Toviaz

(Fesoterodine Fumarate ER)

The active ingredient in Toviaz is fesoterodine fumarate. This medication belongs to a class of drugs known as antimuscarinics. These medications work by blocking the muscarinic receptors, which, when activated, cause the bladder to contract and promote urination. As a result, the bladder stays relaxed, which decreases urinary frequency and urinary incontinence compared to baseline. Other OAB medications with a similar mechanism of action include tolterodine and oxybutynin.

Follow all directions given to you by your doctor and read all documents provided, including the full Prescribing Information, FDA-Approved Product Labeling, Instructions for Use, and Medication Guide, before using Toviaz. However, the following is a synopsis of the general guidelines for the use of Toviaz:

• Toviaz should be used exactly as prescribed. If you have severe kidney problems, your dose of fesoterodine will be lower to keep Toviaz safe and effective for you.
• In children, Toviaz is only used for those 6 years of age and older weighing at least 77 lbs.
• It is typically taken once daily with or without food. The tablet must be taken whole with water and should not be chewed, split, or crushed. Most will start at a dose of Toviaz 4 mg. Depending on your response and tolerability to the medication, your prescriber may increase your dose to a maximum of Toviaz 8 mg daily.
• Toviaz could cause blurred vision, dizziness, and drowsiness in some people. Do not drive or operate heavy machinery until you know how Toviaz affects you.
• Drinking alcohol while taking Toviaz could cause increased drowsiness, so caution should be exercised.
• If you miss a dose, skip the missed dose and continue with your regular dosing schedule the next day. Do not take a double dose to make up for a missed one.

The most common side effects of Toviaz seen in clinical trials for adults as compared to placebo include:

• Dry mouth
• Constipation
• Dry eyes
• Urinary tract infections (UTIs)
• Upper respiratory tract infections

The most common side effects of Toviaz seen in clinical trials for children as compared to placebo include:

• Diarrhea or constipation
• Dry mouth
• Urinary tract infections (UTIs)
• Abdominal pain
• Nausea
• Weight gain
• Headache

Some individuals may experience serious side effects while using Toviaz. These side effects may require immediate medical attention. If you experience any of the following, contact your healthcare provider or seek emergency medical help:

• Signs of a serious allergic reaction such as hives, difficulty breathing, or angioedema (swelling of the face, lips, tongue, or throat).
• Urinary retention or problems emptying your bladder.
• Signs of cognitive adverse events, such as headache, dizziness, and drowsiness.
• Worsening of myasthenia gravis symptoms.

These are not all of the possible adverse reactions of Toviaz. You should always seek medical advice from your healthcare provider for any questions or concerns about your medical condition or treatment. Read all patient information, medication guides, or drug information sheets that come with this medication. You can also report adverse effects to the Food and Drug Administration at www.fda.gov/medwatch or 1-800-FDA-1088.

Before starting Toviaz, it is crucial to discuss any existing health conditions with your healthcare provider. You should be sure that your healthcare provider is aware of all your medical conditions, including whether you have:

• Problems with emptying your bladder
• Stomach problems
• Intestinal problems
• Severe constipation
• Narrow-angle glaucoma
• Myasthenia Gravis
• Kidney problems
• Hepatic impairment or other liver problems
• Are pregnant or planning to become pregnant
• Are breastfeeding or planning to breastfeed

Do not use Toviaz if you have:

• An allergy to fesoterodine or any of the other ingredients in Toviaz
• An allergy to tolterodine
• Urinary retention
• Gastric retention or delayed emptying of your stomach
• Uncontrolled narrow-angle glaucoma

Toviaz will begin to work right after the first dose. However, it can take several weeks of regular use to see the full effects of fesoterodine.

When Toviaz is taken with other prescription drugs, over-the-counter medications, vitamins, and supplements, it may change how they work or increase the frequency or severity of side effects. Make sure that you tell your healthcare professional about anything that you are taking to avoid any negative drug interactions, including:

• Anticholinergics
• Strong CYP3A4 inhibitors such as ketoconazole, itraconazole, atazanavir, clarithromycin, indinavir, nelfinavir, ritonavir, and saquinavir

Toviaz is available as an extended-release tablet in doses of 4 mg and 8 mg. These are extended-release tablets, meaning that you will typically take Toviaz once a day.

Toviaz should be stored at room temperature, away from light and moisture, and out of reach of children.

Toviaz is manufactured by the pharmaceutical company Pfizer.

Yes, there is a generic available for the brand-name Toviaz.

Stopping Toviaz without medical advice could cause your symptoms to recur or become worse. Consult your doctor or pharmacist before starting, stopping, or changing medications while taking Toviaz.

It is unknown whether Toviaz can cause harm to the unborn child. Talk to your doctor if you are already pregnant or if you have any plans to become pregnant. They will know or recommend what is best for you.

It is unknown whether Toviaz passes into the breast milk and what effects it has on lactation or the breastfeeding infant. Talk to your doctor if you are already breastfeeding or if you have any plans to breastfeed. They will know or recommend what is best for you.