Stelara

Stelara (ustekinumab) is a biologic medication approved by the FDA to treat autoimmune conditions such as plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis by moderating the immune system’s activity. It targets specific proteins (IL-12 and IL-23) that trigger inflammation. Its treatment regimen includes an initial IV infusion followed by subcutaneous injections. For Stelara for Crohn’s disease management, patients often receive tailored doses based on body weight to achieve lasting symptom relief. Those seeking Stelara for psoriasis treatment can benefit from reduced flare-ups and improved skin health. It’s crucial to consult healthcare professionals for personalized plans, including how to buy Stelara online safely and ensure proper dosing, minimizing potential risks like infection susceptibility and vaccination interference.

Stelara, a monoclonal antibody, is designed to treat several chronic autoimmune disorders by suppressing parts of the immune system that drive inflammation. FDA-approved uses include plaque psoriasis and psoriatic arthritis in adults and children aged six and older, as well as adult Crohn’s disease and ulcerative colitis. Stelara for Crohn’s disease management involves an initial intravenous (IV) infusion to quickly reach therapeutic levels, followed by subcutaneous injections for ongoing maintenance. Similarly, patients seeking Stelara for psoriasis treatment benefit from reduced skin inflammation, clearer skin, and improved joint mobility.

Stelara works by specifically targeting and neutralizing interleukin-12 (IL-12) and interleukin-23 (IL-23), proteins that play key roles in inflammatory processes in the body. By blocking these pathways, Stelara reduces the inflammation that can cause the painful and debilitating symptoms associated with its indicated conditions. Despite its benefits, Stelara suppresses the immune system, which can increase susceptibility to infections and potentially serious complications such as reactivation of tuberculosis or other severe infections.

Patients must be screened for infections before starting treatment. Additionally, Stelara may affect responses to vaccines; live vaccines are contraindicated during treatment. Patients considering Stelara should discuss potential side effects and interactions with other drugs with their healthcare provider. Monitoring is necessary to manage and adjust treatment based on individual response and side effect profile. Alternatives to Stelara may be considered based on effectiveness, side effects, and personal health needs, emphasizing the importance of medical guidance in managing autoimmune conditions.

Stelara is approved by the FDA for the treatment of:

• Psoriatic arthritis in adults and children aged 6 years and older.
• Ulcerative colitis in adults.
• Plaque psoriasis in adults and children aged 6 years and older.
• Crohn’s disease in adults.

Additionally, Stelara is used off-label for:

• Ankylosing spondylitis.
• Lupus.

[Note: It is important to note that Stelara is not considered appropriate for treating rheumatoid arthritis.]

Stelara is a liquid solution containing the active drug ustekinumab. It is available in the following forms:

• A single-dose, prefilled syringe with 0.5 milliliters (mL) of solution containing 45 milligrams (mg) of ustekinumab
• A single-dose, prefilled syringe with 1 mL of solution containing 90 mg of ustekinumab
• A single-dose vial with 0.5 mL of solution containing 45 mg of ustekinumab

Other Forms and Strengths:

• Stelara is also available in a vial format containing 130 mg of ustekinumab.
• This vial is designated for a single-use intravenous (IV) infusion—a procedure where the medication is administered directly into a vein over a period of time.
• It is particularly used to administer the initial dose of Stelara to patients with Crohn’s disease or ulcerative colitis.
• This initial dose, often referred to as a ‘loading dose’ or ‘induction dose,’ is administered over a minimum duration of one hour.
• Subsequent doses of Stelara, following the IV infusion, are given through subcutaneous injections (injections under the skin).

What Are the Recommended Dosage of Stelara?

Stelara (ustekinumab) is prescribed for various conditions, with dosages tailored to the specific disease, patient age, and body weight. Below are the recommended dosing regimens:

For Plaque Psoriasis

• Adults:
  • Body Weight ≤100 kg: 45 mg administered subcutaneously at Week 0, Week 4, and every 12 weeks thereafter.
  • Body Weight >100 kg: 90 mg administered subcutaneously at Week 0, Week 4, and every 12 weeks thereafter.
• Pediatric Patients (6–17 years):
  • Body Weight <60 kg: 0.75 mg/kg administered subcutaneously at Week 0, Week 4, and every 12 weeks thereafter.
  • Body Weight 60–100 kg: 45 mg administered subcutaneously at Week 0, Week 4, and every 12 weeks thereafter.
  • Body Weight >100 kg: 90 mg administered subcutaneously at Week 0, Week 4, and every 12 weeks thereafter.

