• Before starting Stelara all your vaccinations should be up to date and you should be free of infection.
• Live vaccines, such as BCG, MMR, and chickenpox should NOT be administered during Stelara treatment.
• Inactivated vaccines, such as the flu vaccine, may be given to people taking Stelara and a yearly flu vaccine is recommended for people taking biologics, such as Stelara.
• However, it is not known how much biologics suppress the immune response to vaccination.
• If you develop an infection while on Stelara, your doctor may consider temporarily discontinuing Stelara until the infection resolves or treatment can be instigated.
• If your doctor decides to continue with Stelara, then antibiotics may be administered at the same time if the infection is bacterial in origin.

Stelara (ustekinumab) is a monoclonal antibody. It may also be called a biologic.

Stelara works by binding to the p40 protein subunit that is used by two cytokines, IL-12 and IL-23. Cytokines are signaling substances that help control immunity, inflammation, and the manufacture of blood cells.

How does Stelara increase the risk of infection?

Because Stelara blocks the effects of these cytokines, reducing our immune response, it can increase the risk of infection or precipitate symptoms of an infection that has been asymptomatic. Stelara should NOT be initiated in any person with a current or suspected infection. This includes:

• Active tuberculosis. If a person has latent tuberculosis, treatment for tuberculosis should be initiated prior to Stelara in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed. Anybody with a prior history of TB should be monitored closely for signs and symptoms of active tuberculosis during and after treatment.

Instruct patients to seek medical advice if signs or symptoms suggestive of an infection occur while on treatment with Stelara and consider discontinuing Stelara® for serious or clinically significant infections until the infection resolves or is adequately treated.

Serious infections, caused by bacteria, fungi, or viruses, have been reported in people taking Stelara, for example:

• Appendicitis
• Cellulitis
• Colds, flus and other respiratory viral infections
• Diverticulitis
• Gastroenteritis
• Herpes zoster
• Listeria meningitis
• Osteomyelitis
• Pneumonia
• Sepsis
• Urinary tract infections.

How are infections treated while on biologics?

Call your doctor straight away if you develop an infection of any kind while taking Stelara or if you have an open cut or sore. Even simple infections may need urgent treatment. Infections are common, for example:

• Nose or throat infections (such as the common cold) affect 1 in 10 people
• Chest infections may affect 1 in 100 people
• Cellulitis (tissue inflammation under the skin) may affect 1 in 100 people
• Shingles may infect 1 in 100 people.

Always monitor yourself for symptoms that suggest an infection, such as:

• Burning when urinating
• Diarrhea
• Difficulty breathing
• Fever or flu-like symptoms
• Red, painful, blistered, or swollen skin
• Sweats or chills.

Your doctor may consider temporarily stopping Stelara administration until the infection has resolved or has been treated.

However, in some situations, discontinuing Stelara may not be feasible and may inadvertently result in a longer course of treatment for a particular infection. This is because:

• Biologics, such as Stelara typically have long half-lives and there may be a delay from the time of discontinuation to the time of immune function recovery
• Discontinuing immunosuppressive therapy, such as Stelara might result in immune reconstitution inflammatory syndrome. This is a condition caused by the immune system overeating to the previously unrecognized antigens because it was suppressed.

Many doctors just proceed with biologic therapy during an infection and treat the infection with the appropriate medication, for example antibiotics if it is bacterial, or antivirals if it is a viral infection. Corticosteroids may also be administered.

Can vaccinations be administered to people taking Stelara?

Prior to starting treatment with Stelara, patients should receive all their appropriate immunizations for their age as recommended by National guidelines. It is important people administered Stelara DO NOT receive live vaccines. This includes:

• BCG vaccine for tuberculosis. This should not be given during treatment or within ONE YEAR of initiating or discontinuing Stelara
• Measles, mumps rubella vaccine
• Varicella (chickenpox) vaccine.

Caution should also be exercised when administering live vaccines to close contacts of people taking Stelara as viral shedding and subsequent transmission of the virus to Stelara patients may occur.

In addition, non-live vaccines (such as influenza, hepatitis A, and pertussis [whooping cough]) that are administered during treatment with Stelara may not initiate an immune response that is sufficient to prevent disease.

However, a yearly flu vaccine is currently recommended for people administered Stelara. A trial is currently underway investigating how the immune response is affected to vaccines in people taking biologics.

What is Stelara?

Stelara (ustekinumab) is a targeted treatment that reduces inflammation and may be used in the treatment of:

• Plaque psoriasis in adults and children who are at least 6 years old
• Psoriatic arthritis in adults, sometimes in combination with methotrexate
• Active psoriatic arthritis in children who are at least 6 years old
• Moderate-to-severe Crohn's disease in adults after other medicines have failed
• Moderate-to-severe ulcerative colitis in adults.

Stelara is administered by injection, under the skin (subcutaneous). The dosage and frequency of administration depend on the condition being treated. After appropriate training, people can be taught how to self-administer Stelara or caregivers shown how to give it to another person.

How does Stelara work?

Stelara (ustekinumab) is a monoclonal antibody. Monoclonal antibodies are man-made proteins that act like human antibodies in the immune system. They are a type of “targeted” treatment. Targeted treatments attach only to specific proteins in the body.

Stelara binds to the p40 protein subunit that is used by two cytokines, IL-12 and IL-23. Cytokines are signaling substances that help control immunity, inflammation, and the manufacture of blood cells. By binding to this protein, Stelara disrupts the interaction of these two cytokines which have been identified as being important contributors to chronic inflammation that is a hallmark of Crohn’s disease and ulcerative colitis. These cytokines are also present in skin lesions associated with psoriasis and in the joints of people with psoriatic arthritis.