Ustekinumab (Stelara)

Trade Name : Stelara

Janssen Biotech, Inc.

SOLUTION

Strength 130 mg/26mL

USTEKINUMAB Interleukin-12 Antagonists [MoA],Interleukin-23 Antagonist [EPC],Interleukin-23 Antagonists [MoA],Interleukin-12 Antagonist [EPC]

Delivery Process

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Product information is meant for

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

Disclaimer

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 Ustekinumab (Stelara) which is also known as Stelara and Manufactured by Janssen Biotech, Inc.. It is available in strength of 130 mg/26mL per ml. Read more

Ustekinumab (Stelara) 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

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

No data

No data

STELARA is a human interleukin-12 and -23 antagonist indicated for the treatment of:
Adult patients with:
Pediatric patients 6 years and older with:

Psoriasis Adult Subcutaneous Recommended Dosage ()
Psoriasis Pediatric Patients (6 to 17) Subcutaneous Recommended Dosage ()
Weight based dosing is recommended at the initial dose, 4 weeks later, then every 12 weeks thereafter.
Psoriatic Arthritis Adult Subcutaneous Recommended Dosage ():
Crohn's Disease and Ulcerative Colitis Initial Adult Intravenous Recommended Dosage ()
A single intravenous infusion using weight-based dosing:
Crohn's Disease and Ulcerative Colitis Maintenance Adult Subcutaneous Recommended Dosage ()
A subcutaneous 90 mg dose 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

The recommended dosage is 45 mg administered subcutaneously initially and 4 weeks later, followed by 45 mg administered subcutaneously every 12 weeks.
For patients with co-existent moderate-to-severe plaque psoriasis weighing greater than 100 kg, the recommended dosage is 90 mg administered subcutaneously initially and 4 weeks later, followed by 90 mg administered subcutaneously every 12 weeks.

STELARA (ustekinumab) is a colorless to light yellow solution and may contain a few small translucent or white particles.
3
3

STELARA is contraindicated in patients with clinically significant hypersensitivity to ustekinumab or to any of the excipients n
Clinically significant hypersensitivity to ustekinumab or to any of the excipients. ()

No data

Infections
Theoretical Risk for Particular Infections
Tuberculosis (TB)
Malignancies
Hypersensitivity Reactions
Posterior Reversible Encephalopathy Syndrome (PRES)
Noninfectious Pneumonia

The following serious adverse reactions are discussed elsewhere in the label:
Most common adverse reactions are:
To report SUSPECTED ADVERSE REACTIONS, contact Janssen Biotech, Inc. at 1-800-JANSSEN (1-800-526-7736) or FDA at 1-800-FDA-1088 or n

Psoriasis (u22653%): nasopharyngitis, upper respiratory tract infection, headache, and fatigue. ()
Crohn's Disease, induction (u22653%): vomiting. ()
Crohn's Disease, maintenance (u22653%): nasopharyngitis, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, and sinusitis. ()
Ulcerative colitis, induction (u22653%): nasopharyngitis ()
Ulcerative colitis, maintenance (u22653%): nasopharyngitis, headache, abdominal pain, influenza, fever, diarrhea, sinusitis, fatigue, and nausea ()

No data

No data

Single doses up to 6 mg/kg intravenously have been administered in clinical studies without dose-limiting toxicity. In case of overdosage, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions or effects and appropriate symptomatic treatment be instituted immediately.

Ustekinumab, a human IgG1u03ba monoclonal antibody, is a human interleukin-12 and -23 antagonist. Using DNA recombinant technology, ustekinumab is produced in a murine cell line (Sp2/0). The manufacturing process contains steps for the clearance of viruses. Ustekinumab is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons.
STELARA (ustekinumab) injection is a sterile, preservative-free, colorless to light yellow solution and may contain a few small translucent or white particles with pH of 5.7u2013 6.3.

No data

No data

No data

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STELARA (ustekinumab) injection is a sterile, preservative-free, colorless to light yellow solution and may contain a few small translucent or white particles. It is supplied as individually packaged, single-dose prefilled syringes or single-dose vials.

Advise the patient and/or caregiver to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).

