Monofer® (ferric derisomaltose)
Abbreviated Prescribing Information - Singapore
Before prescribing please read full Summary of Product Characteristics.
Risk factors for Iron Deficiency
Ferric derisomaltose is a dark brown, non-transparent solution for intravenous injection/infusion.
Available in 5ml (500mg iron) and 10mL (1,000mg iron) vials. Indications: treatment of iron deficiency when oral iron preparations are ineffective or cannot be used or when there is a clinical need to deliver iron rapidly. The diagnosis must be based on laboratory tests.
Administration & Dosage:
Monofer® may be administered as an IV bolus injection (up to 500 mg in 2 minutes not more than three times a week), or infusion up to 20 mg iron/kg body weight. Doses up to 1,000 mg must be administered over 20 minutes; dose above 1,000 mg must be administered over 30 minutes. Monofer® should only be diluted with sterile 0.9% sodium chloride to a maximum of 20ml for IV bolus injection and up to 500ml for infusion.
Hypersensitivity to the active substance, to Monofer® or any of its excipients, known serious hypersensitivity to other parenteral iron products, non-iron deficiency anaemia, iron overload or disturbances in utilisation of iron and, decompensated liver cirrhosis and hepatitis.
Parenterally administered iron preparations can cause hypersensitivity reactions including serious and potentially fatal anaphylactic/anaphylactoid reactions. The risk is enhanced for patients with known allergies, a history of severe asthma, eczema or other atopic allergy, and in patients with immune or inflammatory conditions. Parenteral iron should be used with caution in case of acute or chronic infection. Monofer® should not be used in patients with ongoing bacteraemia. Hypotensive episodes may occur if intravenous injection is administered too rapidly.
Pregnancy and lactation:
Treatment with Monofer® should be confined to the second and third trimester if the benefit is judged to outweigh the potential risk for both the mother and the foetus.
Common: Nausea, injection site reactions.
Uncommon: Hypersensitivity, headache, paraesthesia, dysgeusia, blurred vision, loss of consciousness, dizziness, fatigue, tachycardia, hypotension, hypertension, chest pain, dyspnoea, bronchospasm, abdominal pain, vomiting, dyspepsia, constipation, diarrhoea, pruritis, urticaria, flushing, sweating, rash, dermatitis, hypophosphatemia, back pain, myalgia, arthralgia, muscle spasms, pyrexia, chills, infection, hepatic enzyme increased. Rare: Anaphylactoid/anaphylactic reactions, dysphonia, seizure, tremor, altered mental status, arrhythmia, angioedema, malaise, influenza like symptoms.
3 years. Manufacturer: Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark.
Marketing Authorization Holder:
Compai Pharma Ptd. Ltd. 18 Duxton Hill, 089601 Singapore.
Date of Preparation:
July 2022. Further information is available on request to Compai Pharma.