Otulfi: Uses, Dosage & Side Effects
A biosimilar of ustekinumab targeting the IL-12 and IL-23 pathways for the treatment of plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis
Otulfi (ustekinumab) is a biologic biosimilar medicine used to treat several long-term immune-mediated inflammatory conditions, including moderate-to-severe plaque psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis. As a fully human monoclonal antibody directed against the shared p40 subunit of interleukin-12 and interleukin-23, Otulfi interrupts two of the most important inflammatory signaling pathways involved in these diseases. It is a biosimilar of the reference product Stelara and has been shown to have comparable safety, purity, and efficacy. Otulfi is administered as a subcutaneous injection (or as an intravenous infusion for the first dose in inflammatory bowel disease) and requires a prescription. Treatment is typically supervised by a dermatologist, rheumatologist, or gastroenterologist.
Quick Facts: Otulfi
Key Takeaways
- Otulfi (ustekinumab) is a biosimilar of Stelara and blocks the p40 subunit shared by interleukin-12 (IL-12) and interleukin-23 (IL-23), two key inflammatory signaling proteins that drive psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.
- It is approved for moderate-to-severe plaque psoriasis in adults and children aged 6 years and older, active psoriatic arthritis in adults, and for moderately to severely active Crohn’s disease and ulcerative colitis in adults who have not responded to, or are intolerant of, conventional or anti-TNF therapies.
- For inflammatory bowel disease, the first (induction) dose is given as a single intravenous infusion in hospital, followed by subcutaneous maintenance injections every 8 or 12 weeks. For dermatological and rheumatological indications, treatment is entirely subcutaneous.
- The most common side effects are upper respiratory infections, headache, fatigue, dizziness, and injection-site reactions. Serious but less frequent risks include reactivation of tuberculosis, serious infections, hypersensitivity reactions, and rare cases of reversible posterior leukoencephalopathy syndrome (RPLS).
- All patients must be screened for latent tuberculosis and other chronic infections before starting Otulfi, and live vaccines must be avoided during treatment and for at least one year afterwards.
What Is Otulfi and What Is It Used For?
Otulfi is a biological medicinal product (biologic) containing the active substance ustekinumab, a fully human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody. It is produced in a mammalian cell line (Sp2/0 murine myeloma cells) using recombinant DNA technology. Otulfi is classified as a biosimilar, which means it has been developed to be highly similar to an already approved biologic reference product (Stelara, originally marketed by Janssen) and has demonstrated comparable quality, safety, and efficacy in rigorous regulatory assessment. Biosimilars are not identical copies like generic small-molecule drugs, but they are established to have no clinically meaningful differences from their reference product.
Ustekinumab works by specifically targeting the shared p40 protein subunit of two cytokines: interleukin-12 (IL-12) and interleukin-23 (IL-23). These signaling molecules are produced by immune cells and play a central role in the pathogenesis of several chronic inflammatory diseases. IL-12 drives the differentiation of naïve T cells into T-helper 1 (Th1) cells, which produce interferon-gamma and activate cell-mediated immunity. IL-23 promotes the expansion and maintenance of T-helper 17 (Th17) cells, which secrete IL-17 and IL-22 and are implicated in tissue inflammation, particularly in the skin, joints, and gut. By binding with high affinity to the p40 subunit, ustekinumab prevents both IL-12 and IL-23 from engaging their receptors on the surface of target cells, thereby dampening the downstream inflammatory cascade without globally suppressing the immune system.
Because ustekinumab interferes with cytokine pathways rather than directly killing immune cells, it is considered a targeted immunomodulator rather than a broad immunosuppressant like cyclosporine or azathioprine. This selectivity gives Otulfi a generally favorable long-term safety profile compared with conventional systemic treatments. The medicine was first approved as Stelara by the European Medicines Agency (EMA) in 2009 for psoriasis, with indications gradually expanded to psoriatic arthritis, Crohn’s disease, and ulcerative colitis. Otulfi received marketing authorization as a ustekinumab biosimilar in the European Union in 2024 and in the United States in 2024 (under the name ustekinumab-aauz), expanding access to this important biologic therapy.
