Entereg

ENTEREG- alvimopan capsule
Adolor Corporation

WARNING: FOR SHORT-TERM HOSPITAL USE ONLY

ENTEREG is available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have registered in and met all of the requirements for the ENTEREG Access Support and Education (E.A.S.E.) program may use ENTEREG. [see Warnings and Precautions (5.1 and 5.2)]

1 INDICATIONS AND USAGE

ENTEREG is indicated to accelerate the time to upper and lower gastrointestinal recovery following partial large or small bowel resection surgery with primary anastomosis.

2 DOSAGE AND ADMINISTRATION

2.1 Usual Dosage in Adults

For hospital use only. The recommended adult dosage of ENTEREG is 12 mg administered 30 minutes to 5 hours prior to surgery followed by 12 mg twice daily beginning the day after surgery for a maximum of 7 days or until discharge. Patients should not receive more than 15 doses of ENTEREG.

2.2 Special Populations

Geriatric Use: No dosage adjustment is necessary in elderly patients [see Use in Specific Populations (8.5)].

Hepatic Impairment: No dosage adjustment is necessary in patients with mild-to-moderate hepatic impairment (Child-Pugh Class A and B). ENTEREG is not recommended for use in patients with severe hepatic impairment (Child-Pugh Class C) [see Use in Specific Populations (8.6) and Clinical Pharmacology (12.3)].

Renal Impairment: No dosage adjustment is necessary in patients with mild-to-severe renal impairment, but they should be monitored for adverse effects. ENTEREG is not recommended for use in patients with end-stage renal disease. [see Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

Race: No dosage adjustment is necessary in Black, Hispanic and Japanese patients, however, due to observed 2-fold greater ENTEREG plasma concentrations in healthy male Japanese subjects, Japanese patients should be monitored for possible adverse effects. [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.3)]

3 DOSAGE FORMS AND STRENGTHS

12 mg blue, hard gelatin capsules with “ADL2698″ printed on both the body and the cap of the capsule.

4 CONTRAINDICATIONS

ENTEREG is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking ENTEREG.

5 WARNINGS AND PRECAUTIONS

5.1 Myocardial Infarction in a 12 Month Study in Patients treated with Opioids for Chronic Pain

There were more reports of myocardial infarctions in patients treated with alvimopan 0.5 mg twice daily compared with placebo-treated patients in a 12-month study of patients treated with opioids for chronic pain. In this study, the majority of myocardial infarctions occurred between 1 and 4 months after initiation of treatment. This imbalance has not been observed in other studies of alvimopan, including studies in patients undergoing bowel resection surgery who received alvimopan 12 mg twice daily for up to 7 days. A causal relationship with alvimopan has not been established.

5.2 Distribution Program for ENTEREG

ENTEREG is available only to hospitals that enroll in the E.A.S.E. program. To enroll in the E.A.S.E. program, the hospital must acknowledge that:

-hospital staff who prescribe, dispense, or administer ENTEREG have been provided the educational materials on the need to limit use of ENTEREG to short-term, inpatient use;
-patients will not receive more than 15 doses of alvimopan; and
-ENTEREG will not be dispensed to patients after they have been discharged from the hospital.

Contact the E.A.S.E. program at 1-866-4ADOLOR (1-866-423-6567).

5.3 Opioid Tolerance and Gastrointestinal-Related Adverse Effects

Patients recently exposed to opioids are expected to be more sensitive to the effects of µ-opioid receptor antagonists, such as ENTEREG. Since ENTEREG acts peripherally, clinical signs and symptoms of increased sensitivity would likely be limited to the gastrointestinal tract (e.g., abdominal pain, nausea and vomiting, diarrhea). Patients receiving more than 3 doses of an opioid within the week prior to surgery were not studied in the postoperative ileus clinical trials; therefore, ENTEREG 12 mg capsules should be administered with caution to these patients.

5.4 Severe Hepatic Impairment

In patients with severe hepatic impairment, there is a potential for 10-fold higher plasma levels of drug [see Clinical Pharmacology (12.3)]. There are no studies of ENTEREG in patients with severe hepatic impairment undergoing bowel resection. Because of the limited data available, ENTEREG is not recommended for use in patients with severe hepatic impairment.

5.5 End-Stage Renal Disease

No studies have been conducted with end-stage renal disease. ENTEREG is not recommended for use in these patients.

5.6 Bowel Obstruction

Use of ENTEREG in patients undergoing surgery for correction of complete bowel obstruction is not recommended.

6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. The adverse event information from clinical trials does, however, provide a basis for identifying the adverse events that appear to be related to drug use and for approximating rates.

The data described below reflect exposure to ENTEREG in 1,650 patients in 9 placebo-controlled studies worldwide. The population was 19 to 97 years old, 68% were female, and 83% were Caucasian; 61% were undergoing bowel resection surgery. The first dose of ENTEREG was administered 30 minutes to 5 hours before the scheduled start of surgery and then twice daily until hospital discharge (or for a maximum of 7 days of postoperative treatment).

Table 1 presents treatment-emergent adverse reactions reported in ≥3% patients treated with ENTEREG and for which the rate for ENTEREG was ≥1% than placebo. Treatment-emergent adverse reactions are those events occurring after the first dose of study medication treatment and within 7 days of the last dose of study medication or those events present at baseline that increased in severity after the start of study medication treatment.

Table 1. Treatment-Emergent Adverse Reactions That Were Reported in ≥3% of Either Bowel Resection Patients Treated With ENTEREG or All Surgical Patients Treated With ENTEREG and for Which the Rate for ENTEREG Was ≥1% Than Placebo
System Organ Class Bowel Resection Patients All Surgical Patients
Placebo(n = 986)% ENTEREG(n = 999)% Placebo(n = 1,365)% ENTEREG(n = 1,650)%
Blood and lymphatic system disorders
Anemia 4.2 5.2 5.4 5.4
Gastrointestinal disorders
Constipation 3.9 4.0 7.6 9.7
Dyspepsia 4.6 7.0 4.8 5.9
Flatulence 4.5 3.1 7.7 8.7
Metabolism and nutrition disorders
Hypokalemia 8.5 9.5 7.5 6.9
Musculoskeletal and connective tissue disorders
Back pain 1.7 3.3 2.6 3.4
Renal and urinary disorders
Urinary retention 2.1 3.2 2.3 3.5
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