ALBUREX

What it is

ALBUREX is a sterile, preservative-free human albumin solution at 4% w/v concentration (40 g/L), which is iso-oncotic with human serum. It has a nominal osmolality of 260 mOsm/kg, is approximately isotonic and has a pH of 6.7 to 7.3. ALBUREX is manufactured from human plasma collected by Australian Red Cross Lifeblood. It is a solution for intravenous infusion.

Approved indications

— Hypovolaemia and shock, particularly when shock is associated with significant hypoalbuminaemia (albumin concentration less than 25 g/L), or when it is clinically desirable to avoid infusion of large volumes of crystalloid solutions. — Hypovolaemia in seriously ill patients with multiple organ failure or systemic capillary leak syndrome following initial resuscitation with crystalloid or synthetic colloid solutions. — Priming fluid for cardiopulmonary bypass surgery in patients with poor left ventricular function and complicating factors such as long bypass time, anaemia or repeat surgery. — Post-operative hypovolaemia following cardiopulmonary bypass when further colloid is required. — Replacement solution in plasma exchange procedures, particularly when the volume exchanged exceeds 20 mL/kg body weight.

Dosing overview

For hypovolaemia and shock, management usually requires intravenous infusion of at least one litre of ALBUREX into an average adult patient, though the total volume required cannot be accurately predicted and depends on factors such as initial extracellular fluid volume deficit and continuing rate of fluid loss. In plasma exchange, the infusion rate should be adjusted to match the rate of removal.

Key safety warnings

Hypersensitivity reactions occur rarely when human albumin solutions are administered. Should an anaphylactic reaction develop, the infusion should be stopped and treatment instituted with adrenaline (epinephrine), hydrocortisone and antihistamines as appropriate. Hypotension has been associated with human albumin solutions and can aggravate myocardial depression when present in patients with shock. Hypotension has also been reported in patients given albumin who are on Angiotensin Converting Enzyme (ACE) inhibitors. Patients with a history of cardiac failure or pulmonary oedema, or those with renal insufficiency, severe or stabilised chronic anaemia or on cardiopulmonary bypass are at special risk of developing circulatory overload if dosage and rate of infusion are not adjusted appropriately, and should be carefully monitored for this complication. The use of ALBUREX for fluid resuscitation of patients with traumatic brain injury is not recommended. ALBUREX is made from human plasma and may contain infectious agents such as viruses and theoretically Creutzfeldt-Jakob Disease (CJD) agents. The risk has been reduced by screening plasma donors, testing for viral markers, and including virus inactivation and removal procedures in manufacturing that are effective against enveloped viruses such as HIV, hepatitis B and C, and the non-enveloped hepatitis A virus.

Contraindications

ALBUREX must not be used if there is a history of allergy to the product. Albumin is contraindicated in patients with cardiac failure, pulmonary oedema or severe anaemia.

Regulatory history

ALBUREX was first approved on 19 May 1997. Six variants of ALBUREX were listed on the Australian Register of Therapeutic Goods on 7 July 2020: ALBUREX 5 AU (5% w/v in 250 mL and 500 mL vials), ALBUREX 20 AU (20% w/v in 50 mL and 100 mL vials) and ALBUREX 25 AU (25% w/v in 50 mL and 100 mL vials).