People living with chronic obstructive pulmonary disease (COPD) typically rely on maintenance inhalers to manage their daily symptoms. They may also take rescue inhalers for sudden breathing difficulty.
Ohtuvayre is an inhaled medicine that works in multiple ways to improve breathing. It helps control long-term, daily symptoms. For some people, it may also reduce the need for rescue inhalers.
How Does Ohtuvayre Work for COPD?
COPD is a common long-term (chronic) lung disease that happens when the airways or the tiny air sacs in the lungs (called alveoli) are damaged. In some cases, both the airways and alveoli are affected. This damage makes it hard to get enough air and for oxygen to move from the alveoli into the bloodstream.
The main cause of COPD is exposure to tobacco smoke. It can also result from exposure to toxic particles or gases found in household or outdoor air pollution. COPD is a lung disease that can be prevented.
People with COPD have long-lasting trouble with breathing, a condition called dyspnea. Other symptoms include a cough, which may or may not produce mucus (phlegm). Some people may also have wheezing. The severity of these symptoms can change day-to-day. COPD is a progressive disease, which means that symptoms get worse over time.
Sometimes, people with COPD experience a flare-up (exacerbation) of their symptoms. During a flare-up, symptoms worsen within a period of less than two weeks. Triggers for flare-ups can include infections, such as the common cold or flu, or exposure to pollution, which leads to increased swelling in the lungs.
The goals of COPD treatment are to manage the daily symptoms and lower the risk of flare-ups. Medicines for COPD help open the airways to make it easier to breathe. Ohtuvayre is an inhaled treatment that contains the medicine ensifentrine. Ensifentrine helps open airways and reduce inflammation in the lungs.
Can Ohtuvayre Be Used Alone for COPD?
Ohtuvayre contains one long-acting medicine that some doctors call a maintenance inhaler. Some people may still need other maintenance inhalers to control their daily symptoms.
With COPD, your doctor will also prescribe a rescue inhaler to have on hand for flare-ups. A rescue inhaler, such as a short-acting bronchodilator, quickly controls symptoms of a flare-up when they occur.
You will use Ohtuvayre every day to manage your symptoms. Ohtuvayre is not used to control worsening symptoms of COPD during a flare-up. Extra doses of Ohtuvayre will not help control sudden breathing issues.
How Do I Take Ohtuvayre?
You will inhale Ohtuvayre through your mouth twice daily, once in the morning and once in the evening.
To take Ohtuvayre, you'll use a standard jet nebulizer with a mouthpiece that is connected to an air compressor. Before you take Ohtuvayre, read and follow the instructions to operate your nebulizer.
Ohtuvayre comes as a liquid in an ampule (a small, sealed vial) that contains a single dose of the medicine. Shake the ampule vigorously and the liquid will turn cloudy and yellow or pale yellow in color. Twist the tip of the ampule to open it. Squeeze the medicine into the nebulizer cup and attach the mouthpiece. Make sure the mouthpiece is connected to your nebulizer.
Connect the nebulizer to the air compressor. Now, the medicine is ready to be inhaled. Sit upright and place the mouthpiece in your mouth. Seal your lips around the mouthpiece. Turn on the compressor and breathe calmly and deeply. Try to take even breaths. Continue to inhale the medicine into your mouth until there is no more mist in the nebulizer reservoir. This may take up to seven minutes depending on your nebulizer.
Once you have completed your treatment, turn off the compressor. Clean and store the nebulizer as instructed by the manufacturer.
If you take other medicines with your standard jet nebulizer, do not mix them with Ohtuvayre. Ask your doctor about the appropriate waiting time between inhaled medicines.
How Was Ohtuvayre Studied for COPD?
Ohtuvayre was studied in two clinical trials to see whether it is effective and safe for COPD. The participants in the study had moderate to severe COPD and were at least 40 years old. The study did not include people who had both asthma and COPD.
Most of the people in the trials were White (over 90%) with smaller percentages of Black or African American, Asian, and other racial groups. About 3%-5% of participants were of Hispanic or Latino ethnicity. All participants in the study had a history of smoking. More than half (about 55%) were current smokers with an average smoking history of nearly 40 years. Over 20% had a flare-up in the last 15 months before the start of the study. However, anyone who had a flare-up in the previous three months could not be included in the study.
In both studies, people took either Ohtuvayre or a placebo, but they did not know which one they were getting. To see how well Ohtuvayre works, researchers measured how much air participants could blow out of their lungs in one second. This is a measure called forced expiratory volume in one second (FEV1). This measure helps to show how easily air is able to move through a person's lungs. The researchers measured this before participants took Ohtuvayre and several times over the following 12 hours. They checked this measure at the beginning of the study and again after 12 weeks. This helped researchers compare how much Ohtuvayre improved lung function over time compared to the placebo.
