Pregnancy Category: C
ClassificationTherapeutic: antigout agents
Treatment of chronic gout in adults who have not responded to/cannot tolerate xanthine oxidase inhibitors, including allopurinol.
Consists of recombinant uricase covalently bonded to monomethoxypoly(ethylene glycol) [mPEG]; uricase catalyzes the oxidation of uric acid to allantoin, a water soluble byproduct that is readily excreted in urine.
↓ serum uric acid levels with resultant ↓ in attacks of gout and its sequelae.
Absorption: IV administration results in complete bioavailability.
Metabolism and Excretion: Unknown.
Time/action profile (effects on serum uric acid)
|IV||rapid||within 24 hr||>300 hr|
Contraindicated in: genetic implication Glucose-6–phosphate dehydrogenase (G6–PD) deficiency (risk of hemolysis and methemoglobinemia); Lactation: Breast feeding is not recommended.
Use Cautiously in: HF (may ↑ risk of exacerbation);Retreatment after a drug-free interval (↑ risk of allergic reactions, monitor carefully); Geriatric: May be more sensitive to drug effects; Obstetric: Use during pregnancy only if clearly needed; Pediatric: Safety and effectiveness not established.
Adverse Reactions/Side Effects
- chest pain
Ear, Eye, Nose, Throat
- nausea (most frequent)
- contusion/ecchymoses (most frequent)
- gout flare (most frequent)
- allergic reactions including anaphylaxis (life-threatening)
- infusion reactions
Drug-Drug interactionMay interfere with the action of other PEG-containing therapies.
Intravenous (Adults) 8 mg every 2 wk.
Injection: 8 mg/mL
- Monitor for joint pain and swelling. Gout flares frequently occur upon initiation of therapy, but do not require discontinuation. Administer prophylactic doses of colchicine or an NSAID at least 1 wk before and concurrently during the first 6 mo of therapy.
- Monitor for signs and symptoms of anaphylaxis (wheezing, peri-oral or lingual edema, hemodynamic instability, rash, urticaria) during and following infusion. May occur with any infusion, including initial infusion; usually occurs with 2 hr of infusion. Delayed reactions have also been reported. Risk is higher in patients with uric acid level >6 mg/dL.
- Monitor for infusion reactions (rash, redness of skin, dyspnea, flushing, chest discomfort, chest pain) during and periodically after infusion. If infusion reaction occurs, slow or stop infusion; restart at slower rate. If severe reaction occurs, discontinue infusion and treat as needed. Risk is greater in patients who have lost therapeutic response. Monitor patient for at least 1 hr following infusion.
- Lab Test Considerations: Monitor serum uric acid levels prior to infusion. Consider discontinuing therapy if levels ↑ to >6 mg/dL, especially if 2 consecutive levels are >6 mg/dL.
Potential Nursing DiagnosesChronic pain (Indications)
- Premedicate patient with antihistamines and corticosteroids prior to infusion to minimize risk of anaphylaxis and infusion reaction. Administer in a setting with professionals prepared to manage anaphylaxis and infusion reactions.
- Discontinue all oral urate-lowering medications prior to and during therapy.
- pH: 4.4–5.6.
- Intermittent Infusion: Withdraw 1 mL of pegloticase from vial and inject into 250 mL bag of NaCl; discard unused portion. Invert bag several times to mix; do not shake. Solution is clear and colorless; do not administer solutions that are discolored or contain a precipitate. Solution is stable for 4 hr if refrigerated or at room temperature. Store in refrigerator and protect from light; do not freeze. Allow solution to reach room temperature before administering; do not use artificial heating.
- Rate: Infuse over 120 min. Do not administer via IV push or bolus.
- Additive Incompatibility: Do not mix with other medications.
- Explain purpose of pegloticase to patient. Instruct patient to read Medication Guide before starting therapy before each infusion.
- Advise patient to notify health care professional immediately if signs of anaphylaxis or infusion reaction occur.
- genetic implication Advise patient not to take pegloticase if they have G6PD deficiency.
- Inform patient that gout flares may initially ↑ at the start of pegloticase. Advise patient to not to stop therapy but to take medication (colchicine, NSAID) to reduce flares regularly for the first few months of pegloticase therapy.
- Instruct patient to not to take oral urate-lowering medications before or during therapy.
- Advise female patient to notify health care professional if pregnancy is planned or suspected or if breast feeding.
- ↓ in uric acid levels with resultant improvement in gout symptoms in patients with chronic gout.