Posted from: Friday, August 09, 2019 - 02:49 PM - Present

First Hemabate Generic Launched

July 3, 2019 – Dr. Reddy’s has announced the launch of the first generic for Pfizer’s Hemabate® (carboprost tromethamine) sterile solution for injection. The product is indicated to treat postpartum hemorrhage due to uterine atony that has not responded to conventional methods of management, as well as to abort a pregnancy under certain conditions.

A serious complication of childbirth, uterine atony occurs when the uterus fails to contract after delivery of the infant. Normal contraction of the uterus helps to stem bleeding from blood vessels that were attached to the placenta. When the uterus does not contract, it can lead to potentially life-threatening uterine hemorrhage.

The recommended initial dose of carboprost tromethamine is 1mL of sterile solution (containing the equivalent of 250 micrograms of carboprost) administered via deep intramuscular injection. Subsequent doses may be required depending on the indication, clinical response, and attending physician’s best judgment based on the course of clinical events. The total dose should not exceed 2mg (eight doses) in the case of treating postpartum hemorrhage. If aborting a pregnancy, continuous administration for more than two days is not recommended, and the total dose should not exceed 12mg.

A black box warning cautions that carboprost tromethamine, like other potent oxytocic agents, should be used only with strict adherence to recommended dosages. The black box warning also states that only medically trained personnel should administer the product, and that the product should only be used in a hospital that can provide immediate intensive care and acute surgical facilities.

Dr. Reddy’s generic will have 180 days of exclusivity on the U.S. market. It is available in 1mL single-dose vials at an average wholesale price of $382.79 per vial, compared to $425.32 for brand name Hemabate.

Last Updated Friday, October 11, 2019 - 05:57 PM.