Stelara (generic name: ustekinumab) is a monoclonal antibody medication developed by Janssen Pharmaceuticals, for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. It works by targeting a subunit of human interleukin-12 and interleukin-23, which are naturally occurring proteins that regulate the immune system and immune-antibody mediated inflammatory disorders. Stelara is administered either by intravenous infusion or subcutaneous injection. The dosage is calculated based on the patient’s body weight, between 45 mg to 90 mg. Initially, doses are administered at weeks 0 and 4. After that, it is administered every 8 – 12 weeks either by the doctor or it can be self-administered at home after training. The healthcare provider may decide that you need more frequent doses for symptom relief or remission based on your response to the drug.
This medication has been prescribed because your healthcare provider has judged that the benefits are greater than the risk of side effects. Many people using this medication do not have serious side effects.
Precautions
Stelara may lower a patient’s ability to fight infections or may increase the risk of infections. Serious infections, which may require hospitalization, include tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. When you are taking Stelara, consult your healthcare provider immediately if you have any signs of a chest infection, skin infection or shingles.
Decreased activity of the immune system may increase the risk for certain types of cancer. Inform your healthcare provider if you have any new skin growths.
Inform your healthcare provider if you have any new or worsening medical problems including headaches, seizures, confusion, and vision problems. These may be symptoms of posterior reversible encephalopathy syndrome (PRES). If PRES is found early and treated, most people recover.
Serious Allergic Reactions
Consult your healthcare provider immediately if you have any symptoms of a serious allergic reaction such as feeling faint, swelling of the face, eyelids, tongue, or throat, chest tightness,
A skin rash, shortness of breath or a cough may be a sign of serious inflammation. If it persists, consult your healthcare provider immediately.
Other mild side effects may include:
- nasal congestion, sore throat and runny nose, upper respiratory infection, sinus infection, bronchitis
- fever
- headache, tiredness
- itching
- nausea and vomiting
- redness at the injection site
- vaginal yeast infections or urinary tract infections
- diarrhea and stomach pain
- joint pain.
If these persist or get worse, discuss this with your doctor or pharmacist.
The main conditions that are treated by Stelara are:
- Crohn’s Disease (CD)
- Ulcerative Colitis (UC)
- Plaque Psoriasis
- Psoriatic Arthritis.
In all cases, they are diagnosed by healthcare providers with specialist training.
Indications of Crohn’s Disease
- Diarrhea
- Fever
- Fatigue
- Abdominal pain and cramping
- Blood in the stool
- Mouth sores
- Reduced appetite and weight loss
- Pain or drainage near or around the anus due to inflammation from a fistula (a tunnel into the skin).
The main diagnostic tools used to detect CD include blood tests, fecal examination, x-rays, colonoscopy and gastroscopy. In some instances, computed tomography (CT) scanning, magnetic resonance imaging (MRI) and ultrasound may be used.
Crohn’s disease is a chronic relapsing disorder of the gastrointestinal tract. It is one of the main components of inflammatory bowel disease (IBD). Studies have implicated the pro-inflammatory cytokines interleukin-17 and interleukin-23 in the pathogenesis of CD. Interleukin-23 is a member of the IL-12 family of cytokines and is able to enhance and affect the expansion of pathogenic Th17 (T helper type 17) cells. Recent studies have led to major advances in the treatment and diagnosis of CD leading to the development of antibodies against interleukin-12 (IL-12) and interleukin-23 (IL-23) through their common subunit ustekinumab. Stelara is the only FDA-approved medicine that targets IL-12 and IL-23.
Indications of Ulcerative Colitis
- Diarrhea, often with blood or pus
- Abdominal pain and cramping
- Rectal pain
- Rectal bleeding (passing small amounts of blood with stool)
- Urgency to defecate
- Inability to defecate despite urgency
- Weight loss
- Fatigue
- Fever
- Failure of children to grow normally
The main diagnostic tools used to detect UC include blood tests, fecal examination, x-rays, colonoscopy and gastroscopy. In some instances, computed tomography (CT) scanning, magnetic resonance imaging (MRI) and ultrasound may be used.
Indications of Ulcerative colitis
Ulcerative colitis is an inflammatory disease that affects the gastrointestinal tract. It may begin in the rectum but usually spreads to some or all of the large intestine. Ulcerative colitis is an incurable and lifelong condition, with symptoms beginning between the ages of 15 and 40.
It is caused by a breakdown in the linings of the intestines which normally keep bacteria from causing an infection. However, after the breakdown, the bowel bacteria can provoke the immune system to attack the wall of the intestine, which can activate the immune system and trigger an inflammatory response.
Ulcerative colitis may also substantially increase the risk of colon cancer.
Indications of plaque psoriasis
Indications of plaque psoriasis are patches of dry, itchy skin with raised plaques covered with scales. They commonly appear on elbows, knees, lower back and scalp. They vary in color, depending on skin color.
Plaque psoriasis is an autoimmune disease that presents with raised areas of abnormal skin, that are red, (or purple on some people with darker skin), dry, itchy, and scaly. Areas of the body most commonly affected are the back of the forearms, shins, navel area, and scalp. Finger and toenails are affected at some point in most people with psoriasis, including pits in the nails or changes in nail color. Psoriasis is generally believed to be an inherited condition that may be exacerbated by environmental factors. Symptoms are often worse during winter and may be triggered by some medications, such as beta blockers or NSAIDs.
Indications of psoriatic arthritis
Psoriatic arthritis shows up as inflammation of joints and surrounding connective tissue, as well as dactylitis, spondylitis or sacroiliitis.
Psoriatic arthritis is a type of chronic inflammatory arthritis. It usually involves painful inflammation of joints and surrounding connective tissue. It can occur in any joint, but most commonly affects the fingers and toes. It can manifest as dactylitis, where there is a sausage-shaped swelling of the fingers and toes. It can also affect the hips, knees, and cause spondylitis (in the spine) and sacroiliitis (in sacroiliac joints).
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