Ustekinumab

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. Administered initially via IV and subsequently through subcutaneous injections, Stelara is also used off-label for ankylosing spondylitis and lupus. Safety considerations include its impact on infection susceptibility and potential interference with vaccinations. Healthcare providers must be consulted for personalized treatment and management plans, including discussing dosages and possible interactions with other medications.

Stelara Overview

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. The medication is administered as an intravenous (IV) infusion for the initial dose in Crohn’s disease and ulcerative colitis to rapidly achieve therapeutic levels, followed by regular subcutaneous injections for maintenance therapy.

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.

Uses of Stelara

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 Dosage

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).

Recommended Stelara Dosage for Different Patients

Dosage for Plaque Psoriasis

Stelara is approved for treating plaque psoriasis in adults and children aged 6 and older. Here, we focus on the typical adult dosage.

• Schedule for Stelara Injections:
  • The first dose is administered on day 1.
  • The second dose is given 4 weeks after the first.
  • The third dose is scheduled for 12 weeks after the second.
  • Subsequent doses are then administered every 12 weeks.
• Dosage Amounts Based on Body Weight:
  • Adults weighing 100 kilograms (approximately 220 pounds) or less typically receive a dosage of 45 mg.
  • Adults weighing over 100 kilograms are generally given a dosage of 90 mg.

Dosage for Psoriatic Arthritis

Stelara is used to treat adults with psoriatic arthritis, and the typical dosage for each injection is 45 mg.

• Schedule for Stelara Injections:
  • The first dose is administered on day 1.
  • The second dose is given 4 weeks later.
  • The third dose is scheduled for 12 weeks after the second.
  • Further doses are administered every 12 weeks.
• If you have both psoriatic arthritis and plaque psoriasis, your doctor might recommend a higher dosage of Stelara.

Dosage for Crohn’s Disease

Stelara is used to treat adults with Crohn’s disease. The standard maintenance dosage is 90 mg administered every 8 weeks as a subcutaneous injection.

• Initial and Maintenance Doses:
  • The very first dose you will receive is known as the induction or loading dose. This dose is given as an intravenous (IV) infusion, which means the medication is injected directly into your vein over at least 1 hour.
  • Following the loading dose, all subsequent doses are given as subcutaneous injections.
• Dosage for the Loading Dose Based on Body Weight:
  • Adults weighing 55 kilograms (about 121 pounds) or less: The loading dose is 260 mg.
  • Adults weighing between 55 and 85 kilograms (about 187 pounds): The loading dose is 390 mg.
  • Adults weighing over 85 kilograms: The loading dose is 520 mg.

Dosage for Ulcerative Colitis

Stelara is used to treat adults with ulcerative colitis. The standard maintenance dosage is 90 mg, administered every 8 weeks as a subcutaneous injection.

• Initial and Maintenance Doses:
  • The first dose you receive is known as the induction or loading dose. This is administered as an intravenous (IV) infusion, where the medication is injected directly into your vein over at least 1 hour.
  • Subsequent doses, following the loading dose, are given as subcutaneous injections.
• Dosage for the Loading Dose Based on Body Weight:
  • Adults weighing 55 kilograms (about 121 pounds) or less: The loading dose is 260 mg.
  • Adults weighing between 55 and 85 kilograms (about 187 pounds): The loading dose is 390 mg.
  • Adults weighing more than 85 kilograms: The loading dose is 520 mg.

Pediatric Dosage

Stelara is approved to treat both plaque psoriasis and psoriatic arthritis in children aged 6 years and older. Below are the typical dosages for children.

• Schedule for Stelara Injections:
  • The first dose is administered on day 1.
  • The second dose is given 4 weeks later.
  • The third dose is scheduled for 12 weeks after the second.
  • Following doses are administered every 12 weeks.
• Dosage Based on Body Weight:
  • Children weighing less than 60 kilograms (about 132 pounds): The dosage is 0.75 mg of Stelara per kilogram of body weight.
  • Children weighing between 60 kilograms and 100 kilograms (about 220 pounds): The usual dosage is 45 mg.
  • Children weighing more than 100 kilograms: The usual dosage is 90 mg.

For example, a child weighing 88 pounds (approximately 40 kilograms) will receive a dose of 30 mg.

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

How to Take Stelara?

• 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.]

How Does Stelara Work?

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.

Stelara Side Effects

Common side effects of Stelara may include:

• Fatigue (lack of energy)
• Vomiting
• Vaginal yeast infection
• Upper respiratory infections, such as the common cold, bronchitis, or sinus infection
• Mild allergic reaction
• Headache
• Itchy skin
• Redness or deepening of skin color at your injection site
• Urinary tract infection (UTI)

Adverse/Serious side effects of Stelara may include:

• Possible increased risk of cancer. 
• Lung problems are caused by inflammation, such as certain types of non-infectious pneumonia. Signs may include:
  • Shortness of breath
  • Dry cough that doesn’t go away
  • Respiratory failure (weak and shallow breathing)
• Posterior reversible leukoencephalopathy syndrome which in simple terms is known as swelling in your brain. Signs may include:
  • Vision changes
  • Confusion
  • Headache
  • Seizures
• Severe bacterial, fungal, or viral infections. Examples of these infections include:
  • Osteomyelitis (an infection in the bone.
  • Pneumonia (an infection in the lungs.
  • Gastroenteritis (also known as stomach flu, it affects the stomach and intestines.
  • Reactivation of Tuberculosis (TB) (a flare-up of TB in individuals who had TB in the past)
  • Cholecystitis (inflammation of the gallbladder.
  • Appendicitis (inflammation of the appendix.
  • Diverticulitis (inflammation of the small sacs in the large intestine.
  • Cellulitis (type of skin infection.
• Severe allergic reactions, including anaphylaxis. 

