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Pegloticase Dosage

Applies to the following strength(s): 8 mg/mL

The information at Drugs.com is not a substitute for medical advice. Always consult your doctor or pharmacist.

Usual Adult Dose for:

Additional dosage information:

Usual Adult Dose for Gout

8 mg via IV infusion every 2 weeks; infuse over no less than 120 minutes via gravity feed, syringe-type pump, or infusion pump

Comments:
-Patients should receive premedications (e.g., antihistamines, corticosteroids) to minimize the risk of anaphylaxis and infusion reactions.

Use: For the treatment of chronic gout in patients refractory to conventional therapy

Renal Dose Adjustments

No dosage adjustment recommended

Liver Dose Adjustments

Data not available

Dose Adjustments

Due to risk of anaphylaxis and infusion reactions:
-Premedicate patients with antihistamines and corticosteroids prior to each infusion.
-The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response, therefore, monitor serum uric acid levels prior to each infusion.
-Consider discontinuing treatment if levels are greater than 6 mg/dL, especially if 2 consecutive levels exceed 6 mg/dL.

-The safety and efficacy of retreatment with this drug after stopping treatment for more than 4 weeks is unknown. If this drug is restarted after a drug-free interval, patients may be at an increased risk of anaphylaxis and infusion reactions and should be monitored carefully.

Precautions

The US FDA requires a Risk Evaluation and Mitigation Strategy (REMS) for pegloticase. This includes a communication plan. Additional information is available at www.fda.gov/REMS

US BOXED WARNINGS: ANAPHYLAXIS AND INFUSION REACTIONS
-Anaphylaxis and infusion reactions have been reported to occur during and after administration of this drug.
-Anaphylaxis may occur with any infusion, including a first infusion, and generally manifests within 2 hours of the infusion. However, delayed-type hypersensitivity reactions have also been reported.
-This drug should be administered in healthcare settings and by healthcare providers prepared to manage anaphylaxis and infusion reactions.
-Patients should be premedicated with antihistamines and corticosteroids.
-Patients should be closely monitored for an appropriate period of time for anaphylaxis after administration.
-Monitor serum uric acid levels prior to infusions and consider discontinuing treatment if levels increase to above 6 mg/dL, particularly when 2 consecutive levels above 6 mg/dL are observed.

Safety and efficacy have not been established in patients younger than 18 years.

Consult WARNINGS section for additional precautions.

Dialysis

Data not available

Other Comments

Administration advice:
-This drug should be administered in a healthcare setting by healthcare providers prepared to manage anaphylaxis and infusion reactions.
-Patients should be premedicated with antihistamines and corticosteroids to minimize the risk of anaphylaxis and infusion reactions.
-Administer via IV infusion over no less than 120 minutes; do not give as an IV push or bolus
-If an infusion reaction occurs, the infusion should be slowed or stopped and restarted at a slower rate.

Storage:
Prior to dilution: Store in carton, protect from light, keep under refrigeration (2C to 8C [36F to 46F]) at all times; do not shake or freeze.
-Store diluted solutions under refrigeration (2C to 8C [36F to 46F]); protect from light; use within 4 hours of dilution
-Allow diluted solutions to reach room temperature prior to administration; do not subject vial or diluted solution to artificial heating (e.g. hot water, microwave).

Reconstitution/preparation techniques:
-Visually inspect for particulate matter and discoloration; discard if present.
-Withdraw 1 mL (8 mg) of pegloticase (uricase protein) from vial and inject into 250 mL bag of NS or 0.45% NS.
-Invert infusion bag gently to ensure thorough mixing; do not shake.
-Do not mix or dilute with other drugs.
-Following dilution in infusion bag: Stable for 4 hours at 2C to 8C (36F to 46F) and at room temperature 20C to 25C (68F to 77F); if storage is necessary, preferred storage is refrigeration.

General:
-Prior to initiating therapy, patients should discontinue oral urate-lowering medications and not restart on these agents while receiving this drug.
-Patients should receive gout flare prophylaxis starting at least 1 week before initiating therapy and lasting at least 6 months, unless medically contraindicated or not tolerated.
-The risk of anaphylaxis and infusion reactions is higher in patients who have lost therapeutic response, therefore, monitor serum uric acid levels prior to each infusion and consider discontinuing treatment if levels are greater than 6 mg/dL, especially if 2 consecutive levels exceed 6 mg/dL.
-The optimal treatment duration with this drug is unknown.
-This drug is not recommended for the treatment of asymptomatic hyperuricemia

Monitoring:
-Patients at high-risk for G6PD (e.g. patients of African or Mediterranean ancestry) should be screened for G6PD deficiency before starting therapy.
-Monitor serum uric acid levels prior to each infusion
-Monitor for anaphylaxis and infusion reactions during infusion; monitor for hypersensitivity reactions for an appropriate amount of time after administration.

Patient advice:
-Inform patients of the risk of serious hypersensitivity reactions and infusion reactions and explain to patients the importance of adhering to their treatment plan to help prevent or lessen the severity of these reactions.
-Patients should be aware of the most common signs and symptoms of hypersensitivity and infusion reactions and should be instructed to report these symptoms promptly should they occur during or after an infusion.
-Patients should understand that gout flares may increase when starting therapy and they should not stop this medication if they experience a flare.

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