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IRON DEFICIENCY ANEMIA OVERVIEW WITH
FOCUS ON PARENTRAL IRON THERAPY
: DGF CME 30TH December 2023
1
Prevalence of anemia in pregnant women
Data 2019
WHO 2023
India – 50.1%
(44.2-54.2%)
Anemia: Global Burden
WHO. The global prevalence of anaemia in 2011. Geneva: World Health Organization;2015.
Anemia affects around 2 BILLION Peaple globally
Level of public health
significance:
Severe
3
Anemia : Prevalence
• Worldwide almost 2 BILLION people are living with anemia1
• Prevalence of anemia in
• Global:
• 41.8% ∼ pregnant women1
• India:
• Pregnant women age 15-49 years - 52.2%
• Non-pregnant women age 15-49 years- 57.2 %
• All women age 15-49 years - 59.1 %2
1. WHO. Worldwide prevalence of anaemia,1993–2005. 2008 2. MoHFW. NFHS-5, 2019-21. India Fact Sheet. 2021 4
Definitions
Anemia During Pregnancy
Hemoglobin (gm/dl)
CDC <11 ( 1st trimester)
<10.5 (2nd trimester)
<11 (3rd trimester)
WHO <11
Postpartum Anemia
Hemoglobin (gm/dl)
WHO <10
FIGO <11
UK guideline <10
WHO classification of severity of anemia in adult females
[ Hemoglobin in gm/dl]
Mild Moderate Severe
Non pregnant
women(age >15
years or above)
11–11.9 8–10.9 < 8
Pregnant women 10–10.9 7–9.9 < 7
Indian J Hematol Blood Transfus. 2018:1-2. 5
Milman N Ann Hematol 2006; 85(9):559-565 Indian J Hematol Blood Transfus. 2018:1-2.
Total Iron requirement in Pregnancy
Total iron requirement during singleton pregnancy: 1000 to 1200 mg.
• The average daily requirement
of iron has been calculated as
0.8 mg/d in the first trimester
and increases to 7.5 mg/day in
the third trimester.
• The average daily absorption
from:
Western diet  1–5 mg/day
Indian diet  0.8 - 4.5 mg/day
6
Consequences of Iron Deficiency Anemia
Pregnancy complications
• Increased risk of preterm delivery
• Premature rupture of membranes
• Pre-eclampsia
• Intrauterine Death
• Inter-current infection
• Antepartum haemorrhage
• Congestive Heart Failure
Fetal complications
• Low birth weight
• Prematurity
• Infections
• Congenital malformation
• Neonatal Anemia
• Abnormal cognitive development
Maternal anemia contributes to 18% of
perinatal mortality and 20% of maternal
mortality in South Asian countries including
India
• Indian J Hematol Blood Transfus. 2018:1-2.
• Kumar A, et al. BMJ Open Gastro 2022;9:e000759.
• Reduced blood oxygen levels leads to-
- Shortness of breath, fatigue,
palpitations, tachycardia and angina
• Resultant hypoxemia-
- Nausea, weight loss and abdominal
pain.
• Central hypoxia –
- headaches, vertigo and lethargy as
well as cognitive impairment
7
Diagnosis of Iron Deficiency Anemia
• History and clinical examination
• CBC:
 Hemoglobin, RBC count, hematocrit, reticulocyte count
 MCV & RDW :IDA is characterised by Low MCV, Low MCH
 A combination of low MCV accompanied by elevated RDW can be used as a sufficient evidence to start iron
therapy
 RDW – decreased in Thalassemia
 Iron supply Study:
• Serum iron , TIBC, transferrin saturation : unreliable markers
 Serum iron shows diurnal variation and is affected by dietary influences
 Pregnancy itself increases total iron binding capacity (TIBC) even in the absence of IDA
 Ser. Ferritin - cut off 30 µg/dl to diagnose and treat ID in pregnancy
 Peripheral Blood Smear
 Bone marrow Examination
RDW –Red cell distribution width, MCV-Mean corpuscular volume, MCH-Mean Corpuscular Hemoglobin, TIBC – Total Iron Binding Capacity
• Indian J Hematol Blood Transfus. 2018:1-2.
8
First level of treatment
Two tablets of iron and folic acid tablet (100 mg elemental
iron and 500 mcg folic acid) daily for 6 months
Parental iron (IV Iron Sucrose or FCM) may be considered as
the first line of management in pregnant women who are
detected to be anemic late in pregnancy or in whom
compliance is likely to be low (high chance of lost to follow-up).
If no improvement, after
first level of treatment
• Referral to higher health facility
• The case may be managed with IV Iron Sucrose/Ferric
Carboxymaltose
Anemia Mukt Bharat Guidelines 2018
Anemia management protocol for Pregnant women
MoHFW, Govt of India. Anemia Mukt Bharat Operational Guidelines Intensied National Iron Plus Initiative, 2018
First level of treatment
Immediate hospitalization if it is the third trimester of
pregnancy where round-the-clock specialist care is available
The treatment will be done using IV Iron Sucrose/Ferric
Carboxymaltose by the medical officer.
Mild anemia
(Hb 10-10.9g/dL)
&
Moderate anemia
(7-9.9 g/dL)
Severe anemia
(Hb 5-6.9 g/dL)
13
Indications
• Failure of oral iron therapy
• Non-compliance or intolerance to oral iron
• Late second or third trimester with moderate to
severe IDA
• Rapid rectification of anemia and repletion of iron
stores expected
• Malabsorption (e.g. Bowel-resection/Celiac disease)
• Bleeding diathesis when hemorrhage is likely to
continue
Contraindications
• Gestation period < 12 weeks
• Lack of facilities for resuscitation
• Known history of anaphylaxis or
reactions to parenteral iron
• Known state of iron overload
IV iron therapy is superior to oral iron in terms of speed and absolute extent of
rise in hemoglobin and replenishment of iron stores
Indian J Hematol Blood Transfus. 2018:1-2. Arch Gynecol Obstet. 2017 Dec;296(6):1229-1234
Indications Of Parenteral Iron Therapy
10
Evolution of Parenteral
Iron Therapy
11
Fe(OH)3
1932
Iron
Sacchride
1947
HMW
ID
1954
First IV
Iron
Paper
in the
US
LMW
ID
1991
DexFerrum
1996
Ferric
gluconate
1999
Iron
Sucrose
2000
Ferumoxytol
2009
Ferric
Carboxymaltose
2013
Iron
isomaltoside
2020
Hematology Am Soc Hematol Educ Program. 2010;2010:338-47
USFDA Approval Timelines
History of Intravenous Iron
12
Parenteral Iron Structure: Iron and Carbohydrate Complex
• Rapid release of large amounts of labile free iron leads to
toxicity and adverse drug reactions
• Currently available IV irons are iron-carbohydrate complexes
based on spheroidal particles, each consisting of a core of iron
surrounded by a carbohydrate shell
• Larger and more complex carbohydrate shells of newer IV
irons :
- Allow controlled release of iron from core, and
- Mitigate the release of labile free iron
Iron
Oxyhydroxide
core
Carbohydrate Shell
• This allows administration of large doses of IV iron (Complete replacement dose) in a
