Indications & Uses
Difelikefalin Acetate IV Infusion is used to treat moderate-to-severe pruritus (itching) linked to chronic kidney disease, known as CKD-aP, in adults who are on hemodialysis.
Pharmacology
Difelikefalin Acetate is a kappa opioid receptor agonist. Doctors use it to treat pruritus (itching) linked with chronic kidney disease in patients who are undergoing hemodialysis.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
The recommended dose of Difelikefalin Acetate is 0.5 mcg/kg. Administer it by intravenous bolus injection into the venous line of the dialysis circuit at the end of each hemodialysis treatment. Don't mix or dilute it before you administer it, and give it within 60 minutes of preparing the syringe. If a regularly scheduled hemodialysis treatment is missed, resume the medicine 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
Difelikefalin Acetate most commonly causes diarrhea, dizziness, nausea, gait disturbances (including falls), hyperkalemia, headache, somnolence and mental status change.
Cautions & Contraindications
Warnings & Precautions
Dizziness, somnolence, mental status changes and gait disturbances, including falls, have occurred in patients taking Difelikefalin Acetate. These may ease over time as treatment continues. Centrally-acting depressant medicines, sedating antihistamines and opioid analgesics may make these reactions more likely, so they should be used with caution during treatment with Difelikefalin Acetate. Risk of Driving and Operating Machinery Dizziness, somnolence and mental status changes have occurred in patients taking the medicine. Difelikefalin Acetate may affect the mental or physical abilities needed for potentially hazardous activities such as driving a car and operating machinery. Patients should be advised not to drive or operate dangerous machinery until they know how the medicine affects their ability to do so.
Pregnancy & Breastfeeding
There isn't much human data on Difelikefalin Acetate in pregnant women, and what exists is not enough to judge whether the medicine carries a risk of major birth defects or miscarriage. Nothing is known about whether Difelikefalin Acetate passes into human milk. There are also no data on its effects on a breastfed infant or on milk production.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Overdose
In clinical studies, people on haemodialysis (HD) were given single doses of Difelikefalin Acetate up to 12 times, and multiple doses up to 5 times, the recommended dose of 0.5 mcg/kg. The adverse reactions went up as the dose went up. These included dizziness, somnolence, mental status changes, paresthesia, fatigue, hypertension and vomiting.
If an overdose happens, give medical care that suits the patient's clinical condition. Difelikefalin Acetate is cleared mainly by the kidneys, and in dialysis patients its binding to plasma protein is low, at approximately 23% to 28%. Hemodialysis for 4 hours with a high-flux dialyzer effectively removed approximately 70% to 80% of Difelikefalin Acetate from plasma. By the end of the second of two dialysis cycles, it could no longer be detected in plasma.
⚠️ In an emergency call 999 or go to the nearest hospital emergency department.
Storage
Store Difelikefalin Acetate at a temperature no higher than 25°C. Keep it away from light and from damp places. And keep it out of reach of children.
Common questions about Defalix 65 mcg
What is Defalix 65 mcg IV Infusion?
Defalix 65 mcg IV Infusion is a medicine that contains Difelikefalin Acetate. It is made by Eskayef Pharmaceuticals Ltd.
What is Defalix used for?
Difelikefalin Acetate IV Infusion is used to treat moderate-to-severe pruritus (itching) linked to chronic kidney disease, known as CKD-aP, in adults who are on hemodialysis.
What are the side effects of Defalix?
Difelikefalin Acetate most commonly causes diarrhea, dizziness, nausea, gait disturbances (including falls), hyperkalemia, headache, somnolence and mental status change.
Can I take Defalix during pregnancy or while breastfeeding?
There isn't much human data on Difelikefalin Acetate in pregnant women, and what exists is not enough to judge whether the medicine carries a risk of major birth defects or miscarriage. Nothing is known about whether Difelikefalin Acetate passes into human milk. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
What happens if I take too much Defalix?
In clinical studies, people on haemodialysis (HD) were given single doses of Difelikefalin Acetate up to 12 times, and multiple doses up to 5 times, the recommended dose of 0.5 mcg/kg. The adverse reactions went up as the dose went up. In an emergency call 999 or go to the nearest hospital emergency department.
How should I store Defalix?
Store Difelikefalin Acetate at a temperature no higher than 25°C. Keep it away from light and from damp places.
Do I need a prescription for Defalix?
Defalix is a prescription (Rx) medicine. Take it as your doctor advises.