Drug Interaction:
No formal drug interaction studies have been conducted with ILARIS.
Indication:
Proprietary Name- Ilaris
Established Name - Canakinumab - Interlutin-1-beta blocker
Applicant- Novartis pharmaceuticals Corporation
Indication-
Treat Cryopyrin Associated Pediatric Syndrome(CAPS) in adult and
child 4 years of age
Dosage-
150mg for CAPS patients of body weight > 40kg and 2mg/kg with body
weight 15kg and less
Approved by FDA on 17-6-2010 (Ref- FDA approved List- 2010)
Adverse Reaction:
The most common adverse reactions reported by patients with CAPS treate
with ILARIS are nasopharyngitis, diarrhea, influenza, headache and nausea.
Contra-Indications:
CONTRAINDICATIONS
Confirmed hypersensitivity to the active substance or to any of the excipients.
WARNINGS AND PRECAUTIONS
Interleukin-1 blockade may interfere with immune response to infections.
Treatment with medications that work through inhibition of IL-1 has been associated
with an increased risk of serious infections. ILARIS has been associated with an
increased incidence of serious infections.
Physicians should exercise caution when administering ILARIS to patients with infections
, a history of recurring infections or underlying conditions which may predispose them
to infections.
Discontinue treatment with ILARIS if a patient develops a serious infection.
Do not administer ILARIS to patients during an active infection requiring medical intervention.
Live vaccines should not be given concurrently with ILARIS.
Prior to initiation of therapy with ILARIS, patients should receive all recommended
vaccinations.
Dosages/ Overdosage Etc:
INDICATIONS AND USAGE
ILARIS is an interleukin-1 blocker indicated for the treatment of Cryopyrin-
Associated Periodic Syndromes (CAPS), in adults and children 4 years of age
and older including:
Familial Cold Autoinflammatory Syndrome (FCAS)
Muckle-Wells Syndrome (MWS)
DOSAGE AND ADMINISTRATION
150 mg for CAPS patients with body weight greater than 40 kg and 2 mg/kg for CAPS
patients with body weight greater than or equal to 15 kg and less than or equal to 40 kg.
For children 15 to 40 kg with an inadequate response, the dose can be increased
to 3 mg/kg.
DOSAGE FORMS AND STRENGTHS
Sterile, single-use 6-mL, glass vial containing 180 mg of ILARIS as a lyophilized powder
for reconstitution.
Patient Information:
Patient Information ILARISR (i-LAHR-us) (canakinumab)
1.Read the Patient Information that comes with ILARIS before you start taking it and
each time you get a refill. There may be new information.
2.This leaflet does not take the place of talking with your doctor about your medical
condition or treatment.
3.What is ILARIS? ILARIS is a prescription medicine injected just below the skin
(subcutaneous) used in adults and children 4 years and older to treat auto-inflammatory
diseases known as Cryopyrin-Associated Periodic Syndromes (CAPS), including:
Familial Cold Autoinflammatory Syndrome (FCAS)
Muckle-Wells Syndrome (MWS)
4.It is not known if ILARIS is safe or effective in children under 4 years of age.
Pharmacology/ Pharmacokinetics:
Mechanism of Action
CAPS refer to rare genetic syndromes generally caused by mutations in the NLRP-3
[nucleotide-binding domain, leucine rich family (NLR), pyrin domain containing 3]
gene (also known as Cold-Induced Auto-inflammatory Syndrome-1 [CIAS1]).
CAPS disorders are inherited in an autosomal dominant pattern with male and female
offspring equally affected.
Features common to all disorders include fever, urticaria-like rash, arthralgia,
myalgia, fatigue, and conjunctivitis
Absorption
The peak serum canakinumab concentration (Cmax) of 16 ± 3.5 ìg/mL occurred
approximately 7 days after subcutaneous administration of a single,
150-mg dose subcutaneously to adult CAPS patients.
The mean terminal half-life was 26 days.
Pregnancy and lactation:
USE IN SPECIFIC POPULATIONS
Pregnancy:
No Human data. Because animal reproduction studies are not
always predictive of human response, this drug should be used during pregnancy
only if clearly needed.
Nursing Mothers:
Caution should be exercised when administered to a nursing woman.
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