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Drug overview for ALVIMOPAN (alvimopan):
Generic name: ALVIMOPAN
Drug class: Opioid Antagonists
Therapeutic class: Antidotes and other Reversal Agents
Alvimopan is a peripherally acting micro-opiate receptor antagonist.
No enhanced Uses information available for this drug.
Generic name: ALVIMOPAN
Drug class: Opioid Antagonists
Therapeutic class: Antidotes and other Reversal Agents
Alvimopan is a peripherally acting micro-opiate receptor antagonist.
No enhanced Uses information available for this drug.
DRUG IMAGES
ALVIMOPAN 12 MG CAPSULE
The following indications for ALVIMOPAN (alvimopan) have been approved by the FDA:
Indications:
Postoperative ileus
Professional Synonyms:
None.
Indications:
Postoperative ileus
Professional Synonyms:
None.
The following dosing information is available for ALVIMOPAN (alvimopan):
Dosage of alvimopan, which is commercially available as the dihydrate, is calculated on the anhydrous basis.
To accelerate GI recovery in hospitalized patients following partial large or small bowel resection with primary anastomosis, the recommended adult dosage of alvimopan is 12 mg administered 30 minutes to 5 hours prior to surgery followed by 12 mg twice daily beginning the day after surgery and continuing for a maximum of 7 days or until discharge. Alvimopan is indicated for short-term (no more than 15 doses) use in hospitalized patients only. The drug should not be used for longer than 7 days following bowel resection.
To accelerate GI recovery in hospitalized patients following partial large or small bowel resection with primary anastomosis, the recommended adult dosage of alvimopan is 12 mg administered 30 minutes to 5 hours prior to surgery followed by 12 mg twice daily beginning the day after surgery and continuing for a maximum of 7 days or until discharge. Alvimopan is indicated for short-term (no more than 15 doses) use in hospitalized patients only. The drug should not be used for longer than 7 days following bowel resection.
No enhanced Administration information available for this drug.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ALVIMOPAN 12 MG CAPSULE | Maintenance | Adults take 1 capsule (12 mg) by oral route 2 times per day for 7 days |
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| ALVIMOPAN 12 MG CAPSULE | Maintenance | Adults take 1 capsule (12 mg) by oral route 2 times per day for 7 days |
The following drug interaction information is available for ALVIMOPAN (alvimopan):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for ALVIMOPAN (alvimopan):
Drug contraindication overview.
Patients who have taken opiates in therapeutic dosages for more than 7 consecutive days immediately prior to alvimopan administration.
Patients who have taken opiates in therapeutic dosages for more than 7 consecutive days immediately prior to alvimopan administration.
There are 1 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Child-pugh class C hepatic impairment |
There are 1 severe contraindications.
Adequate patient monitoring is recommended for safer drug use.
| Severe List |
|---|
| Acute myocardial infarction |
There are 4 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Child-pugh class A hepatic impairment |
| Child-pugh class B hepatic impairment |
| Chronic kidney disease stage 3B (moderate) GFR 30-44 ml/min |
| Chronic kidney disease stage 4 (severe) GFR 15-29 ml/min |
The following adverse reaction information is available for ALVIMOPAN (alvimopan):
Adverse reaction overview.
Adverse effects reported in 3% or more of patients receiving alvimopan in clinical trials and more frequently (by a difference of at least one percentage point) with alvimopan than with placebo include constipation, hypokalemia, flatulence, dyspepsia, anemia, back pain, and urinary retention.
Adverse effects reported in 3% or more of patients receiving alvimopan in clinical trials and more frequently (by a difference of at least one percentage point) with alvimopan than with placebo include constipation, hypokalemia, flatulence, dyspepsia, anemia, back pain, and urinary retention.
There are 1 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
| None. | None. |
| Rare/Very Rare |
|---|
|
Acute myocardial infarction |
There are 5 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Dyspepsia |
None. |
| Rare/Very Rare |
|---|
|
Acute abdominal pain Diarrhea Nausea Vomiting |
The following precautions are available for ALVIMOPAN (alvimopan):
Safety and efficacy not established in children younger than 18 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category B. (See Users Guide.)
Alvimopan and its metabolite are distributed into milk in rats; it is unknown whether the drug or its metabolite is distributed into human milk. Alvimopan should be used with caution in nursing women.
Approximately 45% of patients enrolled in 5 clinical trials evaluating use of alvimopan for postoperative ileus were 65 years of age or older, and 18% were 75 years of age or older. Although no overall differences in efficacy or safety were observed between geriatric and younger patients and other clinical experience has not revealed any evidence of age-related differences, the possibility that some older patients may exhibit increased sensitivity to the drug cannot be ruled out.
The following prioritized warning is available for ALVIMOPAN (alvimopan):
No warning message for this drug.
No warning message for this drug.
The following icd codes are available for ALVIMOPAN (alvimopan)'s list of indications:
| Postoperative ileus | |
| K91.3 | Postprocedural intestinal obstruction |
| K91.30 | Postprocedural intestinal obstruction, unspecified as to partial versus complete |
| K91.31 | Postprocedural partial intestinal obstruction |
| K91.32 | Postprocedural complete intestinal obstruction |
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