PEDIATRIC USE: The safety and effectiveness of Difelikefalin Acetate in pediatric patients have not been established.
GERIATRIC USE: No overall differences in safety or effectiveness of Difelikefalin Acetate have been observed between patients 65 years of age and older and young adult subjects.
PEDIATRIC USE: The safety and effectiveness of Difelikefalin Acetate in pediatric patients have not been established.
GERIATRIC USE: No overall differences in safety or effectiveness of Difelikefalin Acetate have been observed between patients 65 years of age and older and young adult subjects.
No clinical studies evaluating the drug interaction potential of Difelikefalin Acetate were conducted.
The most common adverse reactions are diarrhea, dizziness, nausea, gait disturbances, including falls, hyperkalemia, headache, somnolence, and mental status change.
The limited human data on use of Difelikefalin Acetate in pregnant women are not sufficient to evaluate a drug-associated risk for major birth defects or miscarriage. There are no data regarding the presence of Difelikefalin Acetate in human milk or effects on the breastfed infant or on milk production.
Risk of Driving and Operating Machinery: Dizziness, somnolence, and mental status changes have occurred in patients taking Difelikefalin Acetate. Difelikefalin Acetate may impair the mental or physical abilities needed to perform potentially hazardous activities such as driving a car and operating machinery. Advise patients not to drive or operate dangerous machinery until the effect of Difelikefalin Acetate on a patient’s ability to drive or operate machinery is known.
Single doses of Difelikefalin Acetate up to 12 times and multiple doses of Difelikefalin Acetate up to 5 times the recommended dosage of 0.5 mcg/kg were administered in clinical studies in subjects undergoing HD. A dose-dependent increase in adverse reactions, including dizziness, somnolence, mental status changes, paresthesia, fatigue, hypertension, and vomiting, were observed. In the event of overdosage, provide the appropriate medical attention based on patient’s clinical status. Difelikefalin is primarily eliminated by the kidneys with a low plasma protein binding of approximately 23% to 28% in dialysis patients. Hemodialysis for 4 hours using a high-flux dialyzer effectively cleared approximately 70% to 80% of Difelikefalin from plasma, and Difelikefalin was not detectable in plasma at the end of the second of two dialysis cycles.
Do not store above 25°C temperature. Keep away from light and wet place. Keep out of reach of children.