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SERZONE®
(nefazodone hydrochloride) Tablets
WARNING
Cases of life-threatening hepatic failure have been reported in patients treated with SERZONE (nefazodone) . The reported rate in the United States is about 1 case of liver failure resulting in death or transplant per 250,000- 300,000 patient-years of SERZONE (nefazodone) treatment. The total patient-years is a summation of each patients duration of exposure expressed in years. For example, 1 patient-year is equal to 2 patients each treated for 6 months, 3 patients each treated for 4 months, etc. (See WARNINGS.)
Ordinarily, treatment with SERZONE (nefazodone) should not be initiated in individuals with active liver disease or with elevated baseline serum transaminases. There is no evidence that pre-existing liver disease increases the likelihood of developing liver failure, however, baseline abnormalities can complicate patient monitoring.Suicidality in Children and Adolescents
Antidepressants increased the risk of suicidal thinking and behavior (suicidality) in short-term studies in children and adolescents with Major Depressive Disorder (MDD) and other psychiatric disorders. Anyone considering the use of SERZONE (nefazodone) or any other antidepressant in a child or adolescent must balance this risk with the clinical need. Patients who are started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. SERZONE (nefazodone) is not approved for use in pediatric patients. (See WARNINGS and PRECAUTIONS: Pediatric Use.)
Pooled analyses of short-term (4 to 16 weeks) placebo-controlled trials of nine antidepressant drugs (SSRIs and others) in children and adolescents with major depressive disorder (MDD), obsessive compulsive disorder (OCD), or other psychiatric disorders (a total of 24 trials involving over 4400 patients) have revealed a greater risk of adverse events representing suicidal thinking or behavior (suicidality) during the first few months of treatment in those receiving antidepressants. The average risk of such events in patients receiving antidepressants was 4%, twice the placebo risk of 2%. No suicides occurred in these trials.
SERZONE® (nefazodone hydrochloride) is an antidepressant for oral administration with a chemical structure unrelated to selective serotonin reuptake inhibitors, tricyclics, tetracyclics, or monoamine oxidase inhibitors (MAOI).
Nefazodone hydrochloride is a synthetically derived phenylpiperazine antidepressant. The chemical name for nefazodone hydrochloride is 2-[3-[4-(3-chlorophenyl) -1-piperazinyl]propyl] -5-ethyl-2,4-dihydro-4-(2-phenoxyethyl) -3H-1,2,4-triazol-3-one monohydrochloride. The molecular formula is C25H32ClN5O2 HCl, which corresponds to a molecular weight of 506.5. The structural formula is:
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Nefazodone hydrochloride is a nonhygroscopic, white crystalline solid. It is freely soluble in chloroform, soluble in propylene glycol, and slightly soluble in polyethylene glycol and water.
SERZONE (nefazodone) is supplied as hexagonal tablets containing 50 mg, 100 mg, 150 mg, 200 mg, or 250 mg of nefazodone hydrochloride and the following inactive ingredients: microcrystalline cellulose, povidone, sodium starch glycolate, colloidal silicon dioxide, magnesium stearate, and iron oxides (red and/or yellow) as colorants.
SERZONE (nefazodone hydrochloride) is indicated for the treatment of depression. When deciding among the alternative treatments available for this condition, the prescriber should consider the risk of hepatic failure associated with SERZONE treatment (see WARNINGS). In many cases, this would lead to the conclusion that other drugs should be tried first.
The efficacy of SERZONE (nefazodone) in the treatment of depression was established in 6-8 week controlled trials of outpatients and in a 6-week controlled trial of depressed inpatients whose diagnoses corresponded most closely to the DSM-III or DSM-IIIR category of major depressive disorder (see CLINICAL PHARMACOLOGY).
A major depressive episode implies a prominent and relatively persistent depressed or dysphoric mood that usually interferes with daily functioning (nearly every day for at least 2 weeks).It must include either depressed mood or loss of interest or pleasure and at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
The efficacy of SERZONE (nefazodone) in reducing relapse in patients with major depression who were judged to have had a satisfactory clinical response to 16 weeks of open-label SERZONE (nefazodone) treatment for an acute depressive episode has been demonstrated in a randomized placebo-controlled trial (see CLINICAL PHARMACOLOGY).Although remitted patients were followed for as long as 36 weeks in the study cited (ie, 52 weeks total), the physician who elects to use SERZONE (nefazodone) for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.
When deciding among the alternative treatments available for depression, the prescriber should consider the risk of hepatic failure associated with SERZONE treatment (see WARNINGS).
Initial Treatment
The recommended starting dose for SERZONE (nefazodone hydrochloride) is 200 mg/day, administered in two divided doses (BID). In the controlled clinical trials establishing the antidepressant efficacy of SERZONE (nefazodone) , the effective dose range was generally 300 to 600 mg/day. Consequently, most patients, depending on tolerability and the need for further clinical effect, should have their dose increased. Dose increases should occur in increments of 100 mg/day to 200 mg/day, again on a BID schedule, at intervals of no less than 1 week. As with all antidepressants, several weeks on treatment may be required to obtain a full antidepressant response.
Dosage for Elderly or Debilitated Patients
The recommended initial dose for elderly or debilitated patients is 100 mg/day, administered in two divided doses (BID). These patients often have reduced nefazodone clearance and/or increased sensitivity to the side effects of CNS-active drugs. It may also be appropriate to modify the rate of subsequent dose titration. As steady-state plasma levels do not change with age, the final target dose based on a careful assessment of the patients clinical response may be similar in healthy younger and older patients.
