difelikefalin (Rx)

Brand and Other Names:Korsuva

Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

injectable solution

  • 65mcg/1.3mL

Pruritus

Indicated for moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis (HD)

0.5 mcg/kg IV push into venous line of dialysis circuit at the end of each HD treatment

Dosage Modifications

Hepatic impairment

  • Mild-to-moderate: No dosage adjustment needed
  • Severe: Pharmacokinetics not evaluated; use not recommended

Dosing Considerations

Limitation of use

  • Not studied in patients on peritoneal dialysis; use not recommended

Safety and efficacy not established

Next:

Interactions

Interaction Checker

and difelikefalin

No Results

     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            All Interactions Sort By:
             activity indicator 

            Contraindicated (0)

              Serious - Use Alternative (2)

              • olopatadine intranasal

                difelikefalin and olopatadine intranasal both increase sedation. Avoid or Use Alternate Drug. Coadministration increases risk of CNS depression, which can lead to additive impairment of psychomotor performance and cause daytime impairment.

              • ropeginterferon alfa 2b

                ropeginterferon alfa 2b and difelikefalin both increase Other (see comment). Avoid or Use Alternate Drug. Narcotics, hypnotics or sedatives can produce additive neuropsychiatric side effects. Avoid use and monitor patients receiving the combination for effects of excessive CNS toxicity.

              Monitor Closely (219)

              • acetazolamide

                difelikefalin and acetazolamide both increase sedation. Use Caution/Monitor.

              • alfentanil

                difelikefalin and alfentanil both increase sedation. Use Caution/Monitor.

              • alprazolam

                difelikefalin and alprazolam both increase sedation. Use Caution/Monitor.

              • amantadine

                difelikefalin and amantadine both increase sedation. Use Caution/Monitor.

              • amitriptyline

                difelikefalin and amitriptyline both increase sedation. Use Caution/Monitor.

              • amobarbital

                difelikefalin and amobarbital both increase sedation. Use Caution/Monitor.

              • amoxapine

                difelikefalin and amoxapine both increase sedation. Use Caution/Monitor.

              • apomorphine

                difelikefalin and apomorphine both increase sedation. Use Caution/Monitor.

              • arbaclofen

                difelikefalin and arbaclofen both increase sedation. Use Caution/Monitor.

              • aripiprazole

                difelikefalin and aripiprazole both increase sedation. Use Caution/Monitor.

              • asenapine

                difelikefalin and asenapine both increase sedation. Use Caution/Monitor.

              • asenapine transdermal

                difelikefalin and asenapine transdermal both increase sedation. Use Caution/Monitor.

              • baclofen

                difelikefalin and baclofen both increase sedation. Use Caution/Monitor.

              • belladonna and opium

                difelikefalin and belladonna and opium both increase sedation. Use Caution/Monitor.

              • benzhydrocodone/acetaminophen

                difelikefalin and benzhydrocodone/acetaminophen both increase sedation. Use Caution/Monitor.

              • brexanolone

                difelikefalin and brexanolone both increase sedation. Use Caution/Monitor.

              • brexpiprazole

                difelikefalin and brexpiprazole both increase sedation. Use Caution/Monitor.

              • bromocriptine

                difelikefalin and bromocriptine both increase sedation. Use Caution/Monitor.

              • brompheniramine

                difelikefalin and brompheniramine both increase sedation. Use Caution/Monitor.

              • buprenorphine

                difelikefalin and buprenorphine both increase sedation. Use Caution/Monitor.

              • buprenorphine transdermal

                difelikefalin and buprenorphine transdermal both increase sedation. Use Caution/Monitor.

              • bupropion

                difelikefalin and bupropion both increase sedation. Use Caution/Monitor.

              • buspirone

                difelikefalin and buspirone both increase sedation. Use Caution/Monitor.

              • butabarbital

                difelikefalin and butabarbital both increase sedation. Use Caution/Monitor.

              • butalbital

                difelikefalin and butalbital both increase sedation. Use Caution/Monitor.

              • butorphanol

                difelikefalin and butorphanol both increase sedation. Use Caution/Monitor.

              • carbamazepine

                difelikefalin and carbamazepine both increase sedation. Use Caution/Monitor.

              • carbinoxamine

                difelikefalin and carbinoxamine both increase sedation. Use Caution/Monitor.

              • cariprazine

                difelikefalin and cariprazine both increase sedation. Use Caution/Monitor.

