Ferric Maltol Treatment Algorithm

Ferric Maltol (Ferracru®) for the treatment of iron deficiency anaemia in inflammatory bowel disease Traffic light classification- Amber 2 Consensus of a local agreement between Primary and Secondary care Secondary care Responsibilities Secondary Fails at least two oral iron salt preparations and HB >9.5g/ dL- see below Start ferric maltol 30mg BD. Hb decreased Stop ferric maltol and consider IV Repeat FBC and ferritin at 1/12 to assess iron- refer to if Hb and ferritin are improving or have anaemia in IBD normalised pathway Hb and ferritin the same or increasing Request primary care to continue prescriptions for ferric maltol and repeat bloods at 3/12. Normalisation of Insufficient rise in Hb Hb and ferritin and ferritin Stop ferric maltol and recheck Refer to secondary care for haematinics in 3/12 consideration of IV iron- refer to anaemia pathway Approved by Nottinghamshire APC: August 2021 Review: August 2024 Ferric maltol inclusion criteria 1. Hb and ferritin failed to normalise with conventional oral iron salts but Hb no less than 9.5 g/dL 2. Deemed intolerant of conventional oral iron salts following an individual patient review by the clinician and side effects are unmanageable by reducing dose e.g: Constipation Diarrhoea Epigastric pain Faecal impaction Gastrointestinal irritation Nausea Exacerbation of IBD Ferric maltol exclusion criteria No previous trial of oral iron salts Hb <9.5 g/dL Haemochromatosis Iron overload syndromes Repeated blood transfusions Secondary care will be responsible for initiating ferric maltol and ensuring that patient is responding after 1 month of treatment prior to transfer to primary care. What increase would you expect over three months? At a dose of 60mg daily, normalisation of Hb and Ferritin would be expected in three months References: BNF accessed online June 2021 Ferraccru Summary of Product Characteristics. Accessed June 2021 Approved by Nottinghamshire APC: August 2021 Review: August 2024 .

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Suomen Lääketilasto 2019
SUOMEN LÄÄKETILASTO S LT FINNISH STATISTICS ON MEDICINES FSM 2019 Keskeisiä lukuja lääkkeiden myynnistä ja lääkekorvauksista vuonna 2019 Milj. € Muutos vuodesta 2018, % Lääkkeiden kokonaismyynti 3 460 5,2 avohoidon reseptilääkkeiden myynti (verollisin vähittäismyyntihinnoin) 2 284 4,4 avohoidon itsehoitolääkkeiden myynti (verollisin vähittäismyyntihinnoin) 357 0,8 sairaalamyynti (tukkuohjehinnoin) 818 9,9 Lääkkeistä maksetut korvaukset 1 551 6,2 peruskorvaukset 316 3,0 erityiskorvaukset 1 029 5,2 lisäkorvaukset 205 17,7 Key figures for medicine sales and their reimburssement in 2019 € million Change from 2018, % Total sales of pharmaceuticals 3,460 5.2 prescription medicines in outpatient care (at pharmacy prices with VAT) 2,284 4.4 OTC medicines in outpatient care (at pharmacy prices with VAT) 357 0.8 sales to hospitals (at wholesale prices) 818 9.9 Reimbursement of medicine costs 1,551 6.2 Basic Refunds 316 3.0 Special Refunds 1,029 5.2 Additional Refunds 205 17.7 Lähde: Fimean lääkemyyntirekisteri, Kelan sairausvakuutuskorvausten tilastointitiedosto. Source: Finnish Medicines Agency, Drug Sales Register; Register of Statistical Information on National Health Insurance General Benefit Payments. SUOMEN LÄÄKETILASTO FINNISH STATISTICS ON MEDICINES 2019 Lääkealan turvallisuus- ja kehittämiskeskus Fimea ja Kansaneläkelaitos Finnish Medicines Agency Fimea and Social Insurance Institution Helsinki 2020 LÄÄKEALAN TURVALLISUUS- KANSANELÄKELAITOS JA KEHITTÄMISKESKUS FIMEA FINNISH MEDICINES AGENCY FIMEA SOCIAL INSURANCE INSTITUTION Lääketurvallisuus Analytiikka- ja tilastoryhmä Pharmacovigilance Section for Analytics and Statistics Mannerheimintie 166 Nordenskiöldinkatu 12 P.O. Box 55 P.O. Box 450 FI-00034 Fimea FI-00056 Kela Finland Finland [email protected] [email protected] Puh. 029 522 3341 Puh. 020 634 11 Tel. +358 29 522 3341 Tel.
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Classification Decisions Taken by the Harmonized System Committee from the 47Th to 60Th Sessions (2011
CLASSIFICATION DECISIONS TAKEN BY THE HARMONIZED SYSTEM COMMITTEE FROM THE 47TH TO 60TH SESSIONS (2011 - 2018) WORLD CUSTOMS ORGANIZATION Rue du Marché 30 B-1210 Brussels Belgium November 2011 Copyright © 2011 World Customs Organization. All rights reserved. Requests and inquiries concerning translation, reproduction and adaptation rights should be addressed to [email protected]. D/2011/0448/25 The following list contains the classification decisions (other than those subject to a reservation) taken by the Harmonized System Committee ( 47th Session – March 2011) on specific products, together with their related Harmonized System code numbers and, in certain cases, the classification rationale. Advice Parties seeking to import or export merchandise covered by a decision are advised to verify the implementation of the decision by the importing or exporting country, as the case may be. HS codes Classification No Product description Classification considered rationale 1. Preparation, in the form of a powder, consisting of 92 % sugar, 6 % 2106.90 GRIs 1 and 6 black currant powder, anticaking agent, citric acid and black currant flavouring, put up for retail sale in 32-gram sachets, intended to be consumed as a beverage after mixing with hot water. 2. Vanutide cridificar (INN List 100). 3002.20 3. Certain INN products. Chapters 28, 29 (See “INN List 101” at the end of this publication.) and 30 4. Certain INN products. Chapters 13, 29 (See “INN List 102” at the end of this publication.) and 30 5. Certain INN products. Chapters 28, 29, (See “INN List 103” at the end of this publication.) 30, 35 and 39 6. Re-classification of INN products.