Maintenance/Continuation/Extended Treatment
There is no body of evidence available from controlled trials to indicate how long the depressed patient should be treated with SERZONE (nefazodone) . It is generally agreed, however, that pharmacological treatment for acute episodes of depression should continue for up to 6 months or longer. Whether the dose of antidepressant needed to induce remission is identical to the dose needed to maintain euthymia is unknown. Systematic evaluation of the efficacy of SERZONE (nefazodone) has shown that efficacy is maintained for periods of up to 36 weeks following 16 weeks of open-label acute treatment (treated for 52 weeks total) at dosages that averaged 438 mg/day. For most patients, their maintenance dose was that associated with response during acute treatment. (See CLINICAL PHARMACOLOGY.) The safety of SERZONE (nefazodone) in long-term use is supported by data from both double-blind and open-label trials involving more than 250 patients treated for at least one year.
Switching Patients to or from a Monoamine Oxidase Inhibitor
At least 14 days should elapse between discontinuation of an MAOI and initiation of therapy with SERZONE (nefazodone) . In addition, at least 7 days should be allowed after stopping SERZONE (nefazodone) before starting an MAOI.
SERZONE® (nefazodone hydrochloride) tablets are hexagonal tablets imprinted with BMS and the strength (ie, 100 mg) on one side and the identification code number on the other. The 100 mg and 150 mg tablets are bisect scored on both tablet faces. The 50 mg, 200 mg, and 250 mg tablets are unscored.
| NDC CODE | DESCRIPTION |
| NDC 0087-0031-47 | 50 mg light pink tablet, bottle of 60 |
| NDC 0087-0032-31 | 100 mg white tablet, bottle of 60 |
| NDC 0087-0039-31 | 150 mg peach tablet, bottle of 60 |
| NDC 0087-0033-31 | 200 mg light yellow tablet, bottle of 60 |
| NDC 0087-0041-31 | 250 mg white tablet, bottle of 60 |
Store at room temperature, below 40º C (104º F) and dispense in a tight container.
SERZONE (nefazodone) ® is a registered trademark of Bristol-Myers Squibb Company. Other brand names listed are trademarks of their respective owners and are not trademarks of Bristol-Myers Squibb Company. Bristol-Myers Squibb Company Princeton, NJ 08543 USA, This Patient Information Leaflet has been approved by the U.S.Food and Drug Administration.
Revised January 2005
Associated with Discontinuation of Treatment
Approximately 16% of the 3496 patients who received SERZONE (nefazodone hydrochloride) in worldwide premarketing clinical trials discontinued treatment due to an adverse experience. The more common (≥1%) events in clinical trials associated with discontinuation and considered to be drug related (ie, those events associated with dropout at a rate approximately twice or greater for SERZONE (nefazodone) compared to placebo) included: nausea (3.5%), dizziness (1.9%), insomnia (1.5%), asthenia (1.3%), and agitation (1.2%).
Incidence in Controlled Trials
Commonly Observed Adverse Events in Controlled Clinical Trials
The most commonly observed adverse events associated with the use of SERZONE (nefazodone) (incidence of 5% or greater) and not seen at an equivalent incidence among placebo-treated patients (ie, significantly higher incidence for SERZONE (nefazodone) compared to placebo, p≥0.05), derived from the table below, were: somnolence, dry mouth, nausea, dizziness, constipation, asthenia, lightheadedness, blurred vision, confusion, and abnormal vision.
Adverse Events Occurring at an Incidence of 1% or More Among SERZONE (nefazodone) -Treated Patients
The table that follows enumerates adverse events that occurred at an incidence of 1% or more, and were more frequent than in the placebo group, among SERZONE (nefazodone) -treated patients who participated in short-term (6- to 8-week) placebo-controlled trials in which patients were dosed with SERZONE (nefazodone hydrochloride) to ranges of 300 to 600 mg/day. This table shows the percentage of patients in each group who had at least one episode of an event at some time during their treatment. Reported adverse events were classified using standard COSTART-based Dictionary terminology.
The prescriber should be aware that these figures cannot be used to predict the incidence of side effects in the course of usual medical practice where patient characteristics and other factors differ from those which prevailed in the clinical trials. Similarly, the cited frequencies cannot be compared with figures obtained from other clinical investigations involving different treatments, uses, and investigators. The cited figures, however, do provide the prescribing physician with some basis for estimating the relative contribution of drug and nondrug factors to the side-effect incidence rate in the population studied.
Treatment-Emergent Adverse Experience Incidence in 6- to 8-Week Placebo-Controlled Clinical Trials1, SERZONE (nefazodone) 300 to 600 mg/day Dose Range
| Percent of Patients | |||
| Body System | Preferred Term | SERZONE (n=393) |
Placebo (n=394) |
| Body as a Whole | Headache | 36 | 33 |
| Asthenia | 11 | 5 | |
| Infection | 8 | 6 | |
| Flu syndrome | 3 | 2 | |
| Chills | 2 | 1 | |
| Fever | 2 | 1 | |
| Neck rigidity | 1 | 0 | |
| Cardiovascular | Postural hypotension | 4 | 1 |
| Hypotension | 2 | 1 | |
| Dermatological | Pruritus | 2 | 1 |
| Rash | 2 | 1 | |
| Gastrointestinal | Dry mouth | 25 | 13 |
| Nausea | 22 | 12 | |
| Constipation | 14 | 8 | |
| Dyspepsia | 9 | 7 | |
| Diarrhea | 8 | 7 | |
| Increased appetite | 5 | 3 | |
| Nausea & vomiting | 2 | 1 | |
| Metabolic | Peripheral edema | 3 | 2 |
| Thirst | 1 | ||
