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Stelara™ Ustekinumab 90 Mg / Ml Injection Prefilled Syringe 1 Ml

  • Manufacturer Name : J-O-M PHARM SERVICES
  • MFG # : 57894006103
  • NDC : 57894006103
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description Ustekinumab inj, 1 MG
Description S
DESI Drug Ind -; -
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category USES: Ustekinumab is used to treat plaque psoriasis, a certain type of arthritis (psoriatic arthritis), or certain bowel conditions (Crohn's disease, ulcerative colitis). It works by blocking certain natural proteins in your body (interleukin-12 and interleukin-23) that cause inflammation (swelling) in these conditions. Ustekinumab does not cure these diseases, but helps to lessen symptoms of the disease. It can help to decrease the amount of plaques in plaque psoriasis, decrease the number of swollen/painful joints in psoriatic arthritis, and decrease symptoms such as abdominal pain/cramping and diarrhea in Crohn's disease and ulcerative colitis.
Drug Category S
Drug Type Code COMMON BRAND NAME(S): Stelara
Drug Type Code 1
FDA Approval Date 09/25/2009
FDA Therap Equiv NR
HCPCS J3357
HCPCS 1
Market Entry Date 02/22/2010
Medical Coverage -
Medical Coverage COVERED WITH CARRIER DISCRETION
Termination Date (US-te-KIN-ue-mab)
Termination Date -
Unit ML
Units Per Pkg 1
Active Ingredients 13009 ustekinumab 815610630
Active Ingredients 13009 ustekinumab 815610630
AHFS Class 84920000 SKIN AND MUCOUS MEMBRANE AGENTS, MISC.; 92200000 IMMUNOMODULATORY AGENTS; 92360000 DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
AHFS Class 84920000 SKIN AND MUCOUS MEMBRANE AGENTS, MISC.; 92200000 IMMUNOMODULATORY AGENTS; 92360000 DISEASE-MODIFYING ANTIRHEUMATIC AGENTS
DEA Class NC
DEA Class NC
Dose Form SYRINGE (ML)
Dose Form SYRINGE (ML)
Fine Line Class 850085008510 All Rx Products
Fine Line Class 850085008510 All Rx Products
Gen Code and Des 65994 ustekinumab SUBCUT SYRINGE 90 MG/ML
Gen Code and Des 65994 ustekinumab SUBCUT SYRINGE 90 MG/ML
Inactive Ingredients 2551 polysorbates 9005645; 2598 sucrose 57501; 8921 latex
Inactive Ingredients 2551 polysorbates 9005645; 2598 sucrose 57501; 8921 latex
OMP Family -
OMP Family -
Product Category RX Pharmaceuticals
Product Category RX Pharmaceuticals
Strength 90MG
Strength 90MG
Common Brand Name J3357
Common Brand Name COMMON BRAND NAME(S): Stelara
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.
Drug Interaction -
Allocation Period Weekly
Allocation Period Weekly
Case Quantity 96
Case Quantity 96
Drug Form Pack Size 1
Drug Form Pack Size 1
Form PRE-FILLED SYRINGE
Form PRE-FILLED SYRINGE
Hazard Code -
Hazard Code -
Listed Chemical -
Listed Chemical -
NIOSH Code -
NIOSH Code -
Orange Book ZB Particular pharmaceutical entity was not evaluated.
Orange Book ZB Particular pharmaceutical entity was not evaluated.
Retail Pack Quantity 1
Retail Pack Quantity 1
Returnable Status Returnable
Returnable Status Returnable
Special Storage Cond 00 None
Special Storage Cond 00 None
Temp Zone 30 Refrige./DoNot Freez
Temp Zone 30 Refrige./DoNot Freez
Unit EA
Unit EA
Unit Size 1
Unit Size 1
How to Use -
How to Use HOW TO USE: Read the Medication Guide and the Instructions for Use provided by your pharmacist before you start using ustekinumab and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Before starting this drug, you should take a tuberculosis (TB) skin test to check for a type of tuberculosis that may not be causing any symptoms (latent TB). If you are diagnosed with TB, to prevent a serious TB infection you must first be treated for it before you start ustekinumab. For the treatment of psoriasis or psoriatic arthritis, this medication is given by injection under your skin as directed by your doctor. You will receive one dose, followed by a second dose 4 weeks later. Then this medication is given every 3 months. For the treatment of Crohn's disease or ulcerative colitis, the first dose of this medication is given by injection into a vein by a health care professional. The medication is then given by injection under your skin every 8 weeks as directed by your doctor. The dosage is based on your weight, medical condition, and response to treatment. If you are giving this medication to yourself at home, learn all preparation and usage instructions from your health care professional. Do not shake the solution. The solution is normally colorless to light yellow. It may contain a few small white particles of protein. Before