Ilaris (Canakinumab Injection)
برای این دارو، اطلاعات عمومی (فارسی) یافت نشد . برای افزودن اطلاعات فارسی به این دارو کلیک نمایید.
Ilaris (Canakinumab Injection)

ILARIS
(canakinumab)

DRUG DESCRIPTION

Canakinumab is a recombinant, human anti-human-IL-1β monoclonal antibody that belongs to the IgG1/κ isotype subclass. It is expressed in a murine Sp2/0-Ag14 cell line and comprised of two 447- (or 448-) residue heavy chains and two 214-residue light chains, with a molecular mass of 145157 Daltons when deglycosylated. Both heavy chains of canakinumab contain oligosaccharide chains linked to the protein backbone at asparagine 298 (Asn 298).

The biological activity of canakinumab is measured by comparing its inhibition of IL-1β-dependent expression of the reporter gene luciferase to that of a canakinumab internal reference standard, using a stably transfected cell line.

ILARIS is supplied in a sterile, single-use, colorless, 6 mL glass vial with coated stopper and aluminum flip-off cap. Each vial contains 180 mg of canakinumab as a white, preservative-free, lyophilized powder. Reconstitution with 1 mL of preservative-free Sterile Water for Injection is required prior to subcutaneous administration of the drug. The reconstituted canakinumab is a 150 mg/mL solution essentially free of particulates, clear to slightly opalescent, and is colorless or may have a slightly brownish-yellow tint. A volume of up to 1 mL can be withdrawn for delivery of 150 mg/mL canakinumab for subcutaneous administration. Each reconstituted vial contains 180 mg canakinumab, sucrose, L-histidine, L-histidine HCL monohydrate, polysorbate 80 and Sterile Water for Injection. No preservatives are present.

What are the possible side effects of canakinumab (Ilaris)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, unusual weakness;
  • cough with yellow or green mucus;
  • stabbing chest pain, feeling short of breath; or
  • severe dizziness or spinning...

Read All Potential Side Effects and See Pictures of Ilaris »

What are the precautions when taking canakinumab injection (Ilaris)?

Before using canakinumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems (such as HIV infection), current/recent/returning infection (including hepatitis and tuberculosis), cancer.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before starting this drug, you should take a tuberculosis (TB) skin test to check for a type of...

Read All Potential Precautions of Ilaris »

Last reviewed on RxList: 10/19/2012
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

ILARIS (canakinumab) is an interleukin-1β 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

General Dosing Information

INJECTION FOR SUBCUTANEOUS USE ONLY.

Recommended Dose

The recommended dose of ILARIS is 150 mg for CAPS patients with body weight greater than 40 kg. For CAPS patients with body weight greater than or equal to 15 kg and less than or equal to 40 kg, the recommended dose is 2 mg/kg. For children 15 to 40 kg with an inadequate response, the dose can be increased to 3 mg/kg.

ILARIS is administered every eight weeks as a single dose via subcutaneous injection.

Four Steps for Preparation and Administration

STEP 1: Using aseptic technique, reconstitute each vial of ILARIS by slowly injecting 1 mL of preservative-free Sterile Water for Injection with a 1 mL syringe and an 18 gauge x 2” needle.

STEP 2: Swirl the vial slowly at an angle of about 45° for approximately 1 minute and allow to stand for 5 minutes. Do not shake. Then gently turn the vial upside down and back again ten times. Avoid touching the rubber stopper with your fingers.

STEP 3: Allow to stand for about 15 minutes at room temperature to obtain a clear solution. Do not shake. Do not use if particulate matter is present in the solution. Tap the side of the vial to remove any residual liquid from the stopper. The reconstituted solution should be essentially free from particulates, and clear to opalescent. The solution should be colorless or may have a slight brownish-yellow tint. If the solution has a distinctly brown discoloration it should not be used. If not used within 60 minutes of reconstitution, the solution should be stored in the refrigerator at 2 to 8° C (36 to 46° F) and used within 4 hours. Slight foaming of the product upon reconstitution is not unusual.

STEP 4: Using a sterile syringe and needle carefully withdraw the required volume depending on the dose to be administered (0.2 mL to 1 mL) and subcutaneously inject using a 27 gauge x 0.5” needle.

Injection into scar tissue should be avoided as this may result in insufficient exposure to ILARIS.

ILARIS 180-mg powder for solution for injection is supplied in a single-use vial. Any unused product or waste material should be disposed of in accordance with local requirements.

HOW SUPPLIED

Dosage Forms And Strengths

ILARIS is supplied as a 180 mg white lyophilized powder for solution for subcutaneous injection. Reconstitution with 1 mL of preservative-free Sterile Water for Injection is required prior to subcutaneous administration of the drug, resulting in a total volume of 1.2 mL reconstituted solution. The reconstituted ILARIS is a clear to slightly opalescent, colorless to a slight brownish yellow tint, essentially free from particulates, 150 mg/mL solution.

Storage And Handling

Carton of 1 vial……………………….NDC 0078-0582-61

Each 6 mL single-use vial of ILARIS contains a sterile, preservative free, white lyophilized powder containing 180 mg of canakinumab. Each vial is to be reconstituted with 1 mL of preservative-free Sterile Water for Injection in a 150 mg/mL solution.

Special Precautions for Storage

The unopened vial must be stored refrigerated at 2 to 8° C (36 to 46° F). Do not freeze. Store in the original carton to protect from light. Do not use beyond the date stamped on the label. After reconstitution, ILARIS should be kept from light, and can be kept at room temperature if used within 60 minutes of reconstitution. Otherwise, it should be refrigerated at 2 to 8° C (36 to 46° F) and used within 4 hours of reconstitution. ILARIS does not contain preservatives. Unused portions of ILARIS should be discarded.

