NHS FORTH VALLEY. Ferinject in Pregnancy

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1 NHS FORTH VALLEY Ferinject in Pregnancy Date of First Issue 23/10/2014 Approved 01/10/2014 Current Issue Date 23/10/2014 Review Date 23/10/2016 Version 1.0 EQIA Yes 23/10/2014 Author / Contact Debbie Forbes Group Committee Final Approval Unit Clinical Governance Meeting This document can, on request, be made available in alternative formats Version rd October, 2014 Page 1 of 6

2 Consultation and Change Record for ALL documents Contributing Authors: Consultation Process: Distribution: Debbie Forbes, Rhona Scott Circulation to all Midwives, Obstetricians, Supervisors Of Midwives, Team Leaders, Clinical Shift Co-ordinators, Department Managers, Unit Service Manager and Head of Midwifery Midwives, Obstetricians, Supervisors Of Midwives, Team Leaders, Clinical Shift Co-ordinators, Department Managers, Unit Service Manager and Head of Midwifery Change Record Date Author Change Version Version rd October, 2014 Page 2 of 6

3 NHS Forth Valley Women & Children s Unit Ferinject in pregnancy 1 Iron deficiency anaemia is the commonest haematological problem in pregnancy. The majority of women can tolerate oral iron but a small percentage of women will require parenteral iron. Ferinject (ferric carboxymaltose) can be used for treatment of iron deficiency anaemia. The diagnosis of iron deficiency must be based on laboratory tests ( Hb, serum iron, serum ferritin, TIBC, MCV, MCH, MCHC) Ferrous fumarate should be used initially if time permits. Where this is not tolerated alternative iron preparations (ferrous sulphate) can be tried. Therapeutic indications for use of Ferinject : Where there is a clinical need to deliver iron rapidly to replenish iron stores Patients who cannot tolerate oral iron therapy Patients who are non-compliant to oral iron In active inflammatory bowel disease where oral iron preparations are ineffective Contra-indications for use of Ferinject: Known hypersensitivity to Ferinject or any of its excipients Anaemia not attributable to iron deficiency Iron overload or disturbances in utilisation of iron Hepatic dysfunction where iron overload is a precipitating factor especially Porphyria Cutanea Tarda (PCT) First trimester of pregnancy Special warnings and precautions for use of Ferinject: Parenteral iron can cause allergic reactions or anaphylaxis which may be potentially fatal. Therefore, facilities for dealing with anaphylaxis and cardiopulmonary resuscitation should be available Hepatic dysfunction: should only be administered after careful risk/benefit assessment Acute or chronic infection: use with caution but should be stopped with ongoing bacteraemia. With chronic infection, a risk/benefit assessment is needed taking into account the suppression of erythropoiesis. Hypotension may occur if injection given too rapidly Allergic reactions, sometimes involving arthralgia, may occur when the recommended dose is exceeded Extravasion at the injection site may cause pain, inflammation, tissue necrosis and brown discolouration of skin. Patients with a history of asthma, eczema or other atopic allergy as they are more susceptible to allergic reaction. Version rd October, 2014 Page 3 of 6

4 NHS Forth Valley Women & Children s Unit Ferinject in pregnancy 2 Dosage and administration: A decision to administer Ferinject should be made by senior medical staff when patient is being seen in ANC or DCU after reviewing blood results. The correct dose should be calculated together with duration of treatment and should be documented clearly in the patient s clinical notes and prescribed by a medical staff or a midwife prescriber. The person prescribing Ferinject should confirm its availability. If the drug is not available it should be ordered from the pharmacy when booking the DCU appointment. The patient should be given an appointment to come to DCU for administration of Ferinject Ferinject should be administered by a midwife or a FY2 doctor in DCU. A standard GP letter to be sent by DCU midwife through external mail on the date of first dose. The total cumulative dose of Ferinject is determined by the Hb and body weight. Please note that it may take several visits to give the total dose as stated in the dosage table below: Hb Patients with body weight 35 kg to <70 kg <100 1,500 mg 2,000 mg 100 1,000 mg 1,500 mg Patients with body weight 70 kg It must be administered by the intravenous (iv) route only: up to a maximum single dose of 1,000mg of iron but not exceeding 15mg per kg body weight Do not administer 1,000 mg of iron (20 ml) more than once a week. The total single dose should not exceed 1000mg of iron given not more than once per week (ie no more than a total of 1 x 20ml ampoule per week). Ferinject should only be given intra-venously by drip infusion. It must not be used for intra-muscular injection. Intra-venous drip infusion It must be diluted only in sterile 0.9% sodium chloride (NaCl) solution and dilution must take place immediately prior to infusion and given as follows; 10ml Ferinject (500mg iron) in maximum 100ml sterile 0.9% NaCl in at least 15 min. 20ml Ferinject (1000mg iron) in maximum 250ml sterile 0.9% NaCl in at least 30 min. Women must be monitored for 30 minutes after administration of the infusion Hb should be taken 4 weeks after the last infusion or on admission to LW if earlier. If required, oral iron therapy should not be started for at least 5 days after the last injection of Ferinject. Version rd October, 2014 Page 4 of 6

5 Forth Valley Acute Operating Division Women & Children s Unit Ferinject in pregnancy 3 Common side effects; Metallic taste Uncommon side effects; Headache, dizziness Hypotension and collapse Tachycardia and palpitations Bronchospasm, dyspnoea Nausea, vomiting Abdominal pain Diarrhoea Pruritis, urticaria, rash, exanthema, erythema Muscle cramps,myalgia Fever, shivering, flushing Chest pain and tightness Injection site: superficial phlebitis, burning, swelling Rare side effects ; Paraesthesia Anaphylactoid reactions, peripheral oedema Fatigue, asthenia, malaise Reduced level of consciousness Light-headed feeling Confusion Angio-oedema Swelling of joints Hyperhydrosis Back pain Effect on pregnancy and lactation: No well-controlled clinical studies are available to date. Animal studies do not indicate direct or indirect harmful effects to pregnancy, fetal development, parturition, post-natal development and the nursing child. Risk/benefit evaluation is nevertheless required Overdose of Ferinject: This can cause acute iron overloading which may manifest itself as haemosiderosis. This should be treated, if required, with an iron chelating agent. Reference: MHRA 50mg Iron per ml solution for injection and Infusion (Approved by UK 2011) September 2014: Review September 2016 or sooner D Forbes, R Scott Version rd October, 2014 Page 5 of 6

6 Publications in Alternative Formats NHS Forth Valley is happy to consider requests for publications in other language or formats such as large print. To request another language for a patient, please contact For other formats contact , text , fax or - Version rd October, 2014 Page 6 of 6

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