Ustekinumab Injection is used to treat Some types of Psoriatic Arthritis and Ulcerative colitis.
What is STELARA and how is it used?
STELARA is a prescription medicine used to treat:
adults and children 6 years and older with moderate or severe psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy(treatment using ultraviolet light alone or with pills).
- adults 18 years and older with active psoriatic arthritis. STELARA can be used alone or with the medicine methotrexate.
- adults 18 years and older with moderately to severely active Crohn's disease.
- adults 18 years and older with moderately to severely active ulcerative colitis.
- It is not known if STELARA is safe and effective in children less than 6 years of age.
What are the possible side effects of STELARA?
STELARA may cause serious side effects, including:
See What is the most important information I should know about STELARA?
Serious allergic reactions. Serious allergic reactions can occur with STELARA. Stop using STELARA and get medical help right away if you have any of the following symptoms of a serious allergic reaction:
swelling of your face, eyelids, tongue, or throat
Lung inflammation. Cases of lung inflammation have happened in some people who receive STELARA, and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesnt go away during treatment with STELARA.
Common side effects of STELARA include:
nasal congestion, sore throat, and runny nose
- upper respiratory infections
- nausea and vomiting
- redness at the injection site
- vaginal yeast infections
- urinary tract infections
- sinus infection
- stomach pain
These are not all of the possible side effects of STELARA. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Ustekinumab is a human IgG1 monoclonal antibody against the p40 subunit of the IL-12 and IL-23 cytokines. Using DNA recombinant technology, ustekinumab is produced in a well characterized recombinant cell line and is purified using standard bio-processing technology. 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 5.7- 6.3.
STELAR For Subcutaneous Use
Available as 45 mg of ustekinumab in 0.5 mL and 90 mg of ustekinumab in 1 mL, supplied as a sterile solution in a single-dose prefilled syringe with a 27 gauge fixed inch needle and as 45 mg of ustekinumab in 0.5 mL in a single-dose 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that contains dry natural rubber (a derivative of latex).
Each 0.5 mL prefilled syringe or vial delivers 45 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg).
Each 1 mL prefilled syringe delivers 90 mg ustekinumab, L-histidine and L-histidine monohydrochloride monohydrate (1 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg).
STELARFor Intravenous Infusion
Available as 130 mg of ustekinumab in 26 mL, supplied as a single-dose 30 mL Type I glass vial with a coated stopper.
Each 26 mL vial delivers 130 mg ustekinumab, EDTA disodium salt dihydrate (0.52 mg), L-histidine (20 mg), L-histidine hydrochloride monohydrate (27 mg), L-methionine (10.4 mg), Polysorbate 80 (10.4 mg) and sucrose (2210 mg).