Otulfi

Pronunciation: oh-tull-fi
Generic name: ustekinumab-aauz
Dosage form: subcutaneous injection, injection for intravenous Infusion
Drug class: Interleukin inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Oct 1, 2024.

What is Otulfi?

Otulfi (ustekinumab-aauz) is an injectable prescription medicine which is a biosimilar to Stelara that may be used to treat Crohn's disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis, which are all autoimmune conditions.

Otulfi's mechanism of action involves blocking certain inflammatory proteins in your body, called IL-12 (interleukin-12) and IL-23 (interleukin-23). These proteins are known as cytokines and they are responsible for the inflammation associated with certain autoimmune conditions. By blocking their activity, Otulfi reduces inflammation, pain, swelling, and skin symptoms.

Otulfi gained FDA approval on September 27, 2024, as a biosimilar to Stelara. A biosimilar is a biological product that is like the reference biologic (in this case Stelara) and for which there are no clinically meaningful differences in terms of safety, purity, and potency. Otulfi is expected to be available in February 2025.

Otulfi is the fourth FDA-approved Stelara biosimilar, following the approvals of Pyzchiva (ustekinumab-ttwe) and Selarsdi (ustekinumab-aekn) in 2024, and Wezlana (ustekinumab-auub) in 2023.

Otulfi uses

Otulfi is used to treat:

• Moderate to severe plaque psoriasis in adults and children aged 6 years and older who are candidates for phototherapy or systemic therapy
• Active psoriatic arthritis (active) in adults and children aged 6 years and older
• Crohn’s disease (moderately to severely active) in adults 18 years and older
• Ulcerative colitis (moderately to severely active ) in adults 18 years and older.

Otulfi side effects

The most common Otulfi side effects are:

• nasal congestion, sore throat, and runny nose
• redness at the injection site
• upper respiratory infections
• vaginal yeast infections
• fever
• urinary tract infections
• headache
• sinus infection
• tiredness
• bronchitis
• itching
• diarrhea
• nausea and vomiting
• stomach pain.

Serious Otulfi side effects and warnings

Otulfi can cause the following serious side effects.

Serious infections. Otulfi may lower the ability of your immune system to fight infections and may increase your risk of infections. Some people have serious infections while taking ustekinumab products, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses. Some people have to be hospitalized for treatment of their infection.

• Your doctor should check you for TB before starting Otulfi.
• If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Otulfi and during treatment.
• Your doctor should watch you closely for signs and symptoms of TB while you are being treated with Otulfi.

You should not start taking Otulfi if you have any kind of infection unless your doctor says it is okay.

After starting Otulfi, call your doctor right away if you have any symptoms of an infection such as fever, chills, muscle pain, shortness of breath, weight loss, diarrhea or stomach pain, burning when you urinate, feeling very tired, skin warmth or redness, painful skin sores, or coughing up blood. People who have a genetic problem where the body does not make any of the proteins interleukin 12 (IL-12) and interleukin 23 (IL-23) are at a higher risk for certain serious infections. These infections can spread throughout the body and cause death.

Cancers. Otulfi may decrease the activity of your immune system and increase your risk for certain types of
cancers. Tell your doctor if you have ever had any type of cancer. Some people who are receiving ustekinumab
products and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with Otulfi, tell your doctor if you develop any new skin growths.

Otulfi may cause a rare but serious condition affecting the brain called Posterior Reversible Encephalopathy Syndrome (PRES). Tell your doctor right away if you have a headache, confusion, vision problems, or a seizure.

Otulfi may decrease the activity of your immune system, and there may be an increase in your risk for certain types of cancers. Tell your doctor if you have ever had any type of cancer. Some people who are receiving this medicine and have risk factors for skin cancer have developed certain types of skin cancers. During your treatment with this medicine, tell your doctor if you develop any new skin growths.

Lung inflammation. Cases of lung inflammation have happened in some people who receive ustekinumab
products, such as Otulfi, and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn't go away during treatment with Otulfi.

Serious allergic reactions. Serious allergic reactions can occur with Otulfi. Stop using Otulfi and get
medical help right away if you have any of the following symptoms of a serious allergic reaction such as hives, chest pain, difficulty breathing; feeling light-headed; or swelling of your face, lips, tongue, or throat.

Also, call your doctor at once if you have:

• a mole that has changed in size or color
• swelling, pain, warmth, or redness anywhere on your body
• stomach pain that is sudden and severe or comes on slowly, changes in bowel habits (diarrhea or constipation)
• new or worsening cough, sudden chest pain, feeling short of breath
• pain or burning when you urinate or
• severe headache, confusion, change in mental status, vision problems, and/or seizure (convulsions).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before taking this medicine

You should not use Otulfi if you:

• are allergic to the active ingredient ustekinumab, Otulfi, Stelara, or any of the inactive ingredients contained in Otulfi
• have received a BCG (Bacillus Calmette and Guérin) vaccine within 1 year before, during, or 1 year following treatment
• have active tuberculosis.

Before you start treatment with this injection, your doctor may perform tests to make sure you do not have tuberculosis.

• Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.

To make sure Otulfi is safe for you, tell your healthcare provider about all your medical conditions, including if you:

• have signs of infection (fever, chills, cough, muscle aches, painful skin sores, diarrhea, pain when you urinate, feeling very tired)
• are being treated for an infection or have any open cuts
• get a lot of infections or have infections that keep coming back
• have new or changing skin lesions within psoriasis areas or on normal skin
• have a latex allergy as the needle cover on the prefilled syringe contains latex
• receive or have received phototherapy (light therapy) for psoriasis
• are receiving or have received allergy shots, especially for serious allergic reactions. Allergy shots may not work as well for you during treatment with Otulfi. Otulfi may also increase your risk of having an allergic reaction to an allergy shot
• recently received or are scheduled to receive any vaccine. People who take this medicine should not receive live vaccines. Tell your doctor if anyone in your house needs a live vaccine. The viruses used in some types of live vaccines can spread to people with a weakened immune system and can cause serious problems
• are pregnant or plan to become pregnant
• are breastfeeding.

