Crofelemer

Crofelemer is used to control some types of diarrhea in patients with human immunodeficiency virus (HIV) infection who are being treated with certain medications. Crofelemer is in a class of medications called botanicals. It works by decreasing the amount of fluid that flows into the bowel that can cause diarrhea.

Crofelemer comes as a delayed-release (releases the medication in the intestine where its effects are needed) tablet to take by mouth. It is usually taken two times a day, with or without food. Take crofelemer at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take crofelemer exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not chew or crush them.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Oral Administration

May take with or without food

Swallow tablet whole; do not crush, chew, or dissolve

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Other drugs may interact with crofelemer, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

In the U.S.

• Mytesi

Available Dosage Forms:

• Tablet, Delayed Release

Therapeutic Class: Antidiarrheal

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Nose and throat irritation.
• Runny nose.
• Stuffy nose.
• Cough.
• Gas.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

• Store at room temperature.
• Protect tablets from water. Do not store in a bathroom or kitchen.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

Inhibits cyclic adenosine monophosphate (cAMP)-stimulated cystic fibrosis transmembrane conductance regulator (CFTR) chloride ion channel and calcium activated chloride ion channels at the enterocyte luminal membrane. This regulates fluid secretion and water loss (high volume) due to diarrhea, normalizing chloride ion and water flow in the GI tract.

Absorption

Minimal systemic absorption

No dosage adjustment provided in the manufacturer’s labeling.

Disease-related concerns:

• HIV/AIDS: CD4 cell count and viral load do not have a clinical impact on crofelemer treatment; no adjustments are necessary based on CD4 cell count or viral load.

• Infectious diarrhea: Crofelemer is not indicated for infectious diarrhea; there is a risk of inadequate or delayed treatment if used when infectious diarrhea is present. Rule out infectious causes for diarrhea prior to initiating treatment.

-Data not available