Kaleo’s AUVI-Q® (epinephrine injection, USP) Selected by Axiom Space to Help Protect Crew from Allergic Emergencies
Richmond, Virginia, July 24, 2025 (GLOBE NEWSWIRE) -- Kaléo, a global leader in drug-delivery device technology and auto-injector innovation, today announced that AUVI-Q® (epinephrine injection, USP) was cleared for use as a part of Axiom Mission 4 that took flight on June 25, 2025, and returned on July 15, 2025. AUVI-Q was selected by Axiom Space to support Axiom Space crew members in the event of an allergic emergency.
Aboard the Ax-4 mission, the four person international crew including Commander Peggy Whitson, Ph.D., America’s most experienced astronaut, Pilot Shubhanshu Shukla, a distinguished pilot in the Indian Air Force (IAF) and Indian Space Research Organization (ISRO) astronaut, Sławosz Uznański-Wiśniewski, scientist and engineer of Poland and European Space Agency (ESA) project astronaut, and Tibor Kapu, a mechanical engineer from Hungary and Hungarian in Orbit (HUNOR) Program, had access to AUVI-Q in the event of an allergic emergency that required rapid delivery of epinephrine. Axiom Space additionally cleared AUVI-Q for inclusion on its flight surgeons’ launch and landing kits used to support the crew in the weeks leading up to launch and later during landing.
“Since the founding of Kaléo 20 years ago, it has been the mission of our team to develop drug-delivery devices that can be trusted by those who depend on them, and to uphold the most rigorous safety and reliability testing. Being trusted by Axiom Space to ensure the Ax-4 crew had access to epinephrine is truly the ultimate responsibility” said Michael Wells, Chairman and Chief Executive Officer of Kaléo. “We are proud to support the women and men who are advancing scientific knowledge and enhancing what is possible in space exploration by helping to provide peace of mind in the event of an allergic emergency.”
The Kaléo forward-thinking approach, including Human Factors Engineering, helps ensure its devices are Built to Trust, meeting quality standards across diverse environments and conditions for real-world use.
“The success of each mission is centered on planning and dependability, and this starts with ensuring the crew has access to essential and trusted medical treatments,” said Mike Harrison, MD, PhD, Chief Medical Officer at Axiom Space. “There is virtually no other situation where people are completely reliant on their accessible resources than in space travel, making the anticipation of potential needs and rigor of our sourcing and selection process crucial to survival.”
The Ax-4 mission, managed and operated by Axiom Space, launched from NASA’s Kennedy Space Center in Florida on June 25 at 2:31a.m. ET. In addition to crew supplies, commercial cargo, and research payloads, the mission carries an in-flight medical kit designed to address a range of potential medical conditions. All medications added to the medical kit undergo rigorous review by Axiom Space.
What is AUVI-Q?
AUVI-Q® (epinephrine injection) is a prescription medicine used to treat life-threatening allergic reactions including anaphylaxis in adults and children who weigh 16.5 pounds or more who are at risk
for or have a history of serious allergic reactions. AUVI-Q is for immediate self (or caregiver)
Administration.
Important Safety Information
What is the most important information I should know about AUVI-Q?
• Always carry two AUVI-Q devices with you because you may not know when a life-threatening allergic
reaction may happen. If a second dose of AUVI-Q is needed, it should be given starting 5 minutes after
the first. If you need more than 2 doses of epinephrine for a single anaphylaxis episode, more doses
must be given by a healthcare provider.
• Talk to your healthcare provider about when it is necessary to get medical care for further treatment of the allergic emergency after using AUVI-Q.
If you have certain medical conditions, or take certain medicines, your condition may get
worse or you may have more or longer lasting side effects when you use AUVI-Q.
Before using AUVI-Q, tell your healthcare provider about all of your medical conditions,
especially if you have heart problems, high blood pressure, diabetes, thyroid problems, kidney
problems, history of depression, Parkinson’s disease, or are pregnant (or plan to become pregnant), are
breastfeeding (or plan to breastfeed).
Tell your healthcare provider about all the medicines you take, including prescription and
nonprescription medicines, vitamins, and herbal supplements. AUVI-Q and other medicines may affect
each other, causing side effects.
AUVI-Q may cause serious side effects.
AUVI-Q should only be injected into your outer thigh, through your clothing if necessary. Do not inject
AUVI-Q into your veins, buttocks, fingers, toes, hands, or feet. If this occurs, go to the nearest hospital
emergency room right away and inform the healthcare provider of the location of the accidental injection.
Rarely, people who use AUVI-Q may get infections at the injection site within a few days of an
injection. Some of these infections can be serious. Call your healthcare provider right away if you
have any of the following at an injection site: redness that does not go away, swelling, tenderness, the
area feels warm to the touch.
If you inject a young child or infant with AUVI-Q, hold their leg firmly in place before and during the
injection to prevent injuries. Ask your healthcare provider to show you how to properly hold the leg
during an injection.
Common side effects of AUVI-Q include: fast, irregular, or ‘pounding’ heartbeat, sweating,
shakiness, headache, paleness, feelings of over excitement, nervousness, or anxiety, weakness,
dizziness, nausea and vomiting, breathing problems. Tell your healthcare provider if you have any
side effect that bothers you or that does not go away. These are not all of the possible side effects of
AUVI-Q.
You are encouraged to report side effects to kaléo, Inc. at 1-877-302-8847 or to the FDA at
www.fda.gov/medwatch or 1-800-FDA-1088.
About Kaléo
Kaléo is a global leader in drug-delivery device technology and auto-injector innovation, providing millions of patients with security and peace of mind. Our patented Aerio™ platform, with unmatched capabilities and Human Factors Engineering, powers our portfolio of auto-injector products, as well as products under development for third parties.
About AUVI-Q (0.3 mg, 0.15 mg and 0.1 mg)
AUVI-Q® (epinephrine injection, USP) is a prescription medicine used to treat emergency allergic reactions, including anaphylaxis, in people who are at risk for or who have a history of serious allergic reactions. AUVI-Q contains epinephrine, a first-line treatment for severe allergic reactions that occur as a result of exposure to allergens including food such as peanuts, tree nuts, fish, shellfish, dairy, eggs, soy and wheat; insect stings or bites; latex and medication, among other allergens and causes.
AUVI-Q is the only compact epinephrine auto-injector with a voice instruction system that helps guide patients and caregivers step-by-step through the injection process, and a needle that automatically retracts following administration. In anaphylaxis emergencies, it is often individuals without medical training who need to step in and deliver potentially life-saving epinephrine. AUVI-Q was designed through careful analysis of the situations where epinephrine auto-injectors are used and with significant input from the allergy community that relies on it, incorporating Human Factors Engineering (HFE). HFE is about designing products or systems that are easy to operate and, most importantly, support correct use, with the goal to remove the potential for error. For more information about AUVI-Q visit www.auvi-q.com.
About Axiom Space
Axiom Space is building the world’s first commercial space station – Axiom Station. Serving as a cornerstone for sustained human presence in space, this next-generation orbital platform fosters groundbreaking innovation and research in microgravity, and cultivates the vibrant, global space economy of tomorrow. Today, driven by the vision of leading humanity's journey off planet, Axiom Space is the principal provider of commercial human spaceflight services to the International Space Station and developer of advanced spacesuits for the Moon and low-Earth orbit. Axiom Space is building era-defining space infrastructure that will empower our civilization to transcend Earth for the benefit of every human, everywhere.
Attachment
Carrie Siragusa Kaléo 908-868-9263 Carrie.Siragusa@kaleo.com
Legal Disclaimer:
EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.
