Cifoban (sodium citrate dihydrate)
Cifoban is approved for use in adults and children for regional citrate anticoagulation (RCA) in continuous venovenous haemodialysis (CVVHD), continuous venovenous haemodiafiltration (CVVHDF), sustained low efficiency (daily) dialysis (SLEDD) and therapeutic plasma exchange (TPE) via membrane plasma separation. Cifoban contains the active ingredient sodium citrate dihydrate.
Cifoban is an anticoagulant (a substance that prevents or reduces blood clotting) used during procedures where a patient’s blood is removed from the body, treated and then returned into circulation (extracorporeal blood circuit).
Cifoban is used during regional citrate anticoagulation in the following kidney replacement and plasma exchange therapies:
- Continuous venovenous haemodialysis (CVVHD)
- Continuous venovenous haemodiafiltration (CVVHDF)
- Sustained low efficiency dialysis (SLEDD)
- Therapeutic plasma exchange (TPE).
Anticoagulants are used in these therapies to prolong filter and circuit survival. Coagulation can lead to blockage of lines and clogging of filters. This can make the treatment less effective.
Cifoban is approved for use in adults and children of all ages, except premature babies.
Cifoban is given in hospitals and clinics. It may be used in intensive care, where patients are closely monitored by healthcare professionals.
Cifoban contains the active ingredient sodium citrate dihydrate. Cifoban prevents clotting by binding to and neutralising calcium in the blood. Calcium is needed for blood to clot. Without calcium, blood cannot form clots.
Regional citrate anticoagulation (RCA) is a way to stop blood clotting in machines used to clean the blood (such as dialysis circuits), without affecting clotting in the rest of the body. It is used in systems where blood flows at a low to moderate rate, and where some of the citrate can be removed during the treatment.
The effectiveness and safety of Cifoban were assessed based on medical literature reports analysed and submitted by the sponsor.
Relevant literature was found by searching Embase and PubMed databases. The search identified 577 publications. Some of these publications were considered duplicates or not relevant to the product application and were excluded. A total of 39 publications were included in the application for Cifoban.
Key conclusions from literature
- Sodium citrate dihydrate, for the proposed purpose, has a well-established safety and efficacy profile.
- Blood filter survival time was used to assess filter performance in the main literature studies. Favourable filter performance contributes to more efficient haemodialysis or haemofiltration and this would be expected to translate into improved patient outcomes overall. Studies found filter survival using citrate generally more favourable or not worse when compared to heparin.
- The literature studies reported decreased risk of bleeding with RCA compared to heparin or to no anticoagulation.
- Citrate accumulation has been reported in the literature but was considered unlikely in the absence of severe liver impairment, hypovolaemia (lower than normal blood volume) or hypoxia (low level of oxygen in body tissues). If there is citrate accumulation, it is captured during patient monitoring and dose adjustments may be needed.
- Adverse events reported in the literature included lowering of calcium and magnesium levels in the blood (hypocalcaemia and hypomagnesaemia), increases in sodium and citrate levels (hypernatraemia and citrate accumulation), and changes in blood acidity (metabolic alkalosis and metabolic acidosis).
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Cifoban and the medicine can be registered in Australia.
More detailed information on why the TGA approved Cifoban will be published in the upcoming Australian Public Assessment Report (AusPAR).
For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
This decision summary will not be updated to reflect any subsequent changes and may therefore not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMI for Cifoban can be accessed through the searchable TGA eBusiness Services or ARTG databases.
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PI for Cifoban can be accessed through the searchable TGA eBusiness Services or ARTG databases.
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Cifoban has been supplied as a device in Australia since 2019. Due to a transition to the new European Union Medical Devices Regulation (EU MDR), Cifoban is no longer considered a device and is therefore now required to be registered as a medicine in Australia.