In a bid to provide effective and convenient option for patients with iron deficiency and iron deficiency anaemia (IDA), Emcure Pharmaceuticals Limited (EPL) has launched Orofer FCM 750, a new extension of its parenteral iron brand containing Ferric carboxymaltose (FCM).
This makes Emcure India’s first company to launch the 750 mg injectable variant of Ferric Carboxymaltose.
With this new intervention, the single dose of FCM up to 750 mg of iron can be infused in 15 minutes, while the dose is suitable for the majority of Indian patients with iron deficiency and iron deficiency anemia (IDA).
The drug regulator - Drug Controller General of India (DCGI) has approved FCM and 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 & bodyweight between 35 kg to 70kg. Orofer FCM can only be obtained through a prescription from a registered medical practitioner,” an Emcure statement said.
Notably, IDA is considered as a significant burden for women, especially during later trimesters of pregnancy and secondary to postpartum hemorrhage (PPH).
“Approximately 36% of maternal deaths are attributed to PPH1 as per Indian studies; whereas anemia during pregnancy is reported among 45.7% and 54.3% of pregnant women in urban and rural areas, respectively, hampering post-partum maternal and early child health outcomes,” the statement said adding that Indian studies using FCM for the treatment of IDA in pregnancy have indicated that most patients have mean Haemoglobin <10 g/dl.3,4 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 saline.
Anil Kothiyal, President India Business at Emcure Pharmaceuticals said, “We feel satisfied to introduce Orofer FCM 750 to help address this significant burden of IDA in India. This bolsters our commitment to providing innovative and effective solutions to meet the healthcare needs of patients in India. We believe Orofer FCM 750, with its convenient dosage strength, will provide an important treatment option for patients with IDA who may not have responded to oral iron preparations or who cannot tolerate them.”
Orofer FCM will be available in leading pharmacies and hospitals soon.