Stelara (Ustekinumab): Uses, Dosage, Side Effects, Warnings

Stelara, also known as Ustekinumab, is a medication used to treat autoimmune conditions such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It is an immunosuppressant drug that targets a specific chemical substance in the body to reduce inflammation.

Stelara is administered through injection and its dosage guidelines depend on the patient's weight and the condition being treated. While Stelara has been successful in treating autoimmune conditions, it also has potential side effects and serious warnings that patients should be aware of before taking the medication.

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Key Takeaways

• Stelara is an immunosuppressant drug used to treat autoimmune conditions such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
• Stelara is administered through injection and its dosage guidelines depend on the patient's weight and the condition being treated.
• While Stelara has been successful in treating autoimmune conditions, it also has potential side effects and serious warnings that patients should be aware of before taking the medication.

What is Stelara (Ustekinumab)?

Stelara (Ustekinumab) is a prescription medication used to treat several autoimmune conditions such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. It is a monoclonal antibody that targets specific chemical substances in the body, including interleukin-12 (IL-12) and interleukin-23 (IL-23).

Ustekinumab is a recombinant DNA-derived human IgG1kappa monoclonal antibody. It is produced by mammalian cell culture and purified by a series of steps that include protein A and size-exclusion chromatography. The active ingredient in Stelara is Ustekinumab, which is a colorless to pale yellow solution and is available as a single-use, preservative-free, prefilled syringe.

Stelara works by binding to the p40 subunit of IL-12 and IL-23, which are cytokines involved in the inflammatory response. By blocking these cytokines, Stelara helps to reduce inflammation and calm the immune system, thereby relieving symptoms of autoimmune conditions.

Stelara is administered as a subcutaneous injection by a healthcare professional or self-administered by the patient after proper training. The dosage of Stelara depends on the patient's weight and the condition being treated. The medication is usually given every 12 weeks after the initial dose.

Like all medications, Stelara may cause side effects. Common side effects include redness, swelling, or itching at the injection site. It is important to discuss any potential side effects with a healthcare provider before starting treatment with Stelara.

Uses of Stelara

Stelara (Ustekinumab) is a medication that belongs to the class of medications called selective immunomodulating agents, also known as biologics. It is used to treat various conditions related to the immune system. Here are some of the uses of Stelara:

Psoriasis

Stelara is FDA-approved to treat moderate-to-severe plaque psoriasis in adults who are candidates for phototherapy or systemic therapy. It is also used for children and adolescents 6 to 17 years old who can't tolerate other therapies or whose symptoms aren't controlled by other treatments.

Psoriatic Arthritis

Stelara is also approved to treat active psoriatic arthritis in adults, either alone or in combination with methotrexate. It is used for patients who have not responded well to other treatments or have had intolerable side effects.

Ulcerative Colitis

Stelara is approved to treat moderate-to-severe ulcerative colitis in adults who have not responded well to other treatments or have had intolerable side effects. It is used to induce and maintain clinical remission, improve symptoms, and achieve mucosal healing.

Crohn's Disease

Stelara is approved to treat moderate-to-severe Crohn's disease in adults who have not responded well to other treatments or have had intolerable side effects. It is used to induce and maintain clinical remission, improve symptoms, and achieve mucosal healing.

Stelara works by targeting specific proteins in the immune system that contribute to inflammation. It helps to reduce inflammation and improve symptoms associated with these conditions. The dosage and frequency of Stelara treatment will depend on the condition being treated and the patient's response to the medication.

How is Stelara Administered?

Stelara (Ustekinumab) is a medication that is administered via subcutaneous injection or intravenous infusion. The method of administration depends on the dosage form prescribed by the healthcare professional.

For subcutaneous injection, Stelara is available in single-dose prefilled syringes or single-dose vials. The injection is given under the skin in the upper arms, buttocks, abdomen, or thighs. The healthcare professional will instruct the patient on how to prepare and administer the injection. It is important to follow the instructions carefully to ensure the correct dosage is delivered and to prevent infection at the injection site.

For intravenous infusion, Stelara is available in a single-dose vial. The infusion is given by a healthcare professional in a hospital or clinic setting. The infusion takes approximately one hour to complete and the patient will be monitored for any adverse reactions.