Some people using this medicine have developed skin cancer (non-melanoma). However, these people may have had a higher risk of skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.

Pregnancy

It is not known whether Otulfi will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ustekinumab on the baby.

If you did receive Otulfi while you were pregnant you must tell your baby’s healthcare provider before any vaccinations are given to your baby.

Breastfeeding

It may not be safe to breastfeed while using this medicine. Otulfi can pass into your breast milk in small amounts. Talk to your doctor about the best way to feed your baby if you receive this medicine.

How is Otulfi administered?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Otulfi is intended for use under the guidance and supervision of your doctor. Prepare your injection only when you are ready to give it. Do not use it if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.

• Crohn’s disease and ulcerative colitis: The first dose of Otulfi is given through a vein in the arm (intravenous infusion) by your healthcare provider. It takes at least 1 hour to receive the infusion. Your next doses will be given as an injection under the skin (subcutaneous injection) every 8 weeks.
• Psoriasis or psoriatic arthritis: Otulfi is given as an injection under the skin (subcutaneous injection) as described below.

How to administer subcutaneous Otulfi

In children 6 years and older, Otulfi should be administered by a healthcare provider.

If your doctor decides that you or a caregiver may give your injections at home, you should receive training on the right way to prepare and inject Otulfi.

• Your doctor will determine the right dose for you, the amount for each injection, and how often you should receive it. Your dose needs may change if you gain or lose weight.
• Do not try to inject yourself unless you or your caregiver have been shown how to use it by your doctor or nurse.
• Inject Otulfi under the skin in your upper arms, buttocks, upper legs (thighs), or stomach area (abdomen).
• Do not give an injection in an area of the skin that is tender, bruised, red, or hard.
• Use a different injection site each time you use this medicine.
• Use a needle and syringe only once and then place them in a puncture-proof "sharps" container. Follow state or local laws about how to dispose of this container. Keep it out of the reach of children and pets. Throw away any unused portion of Otulfi.
• Be sure to keep all of your scheduled follow-up appointments.

Otulfi dosing information

The dosage of Otulfi is dependent on the patient's weight. Your healthcare provider will calculate this for you.

• Adults less than or equal to 100 kg: Otulfi 45 mg
• Adults more than 100 kg: Otulfi 90 mg.

Crohn’s disease and ulcerative colitis: Otulfi is given as an infusion for the first dose then as a subcutaneous injection every 8 weeks thereafter.

Psoriasis and Psoriatic Arthritis: Otulfi is given as a subcutaneous injection initially and 4 weeks later, then a dose is given every 12 weeks.

Otulfi is available as:

Subcutaneous Injection

• Otulfi 90 mg/mL single-dose prefilled syringe
• Otulfi 45 mg/0.5 mL single-dose prefilled syringe.

Intravenous Infusion

• Otulfi single-dose vial 130 mg/26 mL (5 mg/mL).

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Otulfi?

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using this medicine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

You should not receive the BCG vaccine during the one year before receiving Otulfi or one year after
you stop receiving Otulfi.

Non-live vaccines (including flu shots) may not work as well during your treatment, and may not fully protect you from disease. Make sure you are current on all vaccines before you begin treatment with this medicine.

What other drugs will affect Otulfi?

Other drugs may interact with Otulfi, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

It is important to tell your doctor if you are taking any of the following:

• anticoagulants (blood thinners) such as warfarin (Coumadin, Jantoven)
• medications that suppress the immune system such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), methotrexate (Otrexup, Rasuvo, Trexall, Xatmep), sirolimus (Rapamune), and tacrolimus (Astagraf, Envarsus, Prograf)
• oral steroids such as dexamethasone (Hemady), methylprednisolone (Medrol), and prednisone (Rayos).

Your doctor may need to change the doses of your medications or monitor you carefully for side effects. Not all possible interactions are listed here.

Storage

Otulfi vials and prefilled syringes

Store vials and prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C) standing up straight. Do not freeze.

This medicine should be stored in the original carton to protect it from light until time to use it. Do not shake.

If needed, individual Otulfi prefilled syringes may also be stored at room temperature up to 30°C (86ºF) for a maximum single period of up to 60 days in the original carton to protect from light. Record the date when the prefilled syringe is first removed from the refrigerator on the carton in the space provided.

Once a syringe has been stored at room temperature, you may return the prefilled syringe to the refrigerator 1 time only for a maximum of 3 days, either during the 60 days or at the end of the 60 days.

• Discard the prefilled syringe if not used within 60 days of room temperature storage and you did not return it to the refrigerator, or if it has been returned to the refrigerator and is not used within 3 days.

Do not use Otulfi after the expiration date on the carton or on the prefilled syringe.

Otulfi Ingredients

Active ingredient: ustekinumab-aauz

Single-dose prefilled syringe for subcutaneous use inactive ingredients are histidine, polysorbate 80,
sucrose and hydrochloric acid (to adjust pH).

Single-dose vial for intravenous infusion inactive ingredients are edetate disodium, histidine, L-histidine hydrochloride monohydrate, methionine, polysorbate 80, and sucrose.

Who makes Otulfi?

Fresenius Kabi makes Otulfi.

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Further information

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