Veozah (fezolinetant) is a non-hormonal drug approved by the Food and Drug Administration (FDA) in May 2023, specifically designed to alleviate moderate to severe vasomotor symptoms (VMS) of menopause, such as hot flashes and night sweats. It represents a significant advancement in treating these symptoms without relying on hormone replacement therapy (HRT). This article delves into the side effects of Veozah, its mechanism of action, precautions, and other essential information to provide a comprehensive understanding of this medication.
What is Veozah and How Does It Work?
Veozah contains the active ingredient fezolinetant, which works by targeting neurokinin B (NKB) in the brain. During menopause, the balance between estrogen hormones and NKB is disrupted, leading to hot flashes. Veozah helps restore this balance by blocking NKB, thereby reducing the frequency and severity of hot flashes and night sweats. The drug is not a hormone treatment and does not contain estrogen.
Common Side Effects of Veozah
Like all medications, Veozah can cause side effects. The most commonly reported side effects in clinical trials include:
- Abdominal pain
- Diarrhea
- Insomnia (trouble sleeping)
- Back pain
- Hot flashes
These side effects are generally mild and temporary, often resolving as the body adjusts to the medication. However, if these symptoms persist, worsen, or become bothersome, it is essential to consult with a healthcare provider.
Serious Side Effects of Veozah
While less common, Veozah can cause serious side effects that require immediate medical attention:
Read also: Benefits of couples massage detailed
Liver Damage (Hepatotoxicity)
Veozah can cause liver damage, also known as hepatotoxicity. The FDA updated Veozah’s label on September 12, 2024, to warn of the possibility of liver damage and, on December 17, 2024, escalated its initial warning to black box status, the most prominent warning a medication can carry. Postmarketing cases of serious drug-induced hepatotoxicity occurred within 40 days of starting treatment.
Symptoms of liver damage include:
- Nausea or vomiting
- Pain in the upper stomach or belly
- Fever
- Weakness or unusual tiredness
- Itching
- Loss of appetite
- Light-colored stool
- Dark-colored urine
- Yellowing of the skin or eyes (jaundice)
Patients in the postmarketing period experienced elevated transaminases (up to 50 times the upper limit of normal), elevated alkaline phosphatase (up to 4 times the upper limit of normal), and bilirubin (up to 5 times the upper limit of normal) coupled with symptoms of fatigue, nausea, pruritus, jaundice, pale feces, and dark urine.
To monitor liver health, healthcare providers will conduct blood tests to check liver function before starting Veozah treatment and periodically during treatment (at month 3, month 6, and month 9). Patients should contact their healthcare provider immediately if they experience any symptoms of liver damage.
Severe Allergic Reactions
Although not reported in clinical trials, Veozah can cause allergic reactions, which can be serious.
Symptoms of a severe allergic reaction include:
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching, skin rash, or pale red bumps on the skin (hives)
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
If any of these symptoms occur, patients should stop taking Veozah and seek immediate medical attention.
Read also: How digestive health affects weight loss
Precautions and Warnings
Before starting Veozah, it is crucial to inform your healthcare provider about any existing health conditions, medications, and allergies. Veozah has several contraindications, including:
- Liver Problems: Veozah should not be used in individuals with liver problems, especially cirrhosis, as it can worsen liver function.
- Kidney Problems: Veozah is not recommended for individuals with severe kidney problems, including end-stage renal disease (ESRD), as it can lead to a buildup of the drug in the body.
- Drug Interactions: Veozah should not be taken with certain CYP1A2 inhibitors, such as cimetidine (Tagamet®), fluvoxamine (Luvox®), or mexiletine (Mexitil®), as these can increase the levels of Veozah in the blood and raise the risk of side effects.
Other Important Considerations
- Pregnancy and Breastfeeding: The safety of Veozah during pregnancy and breastfeeding is unknown. Patients who are pregnant, planning to become pregnant, or breastfeeding should discuss the potential risks and benefits with their healthcare provider.
- Alcohol Consumption: While there is no known direct interaction between Veozah and alcohol, drinking alcohol can worsen certain side effects of Veozah, such as hot flashes, and may increase the risk of liver damage.
- Allergies: Individuals allergic to fezolinetant or any of the ingredients in Veozah should not take this medication.
Drug Interactions
Veozah can interact with several medications, potentially altering their effects or increasing the risk of side effects. It is essential to inform your healthcare provider about all medications, including prescription drugs, over-the-counter medications, vitamins, and herbal supplements, before starting Veozah treatment.
Notable drug interactions include:
- CYP1A2 Inhibitors: Medications that inhibit the CYP1A2 enzyme, such as fluvoxamine, mexiletine, and cimetidine, can increase the blood levels of Veozah, leading to an increased risk of side effects.
- Caffeine: Caffeine can increase the effect of Veozah. It is advisable to limit caffeine intake while using Veozah. Caffeine is found in coffee, chocolate, tea, colas, energy drinks, and some medicines.
- Green Tea: Drug interactions with green tea can include certain blood pressure medicines, statin cholesterol-lowering treatments, and warfarin, an anticoagulant (blood thinner) used to help prevent blood clots and medicines used to treat hot flashes and night sweats in women due to menopause.
Dosage and Administration
The recommended dosage for Veozah is one 45 mg tablet taken orally once daily, with or without food. The tablet should be swallowed whole with a liquid and taken at the same time each day. If a dose is missed, it should be taken as soon as possible on the same day, with at least 12 hours before the next scheduled dose.
Benefits of Veozah
Veozah offers several potential benefits for women experiencing moderate to severe hot flashes and night sweats due to menopause:
- Non-Hormonal Treatment: Veozah is a non-hormonal option, making it suitable for women who cannot or prefer not to take hormone replacement therapy (HRT).
- Effective Symptom Relief: Clinical trials have shown that Veozah can significantly reduce the frequency and severity of hot flashes within a week of starting treatment.
- Improved Quality of Life: By alleviating hot flashes and night sweats, Veozah can improve sleep, daily activities, and overall quality of life.
Managing Side Effects
While taking Veozah, it is essential to monitor for any side effects and communicate them to your healthcare provider. Here are some tips for managing potential side effects:
Read also: Weight Loss Meds & BCBS
- Abdominal Pain and Diarrhea: Eating smaller, more frequent meals and avoiding spicy or fatty foods can help alleviate abdominal pain and diarrhea.
- Insomnia: Practicing good sleep hygiene, such as maintaining a regular sleep schedule, creating a relaxing bedtime routine, and avoiding caffeine and alcohol before bed, can help improve sleep quality.
- Hot Flashes: Identifying and avoiding triggers, such as caffeine, alcohol, and spicy foods, can help prevent hot flashes. Other strategies include sipping ice water, practicing stress reduction techniques, and wearing loose-fitting clothing.
Alternative Treatments for Menopause Symptoms
Besides Veozah and HRT, several other treatments and lifestyle changes can help manage menopause symptoms:
- Hormone Replacement Therapy (HRT): HRT involves taking estrogen and progesterone to replace the hormones that decline during menopause. While HRT was once controversial, for most women, the benefits outweigh the risks when used short-term.
- Lifestyle Changes: Regular exercise, a healthy diet, prioritizing sleep, and stress management techniques can help alleviate menopause symptoms.
- Herbal Remedies: Some herbal remedies, such as black cohosh and valerian root, have been used to manage hot flashes and other menopause symptoms. However, their effectiveness and safety are not well-established, and it is essential to discuss their use with a healthcare provider.