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KORSUVA has convenient administration

  • Recommended dosage is 0.5 mcg/kg based on patient dry body weight
  • Administer KORSUVA by intravenous bolus injection into the venous line of the dialysis circuit at the end of each hemodialysis session
  • KORSUVA may be given either during or after rinse back of the dialysis circuit
  • KORSUVA can be administered up to 60 minutes after syringe preparation
  • KORSUVA is removed by the dialyzer membrane and must be administered after blood is no longer circulating through the dialyzer
  • If the dose is given after rinse back, administer KORSUVA into the venous line followed by at least 10 mL of normal saline flush

KORSUVA DOSING SCHEDULE

dosing

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  • If a regularly scheduled hemodialysis treatment is missed, resume KORSUVA at the end of the next treatment

KORSUVA DOSING

KORSUVA injection volumes based on target dry body weight
Target dry body weight range (kg) Injection volume (mL)*
36–44 0.4
45–54 0.5
55–64 0.6
65–74 0.7
75–84 0.8
85–94 0.9
95–104 1.0
105–114 1.1
115–124 1.2
125–134 1.3
135–144 1.4
145–154 1.5
155–164 1.6
165–174 1.7
175–184 1.8
185–194 1.9
195–204 2.0

*Total injection volume (mL) = patient target dry body weight (kg) x 0.01, rounded to the nearest tenth
(0.1 mL). For patient target dry body weight outside of the ranges in this table, use this formula.

STORING AND PREPARING KORSUVA

  • KORSUVA can be stored at room temperature
  • Do not mix or dilute KORSUVA prior to administration
  • KORSUVA is supplied in a single-dose vial. Discard any unused product
INDICATION

KORSUVA is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).

Limitation of Use: KORSUVA has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances: These adverse reactions, including falls, have occurred in patients taking KORSUVA and may subside 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 KORSUVA.

Risk of Driving and Operating Machinery: Dizziness, somnolence, and mental status changes have occurred in patients taking KORSUVA. KORSUVA 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 KORSUVA on their ability to do so is known.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥2% and ≥1% higher than placebo) were diarrhea (9.0%), dizziness (6.8%), nausea (6.6%), gait disturbances, including falls (6.6%), hyperkalemia (4.7%), headache (4.5%), somnolence (4.2%), and mental status changes (3.3%).

USE IN SPECIFIC POPULATIONS

Severe Hepatic Impairment: The influence of severe hepatic impairment on the pharmacokinetics of KORSUVA in subjects undergoing hemodialysis (HD) has not been evaluated; therefore, use of KORSUVA in this population is not recommended.

Geriatric Use: The incidence of somnolence was higher in KORSUVA-treated subjects aged 65 years and older (7.0%) than in KORSUVA-treated subjects less than 65 years of age (2.8%). The incidence was comparable in both placebo age groups (3.0% and 2.1%, respectively) (see Warnings and Precautions).

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INDICATION

KORSUVA is indicated for the treatment of moderate-to-severe pruritus associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).

Limitation of Use: KORSUVA has not been studied in patients on peritoneal dialysis and is not recommended for use in this population.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances: These adverse reactions, including falls, have occurred in patients taking KORSUVA and may subside with continued treatment. The incidence of somnolence was higher in KORSUVA-treated subjects 65 years of age and older (7.0%) than in KORSUVA-treated subjects less than 65 years of age (2.8%). 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 KORSUVA.

Risk of Driving and Operating Machinery: Dizziness, somnolence, and mental status changes have occurred in patients taking KORSUVA. KORSUVA 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 KORSUVA on their ability to do so is known.

ADVERSE REACTIONS

The most common adverse reactions (incidence ≥2% and ≥1% higher than placebo) were diarrhea (9.0%), dizziness (6.8%), nausea (6.6%), gait disturbances, including falls (6.6%), hyperkalemia (4.7%), headache (4.5%), somnolence (4.2%), and mental status changes (3.3%).

USE IN SPECIFIC POPULATIONS

Severe Hepatic Impairment: The influence of severe hepatic impairment on the pharmacokinetics of KORSUVA in subjects undergoing hemodialysis (HD) has not been evaluated; therefore, use of KORSUVA in this population is not recommended.

Geriatric Use: The incidence of somnolence was higher in KORSUVA-treated subjects aged
65 years and older (7.0%) than in KORSUVA-treated subjects less than 65 years of age (2.8%). The incidence was comparable in both placebo age groups (3.0% and 2.1%, respectively) (see Warnings and Precautions).