EVZIO’s Commitment to Take Action During the National Opioid Overdose Crisis
We have recently been the subject of negative attention over the price of our drug, EVZIO. Obviously, we are disappointed with the way in which some of the facts are being presented and believe there is much more to this very complex story. However, our commitment and intention remain simple – we aspire to make a meaningful difference in patients’ lives.
We believe two facts are critical to the EVZIO story. First, we have received voluntary reports from recipients of donated product that EVZIO has saved more than 5,500 lives since we launched the product in 2014.1 Second, we have never turned an annual profit on the sale of EVZIO.2 Patients, not profits, have driven our actions.
We believe patients and physicians should have meaningful choices. There is no doubt, the complexity of our healthcare system has had unintended negative implications for everyone involved, but most importantly, for patients. To this end, we explored viable paths within the current healthcare system to make EVZIO available to patients in a responsible, meaningful and affordable way.
We agree changes need to be made. We believe all patients should have the right to innovative products at reasonable prices. We are actively working with stakeholders in the healthcare system, including insurers, policymakers and government officials, to provide EVZIO at a lower cost while ensuring patients and their loved ones have access to this life-saving drug.
This issue is personal to all of us at kaléo. Like you, we are also mothers, fathers, sisters and brothers, taxpayers, and importantly, we are patients too.
What is EVZIO?
EVZIO is a prescription medicine used in adults and children for the treatment of an opioid emergency such as an overdose or a possible opioid overdose with signs of breathing problems and severe sleepiness or not being able to respond.
EVZIO is to be given right away and does not take the place of emergency medical care. Get emergency medical help right away after the first dose of EVZIO, even if the person wakes up.
EVZIO is safe and effective in children for known or suspected opioid overdose.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about EVZIO?
EVZIO is used to temporarily reverse the effects of opioid medicines. The medicine in EVZIO has no effect in people who are not taking opioid medicines. Always carry EVZIO with you in case of an opioid emergency.
- Use EVZIO right away if you or your caregiver think signs or symptoms of an opioid emergency are present, even if you are not sure, because an opioid emergency can cause severe injury or death. Signs and symptoms of an opioid emergency may include:
- unusual sleepiness and you are not able to awaken the person with a loud voice or rubbing firmly on the middle of their chest (sternum)
- breathing problems including slow or shallow breathing in someone difficult to awaken or they look like they are not breathing
- the black circle in the center of the colored part of the eye (pupil) is very small, sometimes called “pinpoint pupils” in someone difficult to awaken
- Family members, caregivers, or other people who may have to use EVZIO in an opioid emergency should know where EVZIO is stored and how to give EVZIO before an opioid emergency happens.
- Get emergency medical help right away after using the first dose of EVZIO. Rescue breathing or CPR (cardiopulmonary resuscitation) may be given while waiting for emergency medical help.
- The signs and symptoms of an opioid emergency can return within several minutes after EVZIO is given. If this happens, give additional injections using new EVZIO auto-injectors every 2 to 3 minutes and continue to closely watch the person until emergency help is received.
Who should not use EVZIO?
Do not use EVZIO if you are allergic to naloxone hydrochloride or any of the ingredients in EVZIO.
What are the ingredients in EVZIO?
Active ingredient: naloxone hydrochloride
Inactive ingredients: sodium chloride, hydrochloric acid to adjust pH, and water
What should I tell my healthcare provider before using EVZIO?
Tell your healthcare provider about all of your medical conditions, including if you:
- have heart problems
- are pregnant or plan to become pregnant. Use of EVZIO may cause withdrawal symptoms in your unborn baby. Your unborn baby should be examined by a healthcare provider right away after you are given EVZIO.
Tell your healthcare provider about the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of EVZIO?
EVZIO may cause serious side effects, including:
- Sudden opioid withdrawal symptoms. In someone who has been using opioids regularly, opioid withdrawal symptoms can happen suddenly after receiving EVZIO and may include: body aches, fever, sweating, runny nose, sneezing, goose bumps, yawning, weakness, shivering or trembling, nervousness, restlessness or irritability, diarrhea, nausea or vomiting, stomach cramping, increased blood pressure, and increased heart rate.In infants under 4 weeks old who have been receiving opioids regularly, sudden opioid withdrawal may be life-threatening if not treated the right way. Signs and symptoms include: seizures, crying more than usual, and increased reflexes.
Common side effects of EVZIO include dizziness and injection site redness.
These are not all of the possible side effects of EVZIO. Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
To learn more about EVZIO visit www.EVZIO.com.
Data on file. Richmond, VA; kaleo, Inc.
Data on file. Richmond, VA; kaleo, Inc.