fesoterodine fumarate

(redirected from Toviaz)

fesoterodine fumarate

Toviaz

Pharmacologic class: Competitive muscarinic receptor antagonist

Therapeutic class: Urinary tract agent

Pregnancy risk category C

Action

Inhibits muscarinic receptors, thereby inhibiting contraction of bladder smooth muscle

Availability

Tablets (extended-release): 4 mg, 8 mg

Indications and dosages

Treatment of overactive bladder with symptoms of urge urinary incontinency, urgency, and frequency

Adults: 4 mg P.O. daily; may increase to 8 mg daily based on response and tolerability

Dosage adjustment

• Severe renal impairment (creatinine clearance of less than 30 ml/minute)

• Coadministration of potent CP3A4 inhibitors (such as clarithromycin, itraconazole, and ketoconazole; dosages above 4 mg not recommended)

Contraindications

• Hypersensitivity to drug or its components

• Urinary or gastric retention

• Uncontrolled narrow-angle glaucoma

Precautions

Use cautiously in:

• severe hepatic impairment (use not recommended)

• severe renal impairment, clinically significant bladder outlet obstruction

• decreased GI motility, such as with severe constipation

• concurrent treatment of narrow-angle glaucoma

• myasthenia gravis

• concurrent use of CYP3A4 inhibitors

• pregnant or breastfeeding patients

• children (safety and efficacy not established).

Administration

• Administer with fluids and have patient swallow tablet whole.

Adverse reactions

CNS: insomnia

EENT: blurred vision, dry eyes, dry throat

GI: dry mouth, constipation, dyspepsia, nausea, upper abdominal pain

GU: urinary retention, urinary tract infection, dysuria

Musculoskeletal: back pain

Respiratory: cough, upper respiratory tract infection

Skin: decreased sweating, rash

Other: heat prostration, peripheral edema, angioedema

Interactions

Drug-drug. CP3A4 inhibitors (such as clarithromycin, itraconazole, ketoconazole): increased fesoterodine Cmax and area under the curve (AUC)

Rifampin: decreased active metabolite of fesoterodine Cmax and AUC

Other antimuscarinics: increased frequency or severity of adverse effects (such as dry mouth, constipation, urinary retention)

Drug-diagnostic tests. Alanine aminotransferase, gamma-glutamyltransferase: increased levels

Drug-behaviors. Alcohol use: increased drowsiness

Patient monitoring

• Monitor kidney and liver function tests closely.

Be aware that life-threatening angioedema of the face, lips, tongue, and larynx has been reported with fesoterodine. In some cases, angioedema occurred after first dose. If involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue drug and initiate appropriate therapy and measures to ensure patent airway.

Patient teaching

• Instruct patient to take drug with fluids and to swallow tablet whole.

Instruct patient to immediately stop drug and seek medical attention if difficulty breathing or swelling of the face, lips, or tongue occurs.

• Inform patient that drug may cause constipation and urinary retention.

• Caution patient to avoid driving and other hazardous activities until drug's effects on concentration and alertness are known.

• Advise patient to avoid excessive exercise in hot weather.

• Advise patient to avoid alcohol use while taking drug.

• As appropriate, review all other significant adverse reactions and interactions, especially those related to the drugs, tests, and behaviors mentioned above.

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References in periodicals archive ?
Its products include Lyrica, the Prevnar family of products, Enbrel, Celebrex, Lipitor, Viagra, Zyvox, Sutent, EpiPen, Toviaz, Tygacil, Rapamune, Xalkori, Inlyta, Norvasc, BeneFIX, Genotropin and Enbrel, among others.
M2 EQUITYBITES-July 4, 2013-Impax confirms patent challenge to generic TOVIAZ 4 mg and 8 mg by Pfizer and UCB Pharma(C)2013 M2 COMMUNICATIONS http://www.
M2 PHARMA-August 6, 2012-Pfizer Inc's phase 4 study of Toviaz reduces urge urinary incontinence in patients with OAB, meeting primary endpoint(C)2012 M2 COMMUNICATIONS
Food and Drug Administration (FDA) has approved a new drug named Toviaz (fumarate) to help patients with overactive bladder (OAB).
The FDA told Pfizer 20 months ago that it was delaying approval until it could inspect the plant where Toviaz would be manufactured.
The newest drug on the market is Toviaz, which has fared well in clinical trials.
NYSE: PFE) announced today that a Phase 4 study assessing the efficacy and safety of Toviaz([R]) (fesoterodine fumarate) 8 mg once daily in patients with overactive bladder (OAB) compared to Toviaz 4 mg once daily or placebo met its primary endpoint.
M2 EQUITYBITES-August 6, 2012-Pfizer Inc's phase 4 study of Toviaz reduces urge urinary incontinence in patients with OAB, meeting primary endpoint(C)2012 M2 COMMUNICATIONS http://www.
M2 PHARMA-December 6, 2011-Pfizera[euro](tm)s Toviaz trial of overactive bladder in vulnerable seniors meets primary endpoint(C)2011 M2 COMMUNICATIONS
Toviaz reduced urge urinary incontinence (UUI) in patients with OAB who had a suboptimal response (less than 50 percent reduction in UUI) to Detrol LA (tolterodine tartrate extended release), a commonly-prescribed treatment for the condition.
M2 EQUITYBITES-December 6, 2011-Pfizer reports Toviaz shows positive top-line primary endpoint result(C)2011 M2 COMMUNICATIONS http://www.
This decline is primarily attributable to the patent expires of key drugs in the OAB therapeutics market such as Oxytrol, Enablex/Esmelex (darifenacin), Toviaz (fesoterodine), Ditropan/Ditropan XL (oxybutynin), Detrol/Detrol LA (tolterodine) and VESIcare (solifenacin).