For Psoriatic Arthritis

• Adults:
  • 45 mg administered subcutaneously at Week 0, Week 4, and every 12 weeks thereafter.
  • For patients with coexistent moderate-to-severe plaque psoriasis weighing >100 kg, consider 90 mg per dose.

Crohn’s Disease and Ulcerative Colitis

• Adults:
  • Induction Dose: A single intravenous infusion based on body weight:
    • ≤55 kg: 260 mg
    • 55 kg to 85 kg: 390 mg
    • 85 kg: 520 mg
  • Maintenance Dose: 90 mg administered subcutaneously 8 weeks after the induction dose, then every 8 weeks thereafter.

[Note: Remember these recommendations may vary depending on person to person. Discuss it with your doctor, and they’ll customize your dosage accordingly.]

This medication is typically administered as an injection, either by a healthcare professional or through self-injection after proper training. Depending on your condition, the first dose may be given intravenously, followed by subcutaneous injections. Below are key guidelines on how to take Stelara safely and effectively.

• Stelara is administered as a subcutaneous injection. It can be injected into your buttocks, thighs, upper arms, or abdomen.
• A healthcare professional may give you Stelara injections at a medical clinic. They can also teach you how to self-inject Stelara at home.
• Stelara is designed for long-term treatment. Continue using Stelara as long as both you and your doctor agree it’s safe and effective for your condition.
• Always use Stelara as directed by your doctor or healthcare professional.
• Stelara is administered as a subcutaneous injection. Your healthcare professional will administer your first dose and may teach you how to self-inject at home for subsequent doses.
• For treating Crohn’s disease or ulcerative colitis, your first dose will be an intravenous (IV) infusion, injected into your vein over a period of time, typically lasting at least 1 hour, in a healthcare office or clinic.
• After the initial IV infusion, all further doses are given as subcutaneous injections, either by a healthcare professional or self-administered.
• The manufacturer of Stelara provides detailed instructions and instructional videos on how to self-inject the medication.
• Stelara can be used at any time of the day, with no specific requirement for timing.
• It is important to attend all scheduled appointments if receiving Stelara injections from a healthcare professional.
• If self-injecting, keep a calendar to track when injections are due.
• To ensure you do not miss a dose, consider setting reminders on your phone or using a medication timer.

[Note: Your doctor will decide the right amount for you based on your condition, following guidelines and studies on the drug. They’ll adjust it as needed over time.]

Stelara is classified as a biological medication, which means it is produced from living organisms, such as plant or animal cells, in a laboratory setting. It is specifically known as a monoclonal antibody—a type of protein developed from immune system cells. The conditions treated by Stelara, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, are all partly driven by an overactive immune system. In such conditions, the immune system mistakenly identifies healthy cells as foreign invaders, like germs, leading to symptoms like skin plaques, joint pain, or intestinal inflammation.

Stelara works by targeting and attaching to specific proteins in the body known as interleukin-12 (IL-12) and interleukin-23 (IL-23). These proteins are involved in triggering inflammation and activating other immune cells that exacerbate symptoms. By binding to these interleukins, Stelara blocks their inflammatory actions and prevents them from activating additional immune cells, thereby reducing inflammation and alleviating symptoms. The therapeutic effects of Stelara begin shortly after administration, although it may take several weeks before noticeable improvements in symptoms are observed.

Common side effects of Stelara

When taking any medication, it’s essential to be aware of potential side effects that may occur. While some side effects are mild and manageable, others may require medical attention. Understanding these effects helps you stay informed and prepared. This section outlines common side effects you might experience, offering clear explanations to help you recognize and address them appropriately.

