Anaemia - guideline for the use of Ferrinject® in pregnancy and post partum for the treatment of iron deficiency anaemia Approval Approval Group
Job Title, Chair of Committee
Date
Maternity & Children’s Services Clinical Governance Committee
Chair, Maternity Clinical Governance Committee
3rd October 2014
Change History Version
Date
Author, job title
Reason
1.0
Oct 2008
J Siddall (Consultant Obstetrician)
Trust requirement
1.1
March 2009
J Ablett (Consultant Obstrician)
Amended
2.0
Aug 2011
J Ablett, J Siddall (Consultant Obstetricians)
Review due
2.1
Oct 2013
J Ablett (Consultant Obstrician)
Flowcharts added (appendices 1 & 2)
3.0
Sept 2014
J Ablett, J Siddall (Consultant Obstetricians)
Bi-annual review overdue
Author: Job Title: Policy Lead: Location:
Jane Siddall, Jil Ablett Consultant obstetricians Group Director Urgent Care
Date: Review Date: Version:
October 2014 October 2016 3.0 ratified 3rd october 2014 Mat CG mtg Maternity CG Shared Drive/ Obstetrics & Midwifery/ Medical conditions & complications/ GL783
This document is valid only on date Last printed 04.02.2015 15:01:00
Page 1 of 9
Ferinject in pregnancy & postpartum for treatement of iron deficiency anaemia (GL783)
October 2014
Overview: Ferinject is a Ferric Carboxymaltose infusion which can be used both in pregnancy and post partum for treatment of iron deficiency anaemia. Ferinject can be given as a single dose of up to 1000mg over 15 minutes which makes it suitable for out patient administration. Venofer insert hyperlink should still be used in most cases for postnatal women as these patients can (usually) have the 2 required doses on consecutive days before discharge. Introduction Ferinject® is a Ferric Carboxymaltose infusion, which can be used as second line treatment when oral iron therapy is deemed inappropriate or has failed. This may be due to malabsorption, poor tolerance, unacceptable side effects or where there is a need to correct iron deficiency and ensuing anaemia urgently. The data on Ferinject usage in preganancy is extremely limited. As with Venofer, it is contra-indicated in the 1st trimester of pregnancy. However, Ferinject® is now licenced for use in the second and third trimester of pregnancy. Non metabolised Ferric Carboxymaltose is unlikely to pass into the mother's milk and therefore, Ferinject® is not contraindicated in breast-feeding. Early detection and appropriate management of iron deficiency anaemia may prevent otherwise young and healthy patients from receiving an unnecessary blood transfusion Patients with thalassaemia who are diagnosed with iron deficiency anaemia should be reviewed by a haematologist for appropriate management and treatment. Patients with thalassaemia or sickle cell disease should NEVER routinely receive iron therapy either oral or intravenous. In the absence of any other diagnosis of anaemia, iron deficiency in pregnancy is defined as: Hb < 10.5g/dl
MCV < 80 fl
Serum Ferritin < 15µg/l
MCH < 25 pg
Fe < 11µmol/l Transferrin saturation 66 kg: the calculated cumulative dose is to be rounded up to the nearest 100 mg. Thus the example patient should be prescribed 1100mg Ferinject.
Author: Job Title: Policy Lead: Location:
Jane Siddall, Jil Ablett Consultant obstetricians Group Director Urgent Care
Date: Review Date: Version:
October 2014 October 2016 3.0 ratified 3rd October 2014 Mat CG mtg Maternity CG Shared Drive/ Obstetrics & Midwifery/ Medical conditions & complications/ GL783
This document is valid only on date Last printed 04.02.2015 15:01:00
Page 3 of 9
Ferinject in pregnancy & postpartum for treatement of iron deficiency anaemia (GL783)
October 2014
Dosage Tables Increase in Hb required (g/dl) Body Weight
1
2
3
4
5
50
6
7
8
9
11
55
6
7
8
10
11
60
6
7
9
10
12
65
6
8
9
11
12
70
7
9
11
12
14
75
7
9
11
13
14
80
7
9
11
13
15
85
8
10
12
14
16
90
8
10
12
14
16
95
8
10
12
15
17
100
8
10
13
15
17
Kg
Dose of Ferinject = number of 100mg vials (see table above) for required Hb increase NB max dose Ferinject = 1000mg / week (15mg/Kg) as a single dose Max dose Venofer = 600mg as 3 divided doses per week
