Canakinumab (Ilaris)

Trade Name : Ilaris

Novartis Pharmaceuticals Corporation

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Strength 150 mg/mL

CANAKINUMAB

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Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Canakinumab (Ilaris) which is also known as Ilaris and Manufactured by Novartis Pharmaceuticals Corporation. It is available in strength of 150 mg/mL per ml. Read more

Canakinumab (Ilaris) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials. Click to know price. Read less

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About GNH

No data

No data

ILARIS is an interleukin-1u03b2 blocker indicated for the treatment of:
Periodic Fever Syndromes:
1.2

Cryopyrin-Associated Periodin- cn- Syndromes (CAPS)
Arrayn- Array
Tumor Necrosis Factor Receptor Associated Periodic Syndrome (TRAPS)
Hyperimmunoglobulin D Syndrome (HIDS)/Mevalonate Kinase Deficiency (MKD)
Familial Mediterranean Fever (FMF)

CAPS
150 mg for CAPS patients with body weight greater than 40 kg and 2 mg/kgu00a0for CAPS patients with body weight greater than or equal to 15 kg and lessu00a0than or equal to 40 kg.u00a0For children 15 to 40 kg with an inadequate response, the dose can be increased to 3 mg/kg. Administer subcutaneously every 8 weeks. ()
TRAPS, HIDS/ MKD, and FMF
SJIA
4 mg/kg (with a maximum of 300u00a0mg) for patients with a body weight greater than or equal to 7.5u00a0kg.u00a0Administer subcutaneously every 4 weeks. ()

No data

For Injection: 150 mg lyophilized powder in single-dose vials for reconstitution.u00a0()u00a0
Injection: 150 mg/mL solution in single-dose vials. ()u00a0

Confirmed hypersensitivity to the active substance or to any of the excipients n n n n n n n n n n n n .
Confirmed hypersensitivity to the active substance or to any of the excipients. ()

No data

Interleukin-1 blockade may interfere with immune response to infections.u00a0Treatment with medications that work through inhibition of IL-1 has been associated with an increased risk of serious infections.u00a0ILARIS hasu00a0been associated with an increased incidence of serious infections.u00a0Physicians should exercise caution when administering ILARIS to patients with infections, a history of recurring infections or underlying conditions which may predispose them to infections.u00a0Discontinue treatment with ILARIS if a patient develops a serious infection.u00a0Do not administer ILARIS to patients during an active infection requiring medical intervention.u00a0()n
Live vaccines should not be given concurrently with ILARIS.u00a0Prior to initiation of therapy with ILARIS, patients should receive all recommended vaccinations. ()

Approximately 570 patientsu00a0have 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 n n
CAPS:
TRAPS, HIDS/MKD, and FMF:
SJIA:

Interactions between ILARISu00a0and other medicinal products have not been investigated in formal studies.
No formal drug interaction studies have been conducted with ILARIS. ()

No data

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.u00a0

Canakinumab is a recombinant, human anti-human-IL-1u03b2 monoclonal antibody that belongs to the IgG1/u03ba isotype subclass.u00a0It 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.u00a0Both heavy chains of canakinumab contain oligosaccharide chains linked to the protein backbone at asparagine 298 (Asn 298).u00a0
The biological activity of canakinumab is measured by comparing its inhibition of IL-1u03b2-dependent expression of the reporter gene luciferase to that of a canakinumab internal reference standard, using a stably transfected cell line.u00a0
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.u00a0Reconstitution with 1 mL of Sterile Water for Injection is required prior to subcutaneous administration of the drug.u00a0The 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.u00a0A volume of up to 1 mL can be withdrawn for delivery of 150u00a0mg 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.u00a0
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.

No data

Long-term animal studies have not been performed to evaluate the carcinogenic potential of canakinumab.u00a0
As canakinumab does not cross-react with rodent IL-1u03b2, male and female fertility was evaluated in a mouse model using a murine analog of canakinumab.u00a0Male mice were treated weekly beginning 4 weeks prior to mating and continuing through 3 weeks after mating.u00a0Female mice were treated weekly for 2 weeks prior to mating through gestation day 3 or 4.u00a0The murine analog of canakinumab did not alter either male or female fertility parameters at subcutaneous doses up to 150 mg/kg.u00a0

No data

ILARIS for Injection (Lyophilized Powder)
Carton of 1 vialu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026.NDC 0078-0582-61
Each 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 resultingu00a0concentration is 150 mg/mL.
ILARIS Injection (Solution)
Carton of 1 vialu2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026u2026.NDC 0078-0734-61
Each 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 n- Sn- torage
The unopened vial must be stored refrigerated at 2u00b0C to 8u00b0C (36u00b0F to 46u00b0 F).u00a0Do not freeze.u00a0Store in the original carton to protect from light. Do not use beyond the date stamped on the label.u00a0ILARIS does not contain preservatives. Discard any unused portions of ILARISu00a0or waste material in accordance with local requirements.
Keep this and all drugs out of the reach of children.

See FDA-approved patient labeling (Medication Guide)
Patients should be advised of the potential benefits and risks of ILARIS. Physicians should instruct their patients to read the Medication Guide before starting ILARIS therapy.
Drug Administrationn- u00a0
Patients should be advised that healthcare providers should perform administration of ILARIS by the subcutaneous injection route.
Infections
Patients should be cautioned that ILARISu00a0use has been associated with serious infections.u00a0Patients should be counseled to contact their healthcare professional immediately if they develop an infection after starting ILARIS.u00a0Treatment with ILARISu00a0should be discontinued if a patient develops a serious infection.u00a0Patients 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.u00a0Use of ILARISu00a0with other IL-1 blocking agents, such as rilonacept and anakinra is not recommended.u00a0Patients 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 withu00a0ILARIS, 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 withu00a0ILARIS.
Injection-site Reactin- ons
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.
Pregnancy
Advise female patients of the potential risk to a fetus n
Manufactured by:Novartis Pharmaceuticals CorporationEast Hanover, New Jersey 07936
US License Number 1244
Distributed by: Novartis Pharmaceuticals Corporation East Hanover, New Jersey 07936
u00a9 Novartis
T2016-102
December 2016

This Medication Guide has been approved by the U.S. Food and Drug Administration.
Revised: December 2016
T2016-103December 2016

PRINCIPAL DISPLAY PANEL
Package Label n- u2013n- u00a0n- 150 mg/vial
Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0582-61
ILARIS (canakinumab)
for Injection
150 mg/vial
For Subcutaneous Use
Reconstitute Prior to Use
Attention: Dispense with enclosed Medication Guide.
Single-Dose Vial. Discard Unused Portion. Sterile, Lyophilized
Reconstitute with 1 mL of Sterile Water for Injection to obtain a concentration of 150 mg/mL canakinumab, L-histidine (2.8 mg/mL), L-histidine hydrochloride monohydrate (1.7 mg/mL), polysorbate 80 (0.6 mg/mL), and sucrose (92.4 mg/mL).

PRINCIPAL DISPLAY PANEL
Package Label n- u2013n- u00a0n- 150 mg/mL
Rx Onlynttu00a0u00a0u00a0u00a0u00a0ntnttu00a0u00a0u00a0u00a0u00a0ntNDC 0078-0734-61
ILARISu00ae (canakinumab)
Injection
150 mg/mL
For Subcutaneous Use
Single-Dose Vial. Discard Unused portion
Attention: Dispense with enclosed Medication Guide

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Canakinumab (Ilaris)

Trade Name : Ilaris

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

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Canakinumab (Ilaris)

Trade Name : Ilaris

INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION

Delivery Process

Product information is meant for

Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

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