              • carisoprodol

                difelikefalin and carisoprodol both increase sedation. Use Caution/Monitor.

              • cenobamate

                difelikefalin and cenobamate both increase sedation. Use Caution/Monitor.

              • chloral hydrate

                difelikefalin and chloral hydrate both increase sedation. Use Caution/Monitor.

              • chlordiazepoxide

                difelikefalin and chlordiazepoxide both increase sedation. Use Caution/Monitor.

              • chlorpheniramine

                difelikefalin and chlorpheniramine both increase sedation. Use Caution/Monitor.

              • chlorpromazine

                difelikefalin and chlorpromazine both increase sedation. Use Caution/Monitor.

              • chlorzoxazone

                difelikefalin and chlorzoxazone both increase sedation. Use Caution/Monitor.

              • citalopram

                difelikefalin and citalopram both increase sedation. Use Caution/Monitor.

              • clemastine

                difelikefalin and clemastine both increase sedation. Use Caution/Monitor.

              • clobazam

                difelikefalin and clobazam both increase sedation. Use Caution/Monitor.

              • clomipramine

                difelikefalin and clomipramine both increase sedation. Use Caution/Monitor.

              • clonazepam

                difelikefalin and clonazepam both increase sedation. Use Caution/Monitor.

              • clonidine

                difelikefalin and clonidine both increase sedation. Use Caution/Monitor.

              • clorazepate

                difelikefalin and clorazepate both increase sedation. Use Caution/Monitor.

              • clozapine

                difelikefalin and clozapine both increase sedation. Use Caution/Monitor.

              • codeine

                difelikefalin and codeine both increase sedation. Use Caution/Monitor.

              • cyclobenzaprine

                difelikefalin and cyclobenzaprine both increase sedation. Use Caution/Monitor.

              • cyproheptadine

                difelikefalin and cyproheptadine both increase sedation. Use Caution/Monitor.

              • dantrolene

                difelikefalin and dantrolene both increase sedation. Use Caution/Monitor.

              • daridorexant

                difelikefalin and daridorexant both increase sedation. Modify Therapy/Monitor Closely. Coadministration increases risk of CNS depression, which can lead to additive impairment of psychomotor performance and cause daytime impairment.

              • desflurane

                difelikefalin and desflurane both increase sedation. Use Caution/Monitor.

              • desipramine

                difelikefalin and desipramine both increase sedation. Use Caution/Monitor.

              • desvenlafaxine

                difelikefalin and desvenlafaxine both increase sedation. Use Caution/Monitor.

              • deutetrabenazine

                difelikefalin and deutetrabenazine both increase sedation. Use Caution/Monitor.

              • dexchlorpheniramine

                difelikefalin and dexchlorpheniramine both increase sedation. Use Caution/Monitor.

              • dexmedetomidine

                difelikefalin and dexmedetomidine both increase sedation. Use Caution/Monitor.

              • diazepam

                difelikefalin and diazepam both increase sedation. Use Caution/Monitor.

              • diazepam buccal

                difelikefalin and diazepam buccal both increase sedation. Use Caution/Monitor.

              • diazepam intranasal

                difelikefalin and diazepam intranasal both increase sedation. Use Caution/Monitor.

              • dichloralphenazone

                difelikefalin and dichloralphenazone both increase sedation. Use Caution/Monitor.

              • dichlorphenamide

                difelikefalin and dichlorphenamide both increase sedation. Use Caution/Monitor.

              • difenoxin hcl

                difelikefalin and difenoxin hcl both increase sedation. Use Caution/Monitor.

              • dimenhydrinate

                difelikefalin and dimenhydrinate both increase sedation. Use Caution/Monitor.

              • diphenhydramine

                difelikefalin and diphenhydramine both increase sedation. Use Caution/Monitor.

              • diphenoxylate hcl

                difelikefalin and diphenoxylate hcl both increase sedation. Use Caution/Monitor.

              • divalproex sodium

                difelikefalin and divalproex sodium both increase sedation. Use Caution/Monitor.

              • doxepin

                difelikefalin and doxepin both increase sedation. Use Caution/Monitor.

              • doxylamine

                difelikefalin and doxylamine both increase sedation. Use Caution/Monitor.

              • dronabinol

                difelikefalin and dronabinol both increase sedation. Use Caution/Monitor.

              • droperidol

                difelikefalin and droperidol both increase sedation. Use Caution/Monitor.

