Stelara (Ustekinumab)

Stelara can increase the risk of infections, including serious bacterial, fungal, and viral infections. Patients should be monitored for signs of infection before and during treatment. The medication may also elevate the risk of malignancies, and patients should be regularly evaluated for new or worsening malignancies.

It is not recommended that you use Stelara if you:

● Are allergic to ustekinumab or any of its inactive ingredients.

● If you have active tuberculosis

● In the past 12 months, have received a BCG (Bacillus Calmette and Guérin) vaccine.

Do not hesitate to inform your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is prevalent.

Stelara may not be safe for you if you have any of the following conditions:

● Infection symptoms (fever, chills, cough, muscular aches, painful skin sores, diarrhea, difficulty urinating, fatigue)

● Infections that are chronic

● Skin lesions that are new or changing

● The needle cover on the prefilled syringe contains latex, causing a latex allergy

● The use of light therapy (phototherapy)

● Vaccinations for allergies

● People who take this medicine should avoid receiving live vaccines if they have recently received or are scheduled to receive any vaccination. If anyone in your household requires a live vaccine, please notify your doctor. Some types of live vaccines contain viruses that can cause serious health problems in individuals with weakened immune systems.

Some people using this medicine have developed skin cancer (non-melanoma). However, these people may have had a higher risk of skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.

Stelara should not be used if you have received a BCG (Bacillus Calmette and Guérin) vaccine within one year prior to, during, or one year after treatment.

The doctor may perform tests to confirm that you are not infected with tuberculosis before starting treatment with this injection.

Stelara may cause serious infections. If you experience fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing blood, call your doctor right away.

Posterior Reversible Encephalopathy Syndrome (PRES) may also be caused by Ustekinumab. If you have headaches, confusion, vision problems, or seizures, call your doctor.

You may be more likely to develop certain types of cancer if you take Stelara. Tell your doctor if you have ever had any type of cancer. This medicine has caused certain types of skin cancer in people with risk factors for skin cancer. During your treatment with this medicine, tell your doctor if you develop any new skin growths.

like any medical treatment, Stelara comes with potential side effects that need to be considered. Understanding these side effects will empower you to have informed discussions with your healthcare provider and make the right decision for your well-being.

Common Side Effects

● Gastrointestinal Distress: Digestive issues such as nausea, vomiting, and diarrhea are among the common side effects reported by individuals undergoing Stelara treatment. These effects are usually mild and tend to subside as the body adjusts to the medication. Staying hydrated and adopting a balanced diet can often help manage these symptoms effectively.

● Skin Reactions: Given that Stelara is frequently used to treat skin-related conditions, it’s paradoxical that some individuals might experience skin reactions as a side effect. These can range from mild rashes to itching. While they might be uncomfortable, these reactions usually don’t persist for long and can be managed with over-the-counter creams or ointments.

● Headache and Fatigue: Headaches and fatigue are commonly reported side effects of Stelara treatment. These can often be attributed to the body’s adjustment to the medication. Ensuring proper rest, staying hydrated, and discussing these symptoms with your healthcare provider can contribute to managing these effects more effectively.

● Respiratory Symptoms: In some cases, individuals might experience mild respiratory symptoms like a runny or stuffy nose. These symptoms are generally transient and tend to diminish with time. However, if they persist or worsen, it’s advisable to consult your healthcare provider.

Rare Side Effects

● Allergic Reactions: While rare, allergic reactions to Stelara can occur. Symptoms might include difficulty breathing, swelling of the face, lips, tongue, or throat, and hives. If you experience any of these symptoms, it’s crucial to seek medical attention immediately.

● Blood Disorders: In very few instances, Stelara has been associated with blood disorders. These might include a decrease in red or white blood cell count. Regular monitoring by your healthcare provider can help detect and manage these rare side effects.

● Liver Issues: Rarely, Stelara treatment can lead to elevated liver enzymes. This can be identified through routine blood tests. It’s important to attend all recommended medical appointments to ensure your liver health is closely monitored.

Severe Side Effects

● Infections: Severe infections, including bacterial, viral, and fungal infections, are potential side effects of Stelara treatment. These infections might affect the respiratory, gastrointestinal, or urinary tract. It’s crucial to promptly address any signs of infection and to inform your healthcare provider if you are experiencing any symptoms.

● Cancer Risk: Stelara’s potential link to an increased risk of certain types of cancer is a concern, albeit a rare one. It’s essential to discuss this risk with your healthcare provider, who can help you weigh the benefits of treatment against potential risks.

● Neurological Symptoms: While extremely rare, some individuals undergoing Stelara treatment have reported neurological symptoms such as vision changes, weakness, or numbness. These symptoms should not be ignored and warrant immediate medical attention.