Researchers also used daily questionnaires to track participants’ COPD symptoms. The St. George’s Respiratory Questionnaire (SGRQ) asks about how severe and frequent their symptoms are. It also evaluates how much COPD limits physical activity. The SGRQ also evaluates participants’ quality of life. This includes questions on how the disease affects overall well-being, emotional health, and social aspects of life. People who took Ohtuvayre had fewer COPD symptoms compared to people taking the placebo and improved quality of life scores at the end of the study compared to those taking the placebo.
At the start of the study, participants also received a diary to record how often they used their rescue inhalers each day. Researchers reviewed these diaries to calculate the average daily use of rescue inhalers over a seven-day period.
What Were the Benefits?
Breathing function. People who took Ohtuvayre were able to exhale more air in one second than people who took the placebo. This improvement in lung function shows that Ohtuvayre helps open the airways, making it easier to breathe.
At the 12-week mark, researchers also measured the highest amount of air participants could exhale in one second after taking Ohtuvayre. This is a measure called the peak FEV1. People who took Ohtuvayre had better peak FEV1 results compared to placebo. This shows how much the lungs can improve right after treatment with Ohtuvayre. It also suggests that the medicine’s benefits continue to last over time.
Moderate or severe COPD flare-up. The studies showed that Ohtuvayre reduced the number of flare-ups and delayed the time until the first flare-up occurred. These benefits were also seen in participants with more severe COPD and those who use other maintenance inhalers.
How Long Does Ohtuvayre Take to Work?
You may start to notice easier breathing with Ohtuvayre after a few days or weeks. Some people may find they need their rescue inhalers less often and have fewer breathing issues.
Do not stop Ohtuvayre without talking to your doctor first, even if your breathing improves. Your breathing may get worse and your symptoms may come back if you stop Ohtuvayre. If you do not see improvements in your breathing after a few weeks, speak with your doctor. Your doctor may first check how you use Ohtuvayre to make sure you are using it properly. If Ohtuvayre does not work for you, you can discuss other treatment options for your COPD with your doctor.
Call your doctor right away if you have more sudden breathing episodes and need your rescue inhaler more often. If your rescue inhalers do not work as well as before, tell your doctor right away.
How Can I Prevent and Manage Side Effects?
The most common side effects reported with Ohtuvayre occurred in less than 2% of people in the clinical trials. The side effects included back pain, high blood pressure, urinary tract infections, and diarrhea.
If you experience diarrhea with Ohtuvayre, it is important to drink plenty of fluids that contain electrolytes. A bland diet of bananas, toast, oatmeal, white rice, applesauce, or soup helps make your stool firmer. If your diarrhea worsens, speak with your doctor.
Tell your doctor if you have a history of depression or suicidal thoughts or behaviors. Two people in the clinical trials reported an increase in depressive symptoms and suicidal thoughts while using Ohtuvayre. The most common mental health side effects that occurred with Ohtuvyre include sleeplessness and anxiety.
If you have worsening mental health with Ohtuvayre, tell your doctor right away. Your doctor will decide if this medicine is still safe for you.
These are not all the side effects you may experience with Ohtuvayre. Talk with your health care provider if you have side effects that bother you. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What Kinds of Drug Interactions May Happen?
The clinical trials did not identify drug interactions with Ohtuvayre. This does not mean that there are no drug interactions with Ohtuvayre. Tell your pharmacist or doctor about all the prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, or other supplements you take or have recently taken.
What Are Some Other Unique Considerations to Be Aware Of?
Sudden breathing problems can occur in rare situations soon after the first dose of Ohtuvayre. If this happens, stop Ohtuvayre treatment right away and go to the nearest emergency room.
Tell your doctor if you have moderate or severe liver problems. These conditions may slow down the removal of Ohtuvayre from your body, causing higher levels of the medicine in your blood.
What Do I Need to Do to Get Ohtuvayre?
Ohtuvayre is not available in local pharmacies. The manufacturer will connect you with a specialty pharmacy of your choice to help you get access to Ohtuvayre. Specialty pharmacies can help you and your health care provider access Ohtuvayre and any necessary supplies, such as a nebulizer.
These pharmacies often assist with navigating insurance coverage, which is important since medicines available only through specialty pharmacies can be expensive, even with insurance. Speak with your specialty pharmacy for support with insurance and payment options. You may also receive Ohtuvayre at your door. To get Ohtuvayre, call the manufacturer at 833-372-8492.
Is There Any Cost Assistance Available?
There is a coupon available from the manufacturer of Ohtuvayre that may allow you to pay $0 for your prescription. Whether you are eligible depends on whether you have prescription insurance and what type of insurance you have. You can find out more at https://ohtuvayre.com/cost-assistance.