              • duloxetine

                difelikefalin and duloxetine both increase sedation. Use Caution/Monitor.

              • efavirenz

                difelikefalin and efavirenz both increase sedation. Use Caution/Monitor.

              • entacapone

                difelikefalin and entacapone both increase sedation. Use Caution/Monitor.

              • escitalopram

                difelikefalin and escitalopram both increase sedation. Use Caution/Monitor.

              • esketamine intranasal

                difelikefalin and esketamine intranasal both increase sedation. Use Caution/Monitor.

              • eslicarbazepine acetate

                difelikefalin and eslicarbazepine acetate both increase sedation. Use Caution/Monitor.

              • estazolam

                difelikefalin and estazolam both increase sedation. Use Caution/Monitor.

              • eszopiclone

                difelikefalin and eszopiclone both increase sedation. Use Caution/Monitor.

              • ethosuximide

                difelikefalin and ethosuximide both increase sedation. Use Caution/Monitor.

              • ethotoin

                difelikefalin and ethotoin both increase sedation. Use Caution/Monitor.

              • etomidate

                difelikefalin and etomidate both increase sedation. Use Caution/Monitor.

              • felbamate

                difelikefalin and felbamate both increase sedation. Use Caution/Monitor.

              • fenfluramine

                difelikefalin and fenfluramine both increase sedation. Use Caution/Monitor.

              • fentanyl

                difelikefalin and fentanyl both increase sedation. Use Caution/Monitor.

              • fentanyl intranasal

                difelikefalin and fentanyl intranasal both increase sedation. Use Caution/Monitor.

              • fentanyl iontophoretic transdermal system

                difelikefalin and fentanyl iontophoretic transdermal system both increase sedation. Use Caution/Monitor.

              • fentanyl transdermal

                difelikefalin and fentanyl transdermal both increase sedation. Use Caution/Monitor.

              • fentanyl transmucosal

                difelikefalin and fentanyl transmucosal both increase sedation. Use Caution/Monitor.

              • flibanserin

                difelikefalin and flibanserin both increase sedation. Use Caution/Monitor.

              • fluoxetine

                difelikefalin and fluoxetine both increase sedation. Use Caution/Monitor.

              • fluphenazine

                difelikefalin and fluphenazine both increase sedation. Use Caution/Monitor.

              • flurazepam

                difelikefalin and flurazepam both increase sedation. Use Caution/Monitor.

              • fluvoxamine

                difelikefalin and fluvoxamine both increase sedation. Use Caution/Monitor.

              • fosphenytoin

                difelikefalin and fosphenytoin both increase sedation. Use Caution/Monitor.

              • gabapentin

                difelikefalin and gabapentin both increase sedation. Use Caution/Monitor.

              • gabapentin enacarbil

                difelikefalin and gabapentin enacarbil both increase sedation. Use Caution/Monitor.

              • gepirone

                difelikefalin and gepirone both increase sedation. Use Caution/Monitor.

              • guanabenz

                difelikefalin and guanabenz both increase sedation. Use Caution/Monitor.

              • guanfacine

                difelikefalin and guanfacine both increase sedation. Use Caution/Monitor.

              • haloperidol

                difelikefalin and haloperidol both increase sedation. Use Caution/Monitor.

              • hydrocodone

                difelikefalin and hydrocodone both increase sedation. Use Caution/Monitor.

              • hydromorphone

                difelikefalin and hydromorphone both increase sedation. Use Caution/Monitor.

              • hydroxyzine

                difelikefalin and hydroxyzine both increase sedation. Use Caution/Monitor.

              • iloperidone

                difelikefalin and iloperidone both increase sedation. Use Caution/Monitor.

              • imipramine

                difelikefalin and imipramine both increase sedation. Use Caution/Monitor.

              • isoflurane

                difelikefalin and isoflurane both increase sedation. Use Caution/Monitor.

              • ketamine

                difelikefalin and ketamine both increase sedation. Use Caution/Monitor.

              • lacosamide

                difelikefalin and lacosamide both increase sedation. Use Caution/Monitor.

              • lamotrigine

                difelikefalin and lamotrigine both increase sedation. Use Caution/Monitor.

              • levodopa

                difelikefalin and levodopa both increase sedation. Use Caution/Monitor.

              • levorphanol

                difelikefalin and levorphanol both increase sedation. Use Caution/Monitor.