Otulfi is approved for the treatment of the following conditions:
- Moderate-to-severe plaque psoriasis in adults: for patients who are candidates for phototherapy or systemic therapy. Plaque psoriasis is a chronic immune-mediated skin disease characterized by well-demarcated, scaly, erythematous plaques, most commonly on the scalp, elbows, knees, and lower back. Otulfi is particularly effective for patients who have failed, are intolerant to, or have contraindications to other systemic therapies such as methotrexate, cyclosporine, or phototherapy.
- Plaque psoriasis in pediatric patients (6 years and older): for moderate-to-severe disease where topical therapy and phototherapy are insufficient or inappropriate. Dosing is adjusted according to body weight.
- Active psoriatic arthritis (PsA) in adults: alone or in combination with methotrexate, when the response to previous non-biologic disease-modifying antirheumatic drug (DMARD) therapy has been inadequate. Ustekinumab has demonstrated improvements in joint symptoms, skin manifestations, enthesitis, dactylitis, and inhibition of structural joint damage on imaging.
- Moderately to severely active Crohn’s disease in adults: in patients who have had an inadequate response, lost response, or were intolerant to either conventional therapy (corticosteroids, immunomodulators) or a tumor necrosis factor (TNF) antagonist, or have medical contraindications to such therapies. Ustekinumab was a landmark addition to the Crohn’s armamentarium based on the UNITI and IM-UNITI trials.
- Moderately to severely active ulcerative colitis in adults: in patients with similar treatment-failure history, based on the positive results of the UNIFI induction and maintenance studies.
Psoriasis is a lifelong disease that affects approximately 2–3% of the global population. About one in three patients with psoriasis will develop psoriatic arthritis, in which joint inflammation can occur alongside or even before skin symptoms. Inflammatory bowel diseases — Crohn’s disease and ulcerative colitis — affect the gastrointestinal tract and cause symptoms such as chronic diarrhea, abdominal pain, rectal bleeding, weight loss, and fatigue. All of these conditions are relapsing-remitting in nature, with disease flares alternating with periods of lower activity. Ustekinumab therapy can induce and maintain remission, reduce inflammation, decrease the need for corticosteroids, and improve quality of life.
Biosimilars like Otulfi offer the same therapeutic benefit as their reference product at a lower cost, helping to expand patient access to advanced biologic treatments. Regulatory agencies including the EMA and FDA require extensive comparative analytical, non-clinical, and clinical studies before approving a biosimilar, ensuring that there are no clinically meaningful differences in safety or effectiveness. Switching between Stelara and Otulfi is generally considered safe, but any change in biologic should be managed by your treating physician.
What Should You Know Before Taking Otulfi?
Contraindications
There are specific situations in which Otulfi must not be used. Your doctor will carefully assess your medical history and current health status before prescribing this medicine.
- Hypersensitivity: Do not use Otulfi if you are allergic to ustekinumab or any of the excipients (L-histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and water for injections). Severe allergic reactions including anaphylaxis and angioedema have been reported.
- Clinically important active infection: Otulfi must not be started if you have an active, clinically important infection such as active tuberculosis, significant bacterial, fungal, viral, or parasitic infection. Treatment should be delayed until the infection is adequately treated and resolved.
Warnings and Precautions
Ustekinumab may increase the risk of infections, including serious and opportunistic infections, and can cause reactivation of latent tuberculosis. All patients must be evaluated for tuberculosis (including a history of possible TB exposure, a tuberculin skin test or interferon-gamma release assay, and a chest X-ray if indicated) before starting Otulfi. Patients with latent TB should receive appropriate anti-TB treatment before Otulfi is initiated. Monitor patients for signs and symptoms of active TB during and after treatment.
Before starting Otulfi and throughout treatment, tell your doctor if any of the following apply to you:
- Infections: Otulfi can make you more prone to infections, including the common cold, sinusitis, urinary tract infections, and more serious bacterial, viral, or fungal infections. If you develop signs of infection such as fever, chills, sustained cough, weight loss, persistent sores, skin redness with warmth, painful urination, or unusual fatigue, contact your doctor without delay. Otulfi may need to be temporarily withheld until the infection has resolved.