Keep this and all drugs out of the reach of children.

Manufactured By: Novartis Pharma Stein AG Stein, Switzerland. Distributed By: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936. October 2012

Last reviewed on RxList: 10/19/2012
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

The data described herein reflect exposure to ILARIS in 104 adult and pediatric CAPS patients, (including 20 FCAS, 72 MWS, 10 MWS/NOMID (Neonatal Onset Multisystem Inflammatory Disorder) overlap, 1 non-FCAS non-MWS, and 1 mis-diagnosed in placebo-controlled (35 patients) and uncontrolled trials. Sixty-two patients were exposed to ILARIS for at least 6 months, 56 for at least 1 year and 4 for at least 3 years. A total of 9 serious adverse reactions were reported for CAPS patients. Among these were vertigo (2 patients), infections (3 patients), including intra-abdominal abscess following appendectomy (1 patient). The most commonly reported adverse reactions associated with ILARIS treatment in the CAPS patients were nasopharyngitis, diarrhea, influenza, headache, and nausea. No impact on the type or frequency of adverse drug reactions was seen with longer-term treatment. One patient discontinued treatment due to potential infection.

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

Clinical Trial Experience

Approximately 833 subjects have been treated with ILARIS in blinded and open-label clinical trials in CAPS and other diseases, and healthy volunteers. A total of 15 patients reported serious adverse reactions during the clinical program.

Study 1 investigated the safety of ILARIS in an 8-week, open-label period (Part 1), followed by a 24-week, randomized withdrawal period (Part 2), followed by a 16-week, open-label period (Part 3). All patients were treated with ILARIS 150 mg subcutaneously or 2 mg/kg if body weight was greater than or equal to 15 kg and less than or equal to 40 kg (see Table 1).

Since all CAPS patients received ILARIS in Part 1, there are no controlled data on adverse events (AEs). Data in Table 1 are for all AEs for all CAPS patients receiving canakinumab. In study 1, no pattern was observed for any type or frequency of adverse events throughout the three study periods.

Table 1 : Number (%) of Patients with AEs by Preferred Terms, in > 10% of Patients in Parts 1 to 3 of the Phase 3 Trial for CAPS Patients

Preferred Term ILARIS
N=35
n (%)
n % of Patients with Adverse Events 35 (100)
Nasopharyngitis 12 (34)
Diarrhea 7 (20)
Influenza 6 (17)
Rhinitis 6 (17)
Nausea 5 (14)
Headache 5 (14)
Bronchitis 4 (11)
Gastroenteritis 4 (11)
Pharyngitis 4 (11)
Weight increased 4 (11)
Musculoskeletal pain 4(11)
Vertigo 4(11)

Vertigo

Vertigo has been reported in 9 to 14% of patients in CAPS studies, exclusively in MWS patients, and reported as a serious adverse event in two cases. All events resolved with continued treatment with ILARIS.

Hypersensitivity

Hypersensitivity reactions have been reported with ILARIS therapy. No anaphylactic reactions have been reported. ILARIS should not be administered to any patients with known clinical hypersensitivity to ILARIS [see CONTRAINDICATIONS and WARNINGS AND PRECAUTIONS].

Injection Site Reactions

In Study 1, subcutaneous injection site reactions were observed in 9% of patients in Part 1 with mild tolerability reactions; in Part 2, one patient each (7%) had a mild or a moderate tolerability reaction and, in Part 3, one patient had a mild local tolerability reaction. No severe injection-site reactions were reported and none led to discontinuation of treatment.

Immunogenicity

A specific biosensor binding assay was used to detect antibodies directed against canakinumab in patients who received ILARIS. None of the 60 CAPS patients who had received ILARIS tested positive for treatment-emergent binding antibodies at the time points tested. Thirty-one of 60 CAPS patients had a duration of exposure to canakinumab > 48 weeks. The data obtained in an assay is highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications, underlying disease, and the number of patients tested. For these reasons, comparison of the incidence of antibodies to canakinumab with the incidence of antibodies to other products may be misleading.

Laboratory Findings

Hematology

During clinical trials with ILARIS, mean values decreased for white blood cells, neutrophils and platelets.

Hepatic transaminases

Elevations of transaminases have been observed in patients treated with ILARIS.

Bilirubin

Asymptomatic and mild elevations of serum bilirubin have been observed in patients treated with ILARIS without concomitant elevations of transaminases.

Read the Ilaris (canakinumab injection) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

Interactions between ILARIS and other medicinal products have not been investigated in formal studies.

TNF-Blocker and IL-1 Blocking Agent

An increased incidence of serious infections and an increased risk of neutropenia have been associated with administration of another IL-1 blocker in combination with TNF inhibitors in another patient population. Use of ILARIS with TNF inhibitors may also result in similar toxicities and is not recommended because this may increase the risk of serious infections [see WARNINGS AND PRECAUTIONS].

The concomitant administration of ILARIS with other drugs that block IL-1 has not been studied. Based upon the potential for pharmacological interactions between ILARIS and a recombinant IL-1ra, concomitant administration of ILARIS and other agents that block IL-1 or its receptors is not recommended.

Immunization

No data are available on either the effects of live vaccination or the secondary transmission of infection by live vaccines in patients receiving ILARIS. Therefore, live vaccines should not be given concurrently with ILARIS. It is recommended that, if possible, pediatric and adult patients should complete all immunizations in accordance with current immunization guidelines prior to initiating ILARIS therapy [see WARNINGS AND PRECAUTIONS].

