"Oct. 17, 2012 -- A drug used to treat psoriasis may provide a much-needed option for people with bad cases of Crohn's disease.
In the new study, some people with moderate to severe Crohn's given Stelara (ustekinumab) began to see imp"...
STELARA® is a human IgG1κ monoclonal antibody against the p40 subunit of the IL-12 and IL23 cytokines. Using DNA recombinant technology, STELARA® 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. STELARA® is comprised of 1326 amino acids and has an estimated molecular mass that ranges from 148,079 to 149,690 Daltons.
STELARA®, for subcutaneous use, is available as: 45 mg of ustekinumab in 0.5 mL and 90 mg of ustekinumab in 1 mL. STELARA® is supplied as a sterile solution in a single-use prefilled syringe with a 27 gauge fixed ½ inch needle, or a single-use 2 mL Type I glass vial with a coated stopper. The syringe is fitted with a passive needle guard and a needle cover that is manufactured using a dry natural rubber (a derivative of latex).
Each 45 mg ustekinumab prefilled syringe also contains: L-histidine and L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg) to fill to a final volume of 0.5 mL.
Each 90 mg ustekinumab prefilled syringe also contains: L-histidine and L-histidine monohydrochloride monohydrate (1 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg) to fill to a final volume of 1 mL.
Each 45 mg ustekinumab vial also contains: L-histidine and L-histidine monohydrochloride monohydrate (0.5 mg), Polysorbate 80 (0.02 mg), and sucrose (38 mg) to fill to a final volume of 0.5 mL.
Each 90 mg ustekinumab vial also contains: L-histidine and L-histidine monohydrochloride monohydrate (1 mg), Polysorbate 80 (0.04 mg), and sucrose (76 mg) to fill to a final volume of 1 mL.
The STELARA® solution is colorless to slightly yellow in appearance and has a pH of 5.7-6.3. STELARA® does not contain preservatives.
What are the possible side effects of ustekinumab (Stelara, Stelara PFS)?
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.
Stop using this medication and 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, swollen glands, unusual weakness;
- mouth and throat ulcers, rapid heart rate, rapid and shallow breathing, fainting;
- swelling, pain, tenderness, or redness anywhere on your body;
- pain or burning when you...
What are the precautions when taking ustekinumab (Stelara Injection)?
Before using ustekinumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as natural rubber/latex found in the needle cover on the prefilled syringe), 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: current/recent/returning infection (including hepatitis and tuberculosis), cancer.
Ustekinumab 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...
Last reviewed on RxList: 3/18/2014
This monograph has been modified to include the generic and brand name in many instances.
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