              • lithium

                difelikefalin and lithium both increase sedation. Use Caution/Monitor.

              • lorazepam

                difelikefalin and lorazepam both increase sedation. Use Caution/Monitor.

              • loxapine

                difelikefalin and loxapine both increase sedation. Use Caution/Monitor.

              • loxapine inhaled

                difelikefalin and loxapine inhaled both increase sedation. Use Caution/Monitor.

              • loxicodegol

                difelikefalin and loxicodegol both increase sedation. Use Caution/Monitor.

              • lumateperone

                difelikefalin and lumateperone both increase sedation. Use Caution/Monitor.

              • lurasidone

                difelikefalin and lurasidone both increase sedation. Use Caution/Monitor.

              • maprotiline

                difelikefalin and maprotiline both increase sedation. Use Caution/Monitor.

              • meclizine

                difelikefalin and meclizine both increase sedation. Use Caution/Monitor.

              • meperidine

                difelikefalin and meperidine both increase sedation. Use Caution/Monitor.

              • mephobarbital

                difelikefalin and mephobarbital both increase sedation. Use Caution/Monitor.

              • meprobamate

                difelikefalin and meprobamate both increase sedation. Use Caution/Monitor.

              • metaxalone

                difelikefalin and metaxalone both increase sedation. Use Caution/Monitor.

              • methadone

                difelikefalin and methadone both increase sedation. Use Caution/Monitor.

              • methocarbamol

                difelikefalin and methocarbamol both increase sedation. Use Caution/Monitor.

              • methohexital

                difelikefalin and methohexital both increase sedation. Use Caution/Monitor.

              • methsuximide

                difelikefalin and methsuximide both increase sedation. Use Caution/Monitor.

              • methyldopa

                difelikefalin and methyldopa both increase sedation. Use Caution/Monitor.

              • metyrosine

                difelikefalin and metyrosine both increase sedation. Use Caution/Monitor.

              • midazolam

                difelikefalin and midazolam both increase sedation. Use Caution/Monitor.

              • midazolam intranasal

                difelikefalin and midazolam intranasal both increase sedation. Use Caution/Monitor.

              • mirtazapine

                difelikefalin and mirtazapine both increase sedation. Use Caution/Monitor.

              • molindone

                difelikefalin and molindone both increase sedation. Use Caution/Monitor.

              • morphine

                difelikefalin and morphine both increase sedation. Use Caution/Monitor.

              • nabilone

                difelikefalin and nabilone both increase sedation. Use Caution/Monitor.

              • nalbuphine

                difelikefalin and nalbuphine both increase sedation. Use Caution/Monitor.

              • nefazodone

                difelikefalin and nefazodone both increase sedation. Use Caution/Monitor.

              • nitrous oxide

                difelikefalin and nitrous oxide both increase sedation. Use Caution/Monitor.

              • nortriptyline

                difelikefalin and nortriptyline both increase sedation. Use Caution/Monitor.

              • olanzapine

                difelikefalin and olanzapine both increase sedation. Use Caution/Monitor.

              • oliceridine

                difelikefalin and oliceridine both increase sedation. Use Caution/Monitor.

              • opium tincture

                difelikefalin and opium tincture both increase sedation. Use Caution/Monitor.

              • orphenadrine

                difelikefalin and orphenadrine both increase sedation. Use Caution/Monitor.

              • oxazepam

                difelikefalin and oxazepam both increase sedation. Use Caution/Monitor.

              • oxcarbazepine

                difelikefalin and oxcarbazepine both increase sedation. Use Caution/Monitor.

              • oxybutynin

                difelikefalin and oxybutynin both increase sedation. Use Caution/Monitor.

              • oxycodone

                difelikefalin and oxycodone both increase sedation. Use Caution/Monitor.

              • oxymorphone

                difelikefalin and oxymorphone both increase sedation. Use Caution/Monitor.

              • paliperidone

                difelikefalin and paliperidone both increase sedation. Use Caution/Monitor.

              • paregoric

                difelikefalin and paregoric both increase sedation. Use Caution/Monitor.

              • paroxetine

                difelikefalin and paroxetine both increase sedation. Use Caution/Monitor.

              • pentazocine

                difelikefalin and pentazocine both increase sedation. Use Caution/Monitor.

              • pentobarbital

                difelikefalin and pentobarbital both increase sedation. Use Caution/Monitor.

              • perampanel

                difelikefalin and perampanel both increase sedation. Use Caution/Monitor.