using, check this product visually for other particles or discoloration. If either is present, do not use the liquid. Learn how to store and discard medical supplies safely. Do not reuse syringes. When given under the skin, this medication should be injected in either the upper arms, buttock, thighs, or abdomen. It is important to change the location of the injection site with each dose to avoid problem areas under the skin. Choose a different injection site with each dose. Do not inject into skin that is irritated, sore, or infected. Use this medication regularly to get the most benefit from it. It may help to mark your calendar with a reminder. Tell your doctor if your condition does not improve or if it worsens.
Missed Dose 1
Missed Dose MISSED DOSE: It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule. Do not double the dose to catch up.
Notes ML
Notes NOTES: Do not share this medication with others. Lab and/or medical tests (such as skin exams) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.
Overdose NR
Phonetic Pronunciation COVERED WITH CARRIER DISCRETION
Phonetic Pronunciation (US-te-KIN-ue-mab)
Precautions PRECAUTIONS: 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 make current infections worse. Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Avoid receiving BCG vaccines for one year after completing treatment with ustekinumab. Also, stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This drug may pass into breast milk. Consult your doctor before breast-feeding.
Precautions -
Side Effects $107.11
Side Effects SIDE EFFECTS: Bruising, itching, pain, redness, swelling, or hardening of the skin at the injection site may occur. Injection site reactions usually go away after 1 or 2 days. Headache, back pain, or sinus/throat pain may also occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: cough that doesn't go away, shortness of breath. This medication can affect your immune system. It can lower your body's ability to fight an infection. You may be more likely to get serious infections, such as lung infections, bone/joint infections, skin infections, sinus infections, or bowel/gallbladder infections. It may also be harder to fight an infection you already have. Tell your doctor right away if you develop any signs of an infection, such as nausea/vomiting that doesn't stop, worsening redness/swelling/tenderness at the injection site after 2 days, fever/chills, cold/flu symptoms, painful/frequent urination, unusual vaginal discharge/burning/itching/odor, or severe stomach pain. (See also Precautions section.) Ustekinumab may cause a rare (sometimes fatal) condition called PRES (posterior reversible encephalopathy syndrome). Get medical help right away if you develop headache that doesn't go away, seizures, sudden vision changes, mental/mood changes (such as confusion). There is a rare risk of developing cancer (including skin cancer) due to this medication. Discuss the risks and benefits of treatment with your doctor. Tell your doctor right away if you develop symptoms such as unusual lumps/growths, unusual skin changes (including a sore that does not heal or a change in the size/shape/color of a mole), swollen glands, unexplained weight loss. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Different brands of this medication have different storage needs. Check the product package for instructions on how to store your brand, or ask your pharmacist. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Storage 09/25/2009
Uses USES: Ustekinumab is used to treat plaque psoriasis, a certain type of arthritis (psoriatic arthritis), or certain bowel conditions (Crohn's disease, ulcerative colitis). It works by blocking certain natural proteins in your body (interleukin-12 and interleukin-23) that cause inflammation (swelling) in these conditions. Ustekinumab does not cure these diseases, but helps to lessen symptoms of the disease. It can help to decrease the amount of plaques in plaque psoriasis, decrease the number of swollen/painful joints in psoriatic arthritis, and decrease symptoms such as abdominal pain/cramping and diarrhea in Crohn's disease and ulcerative colitis.
Uses Ustekinumab inj, 1 MG

Frequently Asked Questions(FAQs)

The cost of Stelara™ Ustekinumab 90 Mg / Ml Injection Prefilled Syringe 1 Ml is available for registerd members only .
Stelara™ Ustekinumab 90 Mg / Ml Injection Prefilled Syringe 1 Ml is manufactured by J-O-M PHARM SERVICES.
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