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CHHS18/138

Canberra Hospital and Health ServicesClinical Procedure Iron Infusions – Adult Only Contents

Contents....................................................................................................................................1

Purpose.....................................................................................................................................2

Scope........................................................................................................................................ 2

Section 1 – Iron Polymaltose Compound Infusion....................................................................2

Section 2 – Iron Sucrose Infusion..............................................................................................5

Section 3 – Iron Carboxymaltose Infusion.................................................................................8

Section 4 – Monitoring and Adverse Effects...........................................................................10

Implementation...................................................................................................................... 12

Related Policies, Procedures, Guidelines and Legislation.......................................................12

References.............................................................................................................................. 12

Search Terms.......................................................................................................................... 13

Doc Number Version Issued Review Date Area Responsible PageCHHS18/138 1 27/04/2018 01/05/2021 CSS - Pharmacy 1 of 13

Do not refer to a paper based copy of this policy document. The most current version can be found on the ACT Health Policy Register

CHHS18/138

Purpose

The purpose of this procedure is to ensure the safe prescribing and administration of iron polymaltose compound infusion, iron sucrose infusion and iron carboxymaltose infusion in the Canberra Hospital and Health Services (CHHS).

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Scope

This procedure applies to all approved ACT Health staff working within their scope of practice that prescribe, administer or advise on the use of iron infusions in CHHS (Women, Youth and Children Unit excluded).


Section 1 – Iron Polymaltose Compound Infusion

Trade Name Ferrosig®

Action Iron is an essential component of haemoglobin and therefore plays an important role in

the production of red blood cells.

Indication For the in-patient treatment of iron deficiency anaemia or for Hospital-In-The-Home

(HITH) and other outpatient clinic settings when the patient has previously been treated with iron polymaltose under one or more of the following circumstances:o When oral therapy is contraindicated or inappropriate,o When enteric absorption of iron is defective,o When patient non-compliance or persistent gastrointestinal upset makes oral

administration impractical. As an adjunct to erythropoietin therapy in patients with chronic renal impairment –

reduces the erythropoietin requirements of these patients.

Contraindications Previous hypersensitivity to iron polymaltose compound – iron sucrose (Venofer®) may

be a suitable alternative for these patients. Anaemia not caused by simple iron deficiency (e.g. haemolytic anaemia, megaloblastic

anaemia caused by vitamin B12 deficiency, disturbances in erythropoiesis, hypoplasia of the marrow).

Iron overload (e.g. haemochromatosis, haemosiderosis). Acute infectious renal complaints. Decompensated hepatic cirrhosis.



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During the first trimester of pregnancy (should only be administered in the second and third trimester if the benefits of treatment outweigh the risk to the foetus).

As elemental iron tends to accumulate in inflamed tissues parenteral iron should not be given to patients with severe inflammation or infection.

Uncontrolled hyperparathyroidism

Precautions Use with Caution (consult treating Medical Officer (MO)):

o Low iron binding capacity (increased chance of hypersensitivity) o Folic acid deficiency (increased chance of hypersensitivity)o Bronchial asthma (increased chance of hypersensitivity)o Chronic polyarthritis o Infectious hepatitis

Restrictions Iron polymaltose infusions are prepared in the pharmacy department Intravenous (IV)

room. Orders need to be scanned down to the pharmacy department between the hours of 9:00am – 3:30pm. To allow administration of the prepared infusion before midday (see timing of administration) it is recommended that orders be scanned down to pharmacy the day before where practical

Presentation 100mg/2mL ampoule

Prescribing Dose is based on weight and haemoglobin (Hb) of the patient. For patients with a Body

mass Index (BMI) > 30 the dose calculation is based on ideal (not actual) body weight. Use the formula provided or the table below to calculate dose.

