Class: Immunologic agent
- Injection, lyophilized powder for solution 220 mg
Acts as a soluble decoy receptor that binds interleukin-1β, preventing interaction with cell surface receptors.
At steady state, the average trough levels are about 24 mcg/mL.
Special PopulationsRenal Function Impairment
No data available.Hepatic Function Impairment
No data available.Elderly
Age does not appear to affect trough concentrations.Gender
Based on limited data, steady state trough levels are similar between men and women.Race
Could not be assessed.
Indications and Usage
Treatment of Cryopyrin-associated periodic syndrome, including familial cold autoinflammatory syndrome and Muckle-Wells syndrome.
Dosage and AdministrationAdults
Subcutaneous Two 160 mg doses as an initial loading dose, administered on the same day at 2 different sites. The weekly maintenance dose is 160 mg as single 2 mL injections.Children 12 to 17 yr of age
Subcutaneous 4.4 mg/kg as an initial loading dose (max, 320 mg) delivered as 1 or 2 injections (single-injection max, 2 mL). If the initial dose is given as 2 injections, give on the same day at 2 different sites. The weekly maintenance dose is 2.2 mg/kg (max, 160 mg) given as a single injection (single-injection max, 2 mL).
- Do not administer more than once weekly.
- Rotate injection sites, such as abdomen, thigh, or upper arm.
- Never make injections at sites that are bruised, hard, red, or tender.
Store lyophilized product at 36° to 46°F. Protect from light. After reconstitution, keep at room temperature and use within 3 h. Protect from light.
Drug InteractionsCYP substrates, especially drugs with a narrow therapeutic index (eg, warfarin)
Monitor the effects of the drug and adjust the dose as needed.Drugs that block interleukin-1, tumor necrosis factor–blocking agents
Coadministration with these agents is not recommended.Live vaccines
Coadministration of live vaccines is not recommended. Vaccinations may not be effective.
Laboratory Test Interactions
None well documented.
Injection-site reactions, including bruising, dermatitis, discomfort, edema, erythema, hemorrhage, inflammation, mass, pain, pruritus, swelling, urticaria, vesicles, and warmth (48%).
Increases in HDL, LDL, mean total cholesterol, and triglycerides.
Upper respiratory tract infection (26%); cough, sinusitis (9%).
Positive test for treatment-emergent binding antibodies (35%); infections (34%); malignancies.
Monitor for changes in the lipid profile.
Category C .
Safety and efficacy not established in children younger than 12 yr of age.
Impact unknown, but may result in increased risk of malignancies.
Risk of infection may be increased.
There have been no reports of overdosage.
- Instruct patients to inform their health care provider if they think they have an infection, are being treated for an infection, have signs of an infection, have any open sores, have a history of an infection that keeps coming back, have asthma, have diabetes or an immune system problem, have tuberculosis or have had close contact with someone who has had tuberculosis, have or have had HIV or hepatitis B or C, or take other medications that affect their immune system.
- Instruct patients that if they miss a dose, to inject the dose as soon as they remember, up to the day before the next scheduled dose. Instruct patients to take the next dose at the next regularly scheduled time.
Copyright © 2009 Wolters Kluwer Health.