IntravenousIron-deficiency anaemiaAdult: In cases when oral Fe therapy is ineffective or cannot be used, and when there is a need to deliver Fe rapidly: As solution for inj or infusion containing 100 mg Fe as ferric derisomaltose/mL: Dosage may be determined using a simplified table based on patient's Hb level and body weight (refer to local product information for the detailed dosing table). Alternatively, the dosage may be calculated using the Ganzoni formula, iron need (mg) = body weight (kg) x (target Hb [g/dL] - actual Hb [g/dL]) x 2.4 + Fe stores (mg). The Fe stores are ≥500 mg in patients with >35 kg body weight; however, some guidelines suggest using 10-15 mg Fe/kg body weight. Doses via bolus inj: Administer up to 500 mg 1-3 times weekly at a Max rate of 250 mg/minute. A single IV bolus inj must not exceed 500 mg Fe. Doses via infusion: Given as a single infusion (Max of 20 mg/kg) or as weekly infusions until the cumulative Fe dose is administered. If the cumulative Fe dose is >20 mg/kg, administer in 2 divided doses with at least 1 week interval. IV infusion doses of ≤1,000 mg are given over at least 15 minutes and doses >1,000 mg are given over at least 30 minutes. All doses are expressed in mg of elemental Fe. Re-assess Hb levels at least 4 weeks after the last administration, then recalculate the Fe need if the patient requires further Fe repletion. Dosage recommendations may vary between countries and individual products (refer to specific product or local official guidelines).
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As 100 mg/mL solution for inj or infusion: IV bolus inj: May dilute in up to 20 mL NaCl 0.9% solution. IV infusion: May dilute in Max of 500 mL NaCl 0.9% solution to prepare a final concentration of ≥1 mg Fe/mL. Doses may also be given undiluted.
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Hypersensitivity to ferric derisomaltose or other parenteral Fe preparations. Non-Fe deficiency anaemia (e.g. haemolytic anaemia); Fe overload or disturbances in Fe utilisation (e.g. haemochromatosis, haemosiderosis); ongoing bacteraemia; decompensated liver cirrhosis or active hepatitis.
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Patient with known allergies, including drug allergy and history of severe asthma, eczema or other atopic allergy; immune or inflammatory conditions (e.g. SLE, rheumatoid arthritis); acute or chronic infection; compensated liver dysfunction. Avoid extravasation. Avoid in hepatic dysfunction (ALT or AST >3 times the ULN) where Fe overload is a precipitating factor, particularly in porphyria cutanea tarda. Elderly. Pregnancy and lactation.
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Significant: Fe overload (particularly if excessive Fe doses are given); hypersensitivity reaction which may result in Kounis syndrome; local skin irritation or discolouration (if extravasation occurs), hypotension (particularly if given via rapid IV inj).
Cardiac disorders: Tachycardia, chest pain.
Eye disorders: Blurred vision.
Gastrointestinal disorders: Nausea, vomiting, constipation, diarrhoea, abdominal pain, dyspepsia, dysgeusia.
General disorders and administration site conditions: Fatigue, pyrexia, chills; inj site reactions (e.g. erythema, swelling, pain, burning sensation, bruising).
Investigations: Increased hepatic enzymes.
Metabolism and nutrition disorders: Hypophosphataemia.
Musculoskeletal and connective tissue disorders: Myalgia, arthralgia, back pain, muscle spasm.
Nervous system disorders: Headache, dizziness.
Respiratory, thoracic and mediastinal disorders: Dyspnoea, bronchospasm.
Skin and subcutaneous tissue disorders: Rash, pruritus, urticaria, sweating, dermatitis.
Vascular disorders: Hypertension, flushing.
Potentially Fatal: Serious hypersensitivity reactions, including anaphylactic or anaphylactoid reactions.
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Monitor Hb, haematocrit, serum ferritin and transferrin saturation during treatment; blood pressure during and after infusion. Closely monitor for signs and symptoms of hypersensitivity reactions during and for at least 30 minutes after each administration. Observe for signs of extravasation.
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Symptoms: May cause Fe accumulation in storage sites resulting in haemosiderosis and haemochromatosis. Management: Supportive treatment. May administer chelating agents and monitor Fe parameters (e.g. serum ferritin).
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May decrease the absorption of oral Fe.
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May cause falsely increased serum bilirubin or falsely reduced serum Ca levels.
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Description: Mechanism of Action: Ferric derisomaltose is a complex of iron (III) hydroxide and derisomaltose. It is metabolised through the reticuloendothelial system (RES) that divides the complex into Fe and derisomaltose. Once the Fe is released from the complex, the Fe binds to transferrin allowing transport to erythroid precursor cells for incorporation into Hb. Synonym(s): Iron isomaltoside 1000; iron (III) isomaltoside 1000. Onset: Therapeutic response: Few days. Pharmacokinetics: Absorption: Time to peak plasma concentration: 0.57-1.53 hours. Distribution: Enters breastmilk. Volume of distribution: 3-3.5 L. Metabolism: Metabolised in the liver and spleen via the cells of RES into Fe and derisomaltose. Excretion: Via urine and faeces (small amounts of Fe). Elimination half-life: 1-4 days.
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B03A - IRON PREPARATIONS ; Used in the treatment of anemia
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A. Menarini New Zealand Pty Limited. Monofer 100 mg/1 mL, 200 mg/2 mL, 500 mg/5 mL, and 1,000 mg/10 mL Solution for Injection Vial data sheet 01 December 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 20/06/2024. Anon. Ferric Derisomaltose. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 20/06/2024. Ferric Derisomaltose Pharmacosmos 100 mg/mL Solution for Injection/Infusion (Pharmacosmos A/S). MHRA. https://products.mhra.gov.uk. Accessed 20/06/2024. Iron Isomaltoside [Ferric Derisomaltose]. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 20/06/2024. Joint Formulary Committee. Ferric Derisomaltose (Iron Isomaltoside 1000). British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 20/06/2024. Monofer 100 mg/mL Solution for Injection/Infusion (Compai Healthcare Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 20/06/2024. Monofer Solution for Injection or Infusion 100 mg/mL (Compai Pharma Pte Ltd). MIMS Singapore. http://www.mims.com/singapore. Accessed 16/08/2024. Monoferric Injection, Solution (Pharmacosmos Therapeutics Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 20/06/2024.
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