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Ferric Maltol) Capsules, for Oral Use ------ADVERSE REACTIONS------Initial U.S
HIGHLIGHTS OF PRESCRIBING INFORMATION ------------------------WARNINGS AND PRECAUTIONS----------------------- These highlights do not include all the information needed to use • IBD flare: Avoid use in patients with IBD flare (5.1) ACCRUFERTM safely and effectively. See full prescribing • Iron overload: Accidental overdose of iron products is a leading information for ACCRUFER. cause of fatal poisoning in children under 6. Keep out of reach of children. (5.2) ACCRUFER (ferric maltol) capsules, for oral use --------------------------- ADVERSE REACTIONS------------------------------ Initial U.S. Approval: 2019 Most common adverse reactions (incidence > 1%) are flatulence, diarrhea, constipation, feces discolored, abdominal pain, nausea, -----------------------------INDICATIONS AND USAGE-------------------------- vomiting and abdominal discomfort/distension. (6.1) ACCRUFER is an iron replacement product indicated for the treatment of iron deficiency in adults. (1) To report SUSPECTED ADVERSE REACTIONS, contact [name of manufacturer] at [toll-free phone #] or FDA at 1-800-FDA-1088 or ------------------------DOSAGE AND ADMINISTRATION---------------------- www.fda.gov/medwatch. • 30 mg twice daily on an empty stomach (2.1) • Continue as long as necessary to replenish body iron stores (2.1) ------------------------------DRUG INTERACTIONS------------------------------- • Dimercaprol: Avoid concomitant use. (7.2) ---------------------DOSAGE FORMS AND STRENGTHS---------------------- • Oral Medications: Separate administration of ACCRUFER from Capsules:
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Ferric Maltol 30Mg Hard Capsules (Feraccru®) SMC No
ferric maltol 30mg hard capsules (Feraccru®) SMC No. (1202/16) Shield TX UK Limited 04 November 2016 The Scottish Medicines Consortium (SMC) has completed its assessment of the above product and advises NHS Boards and Area Drug and Therapeutic Committees (ADTCs) on its use in Scotland. The advice is summarised as follows: ADVICE: following a full submission ferric maltol (Feraccru®) is not recommended for use within NHS Scotland. Indication under review: in adults for the treatment of iron deficiency anaemia (IDA) in patients with inflammatory bowel disease (IBD). In a pooled analysis of two phase III studies in IBD patients with IDA who had failed previous treatment with oral ferrous products, there was a significantly greater increase in haemoglobin concentrations after 12 weeks of ferric maltol treatment compared with placebo. The submitting company did not present sufficiently robust clinical and economic analyses to gain acceptance by SMC. Overleaf is the detailed advice on this product. Chairman, Scottish Medicines Consortium Published 12 December 2016 1 Indication In adults for the treatment of iron deficiency anaemia (IDA) in patients with inflammatory bowel disease (IBD). Dosing Information One capsule twice daily, morning and evening, on an empty stomach. Treatment duration will depend on severity of iron deficiency but generally at least 12 weeks treatment is required. The treatment should be continued as long as necessary to replenish the body iron stores according to blood tests. Ferric maltol capsules should be taken whole on an empty stomach (with half a glass of water) as the absorption of iron is reduced when it is taken with food.
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As Ferric Maltol)
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 1. NAME OF THE MEDICINAL PRODUCT Feraccru 30 mg hard capsules 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each capsule contains 30 mg iron (as ferric maltol). Excipient(s) with known effect Each capsule contains 91.5 mg of lactose monohydrate, 0.3 mg of Allura Red AC (E129) and 0.1 mg Sunset Yellow FCF (E 110). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Hard capsule. Red capsule (19 mm long x 7 mm diameter) printed “30”. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Feraccru is indicated in adults for the treatment of iron deficiency. 4.2 Posology and method of administration Posology The recommended dose is one capsule twice daily, morning and evening, on an empty stomach (see section 4.5). Treatment duration will depend on the severity of iron deficiency, but generally at least 12-weeks treatment is required. It is recommended the treatment is continued as long as necessary to replenish the body iron stores according to blood tests. The elderly and patients with hepatic or renal impairment No dose adjustment is needed in elderly patients or patients with renal impairment (eGFR ≥15 ml/min/1.73 m2). No clinical data on the need to adjust the dose in patients with impaired hepatic function and/or renal impairment (eGFR <15 ml/min/1.73 m2) are available (see section 4.4). Paediatric population The safety and efficacy of Feraccru in children (17 years and under) has not yet been established. No data are available Method of administration Oral use.
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Ferric Citrate
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Evolving Evidence-Based Treatment Guidelines for Iron Deficiency Anemia in Inflammatory Bowel Disease: Considerations in Managed Care
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