Fulyzaq

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

You should not use crofelemer if you are allergic to it.

To make sure crofelemer is safe for you, tell your doctor if you are sick with diarrhea and vomiting or other symptoms of infection.

FDA pregnancy category C. It is not known whether crofelemer will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether crofelemer passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Do not give this medication to anyone under 18 years old without medical advice.

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

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using crofelemer and call your doctor at once if you have:

• dark urine, jaundice (yellowing of the skin or eyes);

• wheezing, chest tightness, trouble breathing; or

• worsening diarrhea.

Common side effects may include:

• bloating, gas; or

• cold symptoms such as stuffy nose, sneezing, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Administration

Oral Administration

Administer orally twice daily without regard to meals.1 (See Absorption under Pharmacokinetics.)

Swallow delayed-release tablets whole; do not crush or chew tablets.1

Dosage

Adults

125 mg twice daily.1

Dosage adjustment not recommended based on CD4+ T-cell count or HIV viral load.1 (See CD4+ T-cell Count and HIV Viral Load under Cautions.)

Special Populations

Hepatic Impairment

No specific dosage recommendations;1 dosage adjustments probably not necessary2 since systemic absorption is minimal.1 10 11

Renal Impairment

No specific dosage recommendations;1 dosage adjustments probably not necessary2 since systemic absorption is minimal.1 10

Geriatric Patients

No specific dosage recommendations at this time;1 dosage adjustments probably not necessary11 since systemic absorption is minimal.1 10

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.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Get emergency medical help if you have any of these signs of an allergic reaction to Fulyzaq: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using Fulyzaq and call your doctor at once if you have:

• dark urine, jaundice (yellowing of the skin or eyes);

• wheezing, chest tightness, trouble breathing; or

• worsening diarrhea.

Common Fulyzaq side effects may include:

• bloating, gas; or

• cold symptoms such as stuffy nose, sneezing, cough.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.