              • perphenazine

                difelikefalin and perphenazine both increase sedation. Use Caution/Monitor.

              • pheniramine

                difelikefalin and pheniramine both increase sedation. Use Caution/Monitor.

              • phenobarbital

                difelikefalin and phenobarbital both increase sedation. Use Caution/Monitor.

              • phenytoin

                difelikefalin and phenytoin both increase sedation. Use Caution/Monitor.

              • pimavanserin

                difelikefalin and pimavanserin both increase sedation. Use Caution/Monitor.

              • pimozide

                difelikefalin and pimozide both increase sedation. Use Caution/Monitor.

              • pramipexole

                difelikefalin and pramipexole both increase sedation. Use Caution/Monitor.

              • pregabalin

                difelikefalin and pregabalin both increase sedation. Use Caution/Monitor.

              • primidone

                difelikefalin and primidone both increase sedation. Use Caution/Monitor.

              • prochlorperazine

                difelikefalin and prochlorperazine both increase sedation. Use Caution/Monitor.

              • promethazine

                difelikefalin and promethazine both increase sedation. Use Caution/Monitor.

              • propofol

                difelikefalin and propofol both increase sedation. Use Caution/Monitor.

              • protriptyline

                difelikefalin and protriptyline both increase sedation. Use Caution/Monitor.

              • quazepam

                difelikefalin and quazepam both increase sedation. Use Caution/Monitor.

              • quetiapine

                difelikefalin and quetiapine both increase sedation. Use Caution/Monitor.

              • ramelteon

                difelikefalin and ramelteon both increase sedation. Use Caution/Monitor.

              • rasagiline

                difelikefalin and rasagiline both increase sedation. Use Caution/Monitor.

              • remifentanil

                difelikefalin and remifentanil both increase sedation. Use Caution/Monitor.

              • remimazolam

                difelikefalin and remimazolam both increase sedation. Use Caution/Monitor.

              • risperidone

                difelikefalin and risperidone both increase sedation. Use Caution/Monitor.

              • ropinirole

                difelikefalin and ropinirole both increase sedation. Use Caution/Monitor.

              • rotigotine

                difelikefalin and rotigotine both increase sedation. Use Caution/Monitor.

              • rufinamide

                difelikefalin and rufinamide both increase sedation. Use Caution/Monitor.

              • safinamide

                difelikefalin and safinamide both increase sedation. Use Caution/Monitor.

              • samidorphan

                difelikefalin and samidorphan both increase sedation. Use Caution/Monitor.

              • scopolamine

                difelikefalin and scopolamine both increase sedation. Use Caution/Monitor.

              • secobarbital

                difelikefalin and secobarbital both increase sedation. Use Caution/Monitor.

              • selegiline

                difelikefalin and selegiline both increase sedation. Use Caution/Monitor.

              • selegiline transdermal

                difelikefalin and selegiline transdermal both increase sedation. Use Caution/Monitor.

              • sertraline

                difelikefalin and sertraline both increase sedation. Use Caution/Monitor.

              • sevoflurane

                difelikefalin and sevoflurane both increase sedation. Use Caution/Monitor.

              • sodium oxybate

                difelikefalin and sodium oxybate both increase sedation. Use Caution/Monitor.

              • stiripentol

                difelikefalin and stiripentol both increase sedation. Use Caution/Monitor.

              • sufentanil

                difelikefalin and sufentanil both increase sedation. Use Caution/Monitor.

              • sufentanil SL

                difelikefalin and sufentanil SL both increase sedation. Use Caution/Monitor.

              • suvorexant

                difelikefalin and suvorexant both increase sedation. Use Caution/Monitor.

              • tapentadol

                difelikefalin and tapentadol both increase sedation. Use Caution/Monitor.

              • tasimelteon

                difelikefalin and tasimelteon both increase sedation. Use Caution/Monitor.

              • temazepam

                difelikefalin and temazepam both increase sedation. Use Caution/Monitor.

              • tetrabenazine

                difelikefalin and tetrabenazine both increase sedation. Use Caution/Monitor.

              • thalidomide

                difelikefalin and thalidomide both increase sedation. Use Caution/Monitor.

              • theophylline

                difelikefalin and theophylline both increase sedation. Use Caution/Monitor.

              • thioridazine

                difelikefalin and thioridazine both increase sedation. Use Caution/Monitor.

