fesoterodine

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 ?
Fesoterodine is available as a 4 mg and 8 mg prolonged-release tablet(8).
There are seven anticholinergics that are used as antispasmodics for the treatment of overactive bladder: darifenacin (Enablex) [C], fesoterodine (Toviaz) [C], flavoxate (Urispas) [B], oxybutynin (Ditropan) [B], solifenacin (Vesicare) [C], tolterodine (Detrol) [C], and trospium (Sanctura) [C].
4) Several approved medications are used in management of OAB in Canada including: oxybutynin chloride, tolterodine tartrate, trospium chloride, solifenacin succinate, darifenacin hydrobromide, and fesoterodine fumarate.
These include fesoterodine, a new drug candidate for
Fesoterodine significantly improved symptoms of overactive bladder in women with an apparent dose-related response in a subanalysis of pooled data from two phase III trials involving more than 1,500 women.
In patients with symptoms of OAB, the addition of an antimuscarinic agent such as solifenacin, fesoterodine, tolterodine, or oxybutynin following initial treatment with an alpha1a-selective alpha-blocker has been shown to improve persistent storage symptoms to a greater degree than the alpha-blocker alone.
A total of 2217 subjects were screened, of which 642 were randomized (322 fesoterodine 8 mg, 320 placebo).
Earlier this year, Schwarz submitted new drug applications for fesoterodine with both the US Food and Drug Administration and the European Medicines Evaluation Agency (EMEA).
New York) and UCB SA won approval to sell the bladder-control drug Toviaz, or fesoterodine, after almost two years of delays.
Other comments: Use of fesoterodine in patients with underlying urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma is contraindicated.
Prescriptions were tracked for the following target drugs: mirabegron, fesoterodine, oxybutynin ER, oxybutynin IR, solifenacin, and tolterodine ER.
Available agents include darifenacin, fesoterodine, oxybutynin, solifenacin, tolterodine, and trospium.