Ferinject can be given in single doses of up to a maximum of 1000mg per week(15mg/Kg/week). The maximum dose of Venofer which can be given is 600mg in 3 divided doses. A repeat FBC should be taken 7-14 days after adequate treatment is given. This should show a rise in Hb in most women, but a rise in MCV and MCH is indicative that treatment is working and iron is being taken up into the red blood cells. A repeat FBC should then show improvement in Hb after a further 7 days. Serum Ferritin should also be taken to indicate the state of the iron stores and whether further treatment is required to replenish these. The safety profile for Ferinject is similar to that of Venofer. The most common side effects are headache (3%), gastrointestinal symptoms and rash. Anaphylaxis is very rare making it a safe preparation to use, though it is recommended that hydrocortisone, chlorpheniramine and adrenaline be available in case of a severe reaction. Ferinject use must be discussed with a Consultant. However, we have sent authorisation to Pharmacy, so that it may now be prescribed by all doctors. It can be drawn up and administered by midwives, and should be given in Day Assessment Unit, on Delivery Suite or Marsh and Iffley Wards. Author: Job Title: Policy Lead: Location:
Jane Siddall, Jil Ablett Consultant obstetricians Group Director Urgent Care
Date: Review Date: Version:
October 2014 October 2016 3.0 ratified 3rd October 2014 Mat CG mtg Maternity CG Shared Drive/ Obstetrics & Midwifery/ Medical conditions & complications/ GL783
This document is valid only on date Last printed 04.02.2015 15:01:00
Page 4 of 9
Ferinject in pregnancy & postpartum for treatement of iron deficiency anaemia (GL783)
October 2014
Post Natal Iron therapy Post partum use of Ferinject or Venofer may be indicated and may avoid transfusion in some cases. The dose may be calculated in the same way and with treatment, increases in Hb of 2-3g by day 14 may be achieved. The Venofer can be given on sequential days if required (max 600mg/week) and then oral iron given at discharge.
Recommendations for treatment with iron or blood usage
If symptomatic and Hb < 80g/l, transfuse. Aim to increase Hb to 80g/l only (1 unit is OK) If post natal Hb > 70 g/l and patient asymptomatic and not at significant risk of further haemorrhage, consider Venofer/ Ferinject If post transfusion Hb > 80 g/l and well, consider Venofer/ Ferinject If Hb > 90 g/l and well, for oral iron. If symptomatic, consider Venofer/Ferinject, rather than transfusion Ferinject should be used in place of Venofer for antenatal women who are outpatients, where the convenience of a single dosing regimen would be advantageous. It may also be used for postnatal women whose discharge would otherwise be delayed, waiting for repeat doses of Venofer. Venofer should still be used in most cases for postnatal women as these patients can (usually) have the 2 required doses on consecutive days before discharge.
Follow up FBC need to be arranged with the GP or community midwives for 7 days after treatment. Please ask the CMW to check the Hb at the routine 10 day post natal visit to ensure adequate treatment has been given and write on the discharge summary
Author: Job Title: Policy Lead: Location:
Jane Siddall, Jil Ablett Consultant obstetricians Group Director Urgent Care
Date: Review Date: Version:
October 2014 October 2016 3.0 ratified 3rd October 2014 Mat CG mtg Maternity CG Shared Drive/ Obstetrics & Midwifery/ Medical conditions & complications/ GL783
This document is valid only on date Last printed 04.02.2015 15:01:00
Page 5 of 9
Ferinject in pregnancy & postpartum for treatement of iron deficiency anaemia (GL783)
October 2014
Guideline for infusion of Ferinject® Equipment required: Ferinject doses up to 1000mg in 50mls Normal Saline 0.9% given over 15 minutes •
1 x steret
•
1 x 21 gauge butterfly (blue)
•
Tape or cannula dressing
•
Vacutainer blood bottles
•
FBC
•
2 x white needle
•
1 x 5ml syringe
•
5mls Normal Saline (to flush cannula)
•
1 x 10ml syringe
•
Ferinject doses up to 1000mg
•
Normal Saline 50mls
•
Giving set (appropriate giving set if using a pump)
•
Gauze
Procedure for administration of Ferinject ® infusion: Baseline observations: •
Prepare infusion of Ferinject®
•
Prepare skin with alcohol steret
•
Insert 22 gauge venflon (blue)
•
Secure cannula in position with tape or cannula dressing
•
Take blood samples from cannula
•
Flush with 2mls Normal Saline
•
Connect infusion of Ferinject® and infuse at pump rate of 210 ml/hr
Observe patient for any adverse events Remove cannula, apply pressure, extend and elevate the arm Post injection observations: Intravenous Chlorpheniramine, Hydrocortisone and Adrenaline should be available for immediate use in the event of a severe adverse drug reaction. Author: Job Title: Policy Lead: Location:
