TM Owner Pfizer
Toviaz 8mg Tablet
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Indications & Clinical Uses
- Toviaz 8 mg (fesoterodine fumarate) extended-release tablets are an antimuscarinic (anticholinergic) medicine approved in the United States for two uses: treatment of overactive bladder (OAB) in adults, with symptoms of urge urinary incontinence, urgency and frequency; and, at a paediatric dose, treatment of neurogenic detrusor overactivity (NDO) in children 6 years and older who weigh more than 25 kg, usually due to spina bifida or spinal cord injury.
- Fesoterodine works by relaxing the bladder muscle to reduce involuntary contractions.
- Toviaz is taken as one tablet once daily, by mouth, with or without food, and swallowed whole - it must not be crushed, split or chewed, because it is an extended-release formulation.
- Toviaz is self-administered at home; the 8 mg strength is the higher of the two available adult doses (4 mg and 8 mg).
Side Effects
- Toviaz carries no boxed warning on its current US label.
- The most common side effects, affecting more than 1 in 20 people, are dry mouth (reported in up to about 35% of patients at the 8 mg dose) and constipation.
- Other reported reactions include dry eyes, difficulty urinating, indigestion, dizziness and headache; children may also report diarrhoea, urinary tract infection and abdominal pain.
- Because fesoterodine is an anticholinergic, it can rarely cause angioedema (sudden swelling of the face, lips, tongue or throat) that can be life-threatening - stop the medicine and seek emergency care immediately if this occurs.
- Urinary retention can also occur, particularly in men with bladder outlet obstruction; report any inability to pass urine straight away.
Precautions & Warnings
- Toviaz is contraindicated in urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, and in people with a known hypersensitivity to fesoterodine or to tolterodine.
- It should be used with caution in people with reduced gastrointestinal motility, bladder outflow obstruction (risk of urinary retention), or myasthenia gravis, which anticholinergic drugs can worsen.
- The dose is limited to 4 mg once daily in severe kidney impairment, in moderate-to-severe liver impairment, and when taken together with a strong CYP3A4 inhibitor.
- Toviaz can cause blurred vision, dizziness or drowsiness, so avoid driving or operating machinery until you know how it affects you.
- Safety in pregnancy has not been established; discuss use with your healthcare provider if you are pregnant, planning pregnancy, or breastfeeding.
Avoid Interactions
- Tell your healthcare provider about every medicine, herbal product and supplement you take before starting Toviaz.
- Strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, ritonavir and clarithromycin, raise fesoterodine levels, so the Toviaz dose is limited to 4 mg once daily when taken together; grapefruit juice may have a similar effect and is best avoided.
- Combining Toviaz with other anticholinergic (antimuscarinic) medicines, such as certain antihistamines, antidepressants or other overactive bladder drugs, can add to side effects like dry mouth, constipation and blurred vision.
- No clinically significant interaction has been found with warfarin or combined oral contraceptives.
- Report any new swelling of the face, lips or throat, or inability to pass urine, straight away.
References
Frequently Asked Questions
Toviaz (fesoterodine) 8 mg treats overactive bladder in adults, easing urgency, frequency and urge incontinence by relaxing the bladder muscle. A paediatric dose also treats neurogenic detrusor overactivity in children aged 6 and over weighing more than 25 kg. It is taken once daily as an extended-release tablet.
Take one Toviaz tablet by mouth once daily, with or without food, at about the same time each day. Swallow it whole with water; never crush, split or chew it, because it is an extended-release tablet designed to release fesoterodine slowly over 24 hours.
The most common side effects of Toviaz (fesoterodine) are dry mouth and constipation. Dizziness, dry eyes and difficulty urinating can also occur. Get emergency help for sudden swelling of the face, lips, tongue or throat, or if you become completely unable to pass urine.
Avoid grapefruit juice and tell your doctor about strong CYP3A4-inhibiting medicines such as ketoconazole or clarithromycin, since these raise Toviaz levels and may need a lower dose. Avoid combining it with other anticholinergic medicines where possible, as side effects like dry mouth and constipation can add up.
If you miss a dose of Toviaz, take it when you remember that day, then continue your normal once-daily schedule the next day. Do not take two doses together to make up for a missed one. If you are unsure, ask your pharmacist or prescriber for advice.
Yes, but only for a specific condition: children aged 6 and over who weigh more than 25 kg can be prescribed Toviaz for neurogenic detrusor overactivity, at a paediatric dose based on age and weight. It is not approved for ordinary overactive bladder in children.
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