Rx Item-Entereg 12Mg Cap 30 By Merck

ENTEREG- alvimopan capsule
Cubist Pharmaceuticals, Inc.

WARNING: POTENTIAL RISK OF MYOCARDIAL INFARCTION WITH LONG-TERM USE: FOR SHORT-TERM HOSPITAL USE ONLY

There was a greater incidence of myocardial infarction in alvimopan-treated patients compared to placebo-treated patients in a 12-month clinical trial, although a causal relationship has not been established. In short-term trials with ENTEREG � , no increased risk of myocardial infarction was observed [see Warnings and Precautions (5.1)].



Because of the potential risk of myocardial infarction with long-term use, ENTEREG is available only through a restricted program for short-term use (15 doses) under a Risk Evaluation and Mitigation Strategy (REMS) called the ENTEREG Access Support and Education (E.A.S.E.�) Program [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 surgeries that include partial bowel resection with primary anastomosis.

2 DOSAGE AND ADMINISTRATION

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 until discharge for a maximum of 7 days. Patients should not receive more than 15 doses of ENTEREG.

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 [see Warnings and Precautions (5.3)].

5 WARNINGS AND PRECAUTIONS

5.1 Potential Risk of Myocardial Infarction with Long-term Use
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 non-cancer pain (alvimopan 0.5 mg, n = 538; placebo, n = 267). 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 ENTEREG in patients treated with opioids for chronic pain, nor in patients treated within the surgical setting, including patients undergoing surgeries that included bowel resection who received ENTEREG 12 mg twice daily for up to 7 days (the indicated dose and patient population; ENTEREG 12 mg, n = 1,142; placebo, n = 1,120). A causal relationship with alvimopan with long-term use has not been established.

ENTEREG is available only through a program under a REMS that restricts use to enrolled hospitals [see Warnings and Precautions (5.2)].

67919-0020-10
ENTEREG 12 MG CAP UD 30 BY MERCK Generic Code : 064325 ALVIMOPAN ORAL CAPSULE 12 MG Fine Line Class : 850085008510 All Rx Products Product Category : RX Pharmaceuticals

Entereg 12Mg Cap 30 By Merck
BRAND: ENTEREG NDC: 67919-0020-10,67919002010 UPC: 3-67919-02010-4,367919020104 Merck & Co.

ALVIMOPAN ORAL CAPSULE 12
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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67919-0020-10
ENTEREG 12 MG CAP UD 30 BY MERCK Generic Code : 064325 ALVIMOPAN ORAL CAPSULE 12 MG Fine Line Class : 850085008510 All Rx Products Product Category : RX Pharmaceuticals