Difelikefalin

Difelikefalin is used in adults who are on dialysis to treat moderate to severe itching related to kidney disease.

Difelikefalin may also be used for reasons not mentioned in this medication guide.

Difelikefalin is given at the end of each dialysis treatment.

A healthcare provider will give you this injection.

Doses are based on weight. Your dose may change if you gain or lose weight.

Tell your doctor if you use other medicines or have other medical conditions or allergies.

Tell your doctor if you have or have ever had:

• trouble with standing, walking or daily activities;
• changes in your mental state;
• if you are on peritoneal dialysis; or
• severe liver disease.

Tell your doctor if you are pregnant or breastfeeding.

Get emergency medical help if you notice signs of an allergic reaction: hives, trouble breathing, swelling of your face, lips, tongue, or throat.

Common side effects of difelikefalin may include:

• high blood levels of potassium (hyperkalemia);
• diarrhea, nausea;
• headache, drowsiness, confusion, changes in your mental state; or
• dizziness, falls, loss of coordination.

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

Usual Adult Dose for Pruritus:

0.5 mcg/kg IV at the end of each hemodialysis (HD) treatmentComments:-This drug should be administered by IV bolus injection into the venous line of the dialysis circuit at the end of each HD treatment. See administration advice for additional information.-Dose is determined by the patient's target dry body weight.-This drug has not been studied in patients on peritoneal dialysis and is therefore not recommended for use in this population.Use: For the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing HD

In a medical setting, it is unlikely that you will miss a dose.

In a medical setting, an overdose would be treated quickly.

Avoid driving or doing dangerous activities until you understand how difelikefalin will affect you. Dizziness or drowsiness can lead to falls, accidents, or severe injuries.

Using difelikefalin with other drugs that cause drowsiness can make you feel even more drowsy. Talk to your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicines for anxiety, allergies, or seizures.

Other drugs may impact how difelikefalin works, including both prescription and over-the-counter medications, vitamins, and herbal products. Inform your doctor about all other medicines you are taking.