Jane Siddall, Jil Ablett Consultant obstetricians Group Director Urgent Care
Date: Review Date: Version:
October 2014 October 2016 3.0 ratified 3rd October 2014 Mat CG mtg Maternity CG Shared Drive/ Obstetrics & Midwifery/ Medical conditions & complications/ GL783
This document is valid only on date Last printed 04.02.2015 15:01:00
Page 6 of 9
Ferinject in pregnancy & postpartum for treatement of iron deficiency anaemia (GL783)
October 2014
References 1. Breymann C. Iron Supplementation during Pregnancy. Fetal and Maternal Medicine Review 2002; 13:1-29 2. Perewusnyk R. et al. Parentral Iron Therapy in Obstetrics: 8 years experience with iron-sucrose complex. British Journal of Nutrition 2002; 88, 3-10 3. Fernandes-Ballart J. Iron Metabolism during Pregnancy. Clin Drug Invest 2000; 19:9-19 4. Bayoumeu F. et al. Iron Therapy in Iron Deficiency Anaemia in Pregnancy: Intravenous Route Versus Oral Route. Am J Obstet & Gynae 2002:186, (3) 5. Al-Momen A. et al. Intravenous Iron Sucrose Complex in the Treatment of Iron Deficiency Anaemia during Pregnancy. Eur J Obstet & Gynae & Repro Bio. 69 (1996) 121-124 Appendix 1
Author: Job Title: Policy Lead: Location:
Jane Siddall, Jil Ablett Consultant obstetricians Group Director Urgent Care
Date: Review Date: Version:
October 2014 October 2016 3.0 ratified 3rd October 2014 Mat CG mtg Maternity CG Shared Drive/ Obstetrics & Midwifery/ Medical conditions & complications/ GL783
This document is valid only on date Last printed 04.02.2015 15:01:00
Page 7 of 9
Ferinject in pregnancy & postpartum for treatement of iron deficiency anaemia (GL783)
October 2014
Appendix 2
Monitoring: The audit team that will audit the above auditable standards will be formed by: A midwife and/or a doctor and/or a maternity support worker Audit and quality midwife A clinical audit facilitator / assistant The audit will compare results with previous audits, if applicable. The audit will review documentation stated in the maternal health records as evidence of compliance with standards. The table below shows the plan to follow based on the audit results obtained. This would be subject to earlier re-audit if concerns are raised from risk management about this particular topic. Continuous and prospective audits might override this plan.
Results
Risk
Minimum Plan
Priority If < 75% compliance
1 If ≥ 75% compliance and results ≤ than previous audit (when applicable) Author: Job Title: Policy Lead: Location:
Jane Siddall, Jil Ablett Consultant obstetricians Group Director Urgent Care
2
Implement action plan and re-audit within 3 months from completion of report Implement action plan and re-audit within 6 months from completion of report Date: Review Date: Version:
October 2014 October 2016 3.0 ratified 3rd October 2014 Mat CG mtg Maternity CG Shared Drive/ Obstetrics & Midwifery/ Medical conditions & complications/ GL783
This document is valid only on date Last printed 04.02.2015 15:01:00
Page 8 of 9
Ferinject in pregnancy & postpartum for treatement of iron deficiency anaemia (GL783)
If ≥ 75% compliance and results ≥ than previous audit (when applicable)
October 2014
Implement action plan and re-audit next financial year from completion of report
3
The results will be disseminated depending on the risk priority.
Risk
Dissemination
Priority Reported in Maternity Audit Forum
1
Uploaded in Maternity Intranet page RBHFT Maternity Newsletter Special measures identified in action plan Summary reported in Maternity Audit Forum
2
Uploaded in Maternity Intranet page RBHFT Maternity Newsletter Summary reported in Maternity Audit Forum
3
RBHFT Maternity Newsletter
The dissemination on results and implementation of action plans and timely re-audit will be coordinated by the Audit and Quality Midwife and reported to the Maternity Clinical Audit Committee on a quarterly basis. This committee reports to Maternity Clinical Governance quarterly.
Author:
Jane Siddall October 2008.
Reviewed:
Jill Ablett (amended) March 2009 and August 2011, Oct 2013 added flowcharts, September 2014
Review due:
October 2016
Author: Job Title: Policy Lead: Location:
Jane Siddall, Jil Ablett Consultant obstetricians Group Director Urgent Care
Date: Review Date: Version:
October 2014 October 2016 3.0 ratified 3rd October 2014 Mat CG mtg Maternity CG Shared Drive/ Obstetrics & Midwifery/ Medical conditions & complications/ GL783
This document is valid only on date Last printed 04.02.2015 15:01:00
Page 9 of 9
