Tuesday, August 31, 2021

Abbott Introduces Room-Temperature-Stable, Single-Dose Formulation Of Carbetocin For The Prevention Of Postpartum Haemorrhage In India

* The novel, room-temperature-stable (RTS), single-dose formulation will address prevailing challenges with existing protocols that require cold-chain storage and transportation, thus helping in prevention of PPH (postpartum haemorrhage) and facilitating better maternal healthcare in India

* Every year, PPH accounts for close to 20% of all maternal mortality[i] in the country

* The formulation’s efficacy and safety is supported by the results of the largest clinical trial in the prevention of PPH published in the New England Journal of Medicine[ii]

Abbott, the global healthcare company has announced the introduction of a room-temperature-stable, single-dose formulation of carbetocin in India, which is available in convenient vials, to help in the prevention of postpartum haemorrhage (PPH). Abbott’s product is available in the private sector. PPH refers to excessive blood loss of 500 ml or more after vaginal delivery and 1000 ml or more after a caesarean procedure, within 24 hours of childbirth[iii].  Although preventable, PPH is associated with almost 20% maternal mortality in the country.

PPH, if left untreated can result in complications like anaemia in the postpartum period or aggravate mental health problems including postnatal depression and post-traumatic stress disorder apart from other issues[iv]. Women may require additional treatment for PPH which can extend hospital stay. Additionally, PPH may also impact breastfeeding and nursing for the newborn[v].

The current prevention and treatment protocol for PPH requires cold-chain storage and distribution, as well as continual administration of medicines via intravenous drip infusion. This can impede access to quality healthcare for pregnant women in care settings where these requirements may not be feasible. The room-temperature-stable formulation addresses the challenge of maintaining cold-chain storage or transportation, which helps increase access to preventive treatment for PPH, across geographies.

Abbott has launched this formulation for the private market under its own brand through an in-licensing and co-marketing agreement with Ferring Pharmaceuticals Pvt. Ltd. India (Ferring), a subsidiary of the Switzerland-based global biopharmaceuticals company.

Results from the largest PPH trial published in the New England Journal of Medicine (NEJM), which enrolled nearly 30,000 women from 10 countries including India[vi],  indicated that carbetocin was non-inferior to oxytocin, the current standard of care, for the prevention of blood loss of 500 ml or additional uterotonic use (for the prevention of PPH during the active management of third-stage labour). 

Discussing the need for effectively preventing PPH, Dr. Sheela Mane, a renowned senior Obstetrics and Gynaecology consultant at Anugraha Nursing home, Bengaluru, commented, “Postpartum haemorrhage, seen in both caesarian and vaginal deliveries in India, could lead to long-term complications. Due to its heat sensitivity, quality of oxytocin maybe affected in areas with frequent power failures and lack of storage facilities. The new room temperature-stable carbetocin, which has been included in both the WHO guidelines and FIGO’s joint consensus statement for PPH prevention, could overcome these cold-chain transportation and storage challenges and prove to be an effective option for PPH prevention.”

A single-dose formulation of carbetocin is convenient to administer since it is a single-dose and offers an intra-muscular dosing option in addition to intra-venous administration. It therefore reduces the need for at-risk pregnant women to undergo a prolonged stay at the hospital post-delivery. This collaboration with Ferring, a leader in innovative reproductive medicine and maternal health, combined with Abbott’s commitment to women’s health, presents an important milestone in the nation’s efforts to enhance maternal health and ensure improved health outcomes post-delivery.

Commenting on this new formulation in India, Dr. Srirupa Das, Medical Director, Abbott India said, “For over five decades, Abbott has helped improve the lives of women throughout their pregnancy and reproductive health. With the introduction of this room-temperature-stable carbetocin formulation in collaboration with Ferring, we are reiterating our commitment to improve maternal care, enabling both mothers and children to live through better health. This formulation has proven efficacy, a convenient formulation that addresses the needs for heat stability and can help with better health outcomes for mothers who just delivered a baby.”[vii]

About Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 109,000 colleagues serve people in more than 160 countries. In India, Abbott was established in 1910, and is one of the country's oldest and most admired healthcare companies. With more than 12,000 employees in the country, Abbott is helping to meet the healthcare needs of consumers, patients and doctors throughout urban and rural India.

[i] Kumar N (2016) Postpartum Hemorrhage; a Major Killer of Woman: Review of Current Scenario. Obstet Gynecol Int J 4(4): 00116. DOI: 10.15406/ogij.2016.04.00116

[ii] https://www.nejm.org/doi/full/10.1056/nejmoa1805489

[iii] Carlisa B. Comparison of Carbetocin with other uterotonic agents in preventing postpartum hemorrhage, Int J Reprod Contracept Obstet Gynecol. 2018 Dec;7(12):5207-5213

[iv] Evensen A, Anderson JM, Fontaine P. Postpartum Hemorrhage: Prevention and Treatment. Am Fam Physician. 2017 Apr 1;95(7):442-449. PMID: 28409600

[v] Thompson, J.F., Heal, L.J., Roberts, C.L. et al. Women's breastfeeding experiences following a significant primary postpartum haemorrhage: A multicentre cohort study. Int Breastfeed J 5, 5 (2010). https://doi.org/10.1186/1746-4358-5-5

[vi] Widmer M, Piaggio G, Nguyen TMH, et al; WHO CHAMPION Trial Group. Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth. N Engl J Med. 2018 Aug 23;379(8):743-752. doi: 10.1056/NEJMoa1805489. Epub 2018 Jun 27. PMID: 29949473.

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