Cytochrome P450 Substrates

The formation of CYP450 enzymes is suppressed by increased levels of cytokines (e.g., IL-1) during chronic inflammation. Thus it is expected that for a molecule that binds to IL-1, such as canakinumab, the formation of CYP450 enzymes could be normalized. This is clinically relevant for CYP450 substrates with a narrow therapeutic index, where the dose is individually adjusted (e.g., warfarin). Upon initiation of canakinumab, in patients being treated with these types of medicinal products, therapeutic monitoring of the effect or drug concentration should be performed and the individual dose of the medicinal product may need to be adjusted as needed.

Last reviewed on RxList: 10/19/2012
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Serious Infections

ILARIS may be associated with an increased risk 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. ILARIS should not be administered to patients during an active infection requiring medical intervention. Administration of ILARIS should be discontinued if a patient develops a serious infection.

Infections, predominantly of the upper respiratory tract, in some instances serious, have been reported with ILARIS. Generally, the observed infections responded to standard therapy. Isolated cases of unusual or opportunistic infections were reported during ILARIS treatment. In clinical trials, ILARIS has not been administered concomitantly with tumor necrosis factor (TNF) inhibitors. An increased incidence of serious infections has been associated with administration of another IL-1 blocker in combination with TNF inhibitors. Co-administration of ILARIS with TNF inhibitors is not recommended because this may increase the risk of serious infections [see DRUG INTERACTIONS].

Drugs that affect the immune system by blocking TNF have been associated with an increased risk of new tuberculosis and reactivation of latent tuberculosis (TB). It is possible that use of IL-1 inhibitors such as ILARIS increases the risk of reactivation of tuberculosis or of opportunistic infections.

Prior to initiating immunomodulatory therapies, including ILARIS, patients should be evaluated for active and latent tuberculosis infection. Appropriate screening tests should be performed in all patients. ILARIS has not been studied in patients with a positive tuberculosis screen, and the safety of ILARIS in individuals with latent tuberculosis infection is unknown. Patients testing positive in tuberculosis screening should be treated according to standard medical practice prior to therapy with ILARIS. All patients should be instructed to seek medical advice if signs, symptoms, or high risk exposure suggestive of tuberculosis (e.g. persistent cough, weight loss, subfebrile temperature) appear during or after ILARIS therapy.

Healthcare providers should follow current CDC guidelines both to evaluate for and to treat possible latent tuberculosis infections before initiating therapy with ILARIS.

Immunosuppression

The impact of treatment with anti-interleukin-1 (IL-1) therapy on the development of malignancies is not known. However, treatment with immunosuppressants, including ILARIS, may result in an increase in the risk of malignancies.

Hypersensitivity

Hypersensitivity reactions have been reported with ILARIS therapy. No anaphylactic reactions have been reported. It should be recognized that symptoms of the underlying disease being treated may be similar to symptoms of hypersensitivity. ILARIS should not be administered to any patients with known clinical hypersensitivity to ILARIS [see CONTRAINDICATIONS and ADVERSE REACTIONS].

Immunizations

Live vaccines should not be given concurrently with ILARIS [see DRUG INTERACTIONS]. Since no data are available on either the efficacy or on the risks of secondary transmission of infection by live vaccines in patients receiving ILARIS, live vaccines should not be given concurrently with ILARIS. In addition, because ILARIS may interfere with normal immune response to new antigens, vaccinations may not be effective in patients receiving ILARIS. No data are available on the effectiveness of vaccinations with inactivated (killed) antigens in patients receiving ILARIS. [see DRUG INTERACTIONS].

Because IL-1 blockade may interfere with immune response to infections, it is recommended that prior to initiation of therapy with ILARIS, adult and pediatric patients receive all recommended vaccinations, as appropriate, including pneumococcal vaccine and inactivated influenza vaccine. (See current recommended immunization schedules at the website of the Centers for Disease Control, http://www.cdc.gov/vaccines/recs/schedules/).

Patient Counseling Information

“See FDA-approved Patient Labeling (PATIENT INFORMATION)

Patients should be provided the opportunity to read the Patient Information for ILARIS prior to the first treatment and any questions resulting from the patient's reading of the guide should be discussed.

Drug Administration

Healthcare providers should perform administration of ILARIS by the subcutaneous injection route.

Infections

Patients should be cautioned that ILARIS use has been associated with serious infections. Patients should be counseled to contact their healthcare professional immediately if they develop an infection after starting ILARIS. Treatment with ILARIS should be discontinued if a patient develops a serious infection. Patients should be counseled not to take any IL-1 blocking drug, including ILARIS, if they are also taking a drug that blocks TNF such as etanercept, infliximab, or adalimumab. Use of ILARIS with other IL-1 blocking agents, such as rilonacept and anakinra is not recommended. Patients should be cautioned not to receive ILARIS if they have a chronic or active infection, including HIV, Hepatitis B or Hepatitis C.

Vaccinations

Prior to initiation of therapy with ILARIS, physicians should review with adult and pediatric patients their vaccination history relative to current medical guidelines for vaccine use, including taking into account the potential of increased risk of infection during treatment with ILARIS.

Injection-site Reactions

Physicians should explain to patients that a very small number of patients in the clinical trials experienced a reaction at the subcutaneous injection site. Injection-site reactions may include pain, erythema, swelling, pruritus, bruising, mass, inflammation, dermatitis, edema, urticaria, vesicles, warmth, and hemorrhage. Healthcare providers should be cautioned to avoid injecting into an area that is already swollen or red. Any persistent reaction should be brought to the attention of the prescribing physician.

