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Drug overview for KRYSTEXXA (pegloticase):
Generic name: PEGLOTICASE (peg-LOE-ti-kase)
Drug class: Hyperuricemia Agents (non-uricosuric)
Therapeutic class: Gout and Hyperuricemia Therapy
Pegloticase is a pegylated biosynthetic (recombinant DNA origin) modified mammalian urate oxidase (uricase) enzyme.
No enhanced Uses information available for this drug.
Generic name: PEGLOTICASE (peg-LOE-ti-kase)
Drug class: Hyperuricemia Agents (non-uricosuric)
Therapeutic class: Gout and Hyperuricemia Therapy
Pegloticase is a pegylated biosynthetic (recombinant DNA origin) modified mammalian urate oxidase (uricase) enzyme.
No enhanced Uses information available for this drug.
DRUG IMAGES
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The following indications for KRYSTEXXA (pegloticase) have been approved by the FDA:
Indications:
Prevention of acute gout attack
Professional Synonyms:
Acute gout attack prophylaxis
Prevention of acute gout flare
Indications:
Prevention of acute gout attack
Professional Synonyms:
Acute gout attack prophylaxis
Prevention of acute gout flare
The following dosing information is available for KRYSTEXXA (pegloticase):
Dosage of pegloticase is expressed in terms of the amount of uricase protein.
The recommended adult dosage of pegloticase for the management of chronic gout that is refractory to conventional therapy is 8 mg (of uricase protein) given as an IV infusion every 2 weeks. The optimum duration of therapy has not been established.
Because the risk of anaphylaxis or infusion reactions is higher in patients who have lost therapeutic response to the drug, discontinuance of therapy should be considered if uric acid concentrations rise above 6 mg/dL, particularly if 2 consecutive measurements exceed 6 mg/dL. (See Sensitivity Reactions under Cautions: Warnings/Precautions.)
The recommended adult dosage of pegloticase for the management of chronic gout that is refractory to conventional therapy is 8 mg (of uricase protein) given as an IV infusion every 2 weeks. The optimum duration of therapy has not been established.
Because the risk of anaphylaxis or infusion reactions is higher in patients who have lost therapeutic response to the drug, discontinuance of therapy should be considered if uric acid concentrations rise above 6 mg/dL, particularly if 2 consecutive measurements exceed 6 mg/dL. (See Sensitivity Reactions under Cautions: Warnings/Precautions.)
Pegloticase is administered by IV infusion via gravity feed, syringe pump, or infusion pump. The drug should not be administered by rapid IV injection, such as IV push or bolus.
| DRUG LABEL | DOSING TYPE | DOSING INSTRUCTIONS |
|---|---|---|
| KRYSTEXXA 8 MG/50 ML VIAL | Maintenance | Adults infuse 50 milliliters (8 mg) over no less than 120 minute(s) by intravenous route every 2 weeks |
No generic dosing information available.
The following drug interaction information is available for KRYSTEXXA (pegloticase):
There are 0 contraindications.
There are 0 severe interactions.
There are 0 moderate interactions.
The following contraindication information is available for KRYSTEXXA (pegloticase):
Drug contraindication overview.
Pegloticase is contraindicated in patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency since the drug may cause hemolysis and methemoglobinemia in these individuals. Patients at higher risk for G-6-PD deficiency (e.g., patients of African or Mediterranean ancestry) should be screened for G-6-PD deficiency before initiating pegloticase therapy.
Pegloticase is contraindicated in patients with glucose-6-phosphate dehydrogenase (G-6-PD) deficiency since the drug may cause hemolysis and methemoglobinemia in these individuals. Patients at higher risk for G-6-PD deficiency (e.g., patients of African or Mediterranean ancestry) should be screened for G-6-PD deficiency before initiating pegloticase therapy.
There are 3 contraindications.
Absolute contraindication.
| Contraindication List |
|---|
| Glucose-6-phosphate dehydrogenase (g6Pd) deficiency |
| Hemoglobin H disease |
| Hemolytic anemia from pyruvate kinase and g6PD deficiencies |
There are 0 severe contraindications.
There are 1 moderate contraindications.
Clinically significant contraindication, where the condition can be managed or treated before the drug may be given safely.
| Moderate List |
|---|
| Chronic heart failure |
The following adverse reaction information is available for KRYSTEXXA (pegloticase):
Adverse reaction overview.
