Difelikefalin Acetate 50 mcg/mL Suppliers & Bulk Manufacturers

Available Forms: Injection

Available Strengths: 50 mcg/mL

Reference Brands: Korsuva (USA)

Category: Nephrology

Difelikefalin injection, a peripherally acting kappa-opioid agonist given after haemodialysis for chronic kidney disease itch. For dialysis networks, hospital renal units and licensed importers.

Product Description:

Difelikefalin is a synthetic peptide that activates kappa-opioid receptors. Its structure keeps it largely out of the brain, so it acts mainly on peripheral nerves and immune cells, damping the itch signal without the central effects of conventional opioids. It is a clear solution for intravenous injection into the venous line of the dialysis circuit at the end of each haemodialysis session. The reference product contains 50 micrograms per mL in single-dose vials.

It is used for moderate to severe itch linked to chronic kidney disease in adults on haemodialysis. The dose is calculated from target dry body weight and given three times a week, after each session. Because dialysis removes the drug, giving it before or during the session would waste it, so dialysis staff need clear timing instructions. Diarrhoea, dizziness, nausea, drowsiness and changes in mental state are reported, and care is needed with other sedating medicines.

Sourcing notes. Registration is limited to a few markets so far, with named-patient supply elsewhere. Although it acts on opioid receptors, the reference product is not a scheduled controlled substance in the United States; check how your own regulator classifies it before import. The vials need no cold chain under the reference labelling but must not be frozen. Ask for a CoA per batch with sterility and endotoxin results, the GMP certificate and CoPP. It is prescription-only. Base vial numbers on patients, weights and three doses a week.