Hypersensitivity

Patients should be counseled to contact their healthcare provider immediately if they develop signs of allergic reaction such as difficulty breathing or swallowing, nausea, dizziness, skin rash, itching, hives, palpitations or low blood pressure.

Information for Patients

See PATIENT INFORMATION leaflet.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies have not been performed to evaluate the carcinogenic potential of canakinumab.

The mutagenic potential of canakinumab was not evaluated.

As canakinumab does not cross-react with rodent IL-1β, male and female fertility was evaluated in a mouse model using a murine analog of canakinumab. Male mice were treated weekly beginning 4 weeks prior to mating and continuing through 3 weeks after mating. Female mice were treated weekly for 2 weeks prior to mating through gestation day 3 or 4. The murine analog of canakinumab did not alter either male or female fertility parameters at subcutaneous doses up to 150 mg/kg.

Use In Specific Populations

Pregnancy

Pregnancy Category C

Canakinumab has been shown to produce delays in fetal skeletal development when evaluated in marmoset monkeys using doses 23-fold the maximum recommended human dose (MRHD) and greater (based on a plasma area under the time-concentration curve [AUC] comparison). Doses producing exposures within the clinical exposure range at the MRHD were not evaluated. Similar delays in fetal skeletal development were observed in mice administered a murine analog of canakinumab. There are no adequate and well-controlled studies of ILARIS in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Embryofetal developmental toxicity studies were performed in marmoset monkeys and mice. Pregnant marmoset monkeys were administered canakinumab subcutaneously twice weekly at doses of 15, 50 or 150 mg/kg (representing 23 to 230-fold the human dose based on a plasma AUC comparison at the MRHD) from gestation days 25 to 109 which revealed no evidence of embryotoxicity or fetal malformations. There were increases in the incidence of incomplete ossification of the terminal caudal vertebra and misaligned and/or bipartite vertebra in fetuses at all dose levels when compared to concurrent controls suggestive of delay in skeletal development in the marmoset. Since canakinumab does not cross-react with mouse or rat IL-1, pregnant mice were subcutaneously administered a murine analog of canakinumab at doses of 15, 50, or 150 mg/kg on gestation days 6, 11 and 17. The incidence of incomplete ossification of the parietal and frontal skull bones of fetuses was increased in a dose-dependent manner at all dose levels tested.

Nursing Mothers

It is not known whether canakinumab is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when ILARIS is administered to a nursing woman.

Pediatric Use

The CAPS trials with ILARIS included a total of 23 pediatric patients with an age range from 4 years to 17 years (11 adolescents were treated subcutaneously with 150 mg , and 12 children were treated with 2 mg/kg based on body weight greater than or equal to 15 kg and less than or equal to 40 kg ). The majority of patients achieved improvement in clinical symptoms and objective markers of inflammation (e.g., Serum Amyloid A and C-Reactive Protein). Overall, the efficacy and safety of ILARIS in pediatric and adult patients were comparable. Infections of the upper respiratory tract were the most frequently reported infection. The safety and effectiveness of ILARIS in patients under 4 years of age has not been established [see Pharmacokinetics].

Geriatric Use

Clinical studies of ILARIS did not include sufficient numbers of subjects aged 65and over to determine whether they respond differently from younger subjects.

Patients with Renal Impairment

No formal studies have been conducted to examine the pharmacokinetics of ILARIS administered subcutaneously in patients with renal impairment.

Patients with Hepatic Impairment

No formal studies have been conducted to examine the pharmacokinetics of ILARIS administered subcutaneously in patients with hepatic impairment.

Last reviewed on RxList: 10/19/2012
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No case of overdose has been reported. In the case of overdose, it is recommended that the subject be monitored for any signs and symptoms of adverse reactions or effects, and appropriate symptomatic treatment be instituted immediately.

CONTRAINDICATIONS

Confirmed hypersensitivity to the active substance or to any of the excipients [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].

Last reviewed on RxList: 10/19/2012
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

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.

The NLRP-3 gene encodes the protein cryopyrin, an important component of the inflammasome. Cryopyrin regulates the protease caspase-1 and controls the activation of interleukin-1 beta (IL-1β). Mutations in NLRP-3 result in an overactive inflammasome resulting in excessive release of activated IL-1β that drives inflammation.

Canakinumab is a human monoclonal anti-human IL-1β antibody of the IgG1/κ isotype. Canakinumab binds to human IL1β and neutralizes its activity by blocking its interaction with IL-1 receptors, but it does not bind IL-1α or IL-1 receptor antagonist (IL-1ra).

Pharmacodynamics

C-reactive protein and Serum Amyloid A (SAA) are indicators of inflammatory disease activity that are elevated in patients with CAPS. Elevated SAA has been associated with the development of systemic amyloidosis in patients with CAPS. Following ILARIS treatment, CRP and SAA levels normalize within 8 days.

Pharmacokinetics

Absorption

The peak serum canakinumab concentration (Cmax) of 16 ± 3.5 μg/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. The absolute bioavailability of subcutaneous canakinumab was estimated to be 70%. Exposure parameters (such as AUC and Cmax) increased in proportion to dose over the dose range of 0.30 to 10 mg/kg given as intravenous infusion or from 150 to 300 mg as subcutaneous injection.

Distribution

Canakinumab binds to serum IL-1β. Canakinumab volume of distribution (Vss) varied according to body weight and was estimated to be 6.01 liters in a typical CAPS patient weighing 70 kg. The expected accumulation ratio was 1.3-fold following 6 months of subcutaneous dosing of 150 mg ILARIS every 8 weeks.