single dose in a short time duration
Hemodial Int. 2017 Jun;21 Suppl 1:S83-S92 13
Arzneimittelforschung 2010;60(6a):345–353; Arzneimittelforschung 2010;60(6a):399–412
Properties of an Ideal Parenteral Iron
14
Property Ideal Iron dextran Iron sucrose Ferric carboxymaltose
Type I (robust) I (robust) II (semi-robust) I (robust)
Mol wt >100 kD >100 kD 34-60 kD 150 kD
Complex stability High High Moderate High
Half life Long 3-4 days 6 hours 16 hours
pH Neutral Neutral High Near-Neutral
Osmolality Isotonic Isotonic High Isotonic
Antigenicity Low High Low Low
Test dose No Yes No No
Time for injection Short 4 - 6 h for 20mg/kg 3.5 h for 7mg/kg 15 min for 1000mg
Max dose High 20mg/kg 600 mg/week 1000 mg/infusion
Type
Thermodynamic
property
Examples
Type I complex Strong FCM, Iron Isomaltoside, Ferumoxytol, Iron
dextran
Type II complex Moderately strong Iron sucrose
Type III complex
Weak
Ferric gluconate
Iron citrate; Iron sorbitol
Classification depending on type of complex:
Under certain conditions, mixed complexes will be formed and such mixtures are classified as Type IV
Arzneimittelforschung 2010;60(6a):345–353
Parenteral Iron Preparations
15
First Generation
• Iron dextran (HMW)
• Iron dextran (LMW)
Second Generation
• Ferric gluconate
• Iron sucrose
Third Generation
• Ferumoxytol
• Ferric Carboxymaltose
• Iron Isomaltoside
Hematology Am Soc Hematol Educ Program. 2010;2010:338-47
As per chronology of approvals
Parenteral Iron Preparations
16
Limitations of Parenteral Iron Preparations
Gen. Parenteral
Iron
Limitations
1st Iron dextran
(HMW)
• Associated with serious allergic reactions that could lead to
anaphylaxis
• Compared to all parenteral irons, risk of serious adverse events
(SAE) is greatest
• Intramuscular injection is painful, stains the buttock and requires
multiple injections
1st Iron dextran
(LMW)
• Associated with non-fatal SAEs, including allergic or anaphylactic
reactions
• Test dose is required and long IV infusion time (1 hour)
Hemodial Int. 2017 Jun;21 Suppl 1:S83-S92 Arzneimittelforschung 2010;60(6a):399–412 17
Limitations of Parenteral Iron Preparations
Hemodial Int. 2017 Jun;21 Suppl 1:S83-S92 Arzneimittelforschung 2010;60(6a):399–412
Gen. Parenteral
Iron
Limitations
2nd
Ferric
Gluconate
• Only approved for treatment of iron deficiency anemia (IDA) in
chronic kidney disease (CKD) receiving hemodialysis who are
receiving supplemental epoetin therapy
• Can only be administered in low doses as associated with high
labile free iron release
• Multiple clinical visits are required
2nd Iron Sucrose • Can only be administered in low doses as associated with high
labile free iron release
• Multiple clinical visits are required
18
Limitations of Parenteral Iron Preparations
Hemodial Int. 2017 Jun;21 Suppl 1:S83-S92 Arzneimittelforschung 2010;60(6a):399–412 European journal of pharmaceutics and biopharmaceutics. 2011 Aug 1;78(3):480-91.
Gen. Parenteral
Iron
Limitations
3rd
Ferumoxytol • Only approved for treatment of IDA in CKD
• Maximum allowed single dose is lower compared to other third
generation parenteral irons
3rd Iron
Isomaltoside
• Contains highest amount of labile iron among the third
generation parenteral irons (More is the labile iron ~ More risk of
hypersensitivity reactions)
19
• Overcomes the low-dosage limitation of Fe+ sucrose
• Type I, dextran-free, robust iron with long half life
• Stable complex – does not release non-transferrin
bound iron
• Structure similar to ferritin, deposited easily in RES
• Low antigenicity
• No test dose required
Safe option at higher dose – 1000 mg of
elemental Fe+ in FCM against 200 mg of
elemental iron in Fe+ sucrose in single infusion
Few clinic visits – unlike iron sucrose with
multiple visits for total dose infusion
Near neutral pH & physiological osmolality – low
rate of injection site reactions
Advantages of Ferric Carboxymaltose Inj.
33
Comparing IS and FCM
Property Iron sucrose Ferric carboxymaltose
Half life 20 hours 7-12 hours
Dosage Total IV single dose up to 200 mg, can be repeated
up to 3 times/wk (Max 600/wk)
Max daily dose >70 kg – 500, < 70 kg – 7 mg/kg BW
Maximum weekly dose 1000 mg
Mol weight 43 kDa 150 kDa
Labile iron 3.5% 0.6%
Test dose First dose new patients only No
Time for injection 3.5 h for 500mg 15 min for 1000 mg
Max dose 600 mg/week 1000 mg/infusion/week
Use in pregnancy Not in first trimester Avoid in first trimester
Adapted from BSH guideline 2019 & SA guideline 2022
Critical Attributes of FCM
Type 1 (robust)
Parenteral iron
Not associated with
dextran-induced
hypersensitivity
Can be administered
in much higher doses
Short infusion time
(minimum 15
minutes)
Iron is released slowly,
avoiding toxicity and
oxidative stress
Structure similar to
ferritin, deposited
easily in RE cells
Test dose is not
required
Low immunogenic
potential
Qualities of FCM are best suited for
real-life clinical usage
34
Contraindications of IV iron
• First trimester of pregnancy
• Known hypersensitivity to intravenous or intramuscular iron
• Haemochromatosis or anaemia that is not due to iron deficiency (seek advice if
cause of anaemia is unclear)
• Asymptomatic thalassaemia minor (normal or mildly reduced hemoglobin level
and coexisting iron deficiency may rarely occur).
• IV iron is not contraindicated as long as the presence of iron deficiency is
confirmed by a low serum ferritin level. If in doubt seek specialist advice.
• Active systemic infection
Precautions
• IV iron can cause hypersensitivity reactions (including anaphylactoid), which
may be fatal and can occur after previous uneventful doses.
• Cardiopulmonary resuscitation facilities MUST be available.
• Avoid in women with hepatic dysfunction where iron overload is a precipitating
factor, in particular porphyria cutanea tarda
• Use with caution in acute or chronic infection
• Use with caution in asthma, eczema, or other atopic allergies
• Paravenous leakage may cause permanent skin staining
Calculation of iron dose
Ganzoni’s formula
𝖨𝗋𝗈𝗇 𝗋𝖾𝗊𝗎𝗂𝗋𝖾𝗆𝖾𝗇𝗍 (𝗆𝗀) (𝖳𝗈𝗍𝖺𝗅 𝗂𝗋𝗈𝗇 𝖽𝖾𝖿𝗂𝖼𝗂𝗍 in mg)
= 𝖡𝖶 in 𝗄𝗀 𝗑 (𝗍𝖺𝗋𝗀𝖾𝗍 𝖧𝖻 − 𝖺𝖼𝗍𝗎𝖺𝗅 𝖧𝖻 in 𝗀/𝖽𝖫) × 𝟢.𝟤𝟦
+ 𝗌𝗍𝗈𝗋𝖺𝗀𝖾 𝗂𝗋𝗈𝗇 (𝟣𝟢𝟢𝟢 𝗆𝗀)
Use ideal body weight (non-pregnant) in overweight women.
If underweight, use actual body weight.