• Fatigue (lack of energy): Many individuals experience fatigue, feeling unusually tired or lacking energy. This can affect daily activities and overall quality of life. It’s important to monitor this symptom and discuss it with your healthcare provider, as it may indicate your body’s response to the medication or an underlying issue.
• Vomiting: Some patients may experience vomiting, which is the forceful expulsion of stomach contents through the mouth. This can lead to dehydration and electrolyte imbalances if persistent. It’s crucial to stay hydrated and inform your doctor if vomiting continues, as it may require medical attention or adjustment of your treatment plan.
• Vaginal yeast infection: Stelara can increase the risk of fungal infections, including vaginal yeast infections. Symptoms include itching, redness, swelling, and a thick, white discharge. Prompt treatment with antifungal medications is typically effective. If you experience these symptoms, consult your healthcare provider for appropriate management.
• Upper respiratory infections (e.g., common cold, bronchitis, sinus infection): The medication may make you more susceptible to infections like the common cold, bronchitis, or sinus infections. Symptoms can include cough, sore throat, nasal congestion, and sinus pressure. Maintaining good hygiene and avoiding close contact with sick individuals can help reduce risk. Seek medical advice if symptoms are severe or persistent.
• Mild allergic reaction: Some individuals might experience mild allergic reactions, such as skin rash, itching, or hives. These reactions are generally not severe but should be monitored. If you notice any signs of an allergic reaction, inform your doctor, as they may recommend antihistamines or other treatments to alleviate symptoms.
• Headache: Headaches are a common side effect and can range from mild to severe. They may be due to the body’s adjustment to the medication. Over-the-counter pain relievers can help, but if headaches persist or worsen, it’s important to consult your healthcare provider to rule out other causes.
• Itchy skin: Some patients report pruritus, or itchy skin, which can be localized or widespread. This can cause discomfort and may lead to scratching, increasing the risk of skin infections. Moisturizers and antihistamines can provide relief, but persistent itching should be evaluated by a healthcare professional.
• Redness or deepening of skin color at your injection site: Injection site reactions, such as redness, swelling, or changes in skin color, are relatively common. These reactions are usually mild and resolve on their own. Applying a cool compress can alleviate discomfort. If the reaction is severe or persists, contact your healthcare provider.
• Urinary tract infection (UTI): Stelara may increase the risk of UTIs, which affect the urinary system. Symptoms include a strong, persistent urge to urinate, a burning sensation during urination, and cloudy urine. Early treatment with antibiotics is important to prevent complications. If you experience symptoms of a UTI, seek medical attention promptly.

Serious side effects of Stelara

While medications play a crucial role in managing health conditions, they can sometimes cause serious side effects that require immediate attention. Being informed about potential risks empowers patients to recognize warning signs early and seek prompt medical care.

• Increased Risk of Cancer: Stelara can suppress the immune system, potentially increasing the risk of certain cancers, including skin cancers. Regular skin examinations and monitoring for unusual growths are recommended during treatment. 
• Lung Problems (Non-Infectious Pneumonia): Some patients may develop lung inflammation, leading to conditions like non-infectious pneumonia. Symptoms include persistent dry cough, shortness of breath, and, in severe cases, respiratory failure. Prompt medical attention is crucial if these symptoms occur. 
• Posterior Reversible Encephalopathy Syndrome (PRES): This rare condition involves brain swelling, presenting with headaches, confusion, vision changes, and seizures. Immediate medical evaluation is necessary, as early detection can lead to reversible outcomes. 
• Severe Infections: Stelara can increase susceptibility to serious infections, including bacterial (e.g., osteomyelitis, pneumonia), fungal, and viral infections. Reactivation of latent infections like tuberculosis is also possible. Patients should be vigilant for signs of infection and seek medical care promptly. 
• Cholecystitis: Inflammation of the gallbladder can occur, causing abdominal pain, fever, and digestive issues. Timely medical intervention is important to prevent complications. 
• Appendicitis: Inflammation of the appendix presents with sharp abdominal pain, fever, and nausea. Immediate medical attention is required to avoid rupture and further complications. 
• Diverticulitis: Inflammation of pouches in the digestive tract can lead to abdominal pain, fever, and digestive disturbances. Early treatment is essential to prevent severe outcomes. 
• Cellulitis: This skin infection causes redness, swelling, and tenderness. Prompt antibiotic treatment is necessary to prevent the spread of infection. 
• Severe Allergic Reactions (Anaphylaxis): Serious allergic reactions may occur, characterized by hives, chest pain, difficulty breathing, and swelling of the face or throat. Immediate emergency medical attention is critical. 

[Note: Remember, this list may not cover all possible side effects. Always consult with your healthcare giver for medical advice about side effects.]

Before starting Stelara, it’s important to discuss your medical history with your doctor. Stelara might not be suitable for you if you have certain health conditions, such as:

• Cancer, including skin cancer: Stelara can impair your immune system’s ability to destroy cancer cells or prevent them from spreading. If you have been diagnosed with cancer, inform your doctor. They will assess whether Stelara is safe for you to use.
• Infections, including tuberculosis (TB): Stelara weakens your immune system’s ability to fight infections, which increases your risk of serious infections. It could also cause previous infections to flare up again. Make sure to inform your doctor about any past infections, including TB, as well as any current infections you may have. Your doctor may advise waiting until your current infections are resolved before you begin treatment with Stelara.
• Latex allergy: The prefilled syringes of Stelara may not be suitable if you are allergic to latex, as the needle cover contains latex. If you have a latex allergy, ensure your doctor is aware so they can prescribe a suitable form of Stelara for you.
• Severe allergy to Stelara: Do not take Stelara if you have had a severe allergic reaction to it or any of its inactive ingredients. If you are unsure whether you have previously had an allergic reaction to Stelara, discuss it with your doctor.