Prefilled Syringe Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864 at Baxter Pharmaceutical Solutions, Bloomington, IN 47403 and at Cilag AG, Schaffhausen, Switzerland
Vial Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864 at Cilag AG, Schaffhausen, Switzerland
u00a9 2012, 2016, 2019 Janssen Pharmaceutical Companies

No data

INSTRUCTIONS FOR USESTELARA (n- )(ustekinumab)injection, for subcutaneous use
Instructions for injecting STELARA using a prefilled syringe.
Read this Instructions for Use before you start using STELARA. Your doctor or nurse should show you how to prepare and give your injection of STELARA the right way.
If you cannot give yourself the injection:
Do not try to inject STELARA yourself until you have been shown how to inject STELARA by your doctor, nurse or health professional.
Important information:
Gather the supplies you will need to prepare and to give your injection. (See )
You will need:
Figure A
Figure B
To prevent early activation of the needle safety guard, do not touch the NEEDLE GUARD ACTIVATION CLIPS at any time during use.
Step 1: Prepare the injection.
Step 2: Prepare your injection site
Figure C
*Areas in gray are recommended injection sites.
Step 3: Inject STELARA
Figure D
Figure E
Figure F
Figure G
Figure H
If your dose is 90 mg, you will receive either one 90 mg prefilled syringe or two 45 mg prefilled syringes. If you receive two 45 mg prefilled syringes for a 90 mg dose, you will need to give yourself a second injection right after the first. Repeat Steps 1u20133 for the second injection using a new syringe. Choose a different site for the second injection.
Step 4: Dispose of the syringe.
Keep STELARA and all medicines out of the reach of children.
Prefilled Syringe Manufactured by:Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864 at Baxter Pharmaceutical Solutions, Bloomington, IN 47403 and at Cilag AG, Schaffhausen, Switzerland
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 03/2020
u00a9 2012 Janssen Pharmaceutical Companies

INSTRUCTIONS FOR USESTELARA (n- )(ustekinumab)injection, for subcutaneous use
Instructions for injecting STELARA from a vial.
Read this Instructions for Use before you start using STELARA. Your doctor or nurse should show you how to prepare, measure your dose, and give your injection of STELARA the right way.
If you cannot give yourself the injection:
Do not try to inject STELARA yourself until you have been shown how to inject STELARA by your doctor, nurse or health professional.
Important information:
Gather the supplies you will need to prepare STELARA and to give your injection. (See )
You will need:
Figure A
Step 1: Prepare the injection.
Step 2: Prepare your injection site
Figure B
*Areas in gray are recommended injection sites.
Step 3: Prepare the vial.
Figure C
Figure D
Step 4:tPrepare the needle
Figure E
Figure F
Figure G
Figure H
Step 5: Inject STELARA
Figure I
Figure J
If your dose is 90 mg, you will receive two 45 mg vials and you will need to give yourself a second injection right after the first. Repeat Steps 1u20135 using a new syringe.
Step 6: Dispose of the needles and syringes.
Keep STELARA and all medicines out of the reach of children.
Vial Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044, US License No. 1864 at Cilag AG, Schaffhausen, Switzerland
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 03/2020
u00a9 2012, 2016 Janssen Pharmaceutical Companies

Stelara
45 mg/0.5 mL
For subcutaneous use
Contains one 45 mg/0.5 mL syringe
NDC 57894-060-03
Single-dose prefilled syringe - Discard unused portionn
The 45 mg prefilled syringe contains:45 mg ustekinumab, 0.5 mg L-histidine and L-histidinemonohydrochloride monohydrate, 0.02 mg polysorbate 80, and 38 mg sucrose to fill a final volume of 0.5 mL
See package insert for dosing information
Rx only
ATTENTION: Dispense the enclosed Medication Guideto each patient.
u00a9 2009 Janssen

Stelara
90 mg/mL
For subcutaneous use
Contains one 90 mg/mL syringe
NDC 57894-061-03
Single-dose prefilled syringe - Discard unused portionn
The 90 mg prefilled syringe contains:90 mg ustekinumab, 1 mg L-histidine and L-histidinemonohydrochloride monohydrate, 0.04 mg polysorbate 80, and 76 mg sucrose to fill a final volume of 1 mL
See package insert for dosing information
Rx only
ATTENTION: Dispense the enclosed MedicationGuide to each patient.
u00a9 2009 Janssen

NDC 57894-054-27
Single-Dose vialDiscard unused portion
Stelara
130 mg/26 mL(5 mg/mL)
For Intravenous Infusion Only
ATTENTION: Dispensethe enclosed MedicationGuide to each patient.
Rx only
janssen

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Ustekinumab (Stelara)

Trade Name : Stelara

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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Ustekinumab (Stelara)

Trade Name : Stelara

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

Can’t find what you’re looking for?

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QUICK LINKS

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