision Pathways. J Am Coll Cardiol 2017;Dec 1:[Epub ahead of print]. Accessed
online at: https://www.acc.org/latest-in-cardiology/ten-points-to-remember/2017/11/29/17/23/2017-acc-expert-consensus-of-bleeding-on-oacs
Updated by J.C.K. Ho on 29/07/2019
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