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Ilaris

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Overview

What is Ilaris?

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 for Injection

ILARIS (canakinumab) for Injection is supplied as a white, preservative-free, lyophilized powder in a sterile, single-dose, colorless, glass vial with coated stopper and aluminum flip-off cap. Reconstitution with 1 mL of 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 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 A volume of up to 1 mL can be withdrawn for delivery of 150 mg canakinumab, L-histidine (2.8 mg), L-histidine HCl monohydrate (1.7 mg), polysorbate 80 (0.6 mg), sucrose (92.4 mg), and Sterile Water for Injection. 

ILARIS Injection

ILARIS (canakinumab) Injection is supplied as a sterile, preservative-free, clear to opalescent, colorless to slightly brownish-yellow solution for subcutaneous injection in a single-dose, glass vial with coated stopper and aluminum flip-off cap. Each vial delivers 1 mL containing 150 mg canakinumab, L-histidine (2.1 mg), L-histidine HCl monohydrate (1.3 mg), mannitol (49.2 mg), polysorbate 80 (0.4 mg), and Sterile Water for Injection.



What does Ilaris look like?



What are the available doses of Ilaris?

What should I talk to my health care provider before I take Ilaris?

How should I use Ilaris?

ILARIS (canakinumab) is an interleukin-1β (IL-1 β) blocker indicated for the treatment of the following autoinflammatory Periodic Fever Syndromes:

Cryopyrin-Associated Periodic Syndromes (CAPS)

ILARIS is indicated for the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), in adults and children 4 years of age and older including:

Tumor Necrosis Factor Receptor (TNF) Associated Periodic Syndrome (TRAPS)

ILARIS is indicated for the treatment of Tumor Necrosis Factor (TNF) receptor Associated Periodic Syndrome (TRAPS) in adult and pediatric patients.

Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD)

ILARIS is indicated for the treatment of Hyperimmunoglobulin D (Hyper-IgD) Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD) in adult and pediatric patients.

Familial Mediterranean Fever (FMF)

ILARIS is indicated for the treatment of Familial Mediterranean Fever (FMF) in adult and pediatric patients.

INJECTION FOR SUBCUTANEOUS USE ONLY.


What interacts with Ilaris?

Sorry No Records found


What are the warnings of Ilaris?

Sorry No Records found


What are the precautions of Ilaris?

Sorry No Records found


What are the side effects of Ilaris?

Sorry No records found


What should I look out for while using Ilaris?

Confirmed hypersensitivity to the active substance or to any of the excipients .


What might happen if I take too much Ilaris?

No confirmed 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. 


How should I store and handle Ilaris?

Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from moisture.Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure (as required).ILARIS for Injection (Lyophilized Powder)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0582-61Each 150 mg single-dose vial of ILARIS (canakinumab) for Injection contains a sterile, preservative free, white lyophilized powder. After reconstitution with 1 mL of Sterile Water for Injection, the resulting concentration is 150 mg/mL.ILARIS Injection (Solution)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0734-61Each single-dose vial of ILARIS (canakinumab) Injection delivers 150 mg/mL sterile, preservative-free, clear to slightly opalescent, colorless to a slight brownish to yellow solution.Special Precautions for StorageThe unopened vial must be stored refrigerated at 2°C to 8°C (36°F 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. ILARIS does not contain preservatives. Discard any unused portions of ILARIS or waste material in accordance with local requirements.Keep this and all drugs out of the reach of children.ILARIS for Injection (Lyophilized Powder)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0582-61Each 150 mg single-dose vial of ILARIS (canakinumab) for Injection contains a sterile, preservative free, white lyophilized powder. After reconstitution with 1 mL of Sterile Water for Injection, the resulting concentration is 150 mg/mL.ILARIS Injection (Solution)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0734-61Each single-dose vial of ILARIS (canakinumab) Injection delivers 150 mg/mL sterile, preservative-free, clear to slightly opalescent, colorless to a slight brownish to yellow solution.Special Precautions for StorageThe unopened vial must be stored refrigerated at 2°C to 8°C (36°F 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. ILARIS does not contain preservatives. Discard any unused portions of ILARIS or waste material in accordance with local requirements.Keep this and all drugs out of the reach of children.ILARIS for Injection (Lyophilized Powder)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0582-61Each 150 mg single-dose vial of ILARIS (canakinumab) for Injection contains a sterile, preservative free, white lyophilized powder. After reconstitution with 1 mL of Sterile Water for Injection, the resulting concentration is 150 mg/mL.ILARIS Injection (Solution)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0734-61Each single-dose vial of ILARIS (canakinumab) Injection delivers 150 mg/mL sterile, preservative-free, clear to slightly opalescent, colorless to a slight brownish to yellow solution.Special Precautions for StorageThe unopened vial must be stored refrigerated at 2°C to 8°C (36°F 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. ILARIS does not contain preservatives. Discard any unused portions of ILARIS or waste material in accordance with local requirements.Keep this and all drugs out of the reach of children.ILARIS for Injection (Lyophilized Powder)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0582-61Each 150 mg single-dose vial of ILARIS (canakinumab) for Injection contains a sterile, preservative free, white lyophilized powder. After reconstitution with 1 mL of Sterile Water for Injection, the resulting concentration is 150 mg/mL.ILARIS Injection (Solution)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0734-61Each single-dose vial of ILARIS (canakinumab) Injection delivers 150 mg/mL sterile, preservative-free, clear to slightly opalescent, colorless to a slight brownish to yellow solution.Special Precautions for StorageThe unopened vial must be stored refrigerated at 2°C to 8°C (36°F 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. ILARIS does not contain preservatives. Discard any unused portions of ILARIS or waste material in accordance with local requirements.Keep this and all drugs out of the reach of children.ILARIS for Injection (Lyophilized Powder)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0582-61Each 150 mg single-dose vial of ILARIS (canakinumab) for Injection contains a sterile, preservative free, white lyophilized powder. After reconstitution with 1 mL of Sterile Water for Injection, the resulting concentration is 150 mg/mL.ILARIS Injection (Solution)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0734-61Each single-dose vial of ILARIS (canakinumab) Injection delivers 150 mg/mL sterile, preservative-free, clear to slightly opalescent, colorless to a slight brownish to yellow solution.Special Precautions for StorageThe unopened vial must be stored refrigerated at 2°C to 8°C (36°F 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. ILARIS does not contain preservatives. Discard any unused portions of ILARIS or waste material in accordance with local requirements.Keep this and all drugs out of the reach of children.ILARIS for Injection (Lyophilized Powder)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0582-61Each 150 mg single-dose vial of ILARIS (canakinumab) for Injection contains a sterile, preservative free, white lyophilized powder. After reconstitution with 1 mL of Sterile Water for Injection, the resulting concentration is 150 mg/mL.ILARIS Injection (Solution)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0734-61Each