Monofer® (ferric derisomaltose)
Abbreviated Prescribing Information - Malaysia
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 (1000mg iron) vials.
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 asan IV bolus injection (up to 500mg in 2 minutes not more than three times a week), or infusion up to 20mg iron/kg body weightonce a week. Doses up to 1000mg must be administered over >15 minutes; dose above 1000mg 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, non-iron deficiency anaemia, iron overload or disturbances in utilisation of iron.
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 immuneor 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, rash, injection site reaction;
Uncommon: Hypersensitivity, headache, paraethesia, dysgeusia, blurred vision, loss of consciousness, dizziness, fatigue, tachycardia, hypotension, hypertension, chest pain, dyspnoea, bronchospasm, abdominal pain,vomiting, dyspepsia, constipation, diarrhoea, pruritus, urticaria, flushing, sweating, dermatitis, hypophosphatemia, back pain, myalgia, arthralgia, muscle spasms, pyrexia, chills/shivering, infection, local phlebitis reaction, skin exfoliation, hepatic enzyme increased; Rare: anaphylactoid/anaphylactic reactions, dysphonia, seizure, tremor, altered mental status, arrhythmia, angioedema, malaise, influenza like illness;Not known: distant skin discoloration.
Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark.
Marketing Authorization Holder:
Compai Healthcare Sdn. Bhd. Unit 501, Block B, Pusat Dagangan Phileo Damansara II, No 15, Jalan 16/11, Off Jalan Damansara, 46350 Petaling Jaya, Selangor Darul Ehsan, Malaysia.
Date of Preparation:
Feb 2022. Further information is available on request to Compai Healthcare Sdn Bhd.