fesoterodine

(redirected from Toviaz)

fesoterodine

(fee-soe-ter-o-deen) ,

Toviaz

(trade name)

Classification

Therapeutic: urinary tract antispasmodics
Pharmacologic: anticholinergics
Pregnancy Category: C

Indications

Treatment of overactive bladder function that results in urinary frequency, urgency, or urge incontinence.

Action

Acts as a competitive muscarinic receptor antagonist resulting in inhibition of cholinergically mediated bladder contraction.

Therapeutic effects

Decreased urinary frequency, urgency, and urge incontinence.

Pharmacokinetics

Absorption: Rapidly absorbed following oral administration, but is rapidly converted to its active metabolite (bioavailability of metabolite 52%); further metabolism occurs in the liver via CYP2D6 and CYP3A4 enzyme systems. 16% of active metabolite is excreted in urine, most of the remainder of inactive metabolites are renally excreted. 7% excreted in feces.
Distribution: Unknown.
Metabolism and Excretion: Rapidly converted by esterases to active metabolite.
Half-life: 7 hr (following oral administration).

Time/action profile (active metabolite)

ROUTEONSETPEAKDURATION
POrapid5 hr24 hr

Contraindications/Precautions

Contraindicated in: Hypersensitivity;Urinary retention;Gastric retention;Severe hepatic impairment;Uncontrolled narrow-angle glaucoma.
Use Cautiously in: Significant bladder outlet obstruction (↑ risk of retention);Severe renal insufficiency (dose adjustment required);↓ GI motility including severe constipation;Treated narrow-angle glaucoma (use only if benefits outweigh risks);Myasthenia gravis;Severe renal impairment (dose should not exceed 4 mg/day); Geriatric: ↑ risk of anticholinergic side effects in patients >75 yr; Obstetric / Lactation: Avoid using unless potential benefits outweighs potential risk to fetus/neonate; Pediatric: Safety not established.

Adverse Reactions/Side Effects

Central nervous system

  • dizziness
  • drowsiness
  • headache

Cardiovascular

  • tachycardia (dose related)

Gastrointestinal

  • dry mouth (most frequent)
  • constipation
  • nausea
  • upper abdominal pain

Genitourinary

  • dysuria
  • urinary retention

Musculoskeletal

  • back pain

Miscellaneous

  • angioedema (life-threatening)

Interactions

Drug-Drug interaction

Concurrent use of potent CYP3A4 enzyme inhibitors including ketoconazole, itraconazole, and clarithromycin ↑ blood levels and risk of toxicity; daily dose should not exceed 4 mg.Use less potent inhibitors of CYP3A4 (such as erythromycin ) with caution; escalate dose carefully.Anticholinergic effects may alter the GI absorption of other drugs.

Route/Dosage

Oral (Adults) 4 mg once daily initially may be ↑ to 8 mg/daily; Concurrent potent CYP3A4 inhibitors or CCr <30 mL/min—dose should not exceed 4 mg/day.

Availability

Extended-release tablets: 4 mg, 8 mg

Nursing implications

Nursing assessment

  • Assess for urinary urgency, frequency, and urge incontinence periodically throughout therapy.
  • Monitor for signs and symptoms of angioedema (swelling of face, lips, tongue, and/or larynx). May occur with first or subsequent doses. Discontinue therapy and prove supportive therapy. Have epinephrine, corticosteroids, and resuscitation equipment available.
  • Lab Test Considerations: May cause ↑ ALT and GGT.

Potential Nursing Diagnoses

Impaired urinary elimination (Indications)
Urinary retention (Indications)

Implementation

  • Oral: Administer without regard to food.
    • Extended-release tablets should be swallowed whole; do not break, crush, or chew.

Patient/Family Teaching

  • Instruct patient to take fesoterodine as directed. If a dose is missed, omit and begin taking again the next day; do not take 2 doses the same day. Advise patient to read the Patient Information sheet prior to initiation of therapy and with each Rx refill.
  • May cause drowsiness, dizziness, and blurred vision. Caution patient to avoid driving or other activities requiring alertness until response to medication is known.
  • Advise patient to avoid alcohol; may increase drowsiness.
  • Advise patient to use caution in hot environments; may cause decreased sweating and severe heat illness.
  • Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and to consult with health care professional before taking other medications.
  • Advise patient to stop medication and notify health care professional if signs and symptoms of angioedema occur.
  • Advise patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.

Evaluation/Desired Outcomes

  • Decreased urinary frequency, urgency, and urge incontinence.
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).