Elimination

Clearance (CL) of canakinumab varied according to body weight and was estimated to be 0.174 L/day in a typical CAPS patient weighing 70 kg. There was no indication of accelerated clearance or time-dependent change in the pharmacokinetic properties of canakinumab following repeated administration. No gender- or age-related pharmacokinetic differences were observed after correction for body weight.

Pediatrics

Peak concentrations of canakinumab occurred between 2 to 7 days following single subcutaneous administration of ILARIS 150 mg or 2 mg/kg in pediatric patients. The terminal half-life ranged from 22.9 to 25.7 days, similar to the pharmacokinetic properties observed in adults.

Clinical Studies

The efficacy and safety of ILARIS for the treatment of CAPS was demonstrated in Study 1, a 3-part trial in patients 9 to 74 years of age with the MWS phenotype of CAPS. Throughout the trial, patients weighing more than 40 kg received ILARIS 150 mg and patients weighing 15 to 40 kg received 2 mg/kg. Part 1 was an 8-week open-label, single-dose period where all patients received ILARIS. Patients who achieved a complete clinical response and did not relapse by Week 8 were randomized into Part 2, a 24-week randomized, double-blind, placebo-controlled withdrawal period. Patients who completed Part 2 or experienced a disease flare entered Part 3, a 16-week open-label active treatment phase. A complete response was defined as ratings of minimal or better for physician's assessment of disease activity (PHY) and assessment of skin disease (SKD) and had serum levels of C-Reactive Protein (CRP) and Serum Amyloid A (SAA) less than 10 mg/L. A disease flare was defined as a CRP and/or SAA values greater than 30 mg/L and either a score of mild or worse for PHY or a score of minimal or worse for PHY and SKD.

In Part 1, a complete clinical response was observed in 71% of patients one week following initiation of treatment and in 97% of patients by Week 8 (see Figure 1 and Table 2). In the randomized withdrawal period, a total of 81% of the patients randomized to placebo flared as compared to none (0%) of the patients randomized to ILARIS. The 95% confidence interval for treatment difference in the proportion of flares was 53% to 96%. At the end of Part 2, all 15 patients treated with ILARIS had absent or minimal disease activity and skin disease (see Table 2).

In a second trial, patients 4 to 74 years of age with both MWS and FCAS phenotypes of CAPS were treated in an open-label manner. Treatment with ILARIS resulted in clinically significant improvement of signs and symptoms and in normalization of high CRP and SAA in a majority of patients within 1 week.

Table 2 : Physician's Global Assessment of Auto-Inflammatory Disease Activity and Assessment of Skin Disease: Frequency Table and Treatment Comparison in Part 2 (Using LOCF, ITT Population)

  Baseline ILARIS
N= 15
Placebo
N= 16
Start of Part 2 (Week 8) End of Part 2 Start of Part 2 (Week 8) End of Part 2
Absent 0/31 (0) 9/15 (60) 8/15 (53) 8/16 (50) 0/16 (0)
Minimal 1/31 (3) 4/15 (27) 7/15 (47) 8/16 (50) 4/16 (25)
Mild 7/31 (23) 2/15 (13) 0/15 (0) 0/16 (0) 8/16 (50)
Moderate 19/31 (61) 0/15 (0) 0/15 (0) 0/16 (0) 4/16 (25)
Severe 4/31 (13) 0/15 (0) 0/15 (0) 0/16 (0) 0/16 (0)
Absent 3/31 (10) 13/15 (87) 14/15 (93) 13/16 (81) 5/16 (31)
Minimal 6/31 (19) 2/15 (13) 1/15 (7) 3/16 (19) 3/16 (19)
Mild 9/31 (29) 0/15 (0) 0/15 (0) 0/16 (0) 5/16 (31)
Moderate 12/31 (39) 0/15 (0) 0/15 (0) 0/16 (0) 3/16 (19)
Severe 1/32 (3) 0/15 (0) 0/15 (0) 0/16 (0) 0/16 (0)

Markers of inflammation CRP and SAA normalized within 8 days of treatment in the majority of patients. Normal mean CRP (Figure 1) and SAA values were sustained throughout study 1 in patients continuously treated with canakinumab. After withdrawal of canakinumab in Part 2 CRP (figure 1) and SAA values again returned to abnormal values and subsequently normalized after reintroduction of canakinumab in Part 3. The pattern of normalization of CRP and SAA was similar.

Figure 1: Mean C-Reactive Protein Levels at the End of Parts 1, 2 and 3 of Study 1

Mean C-Reactive Protein Levels at the End of Parts 1, 2 and 3 - Illustration

Last reviewed on RxList: 10/19/2012
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

ILARIS®
(i-LAHR-us)
(canakinumab)

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. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.

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)

It is not known if ILARIS is safe or effective in children under 4 years of age.

Who should not take ILARIS?

Do not take ILARIS if you:

  • are allergic to canakinumab or any of the ingredients in ILARIS. See the end of this Patient Information leaflet for a complete list of the ingredients in ILARIS.

What should I tell my healthcare provider before taking ILARIS?

