Nucynta (Page 2 of 7)

5.8 Serotonin Syndrome Risk

The development of a potentially life-threatening serotonin syndrome may occur with use of Serotonin and Norepinephrine Reuptake Inhibitor (SNRI) products, including NUCYNTA® , particularly with concomitant use of serotonergic drugs such as Selective Serotonin Reuptake Inhibitors (SSRIs), SNRIs, tricyclic antidepressants (TCAs), MAOIs and triptans, and with drugs that impair metabolism of serotonin (including MAOIs). This may occur within the recommended dose. Serotonin syndrome may include mental-status changes (e.g., agitation, hallucinations, coma), autonomic instability (e.g., tachycardia, labile blood pressure, hyperthermia), neuromuscular aberrations (e.g., hyperreflexia, incoordination) and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea).

5.9 Withdrawal

Withdrawal symptoms may occur if NUCYNTA® is discontinued abruptly. These symptoms may include: anxiety, sweating, insomnia, rigors, pain, nausea, tremors, diarrhea, upper respiratory symptoms, piloerection, and rarely, hallucinations. Withdrawal symptoms may be reduced by tapering NUCYNTA® [see Drug Abuse and Dependence (9.3)].

5.10 Hepatic Impairment

A study of NUCYNTA® in subjects with hepatic impairment showed higher serum concentrations than in those with normal hepatic function. NUCYNTA® should be used with caution in patients with moderate hepatic impairment [see Dosage and Administration (2.2) and Clinical Pharmacology (12.3)].

NUCYNTA® has not been studied in patients with severe hepatic impairment and, therefore, use in this population is not recommended.

5.11 Use in Pancreatic/Biliary Tract Disease

Like other drugs with mu-opioid agonist activity, NUCYNTA® may cause spasm of the sphincter of Oddi and should be used with caution in patients with biliary tract disease, including acute pancreatitis.

6 ADVERSE REACTIONS

The following treatment-emergent adverse events are discussed in more detail in other sections of the labeling:

  • Respiratory Depression [see Contraindications (4.1) and Warnings and Precautions (5.1)]
  • CNS Depression [see Warnings and Precautions (5.2)]

Because clinical studies are conducted under widely varying conditions, adverse event rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice. A treatment-emergent adverse event refers to any untoward medical event associated with the use of the drug in humans, whether or not considered drug-related.

Based on data from nine Phase 2/3 studies that administered multiple doses (seven placebo- and/or active-controlled, one noncontrolled and one Phase 3 active-controlled safety study) the most common adverse events (reported by ≥10% in any NUCYNTA® dose group) were: nausea, dizziness, vomiting and somnolence.

The most common reasons for discontinuation due to adverse events in the studies described above (reported by ≥1% in any NUCYNTA® dose group) were dizziness (2.6% vs. 0.5%), nausea (2.3% vs. 0.6%), vomiting (1.4% vs. 0.2%), somnolence (1.3% vs. 0.2%) and headache (0.9% vs. 0.2%) for NUCYNTA® — and placebo-treated patients, respectively.

Seventy-six percent of NUCYNTA® -treated patients from the nine studies experienced adverse events.

NUCYNTA® was studied in multiple-dose, active- or placebo-controlled studies, or noncontrolled studies (n = 2178), in single-dose studies (n = 870), in open-label study extension (n = 483) and in Phase 1 studies (n = 597). Of these, 2034 patients were treated with doses of 50 mg to 100 mg of NUCYNTA® dosed every 4 to 6 hours.

The data described below reflect exposure to NUCYNTA® in 3161 patients, including 449 exposed for 45 days. NUCYNTA® was studied primarily in placebo- and active-controlled studies (n = 2266, and n = 2944, respectively). The population was 18 to 85 years old (mean age 46 years), 68% were female, 75% white and 67% were postoperative. Most patients received NUCYNTA® doses of 50 mg, 75 mg, or 100 mg every 4 to 6 hours.

6.1 Commonly-Observed Treatment-Emergent Adverse Events in Double-Blind Controlled Clinical Trials

Table 1 lists the adverse events reported in ≥1% or more of NUCYNTA® -treated patients with acute moderate to severe pain in the pooled safety data from nine Phase 2/3 studies that administered multiple doses (seven placebo- and/or active-controlled, one noncontrolled, and one Phase 3 active-controlled safety study).

Table 1 Treatment-Emergent Adverse Events * Reported by ≥1% of NUCYNTA® -Treated Patients In Seven Phase 2/3 Placebo- and/or Oxycodone-Controlled, One Noncontrolled, and One Phase 3 Oxycodone-Controlled Safety, Multiple-Dose Clinical Studies
System/Organ ClassNUCYNTA® Placebo
MedDRA Preferred Term21 mg – 120 mg(n=619)
(n=2178)%
%
Gastrointestinal disorders
Nausea3013
Vomiting184
Constipation83
Dry mouth4<1
Dyspepsia2<1
General disorders and administration site conditions
Fatigue3<1
Feeling hot1<1
Infections and infestations
Nasopharyngitis1<1
Upper respiratory tract infection1<1
Urinary tract infection1<1
Metabolism and nutrition disorders
Decreased appetite20
Musculoskeletal and connective tissue disorders
Arthralgia1<1
Nervous system disorders
Dizziness248
Somnolence153
Tremor1<1
Lethargy1<1
Psychiatric disorders
Insomnia2<1
Confusional state10
Abnormal dreams1<1
Anxiety1<1
Skin and subcutaneous tissue disorders
Pruritus51
Hyperhidrosis3<1
Pruritus generalized3<1
Rash1<1
Vascular disorders
Hot flush1<1

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