single-dose vial of ILARIS (canakinumab) Injection delivers 150 mg/mL sterile, preservative-free, clear to slightly opalescent, colorless to a slight brownish to yellow solution.Special Precautions for StorageThe unopened vial must be stored refrigerated at 2°C to 8°C (36°F 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. ILARIS does not contain preservatives. Discard any unused portions of ILARIS or waste material in accordance with local requirements.Keep this and all drugs out of the reach of children.ILARIS for Injection (Lyophilized Powder)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0582-61Each 150 mg single-dose vial of ILARIS (canakinumab) for Injection contains a sterile, preservative free, white lyophilized powder. After reconstitution with 1 mL of Sterile Water for Injection, the resulting concentration is 150 mg/mL.ILARIS Injection (Solution)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0734-61Each single-dose vial of ILARIS (canakinumab) Injection delivers 150 mg/mL sterile, preservative-free, clear to slightly opalescent, colorless to a slight brownish to yellow solution.Special Precautions for StorageThe unopened vial must be stored refrigerated at 2°C to 8°C (36°F 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. ILARIS does not contain preservatives. Discard any unused portions of ILARIS or waste material in accordance with local requirements.Keep this and all drugs out of the reach of children.ILARIS for Injection (Lyophilized Powder)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0582-61Each 150 mg single-dose vial of ILARIS (canakinumab) for Injection contains a sterile, preservative free, white lyophilized powder. After reconstitution with 1 mL of Sterile Water for Injection, the resulting concentration is 150 mg/mL.ILARIS Injection (Solution)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0734-61Each single-dose vial of ILARIS (canakinumab) Injection delivers 150 mg/mL sterile, preservative-free, clear to slightly opalescent, colorless to a slight brownish to yellow solution.Special Precautions for StorageThe unopened vial must be stored refrigerated at 2°C to 8°C (36°F 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. ILARIS does not contain preservatives. Discard any unused portions of ILARIS or waste material in accordance with local requirements.Keep this and all drugs out of the reach of children.ILARIS for Injection (Lyophilized Powder)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0582-61Each 150 mg single-dose vial of ILARIS (canakinumab) for Injection contains a sterile, preservative free, white lyophilized powder. After reconstitution with 1 mL of Sterile Water for Injection, the resulting concentration is 150 mg/mL.ILARIS Injection (Solution)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0734-61Each single-dose vial of ILARIS (canakinumab) Injection delivers 150 mg/mL sterile, preservative-free, clear to slightly opalescent, colorless to a slight brownish to yellow solution.Special Precautions for StorageThe unopened vial must be stored refrigerated at 2°C to 8°C (36°F 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. ILARIS does not contain preservatives. Discard any unused portions of ILARIS or waste material in accordance with local requirements.Keep this and all drugs out of the reach of children.ILARIS for Injection (Lyophilized Powder)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0582-61Each 150 mg single-dose vial of ILARIS (canakinumab) for Injection contains a sterile, preservative free, white lyophilized powder. After reconstitution with 1 mL of Sterile Water for Injection, the resulting concentration is 150 mg/mL.ILARIS Injection (Solution)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0734-61Each single-dose vial of ILARIS (canakinumab) Injection delivers 150 mg/mL sterile, preservative-free, clear to slightly opalescent, colorless to a slight brownish to yellow solution.Special Precautions for StorageThe unopened vial must be stored refrigerated at 2°C to 8°C (36°F 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. ILARIS does not contain preservatives. Discard any unused portions of ILARIS or waste material in accordance with local requirements.Keep this and all drugs out of the reach of children.ILARIS for Injection (Lyophilized Powder)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0582-61Each 150 mg single-dose vial of ILARIS (canakinumab) for Injection contains a sterile, preservative free, white lyophilized powder. After reconstitution with 1 mL of Sterile Water for Injection, the resulting concentration is 150 mg/mL.ILARIS Injection (Solution)Carton of 1 vial………………………………………………………………………………………….NDC 0078-0734-61Each single-dose vial of ILARIS (canakinumab) Injection delivers 150 mg/mL sterile, preservative-free, clear to slightly opalescent, colorless to a slight brownish to yellow solution.Special Precautions for StorageThe unopened vial must be stored refrigerated at 2°C to 8°C (36°F 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. ILARIS does not contain preservatives. Discard any unused portions of ILARIS or waste material in accordance with local requirements.Keep this and all drugs out of the reach of children.