- History of recurrent infection: Particular caution is needed if you have a history of recurrent or chronic infections (e.g., recurrent pneumonia, chronic sinusitis, chronic bronchitis, osteomyelitis).
- Latent infections (TB, hepatitis B): In addition to tuberculosis screening, your doctor may test you for hepatitis B virus (HBV) and hepatitis C virus (HCV) before starting treatment, as these can reactivate under immunomodulatory therapy.
- Prior malignancy: Ustekinumab is a selective immunosuppressant and a theoretical increased risk of malignancy cannot be fully excluded. Tell your doctor if you have a current or past history of cancer. Non-melanoma skin cancers (e.g., squamous cell carcinoma) have been reported in patients treated with ustekinumab; periodic skin examinations are recommended, particularly in patients older than 60, those with a long history of immunosuppressive therapy, or a history of PUVA therapy.
- Hypersensitivity reactions: Serious allergic reactions have occurred, including anaphylaxis, angioedema (rapid swelling of the face, lips, tongue, or throat), and severe dermatologic reactions. If such a reaction occurs, Otulfi must be permanently discontinued and emergency treatment instituted.
- Reversible Posterior Leukoencephalopathy Syndrome (RPLS): A rare but serious neurological condition has been reported in patients treated with ustekinumab. Symptoms include headache, seizures, confusion, and visual disturbances. Immediate medical attention is required; treatment is typically supportive and RPLS is generally reversible if diagnosed promptly.
- Non-infectious pneumonia: Cases of interstitial pneumonitis, eosinophilic pneumonia, and organizing pneumonia have been reported during therapy. Seek medical advice promptly if you develop new or worsening shortness of breath, a persistent cough, or fever.
- Lupus-like reactions: Isolated reports of cutaneous lupus, lupus-like conditions, and subacute cutaneous lupus erythematosus have been described. Report new rashes, especially after sun exposure, or worsening joint symptoms.
- Exfoliative dermatitis: Rare cases of exfoliative dermatitis and erythrodermic psoriasis have been reported. These require prompt assessment and may necessitate discontinuation.
- Serious cardiovascular events: Very rare cases of serious cardiovascular events, including myocardial infarction and cerebrovascular accidents, have been reported in early-phase studies. Discuss cardiovascular risk factors with your doctor.
- Immunotherapy and vaccines: Live vaccines must not be given during treatment or for at least one year afterwards (see “Vaccinations” below). Allergen immunotherapy (allergy shots) should be used with caution as Otulfi may blunt the therapeutic response, and anaphylactic reactions cannot be reliably predicted.
- Injection-site reactions: Redness, pain, itching, or swelling at the injection site is common but usually mild and transient. Rotate injection sites and follow sterile technique if self-injecting.
Your doctor will perform regular clinical assessments and may repeat blood and infection screening tests as needed throughout your treatment.
Use in Children and Adolescents
Otulfi is approved for plaque psoriasis in children aged 6 years and older. For psoriatic arthritis, Crohn’s disease, and ulcerative colitis, safety and efficacy in children younger than 18 years have not yet been fully established; these indications are for adults only. In pediatric psoriasis, the dose is calculated based on body weight.
Use in Elderly Patients
In clinical studies, no overall differences in efficacy or safety were observed between elderly (≥65 years) and younger adult patients. However, because elderly patients generally have a higher rate of infections and comorbidities, Otulfi should be used with caution in this age group, and monitoring should be particularly vigilant.
Vaccinations
Vaccination planning is a critical part of treatment with Otulfi. Before initiating therapy, you should ideally be up to date with all routine vaccinations recommended by your national immunization schedule, including seasonal influenza, pneumococcal, hepatitis B (if at risk), varicella, measles-mumps-rubella (MMR), and others according to age and risk. Inactivated vaccines can generally be administered during treatment but may have a somewhat reduced immunogenicity. Live vaccines — including BCG, MMR, varicella, yellow fever, oral polio, and oral typhoid — must not be given during Otulfi treatment or within at least one year of the last dose due to the theoretical risk of vaccine-strain infection.
