Rilonacept

Rilonacept
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Vignesh Ponnusamy, M.B.B.S. [2]

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Overview

Rilonacept is an interleukin-1 blocker that is FDA approved for the {{{indicationType}}} of cryopyrin-associated periodic syndromes (CAPS), including familial cold auto-inflammatory syndrome (FCAS) and muckle-wells syndrome (MWS) in adults and children 12 and older. Common adverse reactions include injection-site reactions and upper respiratory tract infections.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Cryopyrin-Associated Periodic Syndromes (CAPS)

• Treatment should be initiated with a loading dose of 320 mg delivered as two, 2 mL, subcutaneous injections of 160 mg each given on the same day at two different sites. Dosing should be continued with a once-weekly injection of 160 mg administered as a single, 2-mL, subcutaneous injection. ARCALYST should not be given more often than once weekly. Dosage modification is not required based on advanced age or gender.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Rilonacept in adult patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Rilonacept in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Rilonacept in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

• Developed by:

• Class of Recommendation:

• Strength of Evidence:

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Guideline-Supported Use of Rilonacept in pediatric patients.

Non–Guideline-Supported Use

Condition1

• Dosing Information

• Dosage

Condition2

There is limited information regarding Off-Label Non–Guideline-Supported Use of Rilonacept in pediatric patients.

Contraindications

• None.

Warnings

Precautions

• Infections

• Interleukin -1 (IL-1) blockade may interfere with the immune response to infections. Treatment with another medication that works through inhibition of IL-1 has been associated with an increased risk of serious infections, and serious infections have been reported in patients taking ARCALYST [see Clinical Studies (14)]. There was a greater incidence of infections in patients on ARCALYST compared with placebo. In the controlled portion of the study, one infection was reported as severe, which was bronchitis in a patient on ARCALYST.
• In an open-label extension study, one patient developed bacterial meningitis and died [see Adverse Reactions (6.3)]. ARCALYST should be discontinued if a patient develops a serious infection. Treatment with ARCALYST should not be initiated in patients with an active or chronic infection.
• In clinical studies, ARCALYST has not been administered concomitantly with tumor necrosis factor (TNF) inhibitors. An increased incidence of serious infections has been associated with administration of an IL-1 blocker in combination with TNF inhibitors. Taking ARCALYST with TNF inhibitors is not recommended because this may increase the risk of serious infections.
• Drugs that affect the immune system by blocking TNF have been associated with an increased risk of reactivation of latent tuberculosis (TB). It is possible that taking drugs such as ARCALYST that block IL-1 increases the risk of TB or other atypical or opportunistic infections. Healthcare providers should follow current CDC guidelines both to evaluate for and to treat possible latent tuberculosis infections before initiating therapy with ARCALYST.

• Immunosuppression

• The impact of treatment with ARCALYST on active and/or chronic infections and the development of malignancies is not known. However, treatment with immunosuppressants, including ARCALYST, may result in an increase in the risk of malignancies.

• Immunizations

• Since no data are available on either the efficacy of live vaccines or on the risks of secondary transmission of infection by live vaccines in patients receiving ARCALYST, live vaccines should not be given concurrently with ARCALYST. In addition, because ARCALYST may interfere with normal immune response to new antigens, vaccinations may not be effective in patients receiving ARCALYST. No data are available on the effectiveness of vaccination with inactivated (killed) antigens in patients receiving ARCALYST.
• Because IL-1 blockade may interfere with immune response to infections, it is recommended that prior to initiation of therapy with ARCALYST adult and pediatric patients receive all recommended vaccinations, as appropriate, including pneumococcal vaccine and inactivated influenza vaccine. (See current Recommended Immunizations schedules at the website of the Centers for Disease Control. http://www.cdc.gov/vaccines/recs/schedules/).

• Lipid Profile Changes

• Patients should be monitored for changes in their lipid profiles and provided with medical treatment if warranted.

• Hypersensitivity

• Hypersensitivity reactions associated with ARCALYST administration in the clinical studies were rare. If a hypersensitivity reaction occurs, administration of ARCALYST should be discontinued and appropriate therapy initiated.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Rilonacept in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Postmarketing Experience

There is limited information regarding Postmarketing Experience of Rilonacept in the drug label.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

• Drug

• Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Rilonacept in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Rilonacept during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Rilonacept with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Rilonacept with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Rilonacept with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Rilonacept with respect to specific gender populations.

Race

There is no FDA guidance on the use of Rilonacept with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Rilonacept in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Rilonacept in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Rilonacept in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Rilonacept in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Rilonacept in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Rilonacept in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Rilonacept in the drug label.

Pharmacology

There is limited information regarding Rilonacept Pharmacology in the drug label.

Mechanism of Action

Structure

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Rilonacept in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Rilonacept in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Rilonacept in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Rilonacept in the drug label.

How Supplied

Storage

There is limited information regarding Rilonacept Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Rilonacept in the drug label.

Precautions with Alcohol

• Alcohol-Rilonacept interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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