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Stelara (Ustekinumab)

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Monoclonal antibody Stelara

Stelara (Ustekinumab)

Stelara (ustekinumab) is a prescription-only drug that falls under the following drug classes: monoclonal antibodies, antipsoriatics, and interleukin inhibitors. It is given by intravenous (IV) or subcutaneous (SC) injection. Stelara can be used alone or with other medications, depending on the patient’s condition and disease.

 

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Patients may self-administer Stelara after proper training from a healthcare professional and with physician approval.

Before using this medicine, inform your doctor or pharmacist if:

  • You are allergic to Stelara.
  • You had any other previous drug or food allergies.
  • You have a prior history of infection, such as tuberculosis, cancer, or hepatitis.
  • You are pregnant or planning to become pregnant.
  • You are breastfeeding.
  • You are using any non-prescription, prescription, or herbal drugs.

 

What Is Stelara?

Stelara is a monoclonal antibody medication, also known by its generic name ustekinumab. It is used to treat various diseases, such as psoriatic arthritis, Crohn’s disease, plaque psoriasis, and ulcerative colitis.

 

What Is Stelara Used To Treat? 

Stelara is a prescription-based medication used to treat the following:

  • A specific type of arthritis, such as psoriatic arthritis. Psoriatic arthritis is the swelling and stiffness of the affected joints and is painful.
  • Plaque psoriasis, characterized by red, flaky, and raised skin, which is painful, itchy, and cracky. It develops anywhere on the skin surface, like the elbows, arms, knees, trunk, or scalp.
  • Certain bowel disorders, such as Crohn’s disease and ulcerative colitis. Ulcerative colitis is the inflammation of the large intestine, commonly the rectum, and Crohn’s disease is the swelling and inflammation of the digestive tract.

 

How Does Stelara Works? Mechanism of Action

Ustekinumab is a human monoclonal antibody that binds to and interferes with the proinflammatory cytokines, interleukin-12 (IL-12) and interleukin-23 (IL-23). Ustekinumab also interferes with the expression of monocyte chemotactic protein-1 (MCP-1), tumor necrosis factor-alpha (TNF-α), interferon-inducible protein-10 (IP-10), and interleukin-8 (IL-8).

In most of the inflammatory diseases, such as Crohn’s disease, the levels of inflammatory cytokine and other interleukins are elevated. Stelara works by inhibiting cytokines and blocking the action of IL-23 and IL-12. This reduces inflammation and treats the disease symptoms.

 

How Is Stelara Used?

  • Stelara can be used intravenously or subcutaneously, depending on the doctor’s recommendation and the patient’s condition. 
  • It can be used alone or in combination with another medicine, like methotrexate (in diseases like psoriatic arthritis).
  • Stelara should not be used in children under 6 years of age.
  • Stelara can be taken with or without food.

 

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Side Effects of Stelara 

The common side effects of Stelara go away as the body gets used to the drug. But if they become persistent, severe, or intolerable, consult your doctor.

Stelara side effectsThe common side effects of Stelara include:

  • Nausea and vomiting
  • Diarrhea
  • Fever
  • Stomach pain
  • Headache
  • Chest discomfort
  • Pain or burning while urinating
  • Itching

The severe side effects of Stelara include:

  • Swelling, pain, redness, and warmth anywhere on the body
  • Worsening cough
  • Seizures
  • Sudden chest pain
  • Severe headache
  • Change in mental status
  • Sudden and severe stomach pain
  • Vision problems
  • Confusion 
  • Shortness of breath 

 

Warnings/Precautions

Stelara may increase the risk for infections or reactivation of latent infections, such as tuberculosis. Common infections include upper respiratory infections, urinary tract infections, sinus infections, bronchitis, and vaginal yeast infections. Avoid use in patients with clinically important active infection until the infection resolves or is successfully treated.

 

Strength

Stelara is available in the following strengths:

  • 45 mg injection
  • 90 mg injection 
  • 130 mg/26 ml for intravenous infusion

The initial dose is given at week 0, then after 4 weeks, followed by every 12 weeks.

 

Dosing

The dose of Stelara varies depending on the patient’s weight and the disease for which they are taking the drug.

The adult dose of Stelara for the following diseases are given below:

Dose for Psoriasis:

  • The recommended subcutaneous dose for patients weighing 100 kg or less is initially 45 mg, followed by 45 mg 4 weeks later, and then 45 mg every 12 weeks.
  • For patients weighing above 100 kg, the subcutaneous dose is initially 90 mg, followed by 90 mg 4 weeks later, and then 90 mg every 12 weeks.

Dose for Crohn’s Disease and Ulcerative Colitis: 

  • The recommended intravenous infusion adult dose of Stelara for patients weighing 55 kg or less is 260 mg.
  • For patients weighing 55 – 85 kg, the IV infusion dose of Stelara is 390 mg.
  • For patients weighing above 85 kg, the IV infusion dose is 520 mg.

After the induction dose above, a maintenance dose of 90 mg should be given every 8 weeks. 

Dose for Psoriatic Arthritis:

  • The recommended subcutaneous dose for patients weighing 100 kg or less is initially 45 mg, followed by 45 mg 4 weeks later, and then 45 mg every 12 weeks.
  • For patients weighing above 100 kg and with moderate to severe psoriatic arthritis, the subcutaneous dose is initially 90 mg, followed by 90 mg 4 weeks later, and then 90 mg every 12 weeks.

 

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Stelara Storage And Administration Instructions

  • Store intact vials and prefilled syringes at 2°C to 8°C (36°F to 46°F); do not freeze.
  • If needed, store the diluted solution at room temperature (below 30°C/86°F) for 30 days or less in the original carton to protect it from light. Once stored at room temperature, the syringe should not be returned to the refrigerator and should be discarded if not used within 30 days.  
  • After administration, if any portion of the infusion remains unused, discard the solution.
  • The injection site should be closely monitored for any signs of bleeding, bruising, or swelling.
  • It is recommended that the injection site should be changed each time the drug is administered. Possible injection sites include the thighs, gluteal region, upper arms, or abdomen.

 

Price 

The price of Stelara depends on various factors. For example, your pharmacy and its location, your prescribed treatment regimen, and your insurance plan can all play a role in influencing the price you pay.

The average cost of a Stelara subcutaneous injection is around $13,434 for 0.5 ml.

 

FAQs

What kind of drug is Stelara?

Stelara is a type of drug known as a biologic. It is approved for the treatment of psoriasis, arthritis, and Crohn’s disease.

Is Stelara a steroid?

No. Stelara is not a steroid; it is an immunomodulator and an interleukin inhibitor that works to inhibit cytokines and block the action of IL-23 and IL-12.

How quickly does Stelara work?

On average, Stelara starts to show its effect within 3 to 6 weeks. However, the response time can vary from patient to patient. The majority of patients stayed in remission 1 year after responding to the initial dose and continuing treatment with Stelara.

 

Conclusion 

Stelara, known by its generic name ustekinumab, is a prescription-based drug used to treat some types of ulcers, arthritis, and inflammatory gastrointestinal diseases. It is available both subcutaneously and intravenously. 

Stelara works by inhibiting inflammatory proteins in our body, such as cytokines and interleukins, hence treating inflammation and its symptoms. The drug should be used cautiously in pregnancy and breastfeeding.

 

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