Description
Stelara: Comprehensive Overview
What is Stelara?
Stelara (generic name: ustekinumab) is a monoclonal antibody medication developed by Janssen Pharmaceuticals, used for treating Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. It functions by targeting interleukin-12 and interleukin-23, proteins that regulate the immune system and inflammatory disorders. Stelara is administered either through intravenous infusion or subcutaneous injection, with dosages ranging from 45 mg to 90 mg based on body weight. Initial doses are given at weeks 0 and 4, followed by administration every 8 to 12 weeks, either by a healthcare provider or self-administered at home after training.
Dosage and Administration
- Dosage: 45 mg to 90 mg, adjusted based on body weight.
- Initial Doses: Administered at weeks 0 and 4.
- Maintenance Doses: Every 8 to 12 weeks, with potential adjustments based on patient response.
Precautions
- Infection Risk: Stelara may lower immune system activity, increasing infection risk. Report signs of infections, such as chest infections or shingles, immediately.
- Cancer Risk: A reduced immune response may increase cancer risk. Notify your healthcare provider of any new skin growths.
- Neurological Symptoms: Report new or worsening headaches, seizures, confusion, or vision problems, as these could indicate posterior reversible encephalopathy syndrome (PRES).
- Allergic Reactions: Seek immediate medical help for symptoms of serious allergic reactions, such as facial swelling, chest tightness, or severe rash.
- Inflammation: Persistent rash, shortness of breath, or cough may indicate serious inflammation; consult your healthcare provider if symptoms persist.
Common Side Effects
- Nasal congestion, sore throat, runny nose
- Upper respiratory infections, sinus infections, bronchitis
- Fever, headache, tiredness
- Itching, nausea, vomiting
- Redness at the injection site
- Vaginal yeast infections or urinary tract infections
- Diarrhea, stomach pain, joint pain
Conditions Treated by Stelara
- Crohn’s Disease (CD): Symptoms include diarrhea, fever, fatigue, abdominal pain, blood in stool, mouth sores, reduced appetite, weight loss, and pain near the anus due to fistulas. Diagnosed using blood tests, fecal examination, x-rays, colonoscopy, and sometimes CT or MRI scans.
- Ulcerative Colitis (UC): Symptoms include diarrhea with blood or pus, abdominal pain, rectal pain, rectal bleeding, urgency to defecate, weight loss, fatigue, fever, and failure to grow in children. Diagnosed similarly to Crohn’s disease with additional tools like x-rays and colonoscopy.
- Plaque Psoriasis: Characterized by dry, itchy skin with raised, scaly plaques, commonly on elbows, knees, lower back, and scalp. This autoimmune disease may also affect nails and is influenced by genetic and environmental factors.
- Psoriatic Arthritis: Involves inflammation of joints and connective tissue, with symptoms including dactylitis (sausage-like swelling of fingers and toes), spondylitis (spinal inflammation), and sacroiliitis (inflammation of sacroiliac joints).
How Stelara Works
Stelara targets interleukin-12 and interleukin-23, proteins involved in regulating the immune system and inflammatory processes. By inhibiting these proteins, Stelara helps manage conditions related to overactive immune responses.
Consultation and Monitoring
If you experience severe or persistent symptoms, discuss them with your healthcare provider. Regular monitoring and consultations will help manage side effects and ensure effective treatment.
How to use Stelara Syringe
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.
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.
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 breastfeeding.
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.
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