Iron Dose = [Weight (kg) x (target Hb – actual Hb (g/L)) x 0.24] + iron depot

Target Hb: Up to 34 kg bodyweight = 130 g/L, 34 kg or over = 150 g/LIron Depot: Up to 34 kg = 15 mg/kg bodyweight, 34 kg or over = 500mg

Example Calculation: Patient weighing 60kg, target Hb = 150 g/L, actual Hb = 60g/L, iron depot = 500mg. Iron Dose = (60 x (150 – 60) x 0.24) + 500mg

≈ 1800mg or 18 ampoules

Haemoglobin (Hb)Body Weight 60 g/L 75 g/L 90 g/L 105 g/L



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(kg) mL amps mL amps mL amps mL amps5 3 1.5 3 1.5 3 1.5 2 1

10 6 3 6 3 5 2.5 4 215 10 5 9 4.5 7 3.5 6 320 13 6.5 11 5.5 10 5 8 425 16 8 14 7 12 6 11 5.530 19 9.5 17 8.5 15 7.5 13 6.535 25 12.5 23 11.5 20 10 18 940 27 13.5 24 12 22 11 19 9.545 30 15 26 13 23 11.5 20 1050 32 16 28 14 24 12 21 10.555 34 17 30 15 26 13 22 1160 36 18 32 16 27 13.5 23 11.565 38 19 33 16.5 29 14.5 24 1270 40 20 35 17.5 30 15 25 12.575 42 21 37 18.5 32 16 26 1380 45 22.5 39 19.5 33 16.5 27 13.585 47 23.5 41 20.5 34 17 28 1490 49 24.5 43 21.5 36 18 29 14.5

Test Dose For iron polymaltose compound infusion a separate test dose is no longer required as

each infusion will be run at a ‘test dose rate’ initially (see Administration below).

Timing of Administration Due to associated risk of anaphylaxis, iron infusions should, if possible, be commenced

before 12 midday on weekdays so that medical staff are available for the majority of the infusion duration.

Line Requirements Iron Poly-maltose should be infused intravenously through a peripheral line.

Administration An emergency trolley and facilities for cardiopulmonary resuscitation must be readily

accessible should a hypersensitivity reaction occur. Two alternative infusion protocols could be considered by Medical Officer:Protocol 1: For 500mL Bag (up to 2500mg):

o 40mL/hr for the first 50mL (takes 75 minutes),o If well tolerated, the rate can be increased to 120mL/hr for the remainder of the

infusion,o Infusion should be given over at least 5 hours.

For 250mL Bag (up to 1250mg):o 20mL/hr for first 25mL (takes 75 minutes),



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o If well tolerated, the rate can be increased to 60mL/hr for the remainder of the infusion,

o Infusion should be given over at least 5 hours.Protocol 2 (accelerated): For 500mL Bag (up to 1500mg):

o 80mL/hr for the first 20mL (takes 15 minutes),o If well tolerated, the rate can be increased to 500mL/hr for the remainder of the

infusiono Infusion should be given over at least 73 minutes

For 250mL Bag (up to 1250mg):o 40mL/hr for first 10mL (takes 15 minutes),o If well tolerated, the rate can be increased to 250mL/hr for the remainder of the

infusiono Infusion should be given over at least 73 minutes

Preparation Iron polymaltose infusions are prepared in the pharmacy department IV room. Doses of 2500mg or less should be diluted in 500mL of sodium chloride (NaCl) 0.9%.

Patients who are fluid restricted can have doses of up to 1250mg diluted in 250mL of sodium chloride (NaCl) 0.9% Stability:o Protect from light (need black bag to hang)o Stable for 24 hours after dilution.


Section 2 – Iron Sucrose Infusion

Trade Name Venofer®



Indication For the treatment of iron deficiency anaemia under one or more of the following

circumstances AND where the patient has experienced a previous sensitivity to iron polymaltose: o When oral therapy is contraindicated or inappropriate,o When enteric absorption of iron is defective,o When patient non-compliance or persistent gastrointestinal upset makes oral

administration impractical.o As an adjunct to erythropoietin therapy in patients with chronic renal impairment –




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Note:There is no data on the safety of Venofer® when used in patients who are allergic to iron polymaltose

Contraindications Previous hypersensitivity to iron sucrose. As elemental iron tends to accumulate in inflamed tissues parenteral iron should not be

given to patients with severe inflammation or infection. Anaemia not caused by simple iron deficiency (e.g. haemolytic anaemia, megaloblastic


Iron overload (e.g. haemochromatosis, haemosiderosis). During the first trimester of pregnancy (should only be administered in the second and

third trimester if the benefits of treatment outweigh the risk to the foetus).

