Korsuva

Medical Editor: John P. Cunha, DO, FACOEP Last updated on RxList: 9/7/2021
Korsuva Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

What Is Korsuva?

Korsuva (difelikefalin) is a kappa opioid receptor agonist used to treat moderate-to-severe itching (pruritus) associated with chronic kidney disease (CKD-aP) in adults undergoing hemodialysis (HD).

What Are Side Effects of Korsuva?

Side effects of Korsuva include:

  • diarrhea,
  • dizziness,
  • nausea,
  • gait disturbances, including falls,
  • high blood potassium (hyperkalemia),
  • headache,
  • drowsiness, and
  • change in mental status.

Dosage for Korsuva

The recommended dosage of KORSUVA is 0.5 mcg/kg administered by intravenous bolus injection into the venous line of the dialysis circuit at the end of each HD treatment [see DOSAGE AND ADMINISTRATION].

If a regularly scheduled HD treatment is missed, resume KORSUVA at the end of the next HD treatment.

Korsuva In Children

The safety and effectiveness of Korsuva in pediatric patients have not been established.

What Drugs, Substances, or Supplements Interact with Korsuva?
 

Korsuva may interact with other medicines.

Tell your doctor all medications and supplements you use.


Korsuva During Pregnancy and Breastfeeding

Tell your doctor if you are pregnant or plan to become pregnant before using Korsuva; it is unknown how it could affect a fetus. It is unknown if Korsuva passes into breast milk. Consult your doctor before breastfeeding.

Additional Information

Our Korsuva (difelikefalin) Injection, for Intravenous Use Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

QUESTION

The only purpose of the kidneys is to filter blood. See Answer
Korsuva Professional Information

SIDE EFFECTS

The following clinically significant adverse reactions are described elsewhere in the labeling:

  • Dizziness, Somnolence, Mental Status Changes, and Gait Disturbances [see WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 1306 subjects undergoing HD who had moderate-to-severe pruritus were treated with KORSUVA in placebo-controlled and uncontrolled Phase 3 clinical trials. Of these, 711 were treated for at least 6 months and 400 were treated for at least one year.

Two placebo-controlled Phase 3 trials (Trial 1 and Trial 2), in subjects undergoing HD who had moderate-tosevere pruritus were pooled to evaluate the safety of KORSUVA in comparison to placebo up to 12 weeks. In total, 848 subjects were evaluated (424 in KORSUVA group and 424 in placebo group). The mean age of the subjects was 59 years (range 22 to 88 years), and 59% of the subjects were male. Of the total subjects, 61% were White, 29% were Black or African American, and 5% were Asian.

Table 2 summarizes the adverse reactions that occurred at a rate of ≥2% in the KORSUVA group and ≥1% higher than that of the placebo group during the 12-week placebo-controlled period of Trials 1 and 2. The percentage of subjects who discontinued treatment due to any adverse reaction was 2.6% for subjects taking KORSUVA and 0.7% for subjects taking placebo. The most common adverse reactions (≥0.5% of subjects) leading to discontinuation were dizziness (0.9% for KORSUVA and 0.2% for placebo), mental status change (0.7% and 0.2%, respectively), nausea (0.5% and 0%, respectively), and headache (0.5% and 0%, respectively). The percentage of subjects who developed serious adverse reactions was 4.5% in the KORSUVA group and 2.8% in the placebo group.

Table 2: Adverse Reactions in ≥ 2% of KORSUVA-Treated Subjects with Moderate-to-Severe CKD-aP Undergoing HD and ≥ 1% Higher Than Placebo in Trials 1 and 2

Adverse Reactions Placebo
(N=424)
n (%)
KORSUVA
(N=424)
n (%)
Diarrhea 24 (5.7) 38 (9.0)
Dizziness 16 (3.8) 29 (6.8)
Nausea 19 (4.5) 28 (6.6)
Gait Disturbancesa 23 (5.4) 28 (6.6)
Hyperkalemia 15 (3.5) 20 (4.7)
Headache 11 (2.6) 19 (4.5)
Somnolence 10 (2.4) 18 (4.2)
Mental Status Changeb 6 (1.4) 14 (3.3)
a Gait disturbances includes: preferred terms of falls and gait disturbances
b Mental Status Change includes: preferred terms of confusional state and mental status change.

Description Of Selected Adverse Reactions

Gait Disturbances, Including Falls

Gait disturbances, including falls, were reported in 6.6% of subjects receiving KORSUVA compared to 5.4% of subjects who received placebo. Falls were reported as serious adverse reactions in < 1% of subjects receiving KORSUVA and placebo, with one subject discontinuing KORSUVA due to gait disturbance.

Dizziness

Dizziness was reported in 6.8% of subjects randomized to KORSUVA compared to 3.8% of subjects who received placebo. Dizziness occurred within the first 3 weeks of treatment and was generally transient.

Dizziness was serious in 0.2% of KORSUVA-treated subjects compared to 0% of subjects who received placebo and led to discontinuation in 0.9% of KORSUVA-treated subjects compared to 0.2% of subjects who received placebo.

Somnolence

Somnolence was reported in 4.2% of subjects randomized to receive KORSUVA compared to 2.4% of subjects who received placebo. Somnolence occurred within the first 3 weeks of treatment and tended to subside with continued dosing. Somnolence was serious in 0.2% of KORSUVA-treated subjects compared to 0% of subjects who received placebo. There were no subjects who discontinued KORSUVA due to an adverse reaction of somnolence.

Mental Status Change

Mental status change (including confusional state) was reported in 3.3% of subjects randomized to receive KORSUVA compared to 1.4% of subjects who received placebo. Most events tended to subside with continued dosing. Mental status change adverse reactions were serious in 1.4% of KORSUVA-treated subjects compared to 0.5% of subjects who received placebo and led to discontinuation in 0.7% of KORSUVA-treated subjects compared to 0.2% of subjects who received placebo.

Hyperkalemia

Hyperkalemia was found in 4.7% of subjects who received KORSUVA compared to 3.5% of subjects who received placebo. The incidence of hyperkalemia was higher in subjects who took concomitant opioids regardless of treatment and was almost doubled in the KORSUVA group (11.7%) compared to the placebo group (6.2%). The clinical relevance of this is unknown.

DRUG INTERACTIONS

No Information provided

Read the entire FDA prescribing information for Korsuva (Difelikefalin Injection)

SLIDESHOW

Kidney Stones: Symptoms, Causes, and Treatment See Slideshow

© Korsuva Patient Information is supplied by Cerner Multum, Inc. and Korsuva Consumer information is supplied by First Databank, Inc., used under license and subject to their respective copyrights.

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