Ilaris: Lyophilisate for solution for injection (180mg)

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What is this Medicine?

CANAKINUMAB is used to treat certain types of arthritis in children. It is also used to treat rare periodic fever syndromes including cryopyrin-associated periodic syndromes (CAPS), tumor necrosis factor receptor associated periodic syndrome (TRAPS), hyperimmunoglobulin D syndrome (HIDS)/mevalonate kinase deficiency (MKD), and familial Mediterranean fever (FMF). This medicine is not a cure.

In-Depth Information

ILARIS 180mg (150mg/mL) Powder for Injection

NDC: 000780582

Prescription Required
Not a Controlled Drug
(CSA Schedule)
FDA Approved

FDA approved for the following conditions:
Systemic Juvenile Idiopathic Arthritis, Cryopyrin-associated Periodic Syndromes (CAPS)

Storage Information
Store unreconstituted product in refrigerator (36 to 46 degrees F)
Protect from light
Store in original container
Do not freeze
Discard unused portion. Do not store for later use.
Reconstituted product should be refrigerated (36 to 46 degrees F) and used within 4 hours if not used immediately

ILARIS 180mg (150mg/mL) Powder for Injection

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Reported Side Effects for ILARIS 180mg (150mg/mL) Powder for Injection

Injection Site Reaction Incidence: <2.0%* Severity: MODERATE
Onset: RAPID

Low White Blood Cells Incidence: 1.0-10.0%* Severity: MODERATE
Onset: DELAYED

Antibody Formation Incidence: 1.5-3.1%* Severity: MODERATE
Onset: DELAYED

Stomach Pain Incidence: 7.0-16.0%* Severity: MILD
Onset: EARLY

Balance Problems Incidence: 9.0-14.0%* Severity: MILD
Onset: EARLY

Infection Incidence: >10.0%* Severity: MILD
Onset: DELAYED

Sore Throat Incidence: 11.0%* Severity: MILD
Onset: DELAYED

Muscle And/Or Bone Pain Incidence: 11.0%* Severity: MILD
Onset: EARLY

Weight Gain Incidence: 11.0%* Severity: MILD
Onset: DELAYED

Headache Incidence: 14.0%* Severity: MILD
Onset: EARLY

Upset Stomach Incidence: 14.0%* Severity: MILD
Onset: EARLY

Flu Incidence: 17.0%* Severity: MILD
Onset: DELAYED

Rhinitis Incidence: 17.0%* Severity: MILD
Onset: EARLY

Loose Stools Incidence: 20.0%* Severity: MILD
Onset: EARLY

*This is an approximate aggregated range of reported side effects from clinical studies performed on this drug. Your experience with this drug may be different.

Pregnancy & Lactation Information

FIRST Trimester

Class C - Animal studies have shown an adverse effect and there are no adequate and well-controlled studies in pregnant women. OR No animal studies have been conducted and there are no adequate and well-controlled studies in pregnant women.

SECOND Trimester

THIRD Trimester

Lactation

Caution - Not enough information is available to rule out harm to infants when this drug is taken by nursing mothers.

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