Adverse effects reported in 5% or more of patients receiving pegloticase at a dosage of 8 mg (of uricase protein) every 2 weeks include gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, and vomiting.
Adverse effects reported in 5% or more of patients receiving pegloticase at a dosage of 8 mg (of uricase protein) every 2 weeks include gout flares, infusion reactions, nausea, contusion or ecchymosis, nasopharyngitis, constipation, chest pain, anaphylaxis, and vomiting.
There are 9 severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Anaphylaxis Chest discomfort Chest pain Dyspnea Erythema Hypersensitivity drug reaction Pruritus of skin Urticaria |
None. |
| Rare/Very Rare |
|---|
|
Worsening of chronic heart failure |
There are 11 less severe adverse reactions.
| More Frequent | Less Frequent |
|---|---|
|
Acute gouty arthritis Arthralgia Constipation Ecchymosis Fatigue Nausea |
Pharyngitis Vomiting |
| Rare/Very Rare |
|---|
|
General weakness Malaise Peripheral edema |
The following precautions are available for KRYSTEXXA (pegloticase):
Safety and efficacy have not been established in children younger than 18 years of age.
Contraindicated
Severe Precaution
Management or Monitoring Precaution
Contraindicated
| None |
Severe Precaution
| None |
Management or Monitoring Precaution
| None |
Category C. (See Users Guide.)
It is not known whether pegloticase is distributed into milk. Because many drugs are distributed into human milk and because of the potential for serious adverse reactions to pegloticase in nursing infants, the manufacturer recommends that the drug not be used in nursing women.
No substantial differences in safety and efficacy relative to younger adults were observed, but increased sensitivity cannot be ruled out.
The following prioritized warning is available for KRYSTEXXA (pegloticase):
WARNING: Pegloticase may rarely cause a serious allergic reaction. This may occur during or after the infusion of the medication. Your doctor will check your blood before each treatment and monitor you closely during and after infusion.
Your doctor should prescribe other medications (such as antihistamines, corticosteroids) to help prevent an allergic reaction. However, serious allergic reactions may still occur in a few patients. Get medical help right away if you develop any signs of an allergic reaction, such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest discomfort/pain.
Do not use this medication if you have a certain metabolic disorder called glucose-6-phosphate dehydrogenase (G6PD) deficiency because it can severely damage your red blood cells leading to anemia (hemolysis). If you are of African, Mediterranean, or Southern Asian descent, you may be at higher risk for G6PD deficiency and should be tested to see if you have this condition before starting this medication.
WARNING: Pegloticase may rarely cause a serious allergic reaction. This may occur during or after the infusion of the medication. Your doctor will check your blood before each treatment and monitor you closely during and after infusion.
Your doctor should prescribe other medications (such as antihistamines, corticosteroids) to help prevent an allergic reaction. However, serious allergic reactions may still occur in a few patients. Get medical help right away if you develop any signs of an allergic reaction, such as rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing, chest discomfort/pain.
Do not use this medication if you have a certain metabolic disorder called glucose-6-phosphate dehydrogenase (G6PD) deficiency because it can severely damage your red blood cells leading to anemia (hemolysis). If you are of African, Mediterranean, or Southern Asian descent, you may be at higher risk for G6PD deficiency and should be tested to see if you have this condition before starting this medication.
The following icd codes are available for KRYSTEXXA (pegloticase)'s list of indications:
| Prevention of acute gout attack | |
| E79.0 | Hyperuricemia without signs of inflammatory arthritis and tophaceous disease |
| M10 | Gout |
| M10.00 | Idiopathic gout, unspecified site |
| M10.30 | Gout due to renal impairment, unspecified site |
| M10.40 | Other secondary gout, unspecified site |
| M10.9 | Gout, unspecified |
| M1A.00x1 | Idiopathic chronic gout, unspecified site, with tophus (tophi) |
| M1A.20x1 | Drug-induced chronic gout, unspecified site, with tophus (tophi) |
| M1A.30x1 | Chronic gout due to renal impairment, unspecified site, with tophus (tophi) |
| M1A.40x1 | Other secondary chronic gout, unspecified site, with tophus (tophi) |
| M1A.9xx0 | Chronic gout, unspecified, without tophus (tophi) |
| M1A.9xx1 | Chronic gout, unspecified, with tophus (tophi) |
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