Before you take ILARIS, tell your healthcare provider if you:

  • think you have an infection
  • are being treated for an infection
  • have signs of an infection, such as fever, cough, or flu-like symptoms
  • have a history of infections that keep coming back
  • have a history of low white blood cells
  • have or have had HIV, Hepatitis B, or Hepatitis C
  • have an immune system problem. People with these conditions have a higher chance for infections.
  • have tuberculosis (TB), or if you have been in close contact with someone who has or has had tuberculosis
  • are scheduled to receive any immunizations (vaccines). You should not get 'live vaccines' if you take ILARIS.
  • are pregnant or planning to become pregnant. It is not known if ILARIS will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking ILARIS.
  • are breastfeeding or planning to breastfeed. It is not known if ILARIS passes into your breast milk. You and your healthcare provider should decide if you will take ILARIS or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Especially tell your healthcare provider if you take:

  • Medicines that affect your immune system
  • IL-1 blocking agents such as Kineret® (anakinra), Arcalyst® (rilonacept)
  • Tumor Necrosis Factor (TNF) inhibitors such as Enbrel® (etanercept), Humira® (adalimumab), or Remicade® (infliximab).
  • Medicines that can affect enzyme metabolism. Ask your healthcare provider if you are not sure.

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How will I receive ILARIS?

  • Do not receive ILARIS if you have an infection.
  • ILARIS is given by your healthcare provider every 8 weeks
  • Your healthcare provider may change your dose if needed.

What are the possible side effects of ILARIS?

ILARIS can cause serious side effects including:

  • serious infections. Symptoms of an infection may include:
    • a fever lasting longer than 3 days
    • a cough that does not go away
    • redness in one part of your body
    • warm feeling or swelling of your skin
  • decrease in white blood cells (neutropenia) which help your body fight infections
  • decrease your body's ability to fight infections (immunosuppression)

Other serious side effects may occur while you are taking and after you finish taking ILARIS including allergic reactions.

Symptoms of an allergic reaction may include:

  • rash (hives)
  • swollen face
  • problems breathing or swallowing

Call your healthcare provider right away or get emergency medical help if you have any of the signs of an infection or allergic reaction.

The most common side effects include:

  • cold symptoms
  • diarrhea
  • flu (influenza)
  • runny nose
  • nausea
  • headache
  • injection site reaction (such as redness, swelling, warmth, itching)
  • feeling like you are spinning (vertigo)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ILARIS. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of ILARIS

Medicines are sometimes prescribed for purposes other than those listed in patient information leaflets. Do not use ILARIS for a condition for which it was not prescribed.

This leaflet summarizes the most important information about ILARIS. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ILARIS that was written for health professionals. For more information about ILARIS, call 1-877-452-7471 or visit www.ILARIS.com.

What are the ingredients in ILARIS?

Active ingredients: canakinumab

Inactive ingredients: sucrose, L-histidine, L-histidine HCl monohydrate, polysorbate 80, preservative-free Sterile Water for Injection.

What is CAPS Disease?

In patients with CAPS, the body produces excessive amounts of a chemical messenger called interleukin-1 beta (IL-1β). This may lead to symptoms such as fever, headache, fatigue, skin rash, painful joints and muscles. In some patients, more severe outcomes such as hearing impairment are observed.

Last reviewed on RxList: 10/19/2012
This monograph has been modified to include the generic and brand name in many instances.

>

PATIENT INFORMATION

ILARIS®
(i-LAHR-us)
(canakinumab)

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. This leaflet does not take the place of talking with your doctor about your medical condition or treatment.

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)

It is not known if ILARIS is safe or effective in children under 4 years of age.

Who should not take ILARIS?

Do not take ILARIS if you:

  • are allergic to canakinumab or any of the ingredients in ILARIS. See the end of this Patient Information leaflet for a complete list of the ingredients in ILARIS.

What should I tell my healthcare provider before taking ILARIS?

Before you take ILARIS, tell your healthcare provider if you:

  • think you have an infection
  • are being treated for an infection
  • have signs of an infection, such as fever, cough, or flu-like symptoms
  • have a history of infections that keep coming back
  • have a history of low white blood cells
  • have or have had HIV, Hepatitis B, or Hepatitis C
  • have an immune system problem. People with these conditions have a higher chance for infections.
  • have tuberculosis (TB), or if you have been in close contact with someone who has or has had tuberculosis
  • are scheduled to receive any immunizations (vaccines). You should not get 'live vaccines' if you take ILARIS.
  • are pregnant or planning to become pregnant. It is not known if ILARIS will harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking ILARIS.
  • are breastfeeding or planning to breastfeed. It is not known if ILARIS passes into your breast milk. You and your healthcare provider should decide if you will take ILARIS or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Especially tell your healthcare provider if you take:

  • Medicines that affect your immune system
  • IL-1 blocking agents such as Kineret® (anakinra), Arcalyst® (rilonacept)
  • Tumor Necrosis Factor (TNF) inhibitors such as Enbrel® (etanercept), Humira® (adalimumab), or Remicade® (infliximab).
  • Medicines that can affect enzyme metabolism. Ask your healthcare provider if you are not sure.

Ask your healthcare provider or pharmacist for a list of these medicines, if you are not sure.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How will I receive ILARIS?

  • Do not receive ILARIS if you have an infection.
  • ILARIS is given by your healthcare provider every 8 weeks
  • Your healthcare provider may change your dose if needed.

What are the possible side effects of ILARIS?

ILARIS can cause serious side effects including:

  • serious infections. Symptoms of an infection may include:
    • a fever lasting longer than 3 days
    • a cough that does not go away
    • redness in one part of your body
    • warm feeling or swelling of your skin
  • decrease in white blood cells (neutropenia) which help your body fight infections
  • decrease your body's ability to fight infections (immunosuppression)

Other serious side effects may occur while you are taking and after you finish taking ILARIS including allergic reactions.

Symptoms of an allergic reaction may include:

  • rash (hives)
  • swollen face
  • problems breathing or swallowing

Call your healthcare provider right away or get emergency medical help if you have any of the signs of an infection or allergic reaction.

