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Monofer

Iron Isomaltoside 1000 (Monofer®­) (total dose infusion)

 

Indication

Management of iron deficiency anaemia in renal patients (NOT haemodialysis patients) where oral iron is ineffective/cannot be used or there is a clinical need to deliver iron rapidly

Dosage and administration

Body Weight (kg)

 

Actual Haemoglobin Concentration (g/L)

60          70          80          90         100        110

40

1100

1000

900

800

700

600

45

1100

1000

900

800

700

600

50

1200

1100

1000

1000

1000

1000

55

1300

1200

1000

1000

1000

1000

60

1400

1200

1100

1000

1000

1000

65

1400

1300

1100

1000

1000

1000

70

1500

1300

1200

1000

1000

1000

75

1600

1400

1200

1000

1000

1000

80

1700

1500

1300

1100

1000

1000

85

1700

1500

1300

1100

1000

1000

90

1800

1600

1400

1100

1000

1000

SHADED DOSES: Divide dose into two for administration as above upper limit of 20mg/kg body weight for total dose infusion.  Allow at least 1 week between infusions.

 

  BOLD DOSES: Doses where patients are less than 50kg so dose  

  cannot be rounded up to 1000mg (>20mg/kg).

 

Administration

Up to 20 mg iron/kg body weight as an intravenous drip infusion over 30 minutes or longer* (If total iron dose exceeds 20 mg iron/kg body weight, dose must be split in two administrations with an interval of at least one week)

 (* taken from SPC for Monofer- this differs from current NHS Lothian IV guide)

Hypotensive episodes may occur if intravenous infusion is administered too rapidly.

Concentration/strength

Add required dose to a bag of sodium chloride 0.9% (usually 100-250mls but maximum of 500mls)

Stability

 

Use reconstituted solution as soon as possible

Reconstitution instructions

Use only sodium chloride 0.9% as an infusion fluid

Additional information

Monitoring

  • BP, pulse and temp at baseline then every 15mins until infusion complete.  If any signs of hypersensitivity or intolerance are detected, the administration must be stopped immediately

 

Side Effects

  • Acute, severe anaphylactoid reactions are very rare. They usually occur within the first few minutes of administration (generally characterised by the sudden onset of respiratory difficulty and/or cardiovascular collapse).
  • Delayed reactions are characterised by arthralgia, myalgia and sometimes fever. The onset varies from several hours up to four days after administration. Symptoms usually last two to four days and settle spontaneously or following the use of simple analgesics.
  • Refer to www.medicines.org.uk for full summary of product characteristics.

 

 

Special Warning and Precautions for Use

  • Patients with a history of asthma, allergic eczema, other atopic allergy, drug allergies or active Rheumatoid arthritis are at increased risk of hypersensitivity reactions.
  • Use with caution in case of acute and chronic infection.

 

Contraindications

  • Non iron deficiency anaemia (e.g. haemolytic anaemia)
  • Iron overload or disturbances in the utilisation or iron (e.g. haemochromatosis, haemosiderosis)
  • Hypersensitivity to the active substance or any of the excipients
  • Known hypersensitivity to other parenteral iron products
  • Decompensated liver cirrhosis and hepatitis

 

Monofer® should not be administered concomitantly with oral iron preparations as the absorption of oral iron will be reduced. Oral iron therapy should not be started until 5 days after the last infusion of Monofer®

 

 

Written by: Sarah MacInnes, Renal Pharmacist

Reviewed by: Sadaf Arshad Renal Pharmacist, Henri Chappelle and Lesley Hay, Anaemia Nurses
Date written: May 2018 Review Date: May 2020

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