It is important to follow the dosing schedule as prescribed by the healthcare professional. Stelara is typically administered every 12 weeks for adults with psoriasis and every 8 weeks for adults with psoriatic arthritis. The dosage may be adjusted based on the patient's response to treatment and any adverse reactions.

In summary, Stelara is administered via subcutaneous injection or intravenous infusion. The injection is given under the skin in the upper arms, buttocks, abdomen, or thighs and the infusion is given by a healthcare professional in a hospital or clinic setting. It is important to follow the dosing schedule and instructions carefully to ensure the correct dosage is delivered and to prevent infection at the injection site.

Dosage Guidelines

Stelara (Ustekinumab) is available in different dosage forms, including subcutaneous injection single-dose prefilled syringe (45 mg/0.5 mL or 90 mg/mL), subcutaneous injection single-dose vial (45 mg/0.5 mL), and intravenous Infusion single-dose vial 130 mg/26 mL (5 mg/mL).

The dosage of Stelara varies depending on the patient's weight and the severity of the condition being treated. The recommended initial dosage of Stelara for intravenous infusion is based on the patient's body weight, as shown in Table 1 below:

Body Weight of Patient at the time of dosingDoseNumber of 130 mg/26 mL (5 mg/mL) STELARA vials55 kg or less260 mg2More than 55 kg to 85 kg390 mg3More than 85 kg520 mg4

After the initial intravenous infusion, the recommended maintenance dosage of Stelara is a subcutaneous injection of 90 mg every 8 weeks for adults. For pediatric patients, the recommended maintenance dosage is based on body weight, as shown in Table 2 below:

Body Weight of Patient at the time of dosingDose20 kg to less than 40 kg0.75 mg/kg40 kg or more45 mg

It is important to follow the dosage instructions provided by the healthcare provider. Missing a dose of Stelara can reduce its effectiveness. If a dose is missed, it should be administered as soon as possible. However, if the next scheduled dose is due within 4 weeks, the missed dose should be skipped and the regular dosing schedule should be resumed.

In case of an overdose, patients should seek immediate medical attention. The symptoms of an overdose may include headache, dizziness, nausea, vomiting, and diarrhea.

Overall, Stelara is a medication that should be administered under the guidance of a healthcare provider. The dosage guidelines should be followed carefully to ensure the best possible outcome for the patient.

Potential Side Effects

Like all medications, Stelara (Ustekinumab) can cause side effects. Some of these side effects may be serious and require medical attention. It is important to understand the potential side effects of Stelara before starting treatment.

Common side effects of Stelara include headache, fatigue, and respiratory infections such as the common cold. Other common side effects include nausea, vomiting, and diarrhea. These side effects are usually mild and go away on their own.

Less common but more serious side effects of Stelara may include confusion, seizures, and severe allergic reactions. If you experience any of these side effects, seek medical attention immediately.

Stelara can also cause injection site reactions, such as itching, burning, tenderness, bruising, and redness. These reactions are usually mild and go away on their own. If you experience any of these reactions, talk to your doctor about ways to manage them.

In rare cases, Stelara can cause serious infections, such as pneumonia or sepsis. Contact your doctor immediately if you experience any signs of infection, such as fever, cough, or shortness of breath.

It is important to tell your doctor about any other medications you are taking before starting Stelara, as some medications may interact with it and increase your risk of side effects.

Overall, Stelara is a safe and effective medication for treating psoriasis, psoriatic arthritis, and Crohn's disease. However, like all medications, it may cause side effects in some people. If you experience any side effects while taking Stelara, talk to your doctor about ways to manage them.

Serious Side Effects and Warnings

While Stelara (Ustekinumab) is generally well-tolerated, it may cause some serious side effects. Patients should be aware of these potential risks and discuss them with their healthcare provider before starting treatment.

Infections

Stelara may increase the risk of infections, including serious infections. Patients should inform their healthcare provider if they develop any signs of infection such as fever, chills, cough, or flu-like symptoms. In some cases, Stelara may reactivate latent tuberculosis (TB), so patients should be screened for TB before starting treatment.

Cancer

There have been reports of Stelara increasing the risk of cancer, including skin cancer. Patients should inform their healthcare provider if they have a history of cancer or if they develop any new or unusual skin growths.

