Emcure Pharmaceuticals Ltd Launches Orofer FCM in 750 mg to Treat Iron Deficiency Anaemia for Patients in India

DCGI-approved FCM is indicated for the treatment of iron deficiency when oral iron preparations are ineffective or cannot be used. It is already available in dosage forms 1000mg/ 20ml and 500mg/ 10ml single-use vials. With this latest launch, Orofer FCM will also be available as a 750mg/15ml dosage form recommended for treatment of Haemoglobin <10 g/dl & bodyweight >35kgs to <70kgs.

Indian studies using FCM for the treatment of Iron Deficiency Anaemia (IDA) in pregnancy have indicated that most patients have mean Haemoglobin <10g/dl.^1,2 They may require FCM 1500 mg at body weight between 35-70 kgs. A single dose of FCM up to 750 mg of iron can be infused in a short time frame of 15 minutes diluted in 250 ml of normal saline³.

The operational guidelines of the Intensified National Iron Plus Initiative (I-NIPI) under the “Anemia Mukt Bharat” Programme released in April 2018 recommended the use of FCM as first line treatment for severe and mild-to-moderate anemia (selected cases) in pregnant women in India. FCM is a novel iron complex consisting of a ferric hydroxide core stabilized by a carbohydrate shell, allowing controlled delivery of iron to target tissues. FCM can elevate serum ferritin & Haemoglobin levels; & provide better compliance than oral iron and iron sucrose therapy.

“A majority of patients need a cumulative dose of 1500 mg divided into two doses of 750 each. With an endeavour to make anaemia treatment more effective & further enhance women's well-being as she embarks on motherhood, Emcure Pharmaceuticals Ltd, for the 1st time in India is launching Orofer FCM 750, containing FCM 750mg/15ml, which is an effective, well tolerated and convenient dose for the majority of Indian patients,” said Rakesh Mehta, Senior Director, Emcure Pharmaceuticals.

Iron Deficiency Anaemia is a magnanimous burden in women; especially through later trimesters of pregnancy, & secondary to postpartum haemorrhage (PPH). Indian studies have shown about 36% of maternal deaths are attributed to PPH⁴. Anaemia during pregnancy is reported among 45.7% & 54.3% of pregnant women in urban & rural areas respectively⁵, hampering post-partum maternal & early child health outcomes.

Emcure Pharmaceuticals Limited is an Indian multinational pharmaceutical company. The company is a major producer in gynaecology, haematology, HIV drugs, and antivirals therapy segments.

References

1. Trivedi P, Chitra S, Natarajan S, et al. Ferric Carboxymaltose in the Management of Iron Deficiency Anemia in Pregnancy: A Subgroup Analysis of a Multicenter Real-World Study Involving 1191 Pregnant Women. Obstet Gynecol Int. 2022;2022:5759740. Published 2022 Nov 28. doi:10.1155/2022/5759740

2. Charmila A, Natarajan S, Chitra TV, et al. Efficacy and Safety of Ferric Carboxymaltose in the Management of Iron Deficiency Anemia: A Multi-Center Real-World Study from India. J Blood Med. 2022;13:303-313. Published 2022 Jun 8. doi:10.2147/JBM.S361210

3. Keating GM. Ferric carboxymaltose: a review of its use in iron deficiency. Drugs. 2015;75(1):101-127. doi:10.1007/s40265-014-0332-3

4. Rathod S, Samal SK, Mahapatra PC, Samal S. Ferric carboxymaltose: A revolution in the treatment of postpartum Anaemia in Indian women. Int J Appl Basic Med Res. 2015;5(1):25-30. doi:10.4103/2229-516X.149230

5. Kaushal S, Priya T, Thakur S, Marwaha P, Kaur H. The Etiology of Anaemia Among Pregnant Women in the Hill State of Himachal Pradesh in North India: A Cross-Sectional Study. Cureus. 2022;14(1):e21444. Published 2022 Jan 20. doi:10.7759/cureus.21444