Precautions Use with caution (consult treating MO): In patients with a history of asthma, eczema, other atopic allergies or allergic reactions

to other parenteral iron preparation Chronic polyarthritis In patients with liver dysfunction (e.g. infectious hepatitis) In patients with acute or chronic infection

Restrictions Iron sucrose infusions are prepared in the pharmacy department IV room. Orders need

to be scanned down to the pharmacy department between the hours of 9:00am – 3:30pm.

Presentation 100mg/5mL ampoule

Prescribing The recommended dosage of iron sucrose for the treatment of iron deficiency in

haemodialysis patients receiving erythropoietin therapy is 100 mg of iron. Frequency of dosing should not be more than three times per week.

o 100mg delivered IV into the venous limb of the dialysis line over 2-5 minutes OR,o As an IV infusion diluted in a maximum of 100mL NaCl 0.9% over 15 minutes, during

dialysis session. o Most patients will require a minimum cumulative dose of 1000mg over 10

consecutive dialysis sessions to achieve desired haemoglobin or haematocrit response.

o May continue to administer at lowest dose necessary to maintain target haemoglobin, haematocrit, and iron storage parameters.

Treatment in peritoneal dialysis dependent chronic kidney disease patients



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o 300mg IV infusion in 250mL NaCl 0.9% over 1.5 hours every 14 days for 2 doses followed by,

o 400mg IV infusion in 250mL NaCl 0.9% over 2.5 hours 14 days later (total cumulative dose of 1000mg within a 28-day period).

Treatment in non-dialysis patients200mg IV infusion in a maximum of 100mL NaCl 0.9% over a period of at least 15 minutes. Administer on 5 different occasions over a 14 day period

Dosage has also been administered as two infusions of 500mg in a maximum of 250mL 0.9% NaCl infused over 3.5-4 hours on day 1 and day 14 (limited experience).

Test Dose For iron sucrose infusion in a new patient, a test dose should be given.

o A dose of 20mg (1mL) of iron sucrose should be diluted in a maximum of 20mL sodium chloride 0.9% and infused IV over 15 minutes.

Line Requirements Iron sucrose should be infused intravenously through a peripheral line or as per

haemodialysis instructions above.


accessible should a hypersensitivity reaction occur.

Iron sucrose infusion Patients who are at increased risk of allergic reactions (see Precautions above) may

require premedication 20 minutes prior to infusion Treatment in haemodialysis patients also receiving erythropoietin:

o 100mg delivered IV into the venous limb of the dialysis line over 2-5 minutes OR,o As an IV infusion diluted in a maximum of 100mL NaCl 0.9% over 15 minutes, during

dialysis session. Treatment in peritoneal dialysis, pre-dialysis or non-dialysis patients:

o 300mg IV infusion in 250mL NaCl 0.9% over 1.5 hours every 14 days for 2 doses followed by

o 400mg IV infusion in 250mL NaCl 0.9% over 2.5 hours 14 days later (total cumulative dose of 1000mg within a 28-day period).

o Dosage has also been administered (American practice) as two infusions of 500mg in a maximum of 250mL NaCl 0.9% infused over 3.5-4 hours on day 1 and day 14.

Preparation Iron sucrose infusions are prepared in the pharmacy department IV room. Stability:

o Protect from light (need black bag to hang),



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o Dilute immediately before administration.


Section 3 – Iron Carboxymaltose Infusion

Trade Name Ferinject®



Indication This is a restricted formulary item for patients receiving an iron infusion in an outpatient

setting (Hospital In The Home, renal outpatient clinics, Capital Region Cancer Centre outpatient clinic, Maternity Assessment Unit)

For the treatment of iron deficiency anaemia under one or more of the following circumstances AND where the patient has experienced a previous sensitivity to iron polymaltose:o When oral therapy is contraindicated or inappropriateo When enteric absorption of iron is defectiveo When patient non-compliance or persistent gastrointestinal upset makes oral

administration impracticalo As an adjunct to erythropoietin therapy in patients with chronic renal impairment –


Contraindications Previous hypersensitivity to iron carboxymaltose or any of its excipients. As elemental iron tends to accumulate in inflamed tissues parenteral iron should not be

given to patients with severe inflammation or infection. Anaemia not caused by simple iron deficiency (e.g. haemolytic anaemia, megaloblastic


Iron overload (e.g. haemochromatosis, haemosiderosis). During the first trimester of pregnancy (should only be administered in the second and

third trimester if the benefits of treatment outweigh the risk to the foetus).