Allergic Reactions

Some patients may experience an allergic reaction to Stelara. Signs of an allergic reaction may include shortness of breath, wheezing, swelling of the face or throat, hives, or itching. Patients who experience these symptoms should seek medical attention immediately.

Posterior Reversible Encephalopathy Syndrome (PRES)

In rare cases, Stelara may cause a condition called posterior reversible encephalopathy syndrome (PRES). Symptoms of PRES may include seizures, headaches, confusion, and vision changes. Patients who experience these symptoms should seek medical attention immediately.

In summary, while Stelara can be an effective treatment for certain conditions, it is important for patients to be aware of the potential risks and to discuss them with their healthcare provider. Patients should inform their healthcare provider if they experience any new or unusual symptoms while taking Stelara.

Interactions with Other Drugs

Stelara (Ustekinumab) has a total of 421 known drug interactions, with 40 of them being major, 374 moderate, and 7 minor. It is important to inform your doctor of all the medications you are currently taking, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements. Below are some of the drugs that may interact with Stelara:

• Methotrexate: Taking methotrexate with Stelara may increase the risk of liver damage. Your doctor may need to adjust the dosage of either medication or monitor you more closely.
• Live vaccines: Stelara may affect your immune system, and taking live vaccines while on this medication may increase the risk of infection. It is recommended to avoid live vaccines while on Stelara.
• BCG vaccine: The BCG vaccine is used to prevent tuberculosis. Stelara may decrease the effectiveness of the BCG vaccine. It is recommended to receive the BCG vaccine before starting Stelara or wait at least 4 weeks after stopping Stelara before receiving the BCG vaccine.

It is important to note that this is not a complete list of all the drugs that may interact with Stelara. Always inform your doctor about all the medications you are taking, including vitamins and herbal supplements, before starting Stelara.

Additionally, it is important to avoid receiving allergy shots or undergoing phototherapy for the skin while on Stelara. Inform your doctor if you have a history of skin cancer, immune system problems, or any infections before starting Stelara.

If you experience any signs of infection such as fever, chills, cough, muscle aches, painful skin sores, diarrhea, or pain when you urinate, contact your doctor immediately.

Special Considerations

When taking Stelara (Ustekinumab), there are several special considerations to keep in mind. These include pregnancy, breastfeeding, and interactions with other medications.

Pregnancy and Breastfeeding

Stelara is classified as a pregnancy category B drug by the FDA. This means that it is not expected to harm an unborn baby if taken during pregnancy. However, it is important to discuss the risks and benefits of taking Stelara during pregnancy with your healthcare provider.

It is also not known if Stelara is excreted in human milk. Therefore, it is recommended that women who are breastfeeding either discontinue Stelara or stop breastfeeding while taking the medication.

Healthcare Providers and Pharmacists

Stelara is a prescription medication that is administered by a healthcare provider. It is important to follow your healthcare provider's instructions for taking Stelara and to inform them of any other medications you are taking.

Pharmacists can also provide valuable information about Stelara, including potential side effects and drug interactions.

FDA and Medication Guide

Stelara has been approved by the FDA for the treatment of several conditions, including plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

Patients taking Stelara should also be provided with a medication guide that includes important information about the medication, including potential side effects and how to take it.

Tests and Inactive Ingredients

Patients taking Stelara may need to undergo certain tests to monitor their condition while taking the medication. These tests may include blood tests and skin exams.

Stelara also contains inactive ingredients that may cause an allergic reaction in some patients. Patients should inform their healthcare provider if they have any allergies or sensitivities to any medications or substances.

Allergy Shots, Latex Allergy, and Phototherapy

Patients who are receiving or have received allergy shots, have a latex allergy, or have received phototherapy for the skin should inform their healthcare provider before taking Stelara. These conditions may increase the risk of an allergic reaction to Stelara.

Overall, Stelara is a safe and effective medication for the treatment of several conditions. However, it is important to follow your healthcare provider's instructions and to inform them of any other medications or conditions you may have.

Storage and Handling

Stelara (Ustekinumab) should be stored in the refrigerator at a temperature of 2°C to 8°C (36°F to 46°F). Do not freeze or shake the solution. The drug should be kept in its original carton to protect it from light until the time of use.

Before injection, Stelara should be removed from the refrigerator and allowed to reach room temperature for at least 30 minutes. Do not heat the solution in any way, such as by placing it in a microwave or hot water.