When using Stelara, it’s essential to follow specific precautions to ensure safe and effective treatment:

• Infection Risk: Stelara can increase the risk of infections, including serious bacterial, fungal, and viral infections. It’s crucial to avoid starting Stelara during any active infection. If a serious infection develops, consult your healthcare provider promptly.
• Tuberculosis Screening: Before initiating Stelara, patients should be evaluated for tuberculosis (TB). If you have a history of latent or active TB, inform your doctor, as appropriate treatment may be necessary before starting Stelara.
• Vaccinations: Avoid receiving live vaccines while undergoing Stelara treatment. Ensure all vaccinations are up to date before starting therapy. Discuss any vaccination plans with your healthcare provider during treatment.
• Allergic Reactions: Serious allergic reactions, including anaphylaxis, have been reported. Seek immediate medical attention if you experience symptoms such as swelling of the face, eyelids, tongue, or throat, or skin rash.
• Malignancies: There is a potential increased risk of malignancies, including non-melanoma skin cancer. Regular skin examinations are recommended during treatment.
• Posterior Reversible Encephalopathy Syndrome (PRES): Although rare, cases of PRES have been reported. Symptoms include headaches, seizures, confusion, and visual disturbances. If these occur, discontinue Stelara and seek appropriate treatment.
• Latex Sensitivity: The needle cover on the Stelara prefilled syringe contains latex. If you have a latex allergy, inform your healthcare provider to discuss alternative administration methods.

• Stelara should not be used by patients who have experienced severe hypersensitivity reactions to ustekinumab or any of the inactive ingredients in Stelara.

• Always try to maintain your appointments for Stelara injections. If you miss an appointment, contact your clinic immediately to reschedule.
• If you administer Stelara at home and miss a dose, take it as soon as you remember. However, never take more than one dose at the same time to avoid increasing the risk of serious side effects.
• If you miss a dose, discuss it with your doctor. They will assist you in adjusting your treatment schedule if necessary.
• To ensure you do not forget a dose, consider setting reminders on your phone or using a medication timer.

[Note: If you have missed a dose of your medication and are unsure about when to take the next one, immediately consult your doctor or pharmacist.]

Do not use more Stelara than your doctor prescribes. If you believe you have taken too much Stelara, contact your doctor immediately. You can also reach out to America’s Poison Centers by calling 800-222-1222 or using their online tool. If you experience severe symptoms, call 911 or visit the nearest emergency room immediately.

[Note: If you consumed more than the recommended dose, get medical help right away or call the Poison Help line at 1-800-222-1222.]

Stelara requires specific storage conditions to preserve its potency and prevent contamination. Following recommended storage guidelines helps avoid potential health risks and ensures that the medication remains safe for future use.

• Store Stelara vials and prefilled syringes in the refrigerator, maintaining a temperature between 36°F and 46°F (2°C to 8°C). Keep the vials upright and protect them from light by storing them in their original container until they are ready to be used.
• Do not freeze or shake the Stelara vials or syringes.
• If you no longer need Stelara and have leftover medication, it is crucial to dispose of it safely to prevent accidental ingestion by others, including children and pets, and to avoid environmental harm.

[Note: Discuss with your healthcare professional about the proper disposal of any unused medicine and any questions you may have regarding its storage.]

Stelara may interact with various medications and treatments, leading to different effects. For example, some interactions might reduce the effectiveness of a drug, while others could intensify the side effects or make them more severe. Before starting Stelara, it is important to discuss all medications you are currently taking with your doctor and pharmacist. This includes all prescription and over-the-counter drugs, as well as any vitamins, herbs, and supplements. Sharing this information is crucial for avoiding potential interactions. If you have any concerns about how other drugs might affect your treatment with Stelara, please consult your doctor or pharmacist for advice.

Interactions of Stelara with Other Medications or Therapies

Below, we provide lists of medications and therapies that can interact with Stelara. However, these lists are not exhaustive and do not cover all possible interactions.

