OPANA ER (Page 7 of 11)

Hepatic Impairment

A study of OPANA ER in patients with hepatic disease indicated greater plasma concentrations than those with normal hepatic function (see CLINICAL PHARMACOLOGY). OPANA ER should be used with caution in patients with mild impairment. These patients should be started with the lowest dose and titrated slowly while carefully monitoring for side effects. OPANA ER is contraindicated for patients with moderate and severe hepatic impairment (see CONTRAINDICATIONS, WARNINGS, and DOSAGE AND ADMINISTRATION).

Renal Impairment

In a study of OPANA ER, patients with moderate to severe renal impairment were shown to have an increase in bioavailability ranging from 57-65% (see CLINICAL PHARMACOLOGY). These patients should be started cautiously with lower doses of OPANA ER and titrated slowly while carefully monitored for side effects (see DOSAGE AND ADMINISTRATION).

Gender Differences

When normalized for body weight, gender differences were not observed (see CLINICAL PHARMACOLOGY). In clinical studies, the overall incidence rates for one or more adverse events were slightly higher among females than males for both OPANA ER subjects and placebo subjects.

ADVERSE REACTIONS

Tables 2 and 3 list the most frequently occurring adverse reactions (in at least 5% of patients) from the placebo-controlled trials in patients with low back pain.

Table 2: Treatment-Emergent Adverse Events Reported in ≥5% of Patients During the Open-Label Titration Period and Double-Blind Treatment Period by Preferred Term —Number (%) of Treated Patients (12-Week Study In Opioid-Naïve Patients with Low Back Pain)
Open-Label Titration Period Double-Blind Treatment Period
OPANA ER OPANA ER Placebo
Preferred Term (N = 325) (N = 105) (N = 100)
Constipation 26.2% 6.7% 1.0%
Somnolence 19.1% 1.9% 0%
Nausea 18.2% 11.4% 9.0%
Dizziness 11.1% 4.8% 3.0%
Headache 10.5% 3.8% 2.0%
Pruritus 6.8% 2.9% 1.0%
Table 3. Treatment-Emergent Adverse Events Reported in ≥5% of Patients During the Open-Label Titration Period and Double-Blind Treatment Period by Preferred Term —Number (%) of Treated Patients (12-Week Study In Opioid-Experienced Patients with Low Back Pain)
Open-Label Titration Period Double-Blind Treatment Period
OPANA ER OPANA ER Placebo
Preferred Term (N = 250) (N = 70) (N = 72)
Nausea 19.6% 2.9% 1.4%
Constipation 11.6% 5.7% 1.4%
Headache 11.6% 2.9% 0%
Somnolence 11.2% 2.9% 0%
Vomiting 8.8% 0% 1.4%
Pruritus 7.6% 0% 0%
Dizziness 6.4% 0% 0%

Adverse Reactions Reported in Placebo-Controlled Trials

The following table lists adverse reactions that were reported in at least 2% of patients in placebo-controlled trials (N=5)

Table 4: Adverse Reactions Reported in Placebo-Controlled Clinical Trials with Incidence ≥2% in Patients Receiving OPANA ER.
MedDRA Preferred Term OPANA ER (N=1259) Placebo (N=461)
Nausea 33.1% 13.2%
Constipation 27.6% 13.2%
Dizziness (Exc Vertigo) 17.8% 7.6%
Somnolence 17.2% 2.2%
Vomiting 15.6% 4.1%
Pruritus 15.2% 7.6%
Headache 12.2% 5.6%
Sweating increased 8.6% 8.7%
Dry mouth 6.4% 0.7%
Sedation 5.9% 7.6%
Diarrhea 4.3% 5.6%
Insomnia 4.0% 2.0%
Fatigue 3.9% 1.3%
Appetite decreased 2.9% 0.4%
Abdominal pain 2.5% 1.5%

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