The most common side effects include:

  • cold symptoms
  • diarrhea
  • flu (influenza)
  • runny nose
  • nausea
  • headache
  • injection site reaction (such as redness, swelling, warmth, itching)
  • feeling like you are spinning (vertigo)

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ILARIS. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects.

You may report side effects to FDA at 1-800-FDA-1088.

General information about the safe and effective use of ILARIS

Medicines are sometimes prescribed for purposes other than those listed in patient information leaflets. Do not use ILARIS for a condition for which it was not prescribed.

This leaflet summarizes the most important information about ILARIS. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ILARIS that was written for health professionals. For more information about ILARIS, call 1-877-452-7471 or visit www.ILARIS.com.

What are the ingredients in ILARIS?

Active ingredients: canakinumab

Inactive ingredients: sucrose, L-histidine, L-histidine HCl monohydrate, polysorbate 80, preservative-free Sterile Water for Injection.

What is CAPS Disease?

In patients with CAPS, the body produces excessive amounts of a chemical messenger called interleukin-1 beta (IL-1β). This may lead to symptoms such as fever, headache, fatigue, skin rash, painful joints and muscles. In some patients, more severe outcomes such as hearing impairment are observed.

Last reviewed on RxList: 10/19/2012
This monograph has been modified to include the generic and brand name in many instances.

Disclaimer

Ilaris Consumer

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

CANAKINUMAB - INJECTION

(KAN-a-KIN-ue-mab)

COMMON BRAND NAME(S): Ilaris

USES: This medication is used to treat a certain group of inherited disorders called cryopyrin-associated periodic syndromes (CAPS), including familial cold autoinflammatory syndrome and Muckle-Wells syndrome. Canakinumab works by blocking a certain natural protein in your body (interleukin-1 beta) that may worsen the symptoms of CAPS. Canakinumab does not cure CAPS, but it can help lessen the symptoms, including rash, joint/muscle pain, fever, eye redness, and tiredness.

HOW TO USE: Read the Patient Information Leaflet provided by your pharmacist before you start using canakinumab and each time you get a refill.

This medication is injected under the skin as directed by your doctor, usually every eight weeks or as directed by your doctor. Dosage is based on your age, weight, medical condition, and response to treatment.

If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. While preparing the liquid, gently swirl the vial to dissolve the powder. Do not shake the vial. Before using, check this product visually for particles or discoloration. The mixed medication should be clear, and either colorless or a pale brownish yellow color. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely.

Before injecting each dose, clean the injection site with rubbing alcohol. It is important to change the location of the injection site each time to avoid problem areas under the skin. Do not inject into skin that is tender, red, or hard. Never reuse syringes or needles.

Use this medication regularly to get the most benefit from it. To help you remember, use it on the same day every 8 weeks. It may help to mark your calendar with a reminder.

Tell your doctor if your condition does not improve or if it worsens.

Disclaimer

Ilaris Consumer (continued)

SIDE EFFECTS: Redness, itching, pain, warmth, or swelling at the injection site may occur. Dizziness, nausea, diarrhea, or headache may also occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication can affect your immune system. It can lower your body's ability to fight an infection. You may be more likely to get serious infections, such as pneumonia, bone/joint infections, skin infections, or sinusitis. It may also be harder to fight an infection you already have. Tell your doctor immediately if you develop any signs of an infection, such as fever/chills, cough, or cold/flu symptoms.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the Ilaris (canakinumab injection) Side Effects Center for a complete guide to possible side effects »

PRECAUTIONS: Before using canakinumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: immune system problems (such as HIV infection), current/recent/returning infection (including hepatitis and tuberculosis), cancer.

This drug may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.

Before starting this drug, you should take a tuberculosis (TB) skin test to check for a type of tuberculosis that may not be causing any symptoms (latent TB). If you are diagnosed with TB, you must first be treated for it before you start canakinumab to prevent a serious TB infection.

Canakinumab can make you more likely to get infections or may worsen any current infections. Therefore, do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Also avoid contact with people who have infections that may spread to others (such as chickenpox, flu). Wash your hands well to prevent the spread of infections.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

Disclaimer

Ilaris Consumer (continued)

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include: other IL-1 blockers (such as anakinra, rilonacept), live vaccines, TNF-blockers (such as adalimumab, etanercept, infliximab).

OVERDOSE: If overdose is suspected, contact a local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this medication with others.

Laboratory and/or medical tests (such as CBC, liver function) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

MISSED DOSE: For the best possible benefit, it is important to receive each scheduled dose of this medication as directed. If you miss a dose, contact your doctor or pharmacist immediately to establish a new dosing schedule. Do not double the dose to catch up.

STORAGE: Store unmixed drug in the original container in the refrigerator between 36-46 degrees F (2-8 degrees C) away from light and moisture. Do not freeze. After mixing, if not used within 1 hour, store in the refrigerator and use within the time specified in the product instructions. Each vial of medication is for single use only. Throw away any unused portion. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.

MEDICAL ALERT: Your condition can cause complications in a medical emergency. For enrollment information call MedicAlert at 1-800-854-1166 (US), or 1-800-668-1507 (Canada).

Information last revised April 2012. Copyright(c) 2012 First Databank, Inc.

Ilaris Patient Information Including Side Effects

Brand Names: Ilaris

Generic Name: canakinumab (Pronunciation: KAN a KIN ue mab)

What is canakinumab (Ilaris)?

Canakinumab reduces the effects of a substance in the body that can cause inflammation.

Canakinumab is used to treat rare genetic conditions such as Familial Cold Autoinflammatory Syndrome (FCAS) and Muckle-Wells Syndrome (MWS) in adults and children who are at least 4 years old.

