Krystexxa

Krystexxa

Krystexxa Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Krystexxa (pegloticase) Injection for Intravenous Infusion is an enzyme that metabolizes uric acid into a harmless chemical that is eliminated from the body in urine and is used to treat chronic gout. It is usually given after other gout medications have been tried without successful treatment of symptoms. Common side effects include nausea, vomiting, sore throat, or runny nose.

The recommended dose and regimen of Krystexxa for adult patients is 8 mg (uricase protein) given as an intravenous infusion every two weeks. Krystexxa may interact with other drugs. Tell your doctor all medications and supplements you use. During pregnancy, Krystexxa should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Krystexxa (pegloticase) Injection, for Intravenous Infusion 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.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Krystexxa in Detail - Patient Information: Side Effects

Some people receiving a pegloticase injection have had a reaction to the infusion (when the medicine is injected into the vein). Infusion reactions may also occur after the injection is given. Tell your caregiver right away if you feel itchy, nervous, light-headed, short of breath, or have a fast heartbeat, chest discomfort, or redness of your skin during the injection.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; wheezing, difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • chest pain; or
  • flushing (warmth, redness, or tingly feeling).

Less serious side effects may include:

  • new gout flares;
  • nausea, vomiting, constipation;
  • easy bruising; or
  • stuffy nose, sore throat.

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.

Read the entire detailed patient monograph for Krystexxa (Pegloticase Injection) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Krystexxa Overview - Patient Information: Side Effects

SIDE EFFECTS: See also Warning section.

Nausea, vomiting, sore throat, or runny nose may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Krystexxa (Pegloticase Injection)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Krystexxa FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

The most commonly reported serious adverse reactions from pre-marketing controlled clinical trials were anaphylaxis, which occurred at a frequency of 6.5% in patients treated with KRYSTEXXA (pegloticase injection) 8 mg every 2 weeks, compared to none with placebo; infusion reactions, which occurred at a frequency of 26% in patients treated with KRYSTEXXA (pegloticase injection) 8 mg every 2 weeks, compared to 5% treated with placebo; and gout flares, which were more common during the first 3 months of treatment with KRYSTEXXA (pegloticase injection) compared with placebo. All patients in pre-marketing controlled clinical trials were pre-treated with an oral antihistamine, intravenous corticosteroid and/or acetaminophen to prevent anaphylaxis and infusion reaction. Patients also received non-steroidal anti-inflammatory drugs or colchicine, or both, for at least 7 days as gout flare prophylaxis before beginning KRYSTEXXA treatment, [see Boxed Warning, WARNINGS AND PRECAUTIONS]

Clinical Trials Experience

The data described below reflect exposure to KRYSTEXXA (pegloticase injection) in patients with chronic gout refractory to conventional therapy in two replicate randomized, placebo-controlled, double-blind 6-month clinical trials: 85 patients were treated with KRYSTEXXA (pegloticase injection) 8 mg every 2 weeks; 84 patients were treated with KRYSTEXXA (pegloticase injection) 8 mg every 4 weeks; and 43 patients were treated with placebo. These patients were between the ages of 23 and 89 years (average 55 years); 173 patients were male and 39 were female; and 143 patients were White/Caucasian, 27 were Black/African American, 24 were Hispanic/Latino and 18 were all other ethnicities. Common co-morbid conditions among the enrolled patients included hypertension (72%), dyslipidemia (49%), chronic kidney disease (28%), diabetes (24%), coronary artery disease (18%) arrhythmia(16%) and cardiac failure/left ventrieute dysfunction (12%).

Because clinical studies are conducted under widely varying and controlled conditions, adverse reaction rates observed in clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug, and may not predict the rates observed in a broader patient population in clinical practice.

Anaphylaxis

Diagnostic criteria of anaphylaxis were skin or mucosal tissue involvement, and, either airway compromise, and/or reduced blood pressure with or without associated symptoms, and a temporal relationship to KRYSTEXXA (pegloticase injection) or placebo injection with no other identifiable cause. Using these clinical criteria, anaphylaxis was identified in 14 (5.1%) of 273 total patients studied in the clinical program of IV KRYSTEXXA (pegloticase injection) . The frequency was 6.5% for the every 2-week dosing regimen (8 of 123 patients), and 4.8% for the 4-week dosing frequency (6 of 126) of KRYSTEXXA (pegloticase injection) . There were no cases of anaphylaxis in patients receiving placebo. Anaphylaxis generally occurred within 2 hours after treatment. This occurred with patients being pre-treated with an oral antihistamine, intravenous corticosteroid, and acetaminophen, [see Boxed Warning, WARNINGS AND PRECAUTIONS]

