GELOFUSINE

What it is

Gelofusine is a 4% colloidal solution of succinylated gelatin (also known as Modified Fluid Gelatin) in physiological saline. Gelofusine contains succinylated gelatin 20.0 g per 500 mL or 40.0 g per 1000 mL, along with sodium chloride, sodium hydroxide, and water for injections. It is manufactured from gelatin derived from bovine material sourced only from BSE-free cattle. The resultant solution is clear, colourless or slightly yellowish. The product contains sulfites.

Approved indications

— Treatment of relative or absolute hypovolaemia and shock. — Prophylaxis of hypotension caused by relative hypovolaemia during induction of epidural or spinal anaesthesia. — Prophylaxis of hypotension due to imminent significant blood loss in a surgical setting. — Procedures involving extracorporeal circulation as a component of priming fluid in combination with crystalloid solutions (e.g. heart-lung machine).

Dosing overview

Total dosage, duration and rate of infusion depend upon the amount of blood or plasma lost and condition of the patient, and will need to be adjusted as necessary by monitoring the usual circulatory parameters such as blood pressure. The first 20–30 mL should be infused slowly and under careful observation to detect anaphylactoid or anaphylactic reactions as early as possible. If haematocrit falls below 25% (or 30% in patients at cardiovascular or pulmonary risk), erythrocytes or full blood should be considered. For significant bleeds, Gelofusine should not be the sole replacement factor used. Before administration, Gelofusine should be warmed to no more than 37°C.

Key safety warnings

Modified fluid gelatin solutions rarely cause allergic (anaphylactic or anaphylactoid) reactions of varying degrees of severity. Due to possible cross-reactions involving the allergen galactose-alpha-1,3-galactose (alpha-Gal), the risk of sensitisation and consequent anaphylactic reaction to gelatin-containing solutions could be highly increased in patients with a history of allergy to red meat and offal or tested positive for anti-alpha-Gal IgE antibodies. Gelofusine has been associated with rare but severe reactions similar to anaphylaxis, and patients should be monitored carefully for relevant symptoms and signs so that product infusion can be stopped and appropriate urgent treatment can be commenced. Gelofusine should be administered with caution to patients at risk of circulatory overload, such as those with right or left ventricular insufficiency, hypertension, pulmonary oedema or renal insufficiency with oliguria or anuria. Gelofusine should only be used if hypovolaemia cannot be sufficiently treated with crystalloids alone, and in severe hypovolaemia colloids are usually applied in combination with crystalloids. Volume overload due to overdose or too rapid infusion must always be avoided, and dosage must be adjusted carefully, particularly in patients with pulmonary or cardiocirculatory problems. As Gelofusine contains no calcium, special attention should be paid to the appearance of symptoms of hypocalcaemia such as tetanie and paraesthesia. During compensation of severe blood losses by infusions of large amounts of Gelofusine, the haematocrit and electrolytes must be monitored, and the dilution effect on coagulation factors should be observed, especially in patients with existing disorders of haemostasis.

Contraindications

Gelofusine is contraindicated in patients with hypersensitivity to gelatin or to any of the excipients, hypersensitivity to galactose-alpha-1,3-galactose (alpha-Gal) or known allergy to red meat, hypervolaemia, hyperhydration, or acute congestive cardiac failure.

Regulatory history

Gelofusine received initial approval on 14 August 1998. The 500 mL injection bottle (ARTG 60644) was first listed on 16 September 1998. The 500 mL injection bag (ARTG 78102) and 1000 mL injection bag (ARTG 78103) were first listed on 23 May 2001.