PrecautionsUse with Caution (consult treating MO): Liver dysfunction In patients with a history of asthma, eczema, other atopic allergies or allergic reactions

to other parenteral iron preparation Chronic polyarthritis Uncontrolled hyperparathyroidism



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Infectious hepatitis Bronchial asthma (increased chance of hypersensitivity) Low iron binding capacity (increased chance of hypersensitivity) Folic acid deficiency (increased chance of hypersensitivity). Do not administer more than 1000mg of Iron in one week

Restrictions Iron carboxymaltose vials are provided by the pharmacy dispensary. Orders need to be

scanned down to the pharmacy department between the hours of 9:00am – 3:30pm.

Presentation 100mg/2mL and 500mg/10mL glass vials

Prescribing Dose is based on weight and haemoglobin (Hb) of the patient. If patient has been given

a blood transfusion in an attempt to correct the low Hb, use the PRE-transfusion Hb to calculate dose.

Use the formula provided or the table below to calculate dose.Haemoglobin (Hb, g/L) Weight 35-<70kg Weight >70kgLess than 100 1500mg 2000mgEqual or above 100 1000mg 1500mg

Cumulative doses greater than 1000mg must be split into two doses given at least one week apart. Up to a maximum of 1000mg may be given as a single dose per week.

Line Requirements Iron carboxymaltose should be infused intravenously through a peripheral line.


accessible should a hypersensitivity reaction occur.

Iron carboxymaltose infusion IV infusion – Doses of 200-500mg in a maximum of 100mL of NaCl 0.9% and infuse over

6 minutes. Doses of 500-1000mg in a maximum of 250mL of NaCl 0.9% and infuse over 15 minutes.

Can also be given by IV injection - Doses up to 500mg to be given undiluted at maximum rate of 100mg/minute. Inject doses of 500-1000mg over 15 minutes.

Preparation Stability:

o Preparation should be used immediately.o If necessary refrigerate at 2-8 C for no more than 12 hours.



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Section 4 – Monitoring and Adverse Effects

Incompatibilities Incompatible with other drugs and all fluids EXCEPT NaCl 0.9%. Refer to the Australian Injectable Drugs Handbook for up-to-date information.

Monitoring Monitor heart rate, blood pressure, oxygen saturation and temperature at:

o Baseline,o Then every 15 minutes for 1 hour (iron polymaltose protocol 1) or every 5 minutes

for 15 minutes (iron polymaltose protocol 2)o Then every hour until 1 hour post infusion (iron polymaltose protocol 1) or every 15

minutes until 30 minutes post infusion (iron polymaltose protocol 2).

Adverse Effects Patients who are at increased risk of allergic reactions (see Precautions above) may

require premedication 20 minutes prior to infusion:o 100mg IV hydrocortisoneo 12.5 - 25mg IV promethazine

Anaphylactic reactions occur most frequently within the first several minutes of administration.

If signs of allergic reaction or intolerance occur at ANYTIME during the infusion, the infusion MUST be stopped and a medical officer contacted immediately. Immediate adverse effects may include:o Anaphylaxis, o Bronchospasm with dyspnoea,o Faintness, syncope, tachycardia, hypotension, circulatory collapse,o Loss of consciousness.

If any adverse reactions fall into the Medical Emergency Team (MET) criteria, a MET must be called.

Mild allergic reactions (mild rash, itching, no respiratory symptoms, no facial swelling) can be treated with an antihistamine such as promethazine.

For iron polymaltose compound infusion side effects may include:o Central Nervous System: headache, dizziness.o Gastrointestinal: nausea & vomiting (may indicate excessive infusion rate).o Musculoskeletal: joint and muscle pain.o Dermatological: rash, urticaria.o General: flushing, sweating.

For iron sucrose infusion side effects may include:o Cardiovascular: hypotension and collapse, tachycardia and palpitations. o Central Nervous System: transient taste disturbances (metallic taste), headache,

dizziness.



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o Gastrointestinal: nausea & vomiting (may indicate excessive infusion rate), abdominal pain, diarrhoea.

o Musculoskeletal: joint and muscle pain.o Dermatological: rash, urticaria.o General: flushing, sweating, fever, shivering, chest tightness.

