Only for short-term (15 doses) use in hospitalized patients. (See MI under Cautions.)
For use only by hospitals enrolled in the Entereg® Access Support and Education (EASE®) program. (See Restricted Distribution Program under Dosage and Administration.)
REMS:
FDA approved a REMS for alvimopan to ensure that the benefits of a drug outweigh the risks. The REMS may apply to one or more preparations of alvimopan and consists of the following: elements to assure safe use, communication plan, and implementation system. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).
Take this medicine by mouth with a glass of water. It will only be given to you by a health care professional while you are in the hospital.
Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
It is important not to miss your dose. Talk to your doctor or health care professional if you miss a dose.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Your condition will be monitored carefully while you are receiving this medicine.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
breathing difficulties
dizziness
unusually weak or tired
Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):
back pain
constipation
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
This does not apply.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
