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.

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.

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;

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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.

3 years.

Pharmacosmos A/S, Roervangsvej 30, DK-4300 Holbaek, Denmark.

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.

Feb 2022. Further information is available on request to Compai Healthcare Sdn Bhd.