Product Dossier
ALBUMEX
Product Dossier for ALBUMEX (Albumin (human), CSL Behring). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: CSL Behring
- Active ingredient: Albumin (human)
- Therapeutic area: Haematology
- Same area: REVOLADE
- Same area: NOVICRIT
What it is
Albumex is a sterile, preservative-free 4% w/v human albumin solution which is iso-oncotic with human serum. It is manufactured from human plasma collected by Australian Red Cross Lifeblood. It is prepared using predominantly chromatographic techniques. Albumex is presented as a solution for intravenous infusion.
Approved indications
— Hypovolaemia or shock associated with significant hypoalbuminaemia (albumin concentration less than 25 g/L), or when it is clinically desirable to avoid the infusion of large volumes of crystalloid solutions. — Hypovolaemia in seriously ill patients with multiple organ failure or the systemic capillary leak syndrome following initial resuscitation with crystalloid or synthetic colloid solutions. — Priming the pump for cardiopulmonary bypass surgery for patients with poor left ventricular function, and other complicating factors such as long bypass time, anaemia or repeat surgery. — Post-operative hypovolaemia if further colloid is required after a moderate amount of synthetic colloid has been given, or there is ongoing bleeding or anaemia. — Replacement solution in plasma exchange procedures, particularly when the volume exchanged exceeds 20 mL/kg body weight.
Dosing overview
For hypovolaemia and shock, the management usually requires the intravenous infusion of at least one litre of Albumex into an average adult patient. The total volume required cannot be accurately predicted, since it depends on factors such as the initial extracellular fluid volume deficit and the 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. Patients with a history of cardiac failure or pulmonary oedema, or who have renal insufficiency, severe or stabilised chronic anaemia, or are on cardiopulmonary bypass are at special risk of developing circulatory overload if the dosage and rate of infusion are not adjusted to the patient's circulatory situation. At the first clinical signs of circulatory overload (headache, dyspnoea, jugular vein congestion), or increased blood pressure or raised venous pressure associated with pulmonary oedema, the infusion is to be stopped immediately. The use of Albumex for fluid resuscitation of patients with traumatic brain injury is not recommended. A post hoc analysis found that, when comparing albumin with saline for intravascular fluid resuscitation in the ICU, higher mortality rates were observed among patients with severe traumatic brain injury (Glasgow Coma Score 3 to 8) who received 4% albumin than among those who received saline.
Contraindications
Albumex must not be used if there is a history of allergy to this product. Albumin is contraindicated in patients with cardiac failure, pulmonary oedema or severe anaemia.
Regulatory history
Albumex 4 containing 2 g/50 mL and 20 g/500 mL were first listed on the ARTG on 19 May 1997. Albumex 4 containing 10 g/250 mL was first listed on 9 March 2000.