For infants of mothers who received Otulfi during pregnancy, live vaccines (such as BCG) should be delayed for at least six months after birth or until the infant’s serum ustekinumab is no longer detectable, whichever is sooner.
Pregnancy and Breastfeeding
There are limited data on the use of ustekinumab in pregnant women. As a precautionary measure, Otulfi should be avoided during pregnancy unless the potential clinical benefit clearly outweighs the risk to the fetus. Ustekinumab is an IgG1 antibody and, like other IgG antibodies, can cross the placenta, particularly in the second and third trimesters; it may be detected in the infant for several months after birth. Women of childbearing potential should use effective contraception during treatment and for at least 15 weeks after the last dose.
A small amount of ustekinumab may pass into breast milk. It is not known whether the drug is absorbed systemically by the breastfed infant, but due to its size (IgG1) significant absorption is considered unlikely. A decision to continue or discontinue breastfeeding, or to continue or discontinue Otulfi, should be made considering the benefit of breastfeeding to the child and the benefit of Otulfi to the mother.
There are no data on the effects of ustekinumab on human fertility. Animal studies have not shown adverse effects on male or female reproductive performance.
Driving and Operating Machinery
Otulfi has no or negligible influence on the ability to drive or use machines. Rarely, dizziness has been reported; if this occurs, avoid driving or operating machinery until symptoms resolve.
Important Information About Ingredients
Otulfi contains less than 1 mmol of sodium (23 mg) per dose, which is essentially “sodium-free.” The product also contains polysorbate 80, which can cause allergic reactions in some individuals. If you have a known allergy to polysorbates, discuss this with your doctor before starting treatment.
How Does Otulfi Interact with Other Drugs?
As a monoclonal antibody, Otulfi is not metabolized by the cytochrome P450 (CYP450) enzyme system in the liver, which means that classic CYP-mediated drug-drug interactions are not typically observed. However, some indirect interactions are clinically important, particularly those involving the immune system. Always inform your doctor about all medicines, supplements, and herbal products you are taking, including any recent changes. The interactions summarized below are the most clinically relevant.
Major Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| Live vaccines (BCG, MMR, varicella, yellow fever, oral polio, oral typhoid) | Risk of vaccine-strain infection due to immunomodulation | Avoid during treatment and for at least 12 months after the last dose |
| Other biologics (TNF inhibitors, IL-17 inhibitors, IL-23 inhibitors, JAK inhibitors, anti-CD20) | Additive immunosuppression, increased infection risk | Concurrent use not recommended; generally considered unsafe |
| Allergen immunotherapy (allergy shots) | Potentially reduced efficacy; risk of unmasked hypersensitivity reactions | Use with caution; discuss with allergist and treating physician |
| Systemic corticosteroids (prednisone, methylprednisolone) at high doses | Additive immunosuppression, increased risk of opportunistic infection | Taper steroids where clinically appropriate once Otulfi is effective |
| Potent immunosuppressants (cyclosporine, tacrolimus, azathioprine, 6-mercaptopurine) | Additive immune suppression | Use in combination only when clearly justified; monitor for infection |
Minor and Other Relevant Interactions
| Interacting Drug | Effect | Clinical Significance |
|---|---|---|
| CYP450 substrates with narrow therapeutic index (warfarin, cyclosporine, theophylline) | Inflammatory cytokines suppress CYP450; reducing inflammation may normalize CYP activity and affect plasma drug levels | Monitor closely when initiating or stopping Otulfi; dose adjustments may be needed |
| Methotrexate (for psoriatic arthritis) | Can be safely co-administered; sometimes used synergistically for PsA | No dose adjustment required; routine monitoring of liver and blood counts |
| Non-steroidal anti-inflammatory drugs (NSAIDs) | No known pharmacokinetic interaction | Safe for concomitant use for symptomatic pain or inflammation |
| Inactivated vaccines (influenza, pneumococcal, COVID-19 mRNA, recombinant zoster) | Possibly reduced immunogenicity, but no safety concern | Recommended per standard schedule; seroprotection may be somewhat lower |
| Oral contraceptives | No pharmacokinetic interaction | Contraception remains effective; recommended in women of childbearing age |
If you are prescribed Otulfi in combination with methotrexate (a common strategy in psoriatic arthritis), your doctor will monitor you with regular liver function tests and complete blood counts. Any new medication — including over-the-counter products, herbal supplements, or treatments prescribed by other specialists — should always be discussed with your treating physician before you start taking it during therapy with Otulfi.