● Pregnancy and Fertility Considerations: For individuals of childbearing age, it’s important to discuss the potential effects of Stelara treatment on pregnancy and fertility. While current data is limited, consulting with a healthcare provider can help you make an informed decision.

Stelara may interact with other drugs, including prescription and over-the-counter medications, vitamins, and herbal supplements. Be sure to inform your doctor about all the medicines you are currently taking, as well as any medicines you intend to take in the future.

You should inform your doctor if you are taking any of the following medications:

● Immunosuppressants: Stelara may be prescribed in conjunction with medications such as methotrexate or corticosteroids. The combination of these drugs can enhance the therapeutic effect, however, careful monitoring is necessary to prevent over-immunosuppression.

● Biologics: It is possible to increase the risk of infections and adverse effects when multiple biologic medications are taken simultaneously. If you are considering combining biologics, please consult your healthcare provider.

● Live vaccines: Your immune response to live vaccines may be compromised by Stelara. If you are taking Stelara, avoid live vaccines and discuss alternative vaccination strategies with your physician

● Anticoagulants: (blood thinners) such as warfarin (Coumadin, Jantoven)

● Medications that suppress the immune system: Azithromycin (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), methotrexate (Otrexup, Rasuvo, Trexall, Xatmep), sirolimus (Rapamune), and tacrolimus (Astagraf, Envarsus, Prograf) are some of the medications prescribed.

● Oral steroids: Among them are dexamethasone (Hemady), methylprednisolone (Medrol), and prednisone (Rayos).

● Non-Biologic Immunomodulators: When Stelara is combined with certain immunomodulators, it can offer synergistic benefits, but the potential interactions must be carefully monitored.

Depending on your condition, your doctor may need to adjust your medication dosages or monitor you closely for side effects.

Ensure that you read the Medication Guide and the Instructions for Use provided by your pharmacist before you begin using ustekinumab and each time you receive a refill. Consult your physician if you have any questions.

If you are considering taking this drug, you should undergo a tuberculosis (TB) skin test to determine whether you have latent tuberculosis, which may not be causing any symptoms. It is necessary to treat TB before starting ustekinumab if you have been diagnosed with TB.

As directed by your doctor, this medication is given by injection under the skin for the treatment of psoriasis or psoriatic arthritis. One dose will be administered, followed by a second dose four weeks later. After that, this medication is administered every three months.

The first dose of this medication is administered by a healthcare professional by injection into a vein for the treatment of Crohn’s disease or ulcerative colitis. As directed by your physician, the medication is then injected under your skin every eight weeks.

Depending on your weight, medical condition, and response to treatment, the dosage will be determined.

Your health care provider should provide you with all preparation and usage instructions if you will be taking this medication at home. The solution should not be shaken. Colorless to light yellow is the normal appearance of the solution. It may contain a few small white protein particles. Check this product visually before use to ensure that there are no other particles or discoloration. Do not use the liquid if either of these conditions exists. Learn how to safely store and dispose of medical supplies. Syringes should not be reused.

Injections of this medication should be administered either in the upper arms, buttocks, thighs, or abdomen when given under the skin. In order to avoid problem areas under the skin, it is important to change the injection site with each dose. Each time you administer a dose, select a different injection site. Skin that is irritated, sore, or infected should not be injected.

To maximize the benefits of this medication, it should be used regularly. A reminder on your calendar may be helpful.

Storing Stelara properly is essential to preserve its effectiveness and prevent any potential harm. Follow these guidelines to ensure optimal storage:

● Stelara Packaging: When you receive Stelara, carefully examine the packaging for any signs of damage. Do not use the medication if the packaging is torn, punctured, or compromised in any way. Proper packaging helps protect the medication from external factors that could affect its quality.

● Temperature Considerations: Stelara should be stored in a refrigerator between 36°F and 46°F (2°C to 8°C). Keep the medication in its original packaging to shield it from light and temperature fluctuations. Avoid freezing the medication, as extreme cold can alter its composition and render it ineffective.

● Avoid Direct Sunlight: Exposure to direct sunlight can degrade the active ingredients in Stelara. Store the medication in a cool, dry place away from windows and sources of UV radiation.

● Keep Away from Moisture: Humidity can impact the integrity of Stelara. Store the medication in a dry environment, and avoid storing it in the bathroom, where moisture levels are higher.

● Original Container: Maintain Stelara in its original container with the label intact. This ensures that you have accurate information readily available and reduces the risk of confusion with other medications.

● Expiration Date: Always check the expiration date on the Stelara packaging. Do not use the medication if it has expired, as it may not provide the intended therapeutic effects.

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