FCM 750 mg – 3D (Dose , Dilution and
Duration)
Total body iron deficit & dosage of FCM
Hb gm% Body weight 35 to <50
kg
Body weight > 50 kg Body weight > 70 kg
< 9
gm%
Total iron deficit: 1,400
mg
1st dose: 700 mg
2nd dose: 700 mg
Total iron deficit: 1,500
mg
1st dose: 1,000 mg
2nd dose: 500 mg
Total iron deficit: 2,000 mg
1st dose: 1,000 mg
2nd dose: 1,000 mg
>9 gm% Total iron deficit: 1,000
mg
1st dose: 500 mg
2nd dose: 500 mg
Total iron deficit: 1,000
mg
1st dose: 1,000 mg
2nd dose: not required
Total iron deficit: 1,500 mg
1st dose: 1,000 mg
2nd dose: 500 mg
South Australian Perinatal Practice Guideline 2022
Setting up the infusion
• Add the calculated dose to 100 ml sodium chloride 0.9%
• To ensure stability of infusion, do not dilute the required dose to concentration
less than 2 mg/mL
• Excess dilution destabilizes the iron complex and may cause increased adverse
effects
• After dilution, infuse immediately using a volumetric infusion pump
Dilution and Duration of administration
Dilution Duration
• Adverse drug reactions of FCM are
considered potentially related to:
• Long duration of infusion
administration
• Dilution of FCM in high volume of
saline beyond recommendations
provided in prescribing
information (Concentration of
FCM <2 mg/ml not permissible)
• Possible mechanism:
• Long duration of administration
and excess dilution may lead to
destabilization of iron complex
that may cause adverse effects
Dilute FCM 750 mg in 250 ml of
Normal Saline
Infuse FCM 750 mg in
minimum 15 minutes
FCM 750 mg
Administration
• Flush cannula with plain saline before infusion to confirm patency.
• Infuse FCM diluted in saline over a minimum of 15 minutes
• Monitor injection site and educate women to immediately report any discomfort,
burning, redness or swelling.
• In case of paravenous leakage STOP infusion immediately.
• CAUTION: Brown staining of the skin (potentially permanent) may occur due to
leakage of the drug into the tissues around the injection site.
• On completion, infuse 50 mL saline to ensure drug is flushed completely.
• Do NOT administer more that 1000mg of FCM in a week.
Monitoring
• Check for any pre-existing skin rashes.
• Monitor vital signs before the infusion, 5 minutes after commencing the infusion
and on completion of the infusion.
• Ensure patient does not feel faint upon mobilization.
• Antenatal: confirm presence of fetal heart rate on admission and before
discharge.
Monitoring
• FCM Infusion should only be administered when staff
trained to evaluate and manage anaphylactic
reactions is immediately available, in an environment
where full resuscitation facilities can be assured.
• The patient should be observed for adverse effects for
at least 30 minutes following each FCM Infusion.
Anaphylactoid reaction
• Occur most frequently within the first several minutes of administration
• Generally characterized by sudden onset of respiratory difficulties, tachycardia
and hypotension.
• Stop the infusion immediately
• Lie the woman flat (If uterus > 20 weeks, use a left lateral wedge / tilt)
• Oxygen at > 6 L /min (preferably 12-15 L/min via non-rebreathing mask).
• Adrenaline, oxygen and steroids should be available for immediate use.
• Response chart with frequent observations including pulse oximetry, blood
pressure and respirations until symptoms resolve (at least 1 hour).
• Do not recommence infusion
Side effects
• Common (≥1/10, <1/10)
• Headache, dizziness, nausea, hypertension, flushing.
• Hypophosphatemia
• Uncommon (≥1/1,000, <1/100)
• Fever, fatigue, peripheral edema, hypotension
• Vomiting, myalgia, back pain, arthralgia
• pruritus, urticaria, rash, dyspnea
• Hypersensitivity
• Rare (≥1/10,000, <1/1,000)
• Anaphylactoid reaction
Place in therapy
• Majority of Indian patients with anemia have
• Weight between 35 to <70 kg & hemoglobin level <10 mg/dl,
• Calculated Iron requirement by wt & Hb chart- 1500 mg &
• 750 mg two doses, 1 week apart – will be sufficient for anemic patient
• Offers Flexibility to doctors-
• Doctor can choose -
• 500 × 3 injections (3 hospital visits )
• or 750 × 2 injections (2 hospital visits ) or
• 1000 × 1 + 500 ×1 injection (2 visits is needed).
• In many patients who are non affordable for FCM 1000 mg, FCM 750 mg would be an ideal to provide good Hb
rise.
Place in Therapy
Body Weight (kg) <35 Kg <35 Kg 35kg - <70kg 35kg - <70kg >70kg >70kg
Hb (g/dL) <10 >10-14 <10 >10-14 <10 >10-14
Cumulative Iron
Dose
500mg 500mg 1500mg 1000 mg 2000mg 1500mg
Dose on day 1 FCM 500 FCM 500 FCM 750 FCM 1K FCM 1K FCM 750
Dose after 7 Days Not required Not required FCM 750 Not required FCM 1K FCM 750
Dilution
Normal Saline
Solution 0.9%
100 ml
Normal Saline
Solution 0.9%
100 ml
Normal Saline
Solution 0.9%
250 ml
Normal Saline
Solution 0.9%
100 ml
Normal Saline
Solution 0.9%
250 ml
Normal Saline
Solution 0.9%
250 ml
Duration
more than 6
minute
more than
6 minute
more than
15 minute
more than
15 minute
more than
15 minute
more than
15 minute
Clinical Evidence:
FCM 750 mg in Management of
IDA
Shin et al. Medicine (2021) 100:20
No serious adverse events were reported in either group.
Study Participants: Consenting patients at least 18 years of age who had a screening hemoglobin (Hb)
value of not more than 11 g/dL with a ferritin level of not more than 100 or not more than 300 ng/mL
when transferrin saturation (TSAT) was not more than 30%
Objective-
Primary efficacy endpoint - change to highest observed Hb from baseline to Day 35.
Composite safety endpoint - all-cause mortality, nonfatal myocardial infarction, nonfatal stroke,
unstable angina, heart failure, arrhythmias, and hyper- or hypotensive events.
Onken JE et al. Transfusion. 2014 Feb;54(2):306-15.
Key Findings
• Mean Hemoglobin rise was significantly greater in Group A–FCM than Group B–oral iron:
1.57 (1.19) g/dL versus 0.80 (0.80) g/dL (p = 0.001).
• Significant mean increase in Hb from baseline to highest value by Day 35 in Group C- FCM
versus Group D- standard of care : 2.90 (1.64) g/dL versus 2.16 (1.25) g/dL (p = 0.001).
• Safety endpoints occurred in 17 of 499 (3.4%) participants receiving FCM versus 16 of 498
(3.2%) in comparator groups.
Conclusion
• Two 750-mg FCM infusions are safe and superior to oral iron in increasing Hb
levels in IDA patients with inadequate oral iron response
• FCM administered as two infusions of 750 mg given 1 week apart was safe and
effective and should be considered a treatment option for IDA in subjects who
have an unsatisfactory response to oral iron, as well as for those who are
intolerant of or unsuitable for oral iron replacement.
Objective- Two open-label, randomized, placebo-controlled trials evaluated safety
of multiple or single 750 mg FCM doses compared to standard medical care (SMC) in IDA patients.
Study Participants: Adults with hemoglobin ≤12 g/dL, ferritin ≤100 or
≤300 ng/mL with transferrin saturation ≤30%
single (n = 366) or weekly (n =
343) FCM
SMC
(n = 360 and n = 366).
Barish CF et al. Anemia. 2012 Jan 1;2012.
Key Findings
• Significantly greater (P ≤ 0.001) increases in hemoglobin and iron indices occurred in FCM
groups versus SMC.
• In the multidose study, up to two infusions of FCM were needed to reach target iron levels
versus 3–5 of intravenous iron comparators.
• FCM and SMC groups had similar incidences and types of adverse events and serious
adverse events.
Conclusion
• Intravenous FCM is safe, well tolerated, and associated with improvements in hemoglobin
and iron indices comparable to SMC when administered in single doses of up to 750 mg at a
rate of 100 mg/min.