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Clinical Information

Chemical Structure

No Image found
Clinical Pharmacology

Canakinumab is a human monoclonal anti-human IL-1β antibody of the IgG1/κ isotype. Canakinumab binds to human IL-1β 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).

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 Autoinflammatory 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 IL-1β. Mutations in NLRP-3 result in an overactive inflammasome resulting in excessive release of activated IL-1β that drives inflammation. SJIA is a severe autoinflammatory disease, driven by innate immunity by means of proinflammatory cytokines such as IL-1β.

Non-Clinical Toxicology
Confirmed hypersensitivity to the active substance or to any of the excipients .

Many drugs affect thyroid hormone pharmacokinetics and metabolism (e.g., absorption, synthesis, secretion, catabolism, protein binding, and target tissue response) and may alter the therapeutic response to Levothyroxine sodium tablets, USP. In addition, thyroid hormones and thyroid status have varied effects on the pharmacokinetics and actions of other drugs. A listing of drug-thyroidal axis interactions is contained in Table 2.

The list of drug-thyroidal axis interactions in Table 2 may not be comprehensive due to the introduction of new drugs that interact with the thyroidal axis or the discovery of previously unknown interactions. The prescriber should be aware of this fact and should consult appropriate reference sources (e.g., package inserts of newly approved drugs, medical literature) for additional information if a drug-drug interaction with levothyroxine is suspected.









Drug-Food Interactions





Carcinogenesis, Mutagenesis, and Impairment of Fertility

Pregnancy - Category A

Hypothyroidism during pregnancy is associated with a higher rate of complications, including spontaneous abortion, pre-eclampsia, stillbirth and premature delivery. Maternal hypothyroidism may have an adverse effect on fetal and childhood growth and development. During pregnancy, serum T levels may decrease and serum TSH levels increase to values outside the normal range. Since elevations in serum TSH may occur as early as 4 weeks gestation, pregnant women taking Levothyroxine sodium tablets, USP should have their TSH measured during each trimester. An elevated serum TSH level should be corrected by an increase in the dose of Levothyroxine sodium tablets, USP. Since postpartum TSH levels are similar to preconception values, the Levothyroxine sodium tablets, USP dosage should return to the pre-pregnancy dose immediately after delivery. A serum TSH level should be obtained 6-8 weeks postpartum.

Thyroid hormones cross the placental barrier to some extent as evidenced by levels in cord blood of athyreotic fetuses being approximately one-third maternal levels. Transfer of thyroid hormone from the mother to the fetus, however, may not be adequate to prevent hypothyroidism.

Nursing Mothers

ILARIS has been 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 (e.g., aspergillosis, atypical mycobacterial infections, cytomegalovirus, herpes zoster) were reported during ILARIS treatment. A causal relationship of ILARIS to these events cannot be excluded. 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. Coadministration of ILARIS 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 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. 

Approximately 570 patients have been treated with ILARIS in interventional trials in CAPS, TRAPS, HIDS/MKD, FMF or SJIA. These clinical trials included approximately 350 children up to 17 years of age. The most frequently reported adverse drug reactions were infections predominantly of the upper respiratory tract. The majority of the events were mild to moderate although serious infections were observed.

Opportunistic infections have also been reported in patients treated with ILARIS

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Reference

This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"

While we update our database periodically, we cannot guarantee it is always updated to the latest version.

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Professional

Clonazepam Description Each single-scored tablet, for oral administration, contains 0.5 mg, 1 mg, or 2 mg Clonazepam, USP, a benzodiazepine. Each tablet also contains corn starch, lactose monohydrate, magnesium stearate, microcrystalline cellulose, and povidone. Clonazepam tablets USP 0.5 mg contain Yellow D&C No. 10 Aluminum Lake. Clonazepam tablets USP 1 mg contain Yellow D&C No. 10 Aluminum Lake, as well as FD&C Blue No. 1 Aluminum Lake. Chemically, Clonazepam, USP is 5-(o-chlorophenyl)-1,3-dihydro-7-nitro-2H-1,4-benzodiazepin-2-one. It is a light yellow crystalline powder. It has the following structural formula: C15H10ClN3O3 M.W. 315.72
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Tips

Tips

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Interactions

Interactions

A total of 440 drugs (1549 brand and generic names) are known to interact with Imbruvica (ibrutinib). 228 major drug interactions (854 brand and generic names) 210 moderate drug interactions (691 brand and generic names) 2 minor drug interactions (4 brand and generic names) Show all medications in the database that may interact with Imbruvica (ibrutinib).