The single-dose prefilled syringe should be inspected visually for particulate matter and discoloration before administration. The solution should be clear to slightly yellow. If the solution is discolored or contains particles, it should not be used.

The needle cover should be removed from the prefilled syringe immediately before use. Stelara should not be administered through a needle that has been bent or damaged.

If necessary, the prefilled syringe may be stored at room temperature up to 30°C (86°F) for a maximum of 14 days. The syringe should be protected from light during storage.

Stelara should be kept out of the reach of children and pets. Unused syringes and needles should be disposed of in a safe and appropriate manner, in accordance with local regulations.

In conclusion, proper storage and handling of Stelara are important to ensure the effectiveness and safety of the drug. The solution should be kept refrigerated, protected from light, and inspected before administration. Unused syringes and needles should be disposed of properly.

Understanding the Risks and Benefits

Stelara (Ustekinumab) is a medication used to treat autoimmune disorders such as plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. While Stelara can be an effective treatment option, it is important to understand the potential risks and benefits before beginning treatment.

Benefits

Stelara works by targeting specific chemical substances in the body that contribute to inflammation and autoimmune disorders. By reducing inflammation, Stelara can help alleviate symptoms such as soreness, lesions, and stomach pain. It can also help improve overall quality of life by reducing tiredness and improving mobility.

Risks

Like all medications, Stelara comes with potential risks and side effects. Some of the most common side effects include headache, injection site reactions, and upper respiratory infections. More serious side effects may include allergic reactions, chest pain, and difficulty breathing.

In rare cases, Stelara may also increase the risk of certain types of cancer or infections. It is important to discuss any concerns or questions with your healthcare provider before beginning treatment with Stelara.

Considerations

Before beginning treatment with Stelara, it is important to consider a few key factors. These may include:

• Consistency: Stelara is typically administered via injection, either by a healthcare provider or self-administered at home. It is important to follow the recommended dosing schedule and administration instructions to ensure the medication is effective.
• Prescriptions: Stelara is a prescription medication and should only be used under the guidance of a healthcare provider. It is important to discuss any other medications or health conditions with your healthcare provider before beginning treatment.
• Hardiness: Stelara can be a hardy medication, meaning it may take longer to clear from the body than other medications. This can be a benefit for some patients, as it may require less frequent dosing. However, it is important to discuss any concerns or questions with your healthcare provider.
• Weight Loss: Stelara is not typically associated with weight loss or weight gain. However, it is important to maintain a healthy lifestyle and discuss any concerns with your healthcare provider.
• Bruising: Injection site bruising is a common side effect of Stelara. This is typically mild and resolves on its own, but it is important to discuss any concerns with your healthcare provider.
• Light Sensitivity: Stelara is not typically associated with light sensitivity. However, it is important to discuss any concerns or questions with your healthcare provider.

Overall, Stelara can be an effective treatment option for those with autoimmune disorders. However, it is important to understand the potential risks and benefits before beginning treatment. It is also important to follow the recommended dosing schedule and administration instructions and to discuss any concerns or questions with your healthcare provider.

Frequently Asked Questions

1. What are the potential neurologic side effects of Stelara?

Stelara may cause potential neurologic side effects, including headaches, dizziness, and seizures. If you experience any of these symptoms, contact your doctor immediately.

2. What are the serious side effects of Stelara?

Serious side effects of Stelara include severe allergic reactions, infections, and malignancies. Contact your doctor if you experience symptoms such as fever, chills, cough, or difficulty breathing.

3. What are some long-term side effects of Stelara?

Long-term use of Stelara may increase the risk of developing infections, malignancies, and autoimmune disorders. Talk to your doctor about the risks and benefits of long-term treatment with Stelara.

4. What foods should be avoided while taking Stelara?

There are no specific foods that need to be avoided while taking Stelara. However, it is important to maintain a healthy diet and avoid alcohol consumption.

5. What are the contraindications for taking Stelara?

Stelara is contraindicated in patients with a history of hypersensitivity to ustekinumab or any of its components. It should not be used in patients with active infections or malignancies.

6. What are the common side effects of Stelara for Crohn's disease?

Common side effects of Stelara for Crohn's disease include abdominal pain, nausea, vomiting, and diarrhea. These symptoms usually resolve on their own, but contact your doctor if they persist or worsen.