Veozah was approved in May 2023 as the first nonhormonal medicine to treat the vasomotor symptoms of menopause. Hot flashes and night sweats not only cause sweating and flushing, but can also cause heart palpitations, anxiety, dizziness, and trouble sleeping. About 75% of people have hot flashes and night sweats during menopause. Studies have shown that Veozah can reduce hot flashes and night sweats by over 50%.
How Does It Work?
During menopause, declining estrogen levels cause the body to become more sensitive to a chemical called neurokinin B (NKB). NKB is in the hypothalamus, or the temperature regulation center. This chemical causes vasomotor symptoms, or hot flashes and night sweats. Veozah blocks the chemical NKB, reducing night sweats and hot flashes.
How Was It Studied?
Studies looked at how Veozah affected how frequent and severe menopausal hot flashes and night sweats were. People in these studies were ages of 40 to 65 with an average age of 54. These people had a minimum average of seven moderate to severe hot flashes or night sweats per day or 50 to 60 episodes per week. The effect of menopausal symptoms on sleep and quality of life was also studied.
Of the people in the study, 81% were White, 17% were Black, and 1% were Asian. These people lived in the U.S., Canada, Hungary, Czech Republic, Latvia, Poland, Spain, and the U.K. People received either Veozah or a placebo once daily for 12 weeks. After 12 weeks, all people received Veozah.
A hot flash diary measured how frequent and severe hot flashes were. Each hot flash was tracked and recorded as mild, moderate, or severe. Sleep was measured by completing an eight-item questionnaire on how well the study subjects slept. Quality of life was measured through a 29-item checklist about the previous week.
What Are the Benefits?
Fewer symptoms. Hot flashes and night sweats were reduced by over half in 61% of people taking Veozah. People had less frequent and less severe hot flashes. In the first trial, people had about 10 hot flashes per day. After 12 weeks of treatment with Veozah, hot flashes decreased to about four per day. In the second study, people had about 12 hot flashes per day. After 12 weeks, hot flashes decreased to about four and a half per day. Results were maintained throughout the 52-week study.
Improvement in sleep. People in the Veozah group had fewer sleep issues vs. those on a placebo at weeks 4 and 12. Improvements in sleep were sustained throughout the study.
Improvement in quality of life. The reduction in hot flashes and night sweats and improved sleep resulted in a better quality of life starting around 4 weeks of treatment.
How Long Does It Take to Work?
Some people reported a decrease in symptoms as early as 1 week after starting treatment. By week 4, most people reported improvement in symptoms. Full results may take up to 12 weeks. Results should continue throughout treatment. Talk to your health care provider if you do not notice improvement in 12 weeks.
Is It Right for Me?
Veozah may be right for you if you are menopausal and have moderate to severe hot flashes and night sweats. Talk with your health care provider for more information.
Veozah was not studied in people with certain health conditions because it can increase the risk of serious side effects. You should not take Veozah if you have severe kidney problems, kidney failure, or liver cirrhosis.
How Can I Prevent and Manage Side Effects?
The most common side effects of Veozah are headache, stomach pain, diarrhea, trouble sleeping, hot flashes, and increased liver enzymes.
Headache was the most commonly reported side effect in studies. Be sure you are staying hydrated, getting enough sleep, and eating properly. If you do get headaches, you can try resting in a cool, dark room, applying a cool compress, or meditation. Your health care provider may recommend an over-the-counter medicine such as acetaminophen.
Upset stomach and diarrhea are also common side effects of Veozah. Try eating smaller, more frequent meals. Be sure to eat slowly and chew your food well. Avoid carbonated beverages and other foods that can cause gas. Also, limit alcohol and caffeine.
If you get diarrhea, make sure you are staying hydrated. Water, sports drinks, broths, coconut water, and rehydration solutions are good options for fluid replenishment. Try to simplify your eating by sticking with bland foods such as rice, toast, bananas, applesauce, oatmeal, and potatoes. Avoid foods that are spicy, fried, fatty, high in sugar, and dairy products. Your pharmacist or other health care provider may recommend an over-the-counter probiotic or anti-diarrhea medicine such as Imodium or Pepto Bismol. Tell your health care provider if your diarrhea becomes severe.
Insomnia and hot flashes may still happen with treatment, but some tips may help you manage them better. Make sure your bedroom environment is dark, quiet, and cool. An eye mask, ear plugs, fan, and white noise machine may help make the environment more comfortable. Try going to bed at the same time every day. Follow a relaxing bedtime routine and limit the use of phones or computers before bed. And avoid alcohol, nicotine, caffeine, or heavy meals later in the day.
Dress in light, loose layers so clothing can be removed as needed. Smoking, alcohol, spicy foods, and caffeine can make hot flashes worse and should be avoided. Meditation, acupuncture, deep breathing, and reducing stress may also help control hot flashes.
Veozah may cause liver damage, also called hepatotoxicity. Your health care provider will likely check your liver function with blood tests before and during treatment with Veozah. Notify your health care provider if you get any of the following symptoms of liver damage:
- Nausea
- Vomiting
- Yellowing of the skin or eyes
- Pain in your right upper stomach
These are not all of the possible side effects. Talk with your health care provider if you are having symptoms 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 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
How Do I Take It?
Veozah is a tablet, taken by mouth once daily. It can be taken with or without food. It should be taken at the same time every day.
If you miss a dose, take it as soon as you remember, as long as there are at least 12 hours before your next dose is due. You can then resume your normal schedule.
What Type of Drug Interactions Can Happen?
Many medications can interact with Veozah. These medications can affect the way Veozah works. They can also increase the risk of side effects. Some medicines are inhibitors of a group of enzymes called CYP1A2. CYP1A2 inhibitors should not be taken with Veozah. Ask your pharmacist or other health care provider if any of your medicines are CYP1A2 inhibitors.
Caffeine can increase the effects of Veozah. Caffeine use should be limited while taking Veozah.
Tell your health care provider and pharmacist about all prescription drugs, over-the-counter (OTC) medications, vitamins/minerals, herbal products, and supplements you take or have recently taken. This will help determine if there are any interactions with Veozah.
What Do I Need to Do to Get It?
Veozah requires a prescription. Your primary care doctor or gynecologist can prescribe Veozah. It is available at retail and mail-order pharmacies.
Is There Any Cost Assistance Available?
A copay assistance program is available from the drugmaker. You may be able to receive your first month free and pay as little as $30 each month for your prescription. Eligibility depends on your current prescription insurance coverage.
Those without insurance or those whose insurance doesn't pay for Veozah may be able to get financial help. You can find out more information at www.VeozahSupportSolutions.com or by calling 866-239-1637.
For questions about cost, insurance coverage, or any other questions related to Veozah, you can call Astellas Pharma at 800-727-7003.