Defalix IV Injection
Difelikefalin
65mcg/1.3ml
Eskayef Pharmaceuticals Ltd.
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| Retail Price | 250.00 AED |
Indications
Defalix IV Injection is used for:
Pruritus, associated with chronic kidney disease
Adult Dose
Pruritus
Indicated for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis (HD)
0.5 mcg/kg IV push into the venous line of dialysis circuit at the end of each HD treatment
Child Dose
Renal Dose
Administration
IV Preparation
Do not mix or dilute before administration
Visually inspect vials for particulate matter and discoloration before administering; solution should be clear and colorless; discard vials if particulate matter or discoloration is observed
Vials are for single-dose use; discard any unused product
May use the following formula to determine total injection volume on target body weight or may refer to prescribing information
Total injection volume (mL) = Patient target dry body weight (kg) x 0.01, rounded to the nearest tenth (0.1 mL)
IV Administration
Administer after blood is no longer circulating through the dialyzer; dialyzer membrane removes difelikefalin
Administer IV push into venous line of the dialysis circuit at the end of each HD session
May be given either during or after rinse back of dialysis circuit
Dose given after rinse back: Administer into venous line followed by ?10 mL of 0.9% NaCl flush
Dose given during rinse back: No additional 0.9% NaCl is needed to flush line
Administer within 60 minutes of syringe preparation; discard any unused product
Missed regularly scheduled HD treatment: Resume at the end of next HD treatment
Contra Indications
Precautions
Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances:
Dizziness, somnolence, mental status changes, and gait disturbances, including falls, have occurred. Centrally-acting depressant medications, sedating antihistamines, and opioid analgesics should be used with caution during treatment with Difelikefalin.
Risk of Driving and Operating Machinery: May impair mental or physical abilities. Advise patients not to drive or operate dangerous machinery until the effect of Difelikefalin on a patient’s ability to drive or operate machinery is known.
Pregnancy-Lactation
Pregnancy
Limited human data are insufficient on use in pregnant females to evaluate drug-associated risks for major birth defects or miscarriage
Lactation
There are no data regarding drug presence in human milk, effects on breastfed infants, or effects on milk production
Studies showed difelikefalin was transferred into milk in lactating rats
When a drug is present in animal milk, it is likely that the drug will be present in human milk
Interactions
Centrally acting depressant medications, sedating antihistamines, and opioid analgesics may increase the adverse reactions of difelikefalin; use with caution
Contraindicated (0)
Serious - Use Alternative (3)
olopatadine intranasal
ropeginterferon alfa 2b
zuranolone
Adverse Effects
Side effects of Difelikefalin :
1-10%
Diarrhea (9%)
Dizziness (6.8%)
Nausea (6.6%)
Gait disturbances (6.6%)
Hyperkalemia (4.7%)
Headache (4.5%)
Somnolence (4.2%)
Mental status change (3.3%)
Mechanism of Action
Kappa opioid receptor (KOR) agonist
Relevance of KOR activation to therapeutic effectiveness is unknown
Note
Defalix 65mcg/1.3ml IV Injection manufactured by Eskayef Pharmaceuticals Ltd.. Its generic name is Difelikefalin. Defalix is availble in Bangladesh.
Farmaco BD drug index information on Defalix IV Injection is not intended for diagnosis, medical advice or treatment; neither intended to be a substitute for the exercise of professional judgment.