Otulfi (Ustekinumab-Aauz) for Psoriasis

Otulfi (ustekinumab-aauz) is a prescription medication approved by the U.S. Food and Drug Administration (FDA) to treat adults and children ages 6 and older with moderate to severe plaque psoriasis.

How Otulfi Works and How It’s Taken

Otulfi is a type of biologic medication called a monoclonal antibody. It works by blocking two immune system proteins called interleukin-12 and interleukin-23. In plaque psoriasis, this helps reduce inflammation and slow the overactive immune signals that lead to skin plaques.

Otulfi is a biosimilar of Stelara. This means it is made from living cells and is designed to work like the original medicine. The FDA requires biosimilars to have no meaningful differences in safety or how well they work.

Doctors prescribe Otulfi for adults and children ages 6 and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy. Phototherapy means treatment with ultraviolet light. Systemic therapy means medicine that works throughout the body.

Otulfi is given as an injection under the skin. It is given at the start, again four weeks later, and then every 12 weeks.

Otulfi should be used under the guidance and supervision of a healthcare provider. In children, it is recommended that a healthcare provider give the injection. An individual or caregiver may give the injection at home if a healthcare provider decides this is appropriate and provides proper training.

Otulfi can be injected under the skin in the upper arms, buttocks, thighs, or stomach area. Do not inject it into skin that is tender, bruised, discolored, or hard. Use a different injection site each time.

Typical Dosing for Plaque Psoriasis

The recommended dose of Otulfi for plaque psoriasis is:

For adults:

100 kilograms or less — 45 milligrams at the start, 45 milligrams four weeks later, and then 45 milligrams every 12 weeks
More than 100 kilograms — 90 milligrams at the start, 90 milligrams four weeks later, and then 90 milligrams every 12 weeks

For children ages 6 and older:

Less than 60 kilograms — 0.75 milligrams per kilogram at the start, 0.75 milligrams per kilogram four weeks later, and then 0.75 milligrams per kilogram every 12 weeks
60 kilograms to 100 kilograms — 45 milligrams at the start, 45 milligrams four weeks later, and then 45 milligrams every 12 weeks
More than 100 kilograms — 90 milligrams at the start, 90 milligrams four weeks later, and then 90 milligrams every 12 weeks

This information is based on the prescribing information, but your healthcare provider may tailor your treatment plan. Always follow their guidance.

Otulfi Side Effects

In clinical studies of ustekinumab for moderate to severe plaque psoriasis, common side effects occurred in about 1 percent to 8 percent of people. These include:

Nasopharyngitis (common cold symptoms, such as a sore throat or runny nose)
Upper respiratory tract infection
Headache
Fatigue (feeling very tired)
Back pain
Dizziness
Pharyngolaryngeal (throat) pain
Pruritus (itching)
Injection-site erythema (redness)
Myalgia (muscle pain)
Depression

Serious Side Effects and Warnings

Otulfi can cause serious side effects that may require immediate medical attention. These include:

Serious infections — Tuberculosis and serious bacterial, fungal, or viral infections can occur.
Malignancies — Cancer, including nonmelanoma skin cancer, can occur.
Serious hypersensitivity reactions — Anaphylaxis and angioedema can occur and may cause trouble breathing, swelling, hives, or rash.
Posterior reversible encephalopathy syndrome (PRES) — This rare brain condition can cause headache, confusion, vision changes, or seizures.
Noninfectious pneumonia — Lung inflammation not caused by an infection can include interstitial pneumonia, eosinophilic pneumonia, or cryptogenic organizing pneumonia and may cause cough or shortness of breath.

Get medical help right away if you think you are having a serious reaction.

How To Save on Otulfi

Fresenius Kabi, the manufacturer of Otulfi, offers the KabiCare Patient Support Program. Eligible individuals with commercial insurance may pay as little as $0 per month.

The KabiCare Patient Support Program also offers help with enrollment, navigating insurance coverage and financial assistance, accessing medication, disease education, injection training, and refill reminders.

Individuals are not eligible for commercial copay assistance or Bridge to Therapy support if the prescription is eligible to be reimbursed, in whole or in part, by any state or federal healthcare program. To learn more, visit the KabiCare Patient Support Program for Otulfi or call 833-522-4227.

What To Know Before Taking Otulfi

Before starting Otulfi, your doctor will check you for active and latent (hidden) tuberculosis (TB).

Before starting Otulfi, make sure your vaccines are up to date. While taking Otulfi, you should avoid live vaccines. You should not receive the Bacille Calmette-Guérin (BCG) vaccine for one year before starting Otulfi, during treatment, or for one year after stopping Otulfi.

Tell your doctor if anyone in your home needs a live vaccine. Some live vaccines may spread from a household contact to an individual taking Otulfi.

Tell your doctor if you have any allergies to ustekinumab products or any ingredients in Otulfi. Do not take Otulfi if you have had a clinically significant allergic reaction to ustekinumab products or any of the ingredients in Otulfi.

Tell your doctor about all medicines you take, including prescription drugs, over-the-counter medicines, vitamins, and herbal supplements.

Before starting Otulfi, tell your doctor if you:

Think you have an infection or have symptoms of an infection
Have any open cuts
Are being treated for an infection
Get a lot of infections
Have infections that keep coming back
Have TB
Have been close to someone with TB
Have ever had cancer
Have any new or changing lesions in psoriasis areas or on normal skin
Receive or have received phototherapy for psoriasis
Receive or have received allergy shots

Also tell your doctor if you have had nervous system problems in the past. Tell your doctor right away if you have headache, seizures, confusion, or vision changes.

Otulfi is also FDA-approved to treat psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

If you are pregnant, planning to become pregnant, or breastfeeding while taking Otulfi, talk with your doctor about the risks and benefits.

Community FAQs

These answers are fact-checked by our editorial staff.

How effective is Otulfi for plaque psoriasis?

In two studies of adults with plaque psoriasis, ustekinumab was compared with placebo (an inactive treatment).

By week 12, 67 percent to 76 percent of people taking ustekinumab reached PASI 75. This means their psoriasis score improved by at least 75 percent. In comparison, 3 percent to 4 percent of people taking placebo reached PASI 75.

By week 12, 59 percent to 73 percent of people taking ustekinumab were rated as “cleared” or “minimal” on the Physician’s Global Assessment. This is a doctor’s rating of psoriasis severity. In comparison, 4 percent of people taking placebo were rated as “cleared” or “minimal.”

How long does Otulfi take to work for plaque psoriasis?

The clinical study results do not say exactly when people first notice improvement in plaque psoriasis. In the adult plaque psoriasis studies, results were measured at week 12. At that time, more people taking ustekinumab had improved psoriasis scores than people taking placebo.

What tests or monitoring are needed with Otulfi for psoriasis?

Before starting Otulfi, your doctor should check you for TB. You should not receive Otulfi if you have active TB. If you have latent (inactive) TB, it should be treated before you start Otulfi.

Individuals receiving Otulfi should be closely monitored and have regular follow-up visits with a healthcare provider. Your doctor should watch for signs and symptoms of infection, active TB, nonmelanoma skin cancer, and PRES. PRES is a rare brain condition that can cause headache, seizures, confusion, or vision problems.