• Fewer FCM infusions were required to reach target iron levels compared to other
intravenous iron preparations
Global Evidence of FCM in Pregnancy
Geography
Total no. of
studies
Countries
No. of pregnant
women treated
with FCM
Highest Hb rise
(g/dL)
Highest Ferritin
rise (µg/L)
Global Studies Eleven (#11) Switzerland,
United Kingdom,
Australia, Spain,
Korea, Australia,
UAE, Turkey
2495 3.6 188
Indian Studies Twenty One
(#21)
India 2685 5.5 180
Current evidence highlighted data of FCM usage in 5180 pregnant women with
maximum Hb rise of 5.5 g/dL and ferritin rise of 180 µg/L
Naqash A et al. BMC Womens Health. 2018; 18(1):6 Jose et al. BMC Pregnancy and Childbirth (2019) 19:54 35
• Published on 8th June 2022
36
Journal of Blood Medicine. 2022 Jun 8;13:303-13.
INDIAN
STUDY
Results: Efficacy & Safety
In 1800 patients, IV FCM resulted in a significant increase in
- Hemoglobin (Hb) of 2.76 g/dL; - Serum ferritin of 35.85 µg/L
Improvement in Hemoglobin Improvement in Serum Ferritin
*P value < 0.001, Statistically significant difference; NS – P value > 0.05, non-significant difference
Adverse effects were seen in 7.6% of the subjects (137/1800)
Mild adverse events like nausea, headache, diarrhea, constipation & mild allergic reaction were observed
No serious adverse events were observed
37
49
• Published on 28 November 2022
• Journal- Obstetrics and Gynecology International
Trivedi P et al. Obstetrics and Gynecology International. 2022 Nov 28;2022
INDIAN
STUDY
Results- FCM in Pregnancy: Analysis in 1191 Pregnant Women
Total 1191 pregnant women in their second or third trimester received FCM in a dose range of 500 to 3000 mg
with a mean dose of 1027 mg
*P value < 0.001, Statistically significant difference; NS – P value > 0.05, non-significant difference
Improvement in Hemoglobin Improvement in Serum Ferritin
In 1191 pregnant women included in study, IV FCM resulted in a significant increase in
- Hemoglobin (Hb) of 2.8 g/dL; - Serum ferritin of 30.03 µg/L
20
• 271 pregnant women in 2nd and 3rd trimester of
pregnancy received FCM (Mean dose ∼1000 mg)
• Significant increase in Hb was noted in just 20
days!
• Significant increase in Hb of 4.23 g/dL was noted
in Severe Anemia
Gupte et al, J Obstet Gynaecol Res. 2021 Oct;47(10):3464-3470.
Insights from Large Indian Real
World Evidence: Efficacy
Single large dose administration of FCM led to rapid rise of Hb in moderate-to-severe anemia during pregnancy
in a real-life scenario.
51
Data of 271 pregnant women receiving FCM of ~1000 mg on vital parameters like systolic blood pressure (SBP),
diastolic blood pressure (DBP), heart rate (HR), and oxygen saturation (SpO2) at baseline (before FCM infusion)
and at 15, 30, 40, and 45 min after start of each FCM infusion were retrieved and analyzed
Gupte et al, J Obstet Gynaecol Res. 2021 Oct;47(10):3464-3470. 41
All the vital parameters were within normal limits
over the monitoring period of 45 min. None of the
patients displayed any signs or symptoms of acute
hypersensitivity reaction.
No clinically significant change in vital parameters
during and immediately after FCM and absence of
any hypersensitivity reactions corroborates the
safety and tolerability of FCM for treatment of IDA
during pregnancy
• Data of 162 newborns born to mothers who had received FCM in
pregnancy was analyzed in terms of:
• Mean gestational age at delivery
• Mean birth weight
• Apgar score
• Stillbirth, perinatal, and early neonatal mortality rates
• Requirement of hospitalization
No adverse effects in terms of perinatal and neonatal outcomes were observed
in newborns of women who received FCM during pregnancy
Neonatal Outcomes
Gupte et al, J Obstet Gynaecol Res. 2021 Oct;47(10):3464-3470. 53
FCM and Neonatal Outcomes: Global Clinical Evidence
Christoph et al. Journal of perinatal medicine. 2012 Sep 1;40(5):469-74
• Neonatal outcomes (week of pregnancy at delivery, Apgar scores, birth weight, neonatal
resuscitation or complications, etc.) were NOT adversely affected due to FCM
Aporta Rodriguez et al. Obstetrics and gynecology international. 2016 Jan 1;2016
Breymann et al. Journal of perinatal medicine. 2017;45(4):443-53 Khalafallah A et al. InSeminars in hematology. 2018; 55(4):223-234
43
Management of IDA in Postnatal period
55
In postpartum anemic patients, parenteral intravenous (Iron sucrose/ ferric
carboxymaltose) may be the preferred alternative over oral iron for ensuring
compliance and faster response (Grade A, level 3)
Ferric carboxymaltose has an advantage of administration as a bolus dose in
the postpartum period for correction of anemia and restoration of iron
stores. (Grade A,level 2)
FOGSI GCPR 2017 recommendations
56
• Level 2- Moderate quality evidence from randomized trials
Benson CS et al Obstet Med. 2021 Jun;14(2):67-76.
Summary of Key Recommendations, 2019 UK Guidelines:
Management of Iron Deficiency Anemia
Recommendations Grade
Intrapartum and postpartum
Women with Hb less than 10 g/dL within 48 h of delivery, who are haemodynamically stable,
asymptomatic or mildly symptomatic, should be offered oral elemental iron daily for at least 3
months
2A
Use of IV intravenous iron postpartum should be considered in women who are previously intolerant
of, or do not respond to, oral iron and/or where the severity of symptoms of anaemia requires
prompt management
2B
57
Supplementation Interventions by Ministry of Health and Family Welfare
(MoHFW)
8
Guidelines for Control of Iron Deficiency Anaemia_2013 50
• The 10 commandments for the transfusion practice in medicine state that transfusion should only be
used when
• Benefits outweigh the risks &
• With signs of shock or acute hemorrhage with signs of hemodynamic instability.
• Severe anemia (Hb <7 gm/dL) with symptoms of hemodynamic alterations.
• During ANC, a trial of FCM is to be given before BT in women presenting with severe anemia.
• Studies from India identify that postpartum hemorrhage (PPH) is the major indication for BT in
obstetric practice.
• IV iron such as FCM can be an alternative to BT, especially in women at high risk of transfusion-
related reactions.
Blood transfusion vs Parenteral iron
Derek N. Transfusion ten commandments. In: Handbook of transfusion medicine. 5th ed. Chawla S et al. J Obstet Gynaecol India 2018;68(3) 59
Eligible72 studies from 1966 to June 2013, including 10 605 patients provided quantitative outcome data for meta-analysis.
Main outcome measures Change in haemoglobin concentration and risk of allogeneic red blood cell transfusion (efficacy)
Key findings
• Intravenous iron was associated with an increase in haemoglobin concentration (standardised mean
difference 6.5 g/L, 95% confidence interval 5.1 g/L to 7.9 g/L) and a reduced risk of requirement for red
blood cell transfusion (risk ratio 0.74, 95% confidence interval 0.62 to 0.88)
• Intravenous iron therapy is effective in increasing haemoglobin concentration and reducing the risk of
allogeneic red blood cell transfusion.
Edward Litton staff specialist clinical senior lecturer1 2, Jing Xiao registrar1, Kwok M Ho staff specialist associate professor 1 3
60
Bmj. 2013 Aug 15;347.
Conclusion
• FCM is an ideal parenteral iron: Requires no test dose; Low risk of hypersensitivity reactions
or anaphylactic reactions.