Canakinumab may also be used for other purposes not listed in this medication guide.

What are the possible side effects of canakinumab (Ilaris)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, unusual weakness;
  • cough with yellow or green mucus;
  • stabbing chest pain, feeling short of breath; or
  • severe dizziness or spinning sensation.

Less serious side effects may include:

  • runny or stuffy nose;
  • diarrhea, mild nausea;
  • headache;
  • joint or muscle pain;
  • mild dizziness; or
  • weight gain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Ilaris (canakinumab injection) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about canakinumab (Ilaris)?

You should not use this medication if you are allergic to canakinumab.

Before using canakinumab, tell your doctor if you have an active infection, a history of recurrent infections, a weak immune system, or a history of tuberculosis.

Your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Make sure you are current on all vaccines before you start treatment with canakinumab.

Canakinumab can make it easier for you to get sick. Avoid being near people who have colds, the flu, or other contagious illnesses.

Serious and sometimes fatal infections may occur during treatment with canakinumab. Contact your doctor right away if you have signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.

Treatment with canakinumab may increase your risk of developing cancer. Talk to your doctor about your individual risk.

Side Effects Centers

Ilaris Patient Information including How Should I Take

What should I discuss with my health care provider before using canakinumab (Ilaris)?

You should not use this medication if you are allergic to canakinumab.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:

  • an active infection;
  • a history of recurrent infections;
  • a weak immune system; or
  • a history of tuberculosis.

FDA pregnancy category C. It is not known whether canakinumab is harmful to an unborn baby. Before using this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

It is not known whether canakinumab passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Treatment with canakinumab may increase your risk of developing cancer. Talk to your doctor about your individual risk.

How should I use canakinumab (Ilaris)?

Use this medication exactly as prescribed by your doctor. Do not use it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Before you start treatment with canakinumab, your doctor may perform tests to make sure you do not have tuberculosis or other infections.

Canakinumab is given as an injection under the skin. Your doctor, nurse, or other healthcare provider will give you this injection. Canakinumab is usually given once every 8 weeks. Follow your doctor's instructions.

You may be shown how to inject your medicine at home. Do not self-inject this medicine if you do not fully understand how to give the injection and properly dispose of used needles and syringes.

You will need to mix canakinumab with a liquid (diluent) before using it. If you are using the injections at home, be sure you understand how to properly mix and store the medication.

Do not shake the medication vial (bottle) after mixing. Vigorous shaking can ruin the medicine. Do not draw your canakinumab dose into a syringe until you are ready to give yourself an injection. Do not use the medication if it has changed colors or has any particles in it. Call your doctor for a new prescription.

After mixing your medicine, protect it from light and use it within 1 hour.

Each single-use vial (bottle) of this medicine is for one use only. Throw away the vial after one use, even if there is still some medicine left in it after injecting your dose.

Use each disposable needle only one time. Throw away used needles in a puncture-proof container (ask your pharmacist where you can get one and how to dispose of it). Keep this container out of the reach of children and pets.

Canakinumab can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. To be sure your blood cells do not get too low, your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.

Store the powder medicine in the refrigerator and do not freeze. Keep the vial in its original carton to protect the medicine from light. Mixed medication may be stored in a refrigerator and used within 4 hours.

Side Effects Centers

Ilaris Patient Information including If I Miss a Dose

What happens if I miss a dose (Ilaris)?

Call your doctor for instructions if you miss a dose of this medicine.

What happens if I overdose (Ilaris)?

Seek emergency medical attention if you think you have used too much of this medicine.

Symptoms of a canakinumab overdose are not known.

What should I avoid while using canakinumab (Ilaris)?

Avoid being near people who have colds, the flu, or other contagious illnesses. Contact your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while you are being treated with canakinumab. The live vaccine may not work as well during this time, and may not fully protect you from disease. Live vaccines include measles, mumps, rubella (MMR), oral polio, chickenpox (varicella), BCG (Bacillus Calmette and Guérin), and nasal flu vaccine.

Make sure you are current on all vaccines before you begin treatment with canakinumab.

What other drugs will affect canakinumab (Ilaris)?

Tell your doctor about all other medications you use, especially:

  • adalimumab (Humira);
  • certolizumab (Cimzia);
  • cyclosporine (Gengraf, Neoral, Sandimmune);
  • digoxin (digitalis, Lanoxin, Lanoxicaps);
  • etanercept (Enbrel);
  • golimumab (Simponi);
  • infliximab (Remicade);
  • a blood thinner such as warfarin (Coumadin);
  • sirolimus (Rapamune) or tacrolimus (Prograf);
  • theophylline (Elixophyllin, Theo-24, Uniphyl);
  • seizure medication such as carbamazepine (Carbatrol, Tegretol), divalproex (Depakote), phenytoin (Dilantin), or valproic acid (Depakene); or
  • a heart rhythm medication such as disopyramide (Norpace), procainamide (Procan, Pronestyl), or quinidine (Quinidex, Quin-Release Quin-G).

This list is not complete and there may be other drugs that can interact with canakinumab. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

Where can I get more information?

Your doctor or pharmacist can provide more information about canakinumab.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 1.03. Revision date: 12/15/2010.

Your use of the content provided in this service indicates that you have read,understood and agree to the End-User License Agreement,which can be accessed by clicking on this link.

Healthwise

Side Effects Centers

توزیع کنندگان این دارو
شرکت های تولید کننده یا وارد کننده دارو

دارونـــما
نوآوری برای سلامت

طراحی و اجرا M.Ramezani
ارتباط با ما Info@darunama.com