Iron isomaltoside 1000


Concise Prescribing Info
Indications/Uses
Iron-deficiency anaemia.
Dosage/Direction for Use
Adult : IV Fe need is individualised based on clinical response to treatment including evaluation of Hb, ferritin, transferrin saturation, and concomitant therapy with erythropoiesis stimulating agents. The total cumulative Fe dose can be calculated individually using the following: 1. Ganzoni formula which is based on ideal body weight, target and actual Hb levels, and Fe stores (refer to detailed guidelines for the formula). 2. Simplified table: Fe need: Hb ≥10 g/dL: 50 kg-<70 kg: 1,000 mg; ≥70 kg: 1,500 mg. Hb <10 g/dL: 50 kg-<70 kg: 1,500 mg; ≥70 kg: 2,000 mg. As bolus inj: Up to 500 mg up to 3 times weekly at a rate of 250 mg/minute. As drip infusion: Given as a single infusion (Max 20 mg Fe/kg) or as weekly infusions until cumulative Fe dose is given. If cumulative Fe dose is >20 mg/kg, administer in 2 divided doses with at least 1 week interval. Doses up to 1,000 mg are given over 15 minutes while doses >1,000 mg are given over at least 30 minutes.
Dosage Details
Intravenous
Iron-deficiency anaemia
Adult: Fe need is individualised based on clinical response to treatment including evaluation of Hb, ferritin, transferrin saturation, and concomitant therapy with erythropoiesis stimulating agents. The total cumulative Fe dose can be calculated individually using the following: 1. Ganzoni formula which is based on ideal body weight, target and actual Hb levels, and Fe stores (refer to detailed guidelines for the formula). 2. Simplified table: Fe need: Hb ≥10 g/dL: 50 kg-<70 kg: 1,000 mg; ≥70 kg: 1,500 mg. Hb <10 g/dL: 50 kg-<70 kg: 1,500 mg; ≥70 kg: 2,000 mg. As bolus inj: Up to 500 mg up to 3 times weekly at a rate of 250 mg/minute. As drip infusion: Given as a single infusion (Max 20 mg Fe/kg) or as weekly infusions until cumulative Fe dose is given. If cumulative Fe dose is >20 mg/kg, administer in 2 divided doses with at least 1 week interval. Doses up to 1,000 mg are given over 15 minutes while doses >1,000 mg are given over at least 30 minutes.
Renal Impairment
Patient with chronic kidney disease on haemodialysis: As 50 mg/mL solution: Up to 200 mg with Max dose of 1,000 mg weekly via bolus inj or direct administration into the venous limb of the dialyser during haemodialysis.
Reconstitution
IV bolus inj: Dilute in up to Max 20 mL of sterile 0.9% NaCl. IV infusion: Dilute in up to Max 500 mL of sterile 0.9% NaCl.
Contraindications
Hypersensitivity to Fe isomaltoside or other parenteral Fe products. Non-Fe deficiency anaemia (e.g. haemolytic anaemia), Fe overload or disturbances in Fe utilisation (e.g. haemochromatosis, haemosiderosis), decompensated liver cirrhosis, active hepatitis, ongoing bacteraemia.
Special Precautions
Patients with known allergies including history of severe asthma, eczema or other atopic allergies, immune or inflammatory conditions (e.g. SLE, rheumatoid arthritis), compensated liver disease, porphyria cutanea tarda, acute or chronic infections. Hepatic impairment. Pregnancy and lactation.
Adverse Reactions
Significant: Hypotension (rapid IV inj), hypophosphataemia, local skin irritation or discolouration (extravasation).
Cardiac disorders: Tachycardia, arrhythmia, foetal bradycardia.
Eye disorders: Blurred vision.
Gastrointestinal disorders: Nausea, abdominal pain, vomiting, diarrhoea, constipation, altered taste.
General disorders and admin site conditions: Fever, chills, fatigue, inj site pain and inflammation.
Immune system disorders: Urticaria.
Investigations: Increased hepatic enzymes.
Musculoskeletal and connective tissue disorders: Back pain, cramps, myalgia, arthralgia.
Nervous system disorders: Headache, dizziness, paraesthesia, loss of consciousness.
Respiratory, thoracic and mediastinal disorders: Chest pain, dyspnoea, nasopharyngitis, cough, bronchospasm.
Skin and subcutaneous tissue disorders: Pruritus, rash, sweating, dermatitis.
Vascular disorders: Flushing, hypertension.
Potentially Fatal: Severe hypersensitivity reactions including anaphylactic/anaphylactoid reactions characterised by sudden respiratory difficulty and/or CV collapse.
MonitoringParameters
Monitor Hb, haematocrit, serum ferritin, serum Fe, and total Fe binding capacity every 1-3 months with more frequent monitoring after the course of therapy; blood pressure and heart rate prior, during and after administration. Monitor closely for signs and symptoms of hypersensitivity reactions.
Overdosage
Symptoms: Accumulation of Fe in storage sites leading to haemosiderosis. Management: Symptomatic and supportive treatment. May administer chelating agents.
Drug Interactions
Nephrotoxic effects may be enhanced by dimercaprol. May decrease the absorption of oral Fe salts.
Lab Interference
May cause falsely elevated serum bilirubin values and falsely decreased serum Ca values.
Action
Description: Iron isomaltoside 1000 contains a complex of Fe and carbohydrate moiety where the Fe is tightly bound in a matrix of Fe (III) atoms and isomaltoside pentamers closely resembling the structure of ferritin. The circulating Fe is removed from the plasma by cells of reticuloendothelial system (RES) which split the complex into Fe and isomaltoside 1000. Fe binds to available proteins to form hemosiderin or ferritin, thereby replenishing Hb and depleted Fe stores.
Onset: Therapeutic response: Few days.
Pharmacokinetics:
Absorption: Time to peak plasma concentration: 0.57-1.53 hours (dose dependent).
Distribution: Enters breast milk. Volume of distribution: 3-3.5 L.
Metabolism: Metabolised in the liver and spleen via RES to Fe and isomaltoside.
Excretion: Via urine and faeces (small amounts). Elimination half-life: 1-4 days (dose-dependent).
Storage
Store between 15-30°C. Do not freeze.
ATC Classification
B03A - IRON PREPARATIONS ; Used in the treatment of anemia
References
Anon. Iron Isomaltoside. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 31/05/2019.

Diafer 50 mg/mL Solution for Injection (Pharmacosmos A/S). MHRA. https://products.mhra.gov.uk/. Accessed 31/05/2019.

Joint Formulary Committee. Iron Isomaltoside 1000. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 31/05/2019.

Monofer (Compai Pharma). MIMS Malaysia. http://www.mims.com/malaysia. Accessed 31/05/2019.

Monofer 100 mg/mL Solution for Injection/Infusion (Pharmacosmos A/S). MHRA. https://products.mhra.gov.uk/. Accessed 31/05/2019.

Disclaimer: This information is independently developed by MIMS based on Iron isomaltoside 1000 from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2020 MIMS. All rights reserved. Powered by MIMS.com
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