Protocol for Ferric Carboxymaltose (Ferinject ) Injection Use in Paediatric Services

Transcription

1 Procol for Ferric Carboxymalse (Ferinject ) Injection Use in Paediatric Services Specialty: Paediatric Services Date Approved: 19 th March 2014 Approved by: W&CH Quality & Safety Group Date for Review: February

2 Introduction Ferinject is an intravenous (I.V.) iron preparation; it has proven clinical efficacy in a number of diseases states characterised by iron deficiency, and a well-established safety profile. Mechanism of action The formulation features a non-dextran carbohydrate shell that surrounds a stable polynuclear iron-hydroxide core; this allows release of iron in a controlled manner. Indications It is indicated for the treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. (Unlicensed for children under 14 years of age) Treatment with Ferinject should only be started and reviewed by a Consultant Paediatrician. Dose & Frequency 15 mg/kg * over 30 minutes. *Round doses whenever feasible ( a maximum of 20 mg/kg) the two closest vial sizes of 100 mg (and 500 mg). For patients weighing less than 20 kg, round doses +/- 50 mg. (see calculation example below) For significantly OVERWEIGHT patients, ideal body weight should be used for determining the iron requirement. For ADOLESCENT (of 70 kg and over): A single dose of Ferinject should not exceed 1000 mg of iron (20 ml) per day. Do not administer 1000 mg of iron (20 ml) more than once a week. 2

3 Determination of the cumulative iron dose: The cumulative dose for repletion of iron using ferric carboxymalse is determined based on the patient's body weight and haemoglobin level and must not be exceeded. The following table should be used determine the cumulative iron dose for patients weighing 35 kg and above: Hb (g/l) Patients with body Patients with body weight 35 kg < 70 kg weight 70 kg < 100 1, 500 mg 2, 000 mg 100 1, 000 mg 1, 500 mg A cumulative iron dose of 500 mg should not be exceeded for patient with a body weight < 35 kg. Formulation/Presentation Each 2 ml vial contains 100 mg (= 50 mg in 1 ml) of iron as ferric carboxymalse. Each 10 m vial contains 500 mg (= 50 mg in 1 ml) of iron as ferric carboxymalse. Always CHECK strength (concentration) on label before preparation. Preparation/Administration Intermittent infusion: Draw up dose required and attach an IV-pump extension set and administer over minutes (the dose can be diluted aid administration via pump). Compatibilities Diluents: Sodium Chloride 0.9% Drugs: NOT compatible with other drugs and TPN. 3

4 Dilution: Weight (kg) 7 kg 9.95 kg 10 kg kg 20 kg 34.9 kg 35 kg 70 kg 70 kg beyond (for a check) 15 mg/kg range 100 mg (2 ml) 150 mg (3 ml) 150 mg (3 ml) 300 mg (6 ml) 300 mg (6 ml) 500 mg (10 ml) 500 mg (10 ml) 1000 mg (20 ml) Max mg (20 ml) May be diluted with Sodium Chloride 0.9% up 20 ml 50 ml 50 ml 100 ml 100 ml 200 ml 250 ml 250 ml Calculation example for 23 kg: To prepare the standard intermittent infusion: 23 kg x 15 mg = 345 mg = round up 350 mg. Volume be drawn up from 50 mg in 1 ml vial: 350 mg/50 mg x 1 ml = 7 ml can be diluted up 100 ml with sodium chloride 0.9%. Moniring Best practice ensure outcome, pre-blood levels and a follow-up blood in FOUR weeks time of: ferritin, haemoglobin, serum iron, and transferrin. Facilities for cardio respirary resuscitation and equipment for handling acute anaphylactic/anaphylacid reactions should be available, including an injectable 1:1000 adrenaline solution. Additional treatment with antihistamines and/or corticosteroids should be given as appropriate. Side effects The most commonly reported adverse drug reaction (ADR) is nausea, followed by dizziness, and hypertension. Hypophosphataemia may occur. The most serious ADR is anaphylacid reactions, which are rare. 4

5 References 1. Moore A. Et al (2011). Meta-analysis of efficacy and safety of intravenous ferric carboxymalse (Ferinject ) from clinical trial reports and published trial data. BMC Blood Disorders. 11:4. 2. SPC Ferinject (ferric carboxymalse). The electronic Medicines Compendium (emc). [Online] Ocber [Cited: November 27, 2013.] 3. SPC Ferinject (ferric carboxymalse) Australia. [Online] April [Cited: November 29, 2013.] pdf 4. Ferric Carboxymalse. BNF for Children s.l. : BMJ Group, Pharmaceutical Press and RCPCH Publications Ltd, pp Iron as Ferric Carboxymalse (Ferinject ) Injection Monograph Oxford University Hospitals NHS Trust. 5

6 Direcrate of Women & Child Health Checklist for Clinical Guidelines being Submitted for Approval by Quality & Safety Group Title of Guideline: Name(s) of Author: Chair of Group or Committee supporting submission: Procol for Ferric Carboxymalse (Ferinject ) Injection use in Paediatrics Bhavee Patel Dr Mike Cosgrove Issue / Version No: 1 Next Review / Guideline Expiry: l Details of persons included in consultation process: Paediatric Consultants across ABMU and Nursing staff Brief outline giving reasons for document being submitted for ratification Need for guideline be used both in an outpatient and inpatient setting Name of Pharmacist (mandary if drugs involved): Please list any policies/guidelines this document will supercede: Bhavee Patel n/a Keywords linked document: Ferric Carboxymalse, Ferinject, Paediatrics *Date approved by Direcrate Quality & Safety Group: * File Name: Used locate where file is sres on hard drive 19 th March 2014 W&CH Mgmt * To be completed by Author and submitted with document for ratification Clinical Governance Facilitar 6