Alvimopan

ALVIMOPAN- alvimopan capsule
Actavis Pharma, 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 alvimopan, 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, alvimopan is available only through a restricted program for short-term use (15 doses) under a Risk Evaluation and Mitigation Strategy (REMS) called the Alvimopan REMS Program [see Warnings and Precautions (5.1, 5.2)].

1 INDICATIONS AND USAGE

Alvimopan capsules are 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 alvimopan capsules 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 alvimopan capsules.

Alvimopan capsules can be taken with or without food [see Clinical Pharmacology (12.3)].

3 DOSAGE FORMS AND STRENGTHS

Capsules: 12 mg white to off-white, hard gelatin capsules printed with “2312 ” on body of the capsule.

4 CONTRAINDICATIONS

Alvimopan capsules are contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking alvimopan capsules [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 alvimopan 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 alvimopan 12 mg twice daily for up to 7 days (the indicated dose and patient population; alvimopan 12 mg, n=1,142; placebo, n=1,120). A causal relationship with alvimopan with long-term use has not been established.

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

5.2 Alvimopan REMS Program

Alvimopan capsules are available only through a program called the Alvimopan REMS Program that restricts use to enrolled hospitals because of the potential risk of myocardial infarction with long-term use of alvimopan capsules [see Warnings and Precautions (5.1)].

Notable requirements of the Alvimopan REMS Program include the following:

Alvimopan capsules are available only for short-term (15 doses) use in hospitalized patients. Only hospitals that have enrolled in and met all of the requirements for the Alvimopan REMS Program may use alvimopan capsules.

To enroll in the Alvimopan REMS Program, an authorized hospital representative must acknowledge that:

  • hospital staff who prescribe, dispense, or administer alvimopan capsules have been provided the educational materials on the need to limit use of alvimopan capsules to short-term, inpatient use;

  • patients will not receive more than 15 doses of alvimopan capsules; and

  • alvimopan capsules will not be dispensed to patients after they have been discharged from the hospital.

Further information is available at www.alvimopanREMS.com or 1-800-278-0340.

5.3 Gastrointestinal-Related Adverse Reactions in Opioid-Tolerant Patients

Patients recently exposed to opioids are expected to be more sensitive to the effects of mu-opioid receptor antagonists, such as alvimopan. Since alvimopan acts peripherally, clinical signs and symptoms of increased sensitivity would be related 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, if alvimopan is administered to these patients, they should be monitored for gastrointestinal adverse reactions. Alvimopan is contraindicated in patients who have taken therapeutic doses of opioids for more than 7 consecutive days immediately prior to taking alvimopan [see Contraindications (4)].

5.4 Risk of Serious Adverse Reactions in Patients with Severe Hepatic Impairment

Patients with severe hepatic impairment may be at higher risk of serious adverse reactions (including dose-related serious adverse reactions) because up to 10-fold higher plasma concentrations of alvimopan have been observed in such patients compared with patients with normal hepatic function. Therefore, the use of alvimopan is not recommended in this population [see Use in Specific Populations (8.6)].

5.5 End-Stage Renal Disease

No studies have been conducted in patients with end-stage renal disease. Alvimopan is not recommended for use in these patients [see Use in Specific Populations (8.7)].

5.6 Risk of Serious Adverse Reactions in Patients with Complete Gastrointestinal Obstruction

No studies have been conducted in patients with complete gastrointestinal obstruction or in patients who have surgery for correction of complete bowel obstruction. Alvimopan is not recommended for use in these patients.

5.7 Risk of Serious Adverse Reactions in Pancreatic and Gastric Anastomoses

Alvimopan has not been studied in patients having pancreatic or gastric anastomosis. Therefore, alvimopan is not recommended for use in these patients.

6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Potential Risk of Myocardial Infarction with Long-Term Use [see Warnings and Precautions (5.1)]
  • Gastrointestinal-Related Adverse Reactions in Opioid-Tolerant Patients [see Warnings and Precautions (5.3)]
  • Risk of Serious Adverse Reactions in Patients with Severe Hepatic Impairment [see Warnings and Precautions (5.4)]
  • Risk of Serious Adverse Reactions in Patients with Complete Gastrointestinal Obstruction [see Warnings and Precautions (5.6)]
  • Risk of Serious Adverse Reactions in Pancreatic and Gastric Anastomoses [see Warnings and Precautions (5.7)]

All MedLibrary.org resources are included in as near-original form as possible, meaning that the information from the original provider has been rendered here with only typographical or stylistic modifications and not with any substantive alterations of content, meaning or intent.

This site is provided for educational and informational purposes only, in accordance with our Terms of Use, and is not intended as a substitute for the advice of a medical doctor, nurse, nurse practitioner or other qualified health professional.

Privacy Policy | Copyright © 2022. All Rights Reserved.