• FCM dose are calculated based on Body weight and Hb deficit.
• Most of Indian patients are of wt of 35- 70 kg and average Hb < 10 gm/dl.
• These patients will require a dose of 1500 mg and lower dose may not be therapeutically
useful.
• Significant increase in hemoglobin and blood indices were seen in various trial with FCM 750
mg compare to other treatment options of IDA.
• FCM 750 mg offers flexibility for doctors to choose various parenteral Iron preparations for
treatment of IDA.
53

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IRON DEFICIENCY ANEMIA OVERVIEW WITH FOCUS ON PARENTRAL IRON THERAPY : Dr Sharda Jain

  • 1. IRON DEFICIENCY ANEMIA OVERVIEW WITH FOCUS ON PARENTRAL IRON THERAPY : DGF CME 30TH December 2023 1
  • 2. Prevalence of anemia in pregnant women Data 2019 WHO 2023 India – 50.1% (44.2-54.2%)
  • 3. Anemia: Global Burden WHO. The global prevalence of anaemia in 2011. Geneva: World Health Organization;2015. Anemia affects around 2 BILLION Peaple globally Level of public health significance: Severe 3
  • 4. Anemia : Prevalence • Worldwide almost 2 BILLION people are living with anemia1 • Prevalence of anemia in • Global: • 41.8% ∼ pregnant women1 • India: • Pregnant women age 15-49 years - 52.2% • Non-pregnant women age 15-49 years- 57.2 % • All women age 15-49 years - 59.1 %2 1. WHO. Worldwide prevalence of anaemia,1993–2005. 2008 2. MoHFW. NFHS-5, 2019-21. India Fact Sheet. 2021 4
  • 5. Definitions Anemia During Pregnancy Hemoglobin (gm/dl) CDC <11 ( 1st trimester) <10.5 (2nd trimester) <11 (3rd trimester) WHO <11 Postpartum Anemia Hemoglobin (gm/dl) WHO <10 FIGO <11 UK guideline <10 WHO classification of severity of anemia in adult females [ Hemoglobin in gm/dl] Mild Moderate Severe Non pregnant women(age >15 years or above) 11–11.9 8–10.9 < 8 Pregnant women 10–10.9 7–9.9 < 7 Indian J Hematol Blood Transfus. 2018:1-2. 5
  • 6. Milman N Ann Hematol 2006; 85(9):559-565 Indian J Hematol Blood Transfus. 2018:1-2. Total Iron requirement in Pregnancy Total iron requirement during singleton pregnancy: 1000 to 1200 mg. • The average daily requirement of iron has been calculated as 0.8 mg/d in the first trimester and increases to 7.5 mg/day in the third trimester. • The average daily absorption from: Western diet  1–5 mg/day Indian diet  0.8 - 4.5 mg/day 6
  • 7. Consequences of Iron Deficiency Anemia Pregnancy complications • Increased risk of preterm delivery • Premature rupture of membranes • Pre-eclampsia • Intrauterine Death • Inter-current infection • Antepartum haemorrhage • Congestive Heart Failure Fetal complications • Low birth weight • Prematurity • Infections • Congenital malformation • Neonatal Anemia • Abnormal cognitive development Maternal anemia contributes to 18% of perinatal mortality and 20% of maternal mortality in South Asian countries including India • Indian J Hematol Blood Transfus. 2018:1-2. • Kumar A, et al. BMJ Open Gastro 2022;9:e000759. • Reduced blood oxygen levels leads to- - Shortness of breath, fatigue, palpitations, tachycardia and angina • Resultant hypoxemia- - Nausea, weight loss and abdominal pain. • Central hypoxia – - headaches, vertigo and lethargy as well as cognitive impairment 7
  • 8. Diagnosis of Iron Deficiency Anemia • History and clinical examination • CBC:  Hemoglobin, RBC count, hematocrit, reticulocyte count  MCV & RDW :IDA is characterised by Low MCV, Low MCH  A combination of low MCV accompanied by elevated RDW can be used as a sufficient evidence to start iron therapy  RDW – decreased in Thalassemia  Iron supply Study: • Serum iron , TIBC, transferrin saturation : unreliable markers  Serum iron shows diurnal variation and is affected by dietary influences  Pregnancy itself increases total iron binding capacity (TIBC) even in the absence of IDA  Ser. Ferritin - cut off 30 µg/dl to diagnose and treat ID in pregnancy  Peripheral Blood Smear  Bone marrow Examination RDW –Red cell distribution width, MCV-Mean corpuscular volume, MCH-Mean Corpuscular Hemoglobin, TIBC – Total Iron Binding Capacity • Indian J Hematol Blood Transfus. 2018:1-2. 8
  • 9. First level of treatment Two tablets of iron and folic acid tablet (100 mg elemental iron and 500 mcg folic acid) daily for 6 months Parental iron (IV Iron Sucrose or FCM) may be considered as the first line of management in pregnant women who are detected to be anemic late in pregnancy or in whom compliance is likely to be low (high chance of lost to follow-up). If no improvement, after first level of treatment • Referral to higher health facility • The case may be managed with IV Iron Sucrose/Ferric Carboxymaltose Anemia Mukt Bharat Guidelines 2018 Anemia management protocol for Pregnant women MoHFW, Govt of India. Anemia Mukt Bharat Operational Guidelines Intensied National Iron Plus Initiative, 2018 First level of treatment Immediate hospitalization if it is the third trimester of pregnancy where round-the-clock specialist care is available The treatment will be done using IV Iron Sucrose/Ferric Carboxymaltose by the medical officer. Mild anemia (Hb 10-10.9g/dL) & Moderate anemia (7-9.9 g/dL) Severe anemia (Hb 5-6.9 g/dL) 13
  • 10. Indications • Failure of oral iron therapy • Non-compliance or intolerance to oral iron • Late second or third trimester with moderate to severe IDA • Rapid rectification of anemia and repletion of iron stores expected • Malabsorption (e.g. Bowel-resection/Celiac disease) • Bleeding diathesis when hemorrhage is likely to continue Contraindications • Gestation period < 12 weeks • Lack of facilities for resuscitation • Known history of anaphylaxis or reactions to parenteral iron • Known state of iron overload IV iron therapy is superior to oral iron in terms of speed and absolute extent of rise in hemoglobin and replenishment of iron stores Indian J Hematol Blood Transfus. 2018:1-2. Arch Gynecol Obstet. 2017 Dec;296(6):1229-1234 Indications Of Parenteral Iron Therapy 10
  • 13. Parenteral Iron Structure: Iron and Carbohydrate Complex • Rapid release of large amounts of labile free iron leads to toxicity and adverse drug reactions • Currently available IV irons are iron-carbohydrate complexes based on spheroidal particles, each consisting of a core of iron surrounded by a carbohydrate shell • Larger and more complex carbohydrate shells of newer IV irons : - Allow controlled release of iron from core, and - Mitigate the release of labile free iron Iron Oxyhydroxide core Carbohydrate Shell • This allows administration of large doses of IV iron (Complete replacement dose) in a single dose in a short time duration Hemodial Int. 2017 Jun;21 Suppl 1:S83-S92 13