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

Stelara Warnings

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.

Stelara Precautions

• Alcohol: There aren’t any known interactions between Stelara and alcohol. If you drink alcohol, talk with your doctor about whether it’s safe for you to drink it while you’re using Stelara.
• Breastfeeding: If you are breastfeeding or planning to breastfeed, it is important to consider how Stelara might affect both you and your child. Currently, it is not known whether Stelara is safe to use during breastfeeding. In animal studies, Stelara was found to pass into the breastmilk of lactating females. However, there is insufficient data to determine if Stelara passes into human breast milk. If you are considering using Stelara while breastfeeding, discuss with your doctor whether this is safe for your child.
• Pregnancy: If you are capable of becoming pregnant, it is crucial to evaluate whether Stelara is a safe option for you. Currently, there are insufficient studies on pregnant individuals to determine the safety of using Stelara during pregnancy. Animal studies have not shown any harm to the fetus when Stelara was administered to pregnant animals. However, results from animal studies may not always be indicative of human outcomes. If you are pregnant or planning to become pregnant, it is important to discuss with your doctor the safest treatment options for your condition.
• Birth Control: If you are sexually active and you or your partner can become pregnant, it’s essential to consider how treatment with Stelara might influence your birth control choices. The safety of using Stelara during pregnancy has not been established. Therefore, it is important to discuss your birth control options with your doctor while you are undergoing treatment with Stelara.

Stelara Contraindications

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

Stelara Missed Dose

• 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.]

Stelara Overdose

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 Storage

• 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 Interactions

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.]

Stelara Alternatives

• 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.]

Frequently Asked Questions

Will I also need to use a topical cream with Stelara treatment?

Yes, you may need to continue using a topical cream along with Stelara if the medication does not fully clear up your plaque psoriasis. Your doctor can prescribe topical creams to use in combination with Stelara to enhance the treatment’s effectiveness.

If I take Stelara for a long time, will I have withdrawal symptoms when I stop using it?

If you stop taking Stelara after using it for a long time, you may not experience traditional withdrawal symptoms, which are typically uncomfortable effects associated with stopping a substance your body has grown accustomed to. However, it’s possible that the condition you were treating with Stelara could return or worsen upon discontinuation. This resurgence or deterioration of symptoms might be mistaken for withdrawal symptoms.

It’s important not to stop taking Stelara without consulting your doctor. If your doctor advises stopping the treatment, they will closely monitor your condition to ensure that you can safely remain off the medication.

Does Stelara have a black box warning?

No, Stelara does not have a black box warning, also known as a boxed warning. These warnings are the most serious type issued by the Food and Drug Administration (FDA) to inform healthcare professionals and patients about potential severe side effects associated with a medication. While Stelara can cause serious side effects, the FDA has not required a black box warning to be included with this medication. This indicates that, according to current data, the risks do not necessitate the highest level of alert.

What vaccines can I get during Stelara treatment?

During Stelara treatment, your immune system’s ability to fight disease is reduced. This makes live vaccines, which contain weakened forms of viruses or bacteria, unsafe for you. Since your immune system may not effectively combat the live virus or bacteria from these vaccines, there’s a risk you could develop the infection the vaccine is intended to prevent.

It’s advisable to receive all necessary vaccinations before starting Stelara treatment. This should include both live and non-live vaccines. One exception is the Bacillus Calmette-Guérin (BCG) vaccine, which is used to prevent tuberculosis (TB) and is more commonly administered outside the United States. You should not begin Stelara treatment until at least 1 year after receiving a BCG vaccine. If you receive non-live vaccines while on Stelara, your immune system may not respond adequately, possibly rendering the vaccine less effective in preventing its targeted infection. Always discuss your vaccination plan with your doctor before starting Stelara.

Does Stelara decrease my immune system function?

Yes, Stelara does reduce the function of your immune system, which makes it harder for your body to fight off infections. This medication is used to treat conditions like plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis, which are caused in part by an overactive immune system. This overactivity can lead to inflammation and other symptoms that affect your health and well-being.

By decreasing the activity of your immune system, Stelara helps prevent it from attacking your joints and organs, which can lead to improvements in your symptoms and overall quality of life. However, a less active immune system increases your risk of developing serious or unusual infections. It can also lead to a reactivation of infections you’ve had before, such as tuberculosis (TB). Additionally, the reduction in immune system activity caused by Stelara may raise your risk of certain types of cancer, including skin cancer.

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