Delayed Adverse Effects:o Patients with rheumatoid arthritis and other inflammatory diseases (e.g. ankylosing

spondylitis, lupus erythematosus) may be at particular risk of delayed reactions, including fever and exacerbation or reactivation of joint pain. They may include: Central Nervous System: dizziness. Musculoskeletal: arthralgia, myalgia, sensation of stiffening of arms, legs or face. Haematological: generalised lymphadenopathy. Dermatological: angioneurotic oedema, rash, urticaria. General: chills, fever, chest & back pain.

Interactions Oral iron supplements should not be given concomitantly with parenteral iron. Stop

oral iron supplements before iron infusion and do not restart for one week. Concomitant administration of Angiotensin Converting Enzyme (ACE) inhibitors may

increase the incidence of adverse effects associated with parenteral iron preparations e.g. erythema, abdominal cramps, nausea, vomiting and hypotension.

Refer to an up-to-date interactions resource or Medicines Information (ext. 43333) for comprehensive information.




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Implementation

This procedure will be: Available to all staff via the Policy Register. Communicated to staff via an all staff email and via team meetings. Incorporated into the orientation of affected staff.


Related Policies, Procedures, Guidelines and Legislation

Policies Nursing and Midwifery Continuing Competence Policy Patient Identification and Procedure Matching Policy Consent and Treatment Policy

Procedures Healthcare Associated Infections Clinical Procedure Medication Handling Procedure Peritoneal Dialysis Procedure Intermittent Dialysis Clinical Procedure Renal Replacement Clinical Procedure

Legislation Health Records (Privacy and Access) Act 1997 Human Rights Act 2004 Work Health and Safety Act 2011


References

1. Ferrosig (Iron Polymaltose Injection Product Information: Sigma Pharmaceutical (Australia) Pty Ltd. Available at MIMS Online.

2. The Society of Hospital Pharmacists of Australia (2018) Australian Injectable Handbook 7th Edition. The Society of Hospital Pharmacists of Australia, Collingwood.

3. Newnham, E., Ahmad, I., Thornton, A., and Gibson, P.R. (2006) ‘Safety of iron polymaltose given as a total dose iron infusion’. Internal Medicine Journal. 36: 672-674.

4. NSW Therapeutic Advisory Group (2008) ‘Iron Polymaltose Infusions Discussion Paper’. New South Wales Therapeutic Advisory Group Inc.

5. Iron Polymaltose Compound Infusion (2010) Ballarat Health Services.6. Drug Protocol: Iron polymaltose infusion (2007) Sydney West Area Health Service.7. Iron Infusion (Iron Polymaltose) Guideline (2007) North Coast Area Health Service.8. Venofer (Iron Sucrose) Injection Product Information: Sigma Pharmaceutical (Australia)

Pty Ltd. Available at MIMS Online.



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9. The Society of Hospital Pharmacists of Australia (2018) Australian Injectable Handbook 7th Edition. The Society of Hospital Pharmacists of Australia, Collingwood.

10. Venofer Practice Guidelines. Drug Information Unit Westmead Hospital Pharmacy Department, Sydney.

11. Policies and procedures: Iron Sucrose (Venofer) (2002) Royal Melbourne Hospital.12. DrugDex Evaluation: Iron. (2018). Available at Micromedex Online.13. Iron Sucrose: Drug Information (2018). Available at UpToDate Online.


Search Terms

Iron infusion, iron sucrose, iron polymaltose compound, administration, prescribing, iron (Fe), anaemia, iron carboxymaltose, ferric, ferritin

Disclaimer: This document has been developed by ACT Health, Canberra Hospital and Health Services specifically for its own use. Use of this document and any reliance on the information contained therein by any third party is at his or her own risk and Health Directorate assumes no responsibility whatsoever.

Policy Team ONLY to complete the following:Date Amended Section Amended Divisional Approval Final Approval 18/04/2018 Complete Review and

Consolidation Lisa Gilmore, ED CSS CHHS Policy Committee

This document supersedes the following: Document Number Document NameCHHS 12/139 Iron Polymaltose Compound Infusion CHHS12/147 Iron Sucrose Infusion



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