MONOFER

What it is

MONOFER is ferric derisomaltose, a dark reddish brown powder containing 24% iron (III). MONOFER is a sterile, dark brown, non-transparent solution with pH 5.0–7.0 containing ferric derisomaltose dissolved in water for injection. Each 1 mL of MONOFER contains 100 mg of iron as ferric derisomaltose.

Approved indications

MONOFER is indicated for the treatment of iron deficiency in adults, under the following conditions: — When oral iron preparations are ineffective or cannot be used — Where there is a clinical need to deliver iron rapidly

Dosing overview

The dose of MONOFER is expressed in mg of elemental iron. The iron need and the administration schedule for MONOFER must be individually established for each patient. The cumulative iron need can be determined using either a simplified table or the Ganzoni formula. It is recommended to use the Ganzoni formula in patients who are likely to require individually adjusted dosing such as patients with anorexia nervosa, cachexia, obesity, pregnancy or anaemia due to bleeding. MONOFER may be administered as an intravenous bolus injection up to 500 mg up to three times a week at an administration rate of up to 250 mg iron/minute. The cumulative iron need required may be administered in a single MONOFER infusion up to 20 mg iron/kg body weight or as weekly infusions until the cumulative iron need has been administered. If the cumulative iron need exceeds 20 mg iron/kg body weight, the dose must be split in two administrations with an interval of at least one week. Doses up to 1000 mg must be administered over 20 minutes. Doses exceeding 1000 mg must be administered over 30 minutes or more.

Key safety warnings

Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions. Hypersensitivity reactions have also been reported after previously uneventful doses of parenteral iron complexes. The risk is enhanced for patients with known allergies including drug allergies, previous severe hypersensitivity to other parenteral iron products, and including patients with a history of severe asthma, eczema or other atopic allergy. MONOFER should only be administered when staff trained to evaluate and manage anaphylactic reactions are immediately available, in an environment where full resuscitation facilities can be assured. The patient should be observed for adverse effects for at least 30 minutes following each MONOFER injection. Hypotensive episodes may occur if intravenous injection is administered too rapidly. Caution should be exercised to avoid paravenous leakage when administrating MONOFER. Paravenous leakage of MONOFER at the injection site may lead to irritation of the skin and potentially long lasting brown discolouration at the site of injection. In patients with compensated liver dysfunction, parenteral iron should only be administered after careful benefit/risk assessment. Parenteral iron administration should be avoided in patients with hepatic dysfunction (alanine aminotransferase and/or aspartate aminotransferase > 3 times upper limit of normal) where iron overload is a precipitating factor, in particular Porphyria Cutanea Tarda (PCT).

Contraindications

MONOFER is contraindicated in hypersensitivity to the active substance, to MONOFER or any of the excipients; non-iron deficiency anaemia (for example, haemolytic anaemia); and iron overload or disturbances in utilisation of iron (for example, haemochromatosis, haemosiderosis).

PBS listing

MONOFER injection 1000 mg in 10 mL is listed on the PBS as a single item with unrestricted access at an ex-manufacturer price of A$245.48. MONOFER injection 500 mg in 5 mL is listed on the PBS as a single item with unrestricted access at an ex-manufacturer price of A$122.74.

Regulatory history

MONOFER was first registered on the ARTG on 4 December 2017, with four strength variants: 100 mg/1 mL, 200 mg/2 mL, 500 mg/5 mL, and 1000 mg/10 mL solutions for injection. In July 2018, PBAC recommended unrestricted listing of MONOFER for iron deficiency anaemia on a cost-minimisation basis with ferric carboxymaltose, with equi-effective doses established. In August 2019, PBAC recommended unrestricted listing of a new 1000 mg/10 mL form and an increase in maximum quantity to 3 with a reduction in repeats to 0 for the existing 500 mg/5 mL solution.