              • thiothixene

                difelikefalin and thiothixene both increase sedation. Use Caution/Monitor.

              • tiagabine

                difelikefalin and tiagabine both increase sedation. Use Caution/Monitor.

              • tizanidine

                difelikefalin and tizanidine both increase sedation. Use Caution/Monitor.

              • tolcapone

                difelikefalin and tolcapone both increase sedation. Use Caution/Monitor.

              • topiramate

                difelikefalin and topiramate both increase sedation. Use Caution/Monitor.

              • tramadol

                difelikefalin and tramadol both increase sedation. Use Caution/Monitor.

              • trazodone

                difelikefalin and trazodone both increase sedation. Use Caution/Monitor.

              • triazolam

                difelikefalin and triazolam both increase sedation. Use Caution/Monitor.

              • trifluoperazine

                difelikefalin and trifluoperazine both increase sedation. Use Caution/Monitor.

              • trimethobenzamide

                difelikefalin and trimethobenzamide both increase sedation. Use Caution/Monitor.

              • trimipramine

                difelikefalin and trimipramine both increase sedation. Use Caution/Monitor.

              • triprolidine

                difelikefalin and triprolidine both increase sedation. Use Caution/Monitor.

              • valerian

                difelikefalin and valerian both increase sedation. Use Caution/Monitor.

              • valproic acid

                difelikefalin and valproic acid both increase sedation. Use Caution/Monitor.

              • vigabatrin

                difelikefalin and vigabatrin both increase sedation. Use Caution/Monitor.

              • vilazodone

                difelikefalin and vilazodone both increase sedation. Use Caution/Monitor.

              • vortioxetine

                difelikefalin and vortioxetine both increase sedation. Use Caution/Monitor.

              • zaleplon

                difelikefalin and zaleplon both increase sedation. Use Caution/Monitor.

              • zileuton

                difelikefalin and zileuton both increase sedation. Use Caution/Monitor.

              • ziprasidone

                difelikefalin and ziprasidone both increase sedation. Use Caution/Monitor.

              • zolpidem

                difelikefalin and zolpidem both increase sedation. Use Caution/Monitor.

              • zonisamide

                difelikefalin and zonisamide both increase sedation. Use Caution/Monitor.

              Minor (0)

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                Adverse Effects

                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%)

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                Warnings

                Contraindications

                None

                Cautions

                Dizziness, somnolence, mental status changes, and gait disturbances (eg, falls) have occurred; may subside over time with continued treatment

                May impair mental or physical abilities; advise patients not to drive or operate dangerous machinery until effect on a patient’s ability to drive or operate machinery is known

                Drug interaction overview

                • Centrally acting depressant medications, sedating antihistamines, and opioid analgesics may increase the adverse reactions of difelikefalin; use with caution
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                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

                Pregnancy Categories

                A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

                B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

                C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

                D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

                X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

                NA: Information not available.

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                Pharmacology

                Mechanism of Action

                Kappa opioid receptor (KOR) agonist

                Relevance of KOR activation to therapeutic effectiveness is unknown

                Absorption

                Steady-state was reached after second dose

                Mean accumulation ratio: 1.6

                Distribution

                Vd: 238 mL/kg

                Protein bound: 23-28%

                Elimination

                Half-life (before dialysis): 23-31 hr

                Excretion: Urine (11%); feces (59%); dialysate fluid (20%)

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                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

                Storage

                Unopened vials

                • Store at 20-25ºC (68-77ºF); excursions permitted to 15-30ºC (59-86ºF)
                • Do not freeze

                Prepared syringe

                • Store at 20-25ºC (68-77ºF); discard after 60 minutes of syringe preparation
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                Images

                No images available for this drug.
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                Patient Handout

                A Patient Handout is not currently available for this monograph.
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                Formulary

                FormularyPatient Discounts

                Adding plans allows you to compare formulary status to other drugs in the same class.

                To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

                Adding plans allows you to:

                • View the formulary and any restrictions for each plan.
                • Manage and view all your plans together – even plans in different states.
                • Compare formulary status to other drugs in the same class.
                • Access your plan list on any device – mobile or desktop.

                The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

                Tier Description
                1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
                2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
                3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
                4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
                NC NOT COVERED – Drugs that are not covered by the plan.
                Code Definition
                PA Prior Authorization
                Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
                QL Quantity Limits
                Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
                ST Step Therapy
                Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
                OR Other Restrictions
                Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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                Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.