STELARA

STELARA is the brand name for ustekinumab and is available as an injection for subcutaneous or IV use.

STELARA is available in the following:
Subcutaneous Injection
45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled
syringe
45 mg/0.5 mL solution in a single-dose vial
Intravenous Infusion
130 mg/26 mL (5 mg/mL) solution

• STELARA is an interleukin antagonist that is used to treat:
• Moderate-to-severe plaque psoriasis (Ps) in adults and children ages 6 years and older
• Psoriatic arthritis (PsA) in adults and children ages 6 years and older
• Moderate-to-severe Crohn’s disease (CD) in adults
• Moderate-to-severe ulcerative colitis (UC) in adults

STELARA is an interleukin antagonist. It blocks proteins in your immune system called interleukin-12 (IL-12) and interleukin-23 (IL-23) from working. This helps to lower inflammation and treat symptoms caused by autoimmune conditions.

• STELARA is typiically dosed as follows:
• Plaque psoriasis
• Adults:
• Weight 220 lbs or less: The typical dose is 45 mg injected under the skin once, then another 45 mg four weeks later. After the second dose, 45 mg is injected every 12 weeks.
• Weight more than 220 lbs: The typical dose is 90 mg injected under the skin once, then another 90 mg four weeks later. After the second dose, 90 mg is injected every 12 weeks.
• Children ages 6 to under 18 years:
• Weight less than 132 lbs: The typical dose is 0.75 mg/kg of body weight injected under the skin once, then another 0.75 mg/kg four weeks later. After the second dose, 0.75 mg/kg is injected every 12 weeks.
• Weight of 132 lbs to 220 lbs: The typical dose is 45 mg injected under the skin once, then another 45 mg four weeks later. After the second dose, 45 mg is injected every 12 weeks.
• Weight more than 220 lbs: The typical dose is 90 mg injected under the skin once, then another 90 mg four weeks later. After the second dose, 90 mg is injected every 12 weeks.
• Psoriatic arthritis
• Adults:
• Psoriatic arthritis only: The typical dose is 45 mg injected under the skin once, then another 45 mg four weeks later. After the second dose, 45 mg is injected every 12 weeks.
• Psoriatic arthritis with plaque psoriasis and weighing more than 220 lbs: The typical dose is 90 mg injected under the skin once, then another 90 mg four weeks later. After the second dose, 90 mg is injected every 12 weeks.
• Children ages 6 to under 18 years:
• Weight less than 132 lbs: The typical dose is 0.75 mg/kg of body weight injected under the skin once, then another 0.75 mg/kg four weeks later. After the second dose, 0.75 mg/kg is injected every 12 weeks.
• Weight of 132 lbs or more: The typical dose is 45 mg injected under the skin once, then another 45 mg four weeks later. After the second dose, 45 mg is injected every 12 weeks.
• Psoriatic arthritis with plaque psoriasis and weighing more than 220 lbs: The typical dose is 90 mg injected under the skin once, then another 90 mg four weeks later. After the second dose, 90 mg is injected every 12 weeks.
• Crohn’s disease and ulcerative colitis:
• Adults: The typical dose is 260 mg to 520 mg infusion into the veins (intravenous, IV) once, then 90 mg under the skin every 8 weeks.

STELARA is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

• Common side effects of STELARA:
• Inflammation of the nasal passages
• Upper respiratory tract infection
• Headache
• Joint pain
• Nausea
• Redness at the injection site
• Yeast infection
• Bronchitis
• Stomach pain
• Flu infection
• Fever

Serious side effects are rare with STELARA. Contact your healthcare provider immediately if you experience any of the following.

Serious infection: fever, cough, weight loss, muscle aches, dark urine, chills, vomiting
Severe allergic reaction: rash; trouble breathing; swelling of your face, eyes, lips, or mouth; hives
Posterior reversible encephalopathy syndrome (PRES): headache, feeling sluggish or confused, vision changes, seizure
Swelling in the lungs: trouble breathing, cough

• The following medications may interact with STELARA:
• Upon initiation of STELARA in patients who are receiving concomitant CYP450 substrates, particularly those with
• a narrow therapeutic index, consider monitoring for therapeutic effect (e.g., for warfarin) or drug
• concentration (e.g., for cyclosporine) and adjust the individual dose of the drug as needed.

Janssen Pharmaceuticals

It is not known if STELARA will harm your unborn baby. If you become pregnant while receiving STELARA talk to your healthcare provider.

• ustekinumab