Patient Medication Information: uses, side effects, how to take - Veozah
What is VEOZAH used for?
VEOZAH is used in menopausal adult women to treat moderate-to-severe vasomotor symptoms (VMS) associated with menopause. VMS are also known as hot flashes (hot flushes) or night sweats.
How does VEOZAH work?
Before menopause, there is a balance between estrogen (a female sex hormone) and neurokinin B (NKB, a chemical in the brain). This balance helps control your body’s temperature. During menopause, your body makes less estrogen, but the amount of NKB is not changed. This balance is disrupted causing hot flashes and night sweats. VEOZAH blocks NKB and helps restore this balance in the body, which lowers the number and the intensity of hot flashes and night sweats.
What are the ingredients in VEOZAH?
Medicinal ingredients: fezolinetant Non-medicinal ingredients: ferric oxide (iron oxide red), hydroxypropyl cellulose, hypromellose, low-substituted hydroxypropyl cellulose, magnesium stearate, mannitol, microcrystalline cellulose, polyethylene glycol (macrogol), talc and titanium dioxide.
VEOZAH comes in the following dosage forms:
tablets, 45 mg.
Do not use VEOZAH if you:
- are allergic to fezolinetant or any of the other ingredients in VEOZAH or the packaging.
- have liver cirrhosis (severe scarring of the liver).
- have serious kidney problems, including kidney failure.
- are taking certain medicines called CYP1A2 inhibitors, such as fluvoxamine.
- are pregnant or think you are pregnant.
To help avoid side effects and ensure proper use, talk to your healthcare professional before you take VEOZAH. Talk about any health conditions or problems you may have, including if you:
- have or had cancer.
- have liver disease or liver problems.
- have kidney problems.
- are 65 years of age or older.
Other warnings you should know about:
Hepatotoxicity (liver injury): Treatment with VEOZAH can cause liver problems, like hepatotoxicity. You will have blood tests done before treatment, monthly for the first 3 months, at 6 months and 9 months after starting treatment. If your liver blood test values are high, your healthcare provider may stop treatment.
See the “Serious side effects and what to do about them” table, below, for more information on these and other serious side effects.
Pregnancy and breastfeeding: Female patients
- Do not take VEOZAH if you are pregnant or think you are pregnant. It may harm your unborn baby.
- Tell your healthcare professional right away if you become pregnant or think you may be pregnant during your treatment with VEOZAH.
- You should not breastfeed while you are taking VEOZAH.
The following may interact with VEOZAH:
- medicines called CYP1A2 inhibitors, such as fluvoxamine (an antidepressant).
How to take VEOZAH:
- Take exactly as your healthcare professional has told you. Check with your healthcare professional if you are not sure.
- Take VEOZAH at about the same time each day.
- Swallow the tablet whole with liquids. Do not break, crush, or chew the tablet.
Take VEOZAH with or without food.
Usual dose:
- Take one tablet (45 mg) by mouth once daily.
Overdose:
If you think you, or a person you are caring for, have taken too much VEOZAH, contact your healthcare professional, hospital emergency department or regional poison control centre immediately, even if there are no symptoms.
Missed dose:
- If you miss a dose of VEOZAH, take the missed dose as soon as you remember on that day. Take your next dose at the usual time the next day.
- If you miss a dose by more than 12 hours, skip the missed dose. Take your next dose at your usual time the next day.
- If you miss several doses, tell your healthcare professional.
What are possible side effects from using VEOZAH?
These are not all the possible side effects you may have when taking VEOZAH. If you experience any side effects not listed here, tell your healthcare professional.
Side effects may include:
- Diarrhea
- Nausea or vomiting
- Headache
- Fever
- Dizziness
Pain: stomach
- Tiredness
- Trouble sleeping
- Hot flushes or hot flashes
- Anxiety
- Acne
- Flu/cold symptoms
VEOZAH can cause abnormal liver blood test results. Your healthcare professional will do blood tests before, during and after your treatment. These tests will tell your healthcare professional if VEOZAH is affecting your liver.
Serious side effects and what to do about them
| Symptom / effect | Talk to your healthcare professional | Stop taking drug and get immediate medical help |
|---|---|---|
| Only if severe | In all cases | |
| UNKNOWN | ||
| Hepatotoxicity (liver injury): jaundice (yellowing of the skin or whites of eyes), dark urine, light-colored stool, loss of appetite for several days or longer, nausea, vomiting, stomach pain, feeling more tired than usual, itchy skin | ||
| ✓ | ||
Reporting Side Effects
You can report any suspected side effects associated with the use of health products to Health Canada by:
NOTE: Contact your health professional if you need information about how to manage your side effects. The Canada Vigilance Program does not provide medical advice. |
|---|
Storage:
- Store VEOZAH at room temperature between 15°C to 30°C.
- Store VEOZAH in the original package to protect from moisture and humidity.
- Keep out of the reach and sight of children.
If you want more information about VEOZAH:
- Talk to your healthcare professional.
- Find the full product monograph that is prepared for healthcare professionals and includes this Patient Medication Information by visiting the Health Canada website (https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html); the manufacturer’s website http://www.astellas.ca, or by calling 1-888-338-1824.