• Stelara and Warfarin: When Stelara is taken with warfarin (also known as Jantoven), it can alter the level of warfarin in your body. This change might impact how effectively warfarin works and could increase your risk of experiencing side effects, such as bleeding. If you are prescribed both Stelara and warfarin, your doctor will likely monitor your blood tests closely to assess your blood clotting ability. Additionally, your doctor will watch for any side effects like bleeding. If you are taking these medications together, your doctor might need to adjust the doses of either Stelara or warfarin to manage these effects safely.
• Stelara and Certain Transplant Drugs: Combining Stelara with certain medications used during and after organ transplants may alter the levels of these transplant drugs in your body. This can influence how effectively these drugs work and could heighten your risk of serious side effects. Examples of transplant drugs that might interact with Stelara include:
  • Prograf, Envarsus XR (tacrolimus)
  • Afinitor, Zortress (everolimus)
  • Gengraf, Neoral (cyclosporine)
  • Rapamune (sirolimus)
• Stelara and Allergy Shots: The safety of receiving allergy shots (also known as immunotherapy) while taking Stelara is currently unclear. Stelara may impact your immune system’s response to the allergy shots, potentially reducing their effectiveness. Additionally, using Stelara with allergy shots might increase your risk of experiencing a serious allergic reaction, including anaphylaxis. If you are undergoing allergy shots, it’s important to inform your doctor that you are also taking Stelara. Your doctor will then discuss the potential risks and benefits with you and may monitor you more closely for any serious reactions to the allergy shots.
• Stelara and Vaccines: It is recommended to avoid live vaccines while you are on Stelara. Live vaccines contain a small, weakened amount of a live virus or bacteria, and getting one during Stelara treatment can increase your risk of developing the disease that the vaccine is intended to prevent. This increased risk occurs because Stelara suppresses your immune system, reducing its ability to fight infections. Therefore, receiving a live vaccine while on Stelara could lead to serious infections. Examples of live vaccines to avoid during Stelara treatment include:
  • Chickenpox (varicella)
  • Rotavirus
  • Measles, mumps, rubella (MMR)
  • Yellow fever
  • Smallpox

You should also avoid receiving the Bacillus Calmette-Guérin (BCG) vaccine, which is used to prevent tuberculosis (TB), for one year before starting Stelara, throughout your treatment, and for one year after stopping Stelara. The BCG vaccine is more commonly administered outside of the United States.

Additionally, it may be risky for you if people in your household receive live vaccines while you are on Stelara. This is because there is a possibility they could transmit the live virus from the vaccine to you. If you receive a non-live (inactivated) vaccine while on Stelara, your immune system might not be strong enough to effectively protect you from the disease the vaccine is designed to prevent. Discuss with your doctor the safety of receiving any type of vaccine during your Stelara treatment.

[Note: This isn’t a complete list, and there could be other drugs that interact with Stelara. Make sure to tell your doctor any prescription, over-the-counter medicines, and herbal products you’re taking.]

When managing autoimmune conditions, various medications are available to help reduce inflammation, control symptoms and improve overall well-being. If Stelara (ustekinumab) isn’t suitable due to effectiveness, side effects, or other concerns, several alternative treatments are commonly prescribed. These alternatives range from biologics and immunosuppressants to anti-inflammatory drugs, offering different mechanisms of action tailored to individual needs.

• Rasuvo (methotrexate)
• Otrexup (methotrexate)
• Soriatane (acitretin)
• Trexall (methotrexate)
• Humira (adalimumab)
• Otezla (apremilast)
• Enbrel (etanercept)
• Siliq (brodalumab)
• Taltz (ixekizumab)
• Remicade (infliximab)
• Tremfya (guselkumab)
• Cosentyx (secukinumab)
• Skyrizi (risankizumab)
• Stelara (ustekinumab)
• Ilumya (tildrakizumab)
• Entocort EC (budesonide)
• Rayos (prednisone)
• Azulfidine (sulfasalazine)
• Azasan (azathioprine)
• Azulfidine EN-tabs (sulfasalazine)
• Imuran (azathioprine)
• Purixan (6-mercaptopurine)
• Purinethol (6-mercaptopurine)
• Tysabri (natalizumab)
• Advil (ibuprofen)
• Entyvio (vedolizumab)
• Motrin IB (ibuprofen)
• Arava (leflunomide)
• Plaquenil (hydroxychloroquine)
• Simponi Aria (golimumab)
• Simponi (golimumab)
• Kineret (anakinra)
• Rituxan (rituximab)
• Orencia (abatacept)
• Xeljanz XR (tofacitinib)
• Xeljanz (tofacitinib)
• Actemra (tocilizumab)

[Note: Your doctor will choose what’s best for you. Don’t use any of these alternative medications without consulting your healthcare provider. Taking them by yourself may cause serious side effects.]

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