Medication Guide App

Rilonacept

Pronunciation: ril-ON-a-sept
Class: Immunologic agent

Trade Names

Arcalyst
- Injection, lyophilized powder for solution 220 mg

Pharmacology

Acts as a soluble decoy receptor that binds interleukin-1β, preventing interaction with cell surface receptors.

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Pharmacokinetics

Absorption

At steady state, the average trough levels are about 24 mcg/mL.

Special Populations

Renal 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.

Contraindications

Standard considerations.

Dosage and Administration

Adults

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).

General Advice

  • 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.

Storage/Stability

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 Interactions

CYP 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.

Adverse Reactions

CNS

Hypoesthesia (9%).

Hematologic-Lymphatic

Transient neutropenia.

Local

Injection-site reactions, including bruising, dermatitis, discomfort, edema, erythema, hemorrhage, inflammation, mass, pain, pruritus, swelling, urticaria, vesicles, and warmth (48%).

Metabolic-Nutritional

Increases in HDL, LDL, mean total cholesterol, and triglycerides.

Respiratory

Upper respiratory tract infection (26%); cough, sinusitis (9%).

Miscellaneous

Positive test for treatment-emergent binding antibodies (35%); infections (34%); malignancies.

Precautions

Monitor

Monitor for changes in the lipid profile.


Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy not established in children younger than 12 yr of age.

Hypersensitivity

Occurs rarely.

Immunosuppression

Impact unknown, but may result in increased risk of malignancies.

Infection

Risk of infection may be increased.

Overdosage

Symptoms

There have been no reports of overdosage.

Patient Information

  • 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.

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