What Is the Correct Dosage of Otulfi?
Otulfi is given by subcutaneous injection for maintenance therapy across all indications. For Crohn’s disease and ulcerative colitis, the first (induction) dose is given as a single intravenous infusion to achieve rapid therapeutic drug levels. The drug is always prescribed and initiated by a specialist physician (dermatologist, rheumatologist, or gastroenterologist) experienced in managing the underlying condition. Patients trained by a healthcare professional may self-administer subcutaneous injections at home using pre-filled syringes.
Adults – Plaque Psoriasis
Standard Adult Dosing
Starting dose (Induction): 45 mg subcutaneously at Week 0, then 45 mg at Week 4.
Maintenance dose: 45 mg subcutaneously every 12 weeks thereafter.
Patients weighing more than 100 kg: 90 mg subcutaneously at Week 0, Week 4, and then every 12 weeks. This higher dose achieves better efficacy in heavier patients.
Inadequate responders: If a patient does not respond by Week 28, consider discontinuation.
Adults – Psoriatic Arthritis
Standard Adult Dosing for PsA
Starting dose: 45 mg subcutaneously at Week 0 and Week 4.
Maintenance: 45 mg subcutaneously every 12 weeks.
For PsA patients with coexisting moderate-to-severe plaque psoriasis weighing more than 100 kg, the 90 mg dose may be used. Combination therapy with methotrexate is permitted.
Inadequate responders: Consider discontinuation after 28 weeks of treatment without a clinical response.
Adults – Crohn’s Disease and Ulcerative Colitis
IV Induction Dose
A single weight-based intravenous infusion is given over at least one hour in a hospital or infusion clinic:
- ≤ 55 kg: 260 mg (two 130 mg vials)
- > 55 kg to 85 kg: 390 mg (three 130 mg vials)
- > 85 kg: 520 mg (four 130 mg vials)
Subcutaneous Maintenance Dose
First maintenance dose: 90 mg subcutaneously, 8 weeks after the IV induction dose.
Thereafter: 90 mg subcutaneously every 12 weeks.
Loss of response: Patients who lose response on the 12-weekly schedule may be shifted to every 8 weeks, which has been shown to be effective for some individuals.
Discontinuation should be considered if there is no evidence of therapeutic benefit by Week 16 for Crohn’s disease and Week 8 (after IV induction) for ulcerative colitis.
Children and Adolescents
Pediatric Plaque Psoriasis (Ages 6–17)
Weight-based dosing (subcutaneous injection):
- Less than 60 kg: 0.75 mg/kg
- 60 kg to 100 kg: 45 mg
- More than 100 kg: 90 mg
Schedule: Doses at Week 0 and Week 4, then every 12 weeks.
In children weighing less than 60 kg, the dose should be calculated using 0.75 mg per kg body weight. Specific volume calculations for the pre-filled syringe should follow the official prescribing information.
Elderly Patients (≥65 Years)
No dose adjustment is needed in elderly patients based on age alone. However, the elderly may be more susceptible to infection; closer clinical monitoring is recommended.
Patients with Renal or Hepatic Impairment
Specific studies have not been conducted in patients with kidney or liver disease. As a monoclonal antibody, ustekinumab is not expected to be eliminated via renal excretion or hepatic metabolism to a significant degree. Dose adjustment is generally not required, but clinical judgment should be exercised in patients with severe organ impairment.
Missed Dose
If you miss an Otulfi injection, contact your doctor or nurse as soon as possible. The missed dose should be given as soon as you remember, and