  • 14. Arzneimittelforschung 2010;60(6a):345–353; Arzneimittelforschung 2010;60(6a):399–412 Properties of an Ideal Parenteral Iron 14 Property Ideal Iron dextran Iron sucrose Ferric carboxymaltose Type I (robust) I (robust) II (semi-robust) I (robust) Mol wt >100 kD >100 kD 34-60 kD 150 kD Complex stability High High Moderate High Half life Long 3-4 days 6 hours 16 hours pH Neutral Neutral High Near-Neutral Osmolality Isotonic Isotonic High Isotonic Antigenicity Low High Low Low Test dose No Yes No No Time for injection Short 4 - 6 h for 20mg/kg 3.5 h for 7mg/kg 15 min for 1000mg Max dose High 20mg/kg 600 mg/week 1000 mg/infusion
  • 15. Type Thermodynamic property Examples Type I complex Strong FCM, Iron Isomaltoside, Ferumoxytol, Iron dextran Type II complex Moderately strong Iron sucrose Type III complex Weak Ferric gluconate Iron citrate; Iron sorbitol Classification depending on type of complex: Under certain conditions, mixed complexes will be formed and such mixtures are classified as Type IV Arzneimittelforschung 2010;60(6a):345–353 Parenteral Iron Preparations 15
  • 16. First Generation • Iron dextran (HMW) • Iron dextran (LMW) Second Generation • Ferric gluconate • Iron sucrose Third Generation • Ferumoxytol • Ferric Carboxymaltose • Iron Isomaltoside Hematology Am Soc Hematol Educ Program. 2010;2010:338-47 As per chronology of approvals Parenteral Iron Preparations 16
  • 17. Limitations of Parenteral Iron Preparations Gen. Parenteral Iron Limitations 1st Iron dextran (HMW) • Associated with serious allergic reactions that could lead to anaphylaxis • Compared to all parenteral irons, risk of serious adverse events (SAE) is greatest • Intramuscular injection is painful, stains the buttock and requires multiple injections 1st Iron dextran (LMW) • Associated with non-fatal SAEs, including allergic or anaphylactic reactions • Test dose is required and long IV infusion time (1 hour) Hemodial Int. 2017 Jun;21 Suppl 1:S83-S92 Arzneimittelforschung 2010;60(6a):399–412 17
  • 18. Limitations of Parenteral Iron Preparations Hemodial Int. 2017 Jun;21 Suppl 1:S83-S92 Arzneimittelforschung 2010;60(6a):399–412 Gen. Parenteral Iron Limitations 2nd Ferric Gluconate • Only approved for treatment of iron deficiency anemia (IDA) in chronic kidney disease (CKD) receiving hemodialysis who are receiving supplemental epoetin therapy • Can only be administered in low doses as associated with high labile free iron release • Multiple clinical visits are required 2nd Iron Sucrose • Can only be administered in low doses as associated with high labile free iron release • Multiple clinical visits are required 18
  • 19. Limitations of Parenteral Iron Preparations Hemodial Int. 2017 Jun;21 Suppl 1:S83-S92 Arzneimittelforschung 2010;60(6a):399–412 European journal of pharmaceutics and biopharmaceutics. 2011 Aug 1;78(3):480-91. Gen. Parenteral Iron Limitations 3rd Ferumoxytol • Only approved for treatment of IDA in CKD • Maximum allowed single dose is lower compared to other third generation parenteral irons 3rd Iron Isomaltoside • Contains highest amount of labile iron among the third generation parenteral irons (More is the labile iron ~ More risk of hypersensitivity reactions) 19
  • 20. • Overcomes the low-dosage limitation of Fe+ sucrose • Type I, dextran-free, robust iron with long half life • Stable complex – does not release non-transferrin bound iron • Structure similar to ferritin, deposited easily in RES • Low antigenicity • No test dose required Safe option at higher dose – 1000 mg of elemental Fe+ in FCM against 200 mg of elemental iron in Fe+ sucrose in single infusion Few clinic visits – unlike iron sucrose with multiple visits for total dose infusion Near neutral pH & physiological osmolality – low rate of injection site reactions Advantages of Ferric Carboxymaltose Inj. 33
  • 21. Comparing IS and FCM Property Iron sucrose Ferric carboxymaltose Half life 20 hours 7-12 hours Dosage Total IV single dose up to 200 mg, can be repeated up to 3 times/wk (Max 600/wk) Max daily dose >70 kg – 500, < 70 kg – 7 mg/kg BW Maximum weekly dose 1000 mg Mol weight 43 kDa 150 kDa Labile iron 3.5% 0.6% Test dose First dose new patients only No Time for injection 3.5 h for 500mg 15 min for 1000 mg Max dose 600 mg/week 1000 mg/infusion/week Use in pregnancy Not in first trimester Avoid in first trimester Adapted from BSH guideline 2019 & SA guideline 2022
  • 22. Critical Attributes of FCM Type 1 (robust) Parenteral iron Not associated with dextran-induced hypersensitivity Can be administered in much higher doses Short infusion time (minimum 15 minutes) Iron is released slowly, avoiding toxicity and oxidative stress Structure similar to ferritin, deposited easily in RE cells Test dose is not required Low immunogenic potential Qualities of FCM are best suited for real-life clinical usage 34
  • 23. Contraindications of IV iron • First trimester of pregnancy • Known hypersensitivity to intravenous or intramuscular iron • Haemochromatosis or anaemia that is not due to iron deficiency (seek advice if cause of anaemia is unclear) • Asymptomatic thalassaemia minor (normal or mildly reduced hemoglobin level and coexisting iron deficiency may rarely occur). • IV iron is not contraindicated as long as the presence of iron deficiency is confirmed by a low serum ferritin level. If in doubt seek specialist advice. • Active systemic infection
  • 24. Precautions • IV iron can cause hypersensitivity reactions (including anaphylactoid), which may be fatal and can occur after previous uneventful doses. • Cardiopulmonary resuscitation facilities MUST be available. • Avoid in women with hepatic dysfunction where iron overload is a precipitating factor, in particular porphyria cutanea tarda • Use with caution in acute or chronic infection • Use with caution in asthma, eczema, or other atopic allergies • Paravenous leakage may cause permanent skin staining
  • 25. Calculation of iron dose Ganzoni’s formula 𝖨𝗋𝗈𝗇 𝗋𝖾𝗊𝗎𝗂𝗋𝖾𝗆𝖾𝗇𝗍 (𝗆𝗀) (𝖳𝗈𝗍𝖺𝗅 𝗂𝗋𝗈𝗇 𝖽𝖾𝖿𝗂𝖼𝗂𝗍 in mg) = 𝖡𝖶 in 𝗄𝗀 𝗑 (𝗍𝖺𝗋𝗀𝖾𝗍 𝖧𝖻 − 𝖺𝖼𝗍𝗎𝖺𝗅 𝖧𝖻 in 𝗀/𝖽𝖫) × 𝟢.𝟤𝟦 + 𝗌𝗍𝗈𝗋𝖺𝗀𝖾 𝗂𝗋𝗈𝗇 (𝟣𝟢𝟢𝟢 𝗆𝗀) Use ideal body weight (non-pregnant) in overweight women. If underweight, use actual body weight.
