TOVIAZ^® (fesoterodine fumarate) is indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency.

TOVIAZ is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, and in patients with known hypersensitivity to the drug or its ingredients.

TOVIAZ tablets should be used with caution in patients with clinically significant bladder outlet obstruction, decreased gastrointestinal motility, controlled narrow-angle glaucoma, or myasthenia gravis. TOVIAZ is not recommended for use in patients with severe hepatic impairment.

The recommended starting dose of TOVIAZ is 4 mg once daily. Based upon individual response and tolerability, the dose may be increased to 8 mg once daily. Doses greater than 4 mg are not recommended in patients with severe renal insufficiency or in patients taking a potent CYP3A4 inhibitor; in patients taking a weak or moderate CYP3A4 inhibitor, careful assessment at 4 mg is advised prior to increasing to 8 mg.

The most frequently reported adverse events (≥4%) for TOVIAZ were: dry mouth (placebo, 7%; TOVIAZ 4 mg, 19%; TOVIAZ 8 mg, 35%) and constipation (placebo, 2%; TOVIAZ 4 mg, 4%; TOVIAZ 8 mg, 6%).

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TOVIAZ^® (fesoterodine fumarate)

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Important Safety Information

All patients being treated with CHANTIX should be observed for neuropsychiatric symptoms including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide. These symptoms, as well as worsening of pre-existing psychiatric illness and completed suicide have been reported in some patients attempting to quit smoking while taking CHANTIX in the post-marketing experience.

These events have occurred in patients with and without pre-existing psychiatric disease. Patients with serious psychiatric illness such as schizophrenia, bipolar disorder, and major depressive disorder did not participate in the pre-marketing studies of CHANTIX and the safety and efficacy of CHANTIX in such patients has not been established.

Advise patients and caregivers that the patient should stop taking CHANTIX and contact a health care provider immediately if agitation, hostility, depressed mood, or changes in behavior or thinking that are not typical for the patient are observed, or if the patient develops suicidal ideation or suicidal behavior. In many post-marketing cases, resolution of symptoms after discontinuation of CHANTIX was reported, although in some cases the symptoms persisted; therefore, ongoing monitoring and supportive care should be provided until symptoms resolve.

Patients should be informed that there have been reports of serious skin reactions, such as Stevens Johnson Syndrome and Erythema Multiforme and of angioedema, with swelling of the face, mouth and neck that can lead to life-threatening respiratory compromise. Patients should be instructed to discontinue CHANTIX and immediately seek medical care if they experience these symptoms or at the first sign of rash with mucosal lesions or any other signs of hypersensitivity.

The most common adverse reactions include nausea (30%), sleep disturbance, constipation, flatulence, and vomiting. Patients should be informed that they may experience vivid, unusual, or strange dreams during treatment with CHANTIX. Patients should be advised to use caution driving or operating machinery or engaging in other potentially hazardous activities until they know how CHANTIX may affect them.

Safety and efficacy of CHANTIX in combination with other smoking cessation drug therapies have not been studied. Dosage adjustment with CHANTIX is recommended in patients with severe renal impairment or in patients undergoing hemodialysis.

Smoking cessation, with or without treatment with CHANTIX, may alter the pharmacokinetics or pharmacodynamics of some drugs, such as theophylline, warfarin, and insulin. Dosage adjustment for these drugs may be necessary.

CHANTIX is indicated as an aid to smoking cessation treatment in adults 18 and over. Patients may benefit from behavioral modification and support during their quit attempt. Patients should be encouraged to continue to attempt to quit if they have early lapses after quit day.

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CHANTIX^® (varenicline)

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Important Safety Information

Abnormalities in LFTs have been observed with ERAXIS. Clinically significant hepatic abnormalities have occurred in some patients with serious underlying medical conditions who were receiving multiple medications concomitantly with ERAXIS. Isolated cases of significant hepatic dysfunction, hepatitis, or worsening hepatic failure have been reported, but a causal relationship with ERAXIS has not been established. Patients who develop abnormal LFTs during ERAXIS therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing ERAXIS therapy.

Possible histamine-mediated symptoms have been reported with ERAXIS, including rash, urticaria, flushing, pruritus, dyspnea, and hypotension. These events are infrequent when the rate of infusion does not exceed 1.1 mg/min.

In the treatment of candidemia, the most common treatment-related AEs included diarrhea (3.1%), hypokalemia (3.1%), and elevated ALT (2.3%).

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Eraxis ™ (anidulafungin) for injection

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