ALBUNATE

What it is

Albunate is indicated for restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate. Albunate is supplied in six strengths: 5% (50 g/L) in 250 mL and 500 mL vials; 20% (200 g/L) in 50 mL and 100 mL vials; and 25% (250 g/L) in 50 mL and 100 mL vials, all presented as solutions for intravenous infusion.

Approved indications

— Restoration and maintenance of circulating blood volume where volume deficiency has been demonstrated and use of a colloid is appropriate.

Key safety warnings

Albumin is contraindicated in patients with cardiac failure, pulmonary oedema or severe anaemia. 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, and patients should be carefully monitored for this potential complication. Hypotension has been associated with human albumin solutions, and hypotension following administration of albumin can aggravate myocardial depression when present in patients with shock. The use of albumin for fluid resuscitation of patients with traumatic brain injury is not recommended. Hypersensitivity reactions occur rarely when human albumin solutions are administered because of the human origin of the product. This product is made from human plasma and products made from human plasma may contain infectious agents such as viruses and theoretically Creutzfeldt-Jakob Disease agents.

Contraindications

Albunate 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

Albunate was first listed on the ARTG on 30 July 2015 across six registrations encompassing 5%, 20% and 25% strengths. The TGA approval decision was made on 15 July 2015. The TGA evaluation confirmed that Albunate, a human albumin solution, met European Pharmacopoeia standards, despite its manufacturing process differing from the existing Australian product Albumex, with clinical efficacy and safety supported by a hybrid literature-based submission and extensive post-marketing experience.