  • 26. FCM 750 mg – 3D (Dose , Dilution and Duration)
  • 27. Total body iron deficit & dosage of FCM Hb gm% Body weight 35 to <50 kg Body weight > 50 kg Body weight > 70 kg < 9 gm% Total iron deficit: 1,400 mg 1st dose: 700 mg 2nd dose: 700 mg Total iron deficit: 1,500 mg 1st dose: 1,000 mg 2nd dose: 500 mg Total iron deficit: 2,000 mg 1st dose: 1,000 mg 2nd dose: 1,000 mg >9 gm% Total iron deficit: 1,000 mg 1st dose: 500 mg 2nd dose: 500 mg Total iron deficit: 1,000 mg 1st dose: 1,000 mg 2nd dose: not required Total iron deficit: 1,500 mg 1st dose: 1,000 mg 2nd dose: 500 mg South Australian Perinatal Practice Guideline 2022
  • 28. Setting up the infusion • Add the calculated dose to 100 ml sodium chloride 0.9% • To ensure stability of infusion, do not dilute the required dose to concentration less than 2 mg/mL • Excess dilution destabilizes the iron complex and may cause increased adverse effects • After dilution, infuse immediately using a volumetric infusion pump
  • 29. Dilution and Duration of administration Dilution Duration • Adverse drug reactions of FCM are considered potentially related to: • Long duration of infusion administration • Dilution of FCM in high volume of saline beyond recommendations provided in prescribing information (Concentration of FCM <2 mg/ml not permissible) • Possible mechanism: • Long duration of administration and excess dilution may lead to destabilization of iron complex that may cause adverse effects Dilute FCM 750 mg in 250 ml of Normal Saline Infuse FCM 750 mg in minimum 15 minutes FCM 750 mg
  • 30. Administration • Flush cannula with plain saline before infusion to confirm patency. • Infuse FCM diluted in saline over a minimum of 15 minutes • Monitor injection site and educate women to immediately report any discomfort, burning, redness or swelling. • In case of paravenous leakage STOP infusion immediately. • CAUTION: Brown staining of the skin (potentially permanent) may occur due to leakage of the drug into the tissues around the injection site. • On completion, infuse 50 mL saline to ensure drug is flushed completely. • Do NOT administer more that 1000mg of FCM in a week.
  • 31. Monitoring • Check for any pre-existing skin rashes. • Monitor vital signs before the infusion, 5 minutes after commencing the infusion and on completion of the infusion. • Ensure patient does not feel faint upon mobilization. • Antenatal: confirm presence of fetal heart rate on admission and before discharge.
  • 32. Monitoring • FCM Infusion should only be administered when staff trained to evaluate and manage anaphylactic reactions is immediately available, in an environment where full resuscitation facilities can be assured. • The patient should be observed for adverse effects for at least 30 minutes following each FCM Infusion.
  • 33. Anaphylactoid reaction • Occur most frequently within the first several minutes of administration • Generally characterized by sudden onset of respiratory difficulties, tachycardia and hypotension. • Stop the infusion immediately • Lie the woman flat (If uterus > 20 weeks, use a left lateral wedge / tilt) • Oxygen at > 6 L /min (preferably 12-15 L/min via non-rebreathing mask). • Adrenaline, oxygen and steroids should be available for immediate use. • Response chart with frequent observations including pulse oximetry, blood pressure and respirations until symptoms resolve (at least 1 hour). • Do not recommence infusion
  • 34. Side effects • Common (≥1/10, <1/10) • Headache, dizziness, nausea, hypertension, flushing. • Hypophosphatemia • Uncommon (≥1/1,000, <1/100) • Fever, fatigue, peripheral edema, hypotension • Vomiting, myalgia, back pain, arthralgia • pruritus, urticaria, rash, dyspnea • Hypersensitivity • Rare (≥1/10,000, <1/1,000) • Anaphylactoid reaction
  • 35. Place in therapy • Majority of Indian patients with anemia have • Weight between 35 to <70 kg & hemoglobin level <10 mg/dl, • Calculated Iron requirement by wt & Hb chart- 1500 mg & • 750 mg two doses, 1 week apart – will be sufficient for anemic patient • Offers Flexibility to doctors- • Doctor can choose - • 500 × 3 injections (3 hospital visits ) • or 750 × 2 injections (2 hospital visits ) or • 1000 × 1 + 500 ×1 injection (2 visits is needed). • In many patients who are non affordable for FCM 1000 mg, FCM 750 mg would be an ideal to provide good Hb rise.
  • 36. Place in Therapy Body Weight (kg) <35 Kg <35 Kg 35kg - <70kg 35kg - <70kg >70kg >70kg Hb (g/dL) <10 >10-14 <10 >10-14 <10 >10-14 Cumulative Iron Dose 500mg 500mg 1500mg 1000 mg 2000mg 1500mg Dose on day 1 FCM 500 FCM 500 FCM 750 FCM 1K FCM 1K FCM 750 Dose after 7 Days Not required Not required FCM 750 Not required FCM 1K FCM 750 Dilution Normal Saline Solution 0.9% 100 ml Normal Saline Solution 0.9% 100 ml Normal Saline Solution 0.9% 250 ml Normal Saline Solution 0.9% 100 ml Normal Saline Solution 0.9% 250 ml Normal Saline Solution 0.9% 250 ml Duration more than 6 minute more than 6 minute more than 15 minute more than 15 minute more than 15 minute more than 15 minute
  • 37. Clinical Evidence: FCM 750 mg in Management of IDA
  • 38. Shin et al. Medicine (2021) 100:20 No serious adverse events were reported in either group.
  • 39.
  • 40. Study Participants: Consenting patients at least 18 years of age who had a screening hemoglobin (Hb) value of not more than 11 g/dL with a ferritin level of not more than 100 or not more than 300 ng/mL when transferrin saturation (TSAT) was not more than 30% Objective- Primary efficacy endpoint - change to highest observed Hb from baseline to Day 35. Composite safety endpoint - all-cause mortality, nonfatal myocardial infarction, nonfatal stroke, unstable angina, heart failure, arrhythmias, and hyper- or hypotensive events. Onken JE et al. Transfusion. 2014 Feb;54(2):306-15.
  • 41. Key Findings • Mean Hemoglobin rise was significantly greater in Group A–FCM than Group B–oral iron: 1.57 (1.19) g/dL versus 0.80 (0.80) g/dL (p = 0.001). • Significant mean increase in Hb from baseline to highest value by Day 35 in Group C- FCM versus Group D- standard of care : 2.90 (1.64) g/dL versus 2.16 (1.25) g/dL (p = 0.001). • Safety endpoints occurred in 17 of 499 (3.4%) participants receiving FCM versus 16 of 498 (3.2%) in comparator groups.
  • 42. Conclusion • Two 750-mg FCM infusions are safe and superior to oral iron in increasing Hb levels in IDA patients with inadequate oral iron response • FCM administered as two infusions of 750 mg given 1 week apart was safe and effective and should be considered a treatment option for IDA in subjects who have an unsatisfactory response to oral iron, as well as for those who are intolerant of or unsuitable for oral iron replacement.
  • 43. Objective- Two open-label, randomized, placebo-controlled trials evaluated safety of multiple or single 750 mg FCM doses compared to standard medical care (SMC) in IDA patients. Study Participants: Adults with hemoglobin ≤12 g/dL, ferritin ≤100 or ≤300 ng/mL with transferrin saturation ≤30% single (n = 366) or weekly (n = 343) FCM SMC (n = 360 and n = 366). Barish CF et al. Anemia. 2012 Jan 1;2012.
  • 44. Key Findings • Significantly greater (P ≤ 0.001) increases in hemoglobin and iron indices occurred in FCM groups versus SMC. • In the multidose study, up to two infusions of FCM were needed to reach target iron levels versus 3–5 of intravenous iron comparators. • FCM and SMC groups had similar incidences and types of adverse events and serious adverse events.
