Defalix
Cheaper & Alternative Brands
Same generic (Difelikefalin Acetate), same form (IV Infusion)No other brands currently registered with this exact active generic and dosage form.
Clinical Prescribing Information
Medical monograph and safety information for healthcare professionals & patients.Indications & Clinical Uses
Defalix IV Infusion is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis.
Dosage & Administration
Recommended dosage is 0.5 mcg/kg. Administer by intravenous bolus injection into the venous line of the dialysis circuit at the end of each hemodialysis treatment। Do not mix or dilute Difelikefalin Acetate prior to administration। Administer within 60 minutes of syringe preparation. If a regularly scheduled hemodialysis treatment is missed, resume Difelikefalin Acetate at the end of the next hemodialysis treatment.
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.
Side Effects & Adverse Reactions
The most common adverse reactions are diarrhea, dizziness, nausea, gait disturbances, including falls, hyperkalemia, headache, somnolence, and mental status change.
Warnings & Precautions
Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances
: Dizziness, somnolence, mental status changes, and gait disturbances, including falls, have occurred in patients taking Defalix and may subside over time with continued treatment. Concomitant use of centrally-acting depressant medications, sedating antihistamines and opioid analgesics may increase the likelihood of these adverse reactions and should be used with caution during treatment with Defalix.
Risk of Driving and Operating Machinery
: Dizziness, somnolence, and mental status changes have occurred in patients taking Defalix. Defalix 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 Defalix on a patient’s ability to drive or operate machinery is known.
Pharmacology & Mechanism of Action
Difelikefalin Acetate is a kappa opioid receptor agonist used in the treatment of pruritus associated with chronic kidney disease in patients undergoing hemodialysis.