Emcure Pharmaceuticals has launched Orofer FCM 750, a new extension of its parenteral iron brand containing ferric carboxymaltose (FCM).
The new dosage variant is designed to provide a more effective and convenient option for patients with iron deficiency and iron deficiency anaemia (IDA). DCGI-approved FCM is indicated for 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 patients with hemoglobin less than 10 g/dl and bodyweight between 35 kg to 70kg. Orofer FCM can only be obtained through a prescription from a registered medical practitioner.
Indian studies using FCM for the treatment of IDA in pregnancy have indicated that most patients have mean haemoglobin <10 g/dl.. They may require FCM 1500 mg at body weight between 35-70 kg. 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 saline.
In April 2018, the Intensified National Iron Plus Initiative (I-NIPI) operational guidelines for the ‘Anemia Mukt Bharat’ Programme recommended FCM as the first-line treatment for severe and selected cases of mild-to-moderate anemia in pregnant women in India. FCM consists of a ferric hydroxide core stabilised by a carbohydrate shell, enabling controlled iron delivery to target tissues. FCM can elevate serum ferritin and hemoglobin levels and provide better compliance as compared to oral iron and iron sucrose therapy.
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