  • 45. Conclusion • Intravenous FCM is safe, well tolerated, and associated with improvements in hemoglobin and iron indices comparable to SMC when administered in single doses of up to 750 mg at a rate of 100 mg/min. • Fewer FCM infusions were required to reach target iron levels compared to other intravenous iron preparations
  • 46. Global Evidence of FCM in Pregnancy Geography Total no. of studies Countries No. of pregnant women treated with FCM Highest Hb rise (g/dL) Highest Ferritin rise (µg/L) Global Studies Eleven (#11) Switzerland, United Kingdom, Australia, Spain, Korea, Australia, UAE, Turkey 2495 3.6 188 Indian Studies Twenty One (#21) India 2685 5.5 180 Current evidence highlighted data of FCM usage in 5180 pregnant women with maximum Hb rise of 5.5 g/dL and ferritin rise of 180 µg/L Naqash A et al. BMC Womens Health. 2018; 18(1):6 Jose et al. BMC Pregnancy and Childbirth (2019) 19:54 35
  • 47. • Published on 8th June 2022 36 Journal of Blood Medicine. 2022 Jun 8;13:303-13. INDIAN STUDY
  • 48. Results: Efficacy & Safety In 1800 patients, IV FCM resulted in a significant increase in - Hemoglobin (Hb) of 2.76 g/dL; - Serum ferritin of 35.85 µg/L Improvement in Hemoglobin Improvement in Serum Ferritin *P value < 0.001, Statistically significant difference; NS – P value > 0.05, non-significant difference Adverse effects were seen in 7.6% of the subjects (137/1800) Mild adverse events like nausea, headache, diarrhea, constipation & mild allergic reaction were observed No serious adverse events were observed 37
  • 49. 49 • Published on 28 November 2022 • Journal- Obstetrics and Gynecology International Trivedi P et al. Obstetrics and Gynecology International. 2022 Nov 28;2022 INDIAN STUDY
  • 50. Results- FCM in Pregnancy: Analysis in 1191 Pregnant Women Total 1191 pregnant women in their second or third trimester received FCM in a dose range of 500 to 3000 mg with a mean dose of 1027 mg *P value < 0.001, Statistically significant difference; NS – P value > 0.05, non-significant difference Improvement in Hemoglobin Improvement in Serum Ferritin In 1191 pregnant women included in study, IV FCM resulted in a significant increase in - Hemoglobin (Hb) of 2.8 g/dL; - Serum ferritin of 30.03 µg/L 20
  • 51. • 271 pregnant women in 2nd and 3rd trimester of pregnancy received FCM (Mean dose ∼1000 mg) • Significant increase in Hb was noted in just 20 days! • Significant increase in Hb of 4.23 g/dL was noted in Severe Anemia Gupte et al, J Obstet Gynaecol Res. 2021 Oct;47(10):3464-3470. Insights from Large Indian Real World Evidence: Efficacy Single large dose administration of FCM led to rapid rise of Hb in moderate-to-severe anemia during pregnancy in a real-life scenario. 51
  • 52. Data of 271 pregnant women receiving FCM of ~1000 mg on vital parameters like systolic blood pressure (SBP), diastolic blood pressure (DBP), heart rate (HR), and oxygen saturation (SpO2) at baseline (before FCM infusion) and at 15, 30, 40, and 45 min after start of each FCM infusion were retrieved and analyzed Gupte et al, J Obstet Gynaecol Res. 2021 Oct;47(10):3464-3470. 41 All the vital parameters were within normal limits over the monitoring period of 45 min. None of the patients displayed any signs or symptoms of acute hypersensitivity reaction. No clinically significant change in vital parameters during and immediately after FCM and absence of any hypersensitivity reactions corroborates the safety and tolerability of FCM for treatment of IDA during pregnancy
  • 53. • Data of 162 newborns born to mothers who had received FCM in pregnancy was analyzed in terms of: • Mean gestational age at delivery • Mean birth weight • Apgar score • Stillbirth, perinatal, and early neonatal mortality rates • Requirement of hospitalization No adverse effects in terms of perinatal and neonatal outcomes were observed in newborns of women who received FCM during pregnancy Neonatal Outcomes Gupte et al, J Obstet Gynaecol Res. 2021 Oct;47(10):3464-3470. 53
  • 54. FCM and Neonatal Outcomes: Global Clinical Evidence Christoph et al. Journal of perinatal medicine. 2012 Sep 1;40(5):469-74 • Neonatal outcomes (week of pregnancy at delivery, Apgar scores, birth weight, neonatal resuscitation or complications, etc.) were NOT adversely affected due to FCM Aporta Rodriguez et al. Obstetrics and gynecology international. 2016 Jan 1;2016 Breymann et al. Journal of perinatal medicine. 2017;45(4):443-53 Khalafallah A et al. InSeminars in hematology. 2018; 55(4):223-234 43
  • 55. Management of IDA in Postnatal period 55
  • 56. In postpartum anemic patients, parenteral intravenous (Iron sucrose/ ferric carboxymaltose) may be the preferred alternative over oral iron for ensuring compliance and faster response (Grade A, level 3) Ferric carboxymaltose has an advantage of administration as a bolus dose in the postpartum period for correction of anemia and restoration of iron stores. (Grade A,level 2) FOGSI GCPR 2017 recommendations 56 • Level 2- Moderate quality evidence from randomized trials
  • 57. Benson CS et al Obstet Med. 2021 Jun;14(2):67-76. Summary of Key Recommendations, 2019 UK Guidelines: Management of Iron Deficiency Anemia Recommendations Grade Intrapartum and postpartum Women with Hb less than 10 g/dL within 48 h of delivery, who are haemodynamically stable, asymptomatic or mildly symptomatic, should be offered oral elemental iron daily for at least 3 months 2A Use of IV intravenous iron postpartum should be considered in women who are previously intolerant of, or do not respond to, oral iron and/or where the severity of symptoms of anaemia requires prompt management 2B 57
  • 58. Supplementation Interventions by Ministry of Health and Family Welfare (MoHFW) 8 Guidelines for Control of Iron Deficiency Anaemia_2013 50
  • 59. • The 10 commandments for the transfusion practice in medicine state that transfusion should only be used when • Benefits outweigh the risks & • With signs of shock or acute hemorrhage with signs of hemodynamic instability. • Severe anemia (Hb <7 gm/dL) with symptoms of hemodynamic alterations. • During ANC, a trial of FCM is to be given before BT in women presenting with severe anemia. • Studies from India identify that postpartum hemorrhage (PPH) is the major indication for BT in obstetric practice. • IV iron such as FCM can be an alternative to BT, especially in women at high risk of transfusion- related reactions. Blood transfusion vs Parenteral iron Derek N. Transfusion ten commandments. In: Handbook of transfusion medicine. 5th ed. Chawla S et al. J Obstet Gynaecol India 2018;68(3) 59
  • 60. Eligible72 studies from 1966 to June 2013, including 10 605 patients provided quantitative outcome data for meta-analysis. Main outcome measures Change in haemoglobin concentration and risk of allogeneic red blood cell transfusion (efficacy) Key findings • Intravenous iron was associated with an increase in haemoglobin concentration (standardised mean difference 6.5 g/L, 95% confidence interval 5.1 g/L to 7.9 g/L) and a reduced risk of requirement for red blood cell transfusion (risk ratio 0.74, 95% confidence interval 0.62 to 0.88) • Intravenous iron therapy is effective in increasing haemoglobin concentration and reducing the risk of allogeneic red blood cell transfusion. Edward Litton staff specialist clinical senior lecturer1 2, Jing Xiao registrar1, Kwok M Ho staff specialist associate professor 1 3 60 Bmj. 2013 Aug 15;347.
  • 61. Conclusion • FCM is an ideal parenteral iron: Requires no test dose; Low risk of hypersensitivity reactions or anaphylactic reactions. • FCM dose are calculated based on Body weight and Hb deficit. • Most of Indian patients are of wt of 35- 70 kg and average Hb < 10 gm/dl. • These patients will require a dose of 1500 mg and lower dose may not be therapeutically useful. • Significant increase in hemoglobin and blood indices were seen in various trial with FCM 750 mg compare to other treatment options of IDA. • FCM 750 mg offers flexibility for doctors to choose various parenteral Iron preparations for treatment of IDA.
  • 62. 53