Infusion Reactions

Infusion reactions occurred in 26% of patients in the 2 week dosing regimen group and 41% of patients in the 4 week dosing regimen group^ compared to 5% of placebo-treated patients. Manifestations of these reactions included urticaria (frequency of 10.6%), dyspnea (frequency of 7.1%), chest discomfort (frequency of 9.5%), chest pain (frequency of 9.5%), erythema (frequency of 9.5%), and pruritus (frequency of 9.5%). These manifestations overlap with the symptoms of anaphylaxis, but in a given patient did not occur together to satisfy the clinical criteria for diagnosing anaphylaxis. Infusion reactions are thought to result from release of various mediators, such as cytokines. Infusion reactions occurred at any time during a course of treatment with approximately 3% occurring with the first infusion^ and approximately 91% occurred during the time of infusion. Some infusion reaction manifestations were reduced with slowing the rate of infusion, or stopping the infusion and restarting the infusion at a slower rate. These infusion reactions occurred with all patients being pre-treated with an oral antihistamine, intravenous corticosteroid and acetaminophen. [see Boxed Warning, WARNINGS AND PRECAUTIONS]

Gout Flares

Gout flares were common in the study patients before randomization to treatment, with patients experiencing an average of 10 flares in the preceding 18 months prior to study entry. During the controlled treatment period with KRYSTEXXA (pegloticase injection) or placebo, the frequencies of gout flares were high in all treatment groups, but more so with KRYSTEXXA (pegloticase injection) treatment during the first 3 months of treatment, which seemed to decrease in the subsequent 3 months of treatment. The percentages of patients with any flare for the first 3 months were 74%, 81 %, and 51 %, for KRYSTEXXA (pegloticase injection) 8 mg every 2 weeks, KRYSTEXXA (pegloticase injection) 8 mg every 4 weeks, and placebo, respectively. The percentages of patients with any flare for the subsequent 3 months were 41%, 57% and 67%, for KRYSTEXXA (pegloticase injection) 8 mg every 2 weeks, KRYSTEXXA (pegloticase injection) 8 mg every 4 weeks, and placebo, respectively. Patients received gout flare prophylaxis with colchicine and/or nonsteroidal anti-inflammatory drugs (NS AIDs) starting at least one week before receiving KRYSTEXXA. [see WARNINGS AND PRECAUTIONS]

Congestive Heart Failure

Two cases of congestive heart failure exacerbation occurred during the trials in patients receiving treatment with KRYSTEXXA (pegloticase injection) 8 mg every 2 weeks. No cases were reported in placebo-treated patients. Four subjects had exacerbations of pre-existing congestive heart failure while receiving KRYSTEXXA (pegloticase injection) 8 mg every 2 weeks during the open-label extension study, [see WARNINGS AND PRECAUTIONS].

Other Adverse Reactions

The most commonly reported adverse reactions that occurred in greater than or equal to 5% of patients treated with KRYSTEXXA (pegloticase injection) 8mg every 2 weeks are provided in Table I.

Table 1. Adverse Reactions Occurring in 5% or More of Patients Treated with KRYSTEXXA (pegloticase injection) Compared to Placebo

Adverse Reaction
(Preferred Term)
KRYSTEXXA (pegloticase injection)
8 mg every 2 weeks
(N-85)
Na (%)
Placebo
(N=43)
N (%)
Gout flare 65(77%) . 35 (81%)
Infusion reaction 22 (26%) 2(5%)
Nausea 10(12%) 1 (2%)
Contusionb or Ecchymosisb 9(11%) 2 (5%)
Nasopharyngitis 6(7%). 1(2%)
Constipation 5 (6%) 2 (5%)
Chest Pain 5(6%) 1 (2%)
Anaphylaxis 4 (5%) 0 (0%)
Vomiting 4 (5%) 1 (2%)
a If the same subject in a given group had more than one occurrence in the same preferred term event category, the subject was counted only once.
b Most did not occur on the day of infusion and could be related to other factors (e.g. concomitant medications relevant to contusion or ecchymosis, insulin dependent diabetes mellitus).

Immunogenicity

Anti-pegloticase antibodies developed in 92% of patients treated with KRYSTEXXA (pegloticase injection) every 2 weeks, and 28% for placebo. Anti-PEG antibodies were also detected in 42% of patients treated with KRYSTEXXA. High anti-pegloticase antibody titer was associated with a failure to maintain pegloticase-induced normalization of uric acid. The impact of anti-PEG antibodies on patients' responses to other PEG-containing therapeutics is unknown.

There was a higher incidence of infusion reactions in patients with high anti-pegloticase antibody titer: 53% (16 of 30) in the KRYSTEXXA (pegloticase injection) every 2 weeks group compared to 6% in patients who had undetectable or low antibody titers.

As with all therapeutic proteins, there is a potential for immunogenicity. The observed incidence of antibody positivity in an assay is highly dependent on several factors including assay sensitivity and specificity and assay methodology, sample handling, timing of sample collection, concomitant medications, and underlying disease. For these reasons, the comparison of the incidence of antibodies to pegloticase with the incidence of antibodies to other products may be misleading.

Read the entire FDA prescribing information for Krystexxa (Pegloticase Injection) »

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Krystexxa - User Reviews

Krystexxa User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Krystexxa sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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