What alternatives are there for Stimate Nasal Spray?
That’s a question many people in the bleeding disorders community have been asking since summer 2020, when Ferring Pharmaceuticals issued a voluntary recall of the nasal spray version of desmopressin (DDAVP). The nasal spray is commonly used to treat von Willebrand disease (VWD) and mild hemophilia A and is sold under the brand name Stimate.
Desmopressin is a synthetic analog of vasopressin, which boosts plasma levels of von Willebrand factor and factor VIII and helps stop bleeding. The nasal spray is often prescribed for people with frequent nosebleeds, serious bruising, or heavy menstrual periods (menorrhagia). DDAVP is also sometimes given to people before procedures that involve the mucous membranes, such as dental work, as well as for home treatment of minor injuries and before minor surgeries.
Stimate, which is owned and manufactured by Ferring, was recalled due to superpotency, meaning that some products contained higher-than-specified amounts of the medication. In June 2022, the company announced that the nasal spray will not be available until mid-2024 at the earliest.
Here are some other medication options that are available as alternatives to the recalled nasal spray:
DDAVP Nasal Spray from STAQ
In September 2021, a DDAVP nasal spray manufactured by STAQ Pharma Inc. (DDAVP NS) began distribution. As of April 4, 2022, the product had been fully licensed in 44 states, and the National Hemophilia Foundation (NHF), the Hemophilia Federation of America (HFA), and the Hemophilia Alliance were working with the manufacturer to get licenses in the remaining states..
“The Hemophilia Alliance and its members were delighted to fund the development of DDAVP NS for the bleeding disorders community,” says Joe Pugliese, president and CEO of the Hemophilia Alliance. “We have been working closely with NHF and HFA to help ensure coverage for and access to the product. If you have questions about how to obtain DDAVP NS and you are a patient, please contact your health care provider. If you are a health care provider with questions, please contact me.”
Antifibrinolytics
Oral medications such as tranexamic acid (Lysteda) and aminocaproic acid (Amicar) help promote blood clotting by preventing the breakdown of fibrin, which is the main protein involved in a blood clot.
Robert Sidonio Jr., M.D., director of hemostasis and thrombosis clinical operations at the Aflac Cancer and Blood Disorders Center of Children’s Healthcare of Atlanta, says he often prescribes high doses of an antifibrinolytic instead of DDAVP for patients with mildly reduced levels of von Willebrand factor or mild hemophilia A or B who are having minor mucosal surgeries. “We have been following this strategy for a while now, and we also apply it to nonmucosal procedures, such as skin biopsies, ear tube placement, colonoscopies, and tattoos,” Sidonio says.
IV or Subcutaneous DDAVP
Before the nasal spray version was introduced, DDAVP was primarily given as an injection, either intravenously or subcutaneously. Both of these options are still available.
“If DDAVP is working well for someone and they want to be maintained on the same medication, then subcutaneous injections of DDAVP, which patients can be taught to do at home, are an option that’s worth considering,” says Alexis Koon, PharmD, a hematology/oncology pharmacy resident at Atrium Health Carolinas Medical Center in Charlotte, North Carolina, who co-authored a 2021 paper outlining alternatives to the recalled nasal spray. Sidonio notes, however, that subcutaneous DDAVP is less practical for obese and overweight people because of the high volume of injections needed in addition to the higher rate of side effects such as facial flushing, headaches, and nausea.
Factor Replacement Products
People who have more severe VWD or who don’t respond to DDAVP are often prescribed factor replacement therapy, which is injected into a vein in the arm to replace the missing factor in the blood.
“If the patient has a clinically severe phenotype of VWD and it isn’t clear how invasive the procedure is, then we will need to rely on factor replacement, typically one dose prior to the procedure, followed by a prolonged course of an antifibrinolytic with possible additional factor doses,” Sidonio says. “For persons with mild hemophilia A and B, we have definitely been using more single-dose factor replacement, particularly if their levels are below 30%.”