Is Stelara FDA approved for ulcerative colitis?

• Yes, Stelara was approved by the FDA on October 21, 2019 for the treatment of adult patients with moderately to severely active ulcerative colitis (UC).
• Ulcerative colitis is a serious and long-term inflammatory disease that affects the large intestine (colon) and rectum.
• Stelara (ustekinumab) is manufactured by Janssen Pharmaceuticals.

Symptoms of ulcerative colitis include:

• Diarrhea, possibly with blood or pus
• Stomach pain and cramping
• Weight loss
• Fever
• Fatigue
• Rectal bleeding, blood in stool
• Rectal pain
• Urgent need to defecate
• Inability to defecate despite an urgency
• Failure to grow (in children)

Ulcerative colitis has no known cure, but treatment can reduce signs and symptoms of the disease and bring about long-term remission. Remission occurs when inflammation is controlled and symptoms improve, which can be long-lasting, from months to years.

Ulcerative colitis remission is defined as:

• Having three or less stools per day
• No bleeding in stools
• No urgency to defecate

In addition to ulcerative colitis, Stelara is also FDA-approved to treat:

Adult patients with:

• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
• active psoriatic arthritis (PsA), alone or in combination with methotrexate
• moderately to severely active Crohn’s disease

Children 6 years and older with:

• moderate to severe plaque psoriasis, who are candidates for phototherapy or systemic therapy
• active psoriatic arthritis (PsA)

How does Stelara work for ulcerative colitis?

Stelara works by targeting proteins called interleukins (IL)-12 and IL-23. These proteins are thought to contribute to the long-lasting inflammation that is a main feature of ulcerative colitis.

Stelara is a biologic medicine. Biologics target proteins, enzymes and other molecules that cause inflammation, pain and destruction.

How is Stelara given?

• In ulcerative colitis in adults, Stelara is initially given as a one-time, weight-based intravenous (IV) infusion dose.
• It is followed by a maintenance injection dose of 90 mg given by a subcutaneous (just under the skin) injection every 8 weeks.

In studies, most patients saw rapid relief from UC symptoms in 8 weeks, with 20% of patients (1 out of 5) reaching remission. At one year, 40% of patients (4 out of 10) were in remission. At 2 years, 70% of patients (7 out of 10) had no rectal bleeding and fewer daily bowel movements.

The most common side effects (3% or more) in ulcerative colitis studies include:

• Nasopharyngitis (the common cold, sore throat)
• Headache
• Stomach pain
• Flu
• Fever
• Diarrhea
• Sinusitis
• Fatigue
• Nausea

This is not all the information you need to know about Stelara (ustekinumab) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.