Lupin reintroduces Methergine® Oral Tablets in the US for postpartum hemorrhage

Mumbai : Pharma Major Lupin Limited and its US subsidiary, Lupin Pharmaceuticals, Inc. (collectively Lupin) have announced the re-introduction of Methergine® (methylergonovine maleate) Oral Tablets 0.2mg for the prevention and management of postpartum hemorrhage (PPH).

Methergine® is the only FDA-approved oral uterotonic and is a preferred oral agent in the management of PPH1, according to guidelines issued by the American Congress of Obstetricians and Gynecologists (ACOG). More than half of all maternal deaths occur within 24 hours of birth, most commonly from excessive bleeding 3 and rates of maternal mortality continue to rise in the US4 where PPH is a leading cause of pregnancy complications.

"The re-introduction of Methergine is a proud moment for Lupin, but also an important moment for expectant mothers across the country to feel confident in care options," said Paul McGarty, President, Lupin Pharmaceuticals Inc.

"With Methergine, Lupin is making a significant investment to help improve the management of PPH, providing professional medical education, leveraging its specialized sales force to drive better awareness and access to care, and ensuring a more stable supply of this essential medicine," McGarty added.

One area of need is further physician education around ascertaining accurate blood loss a barrier to optimal care. PPH is defined as blood loss in excess of 500 mL after vaginal delivery or 1000 mL after cesarean delivery, and according to the Association of Women's Health Obstetric and Neonatal Nurses, visual estimation of blood loss is consistently underestimated for volumes over 1000 mL and usually overestimated for smaller volumes.

Underestimation of blood loss can lead to the delay of life-saving interventions, while overestimation can lead to costly, unnecessary treatments, such as blood transfusions.

"Postpartum hemorrhage (PPH) is one of the most preventable causes of maternal mortality and it should be better managed in pursuit of improved patient care," said David B. Schwartz, MD, FACOG, independent OBGYN and ACOG fellow.

"I commend Lupin for spotlighting this public health issue and making an investment in treatment, education and awareness of PPH," he added.

A semi-synthetic ergot alkaloid, Methergine is indicated for routine management of uterine atony, hemorrhage and subinvolution of the uterus following delivery of the placenta, and for control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder. Methergine provides specific and rapid (onset of action under 10 minutes) uterotonic action on the smooth muscle of the uterus to increase contractions, resulting in restricting blood loss.

The Methergine dosing schedule is one tablet (0.2 mg) three or four times daily in the puerperium for a maximum of one week. The most common adverse event is hypertension associated in several cases with seizure and/or headache. Methylergonovine maleate is available as an intramuscular injection or as an oral tablet; Lupin acquired oral methylergonovine maleate earlier this year.

Postpartum hemorrhage (PPH) is often defined as blood loss in excess of 500 mL after vaginal delivery or 1000 mL after cesarean delivery. It is generally classified as primary occurring within the first 24 hours of delivery or secondary, up to 6-12 weeks postpartum.

PPH is a leading cause of birth complications, and it is estimated that 2.9 percent of the women who give birth in the United States will bleed too much.11 In the past decade, there has been a 183 percent increase in the number of women receiving a blood transfusion around the time they gave birth. It is estimated that, worldwide, 140,000 women die of postpartum hemorrhage each year one every four minutes. The US is ranked 47th in the world for maternal mortality.

Causes of postpartum hemorrhage include uterine atony, retained placenta, placenta accreta, defects in coagulation, and uterine inversion while secondary causes include sub involution of placental site, retained products of conception, infection and inherited coagulation defects. Uterine atony accounts for 79 percent of the cases of PPH.21 Patient risk factors for postpartum hemorrhage include labor induction and augmentation, current or prior cesarean delivery, history of postpartum hemorrhage, hypertensive disorder of pregnancy, fibroids, placenta previa, coagulopathy, and obesity. Women of Hispanic and Asian descent have an increased risk of postpartum hemorrhage.

Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and amp; generic formulations, biotechnology products and APIs globally. The company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership positions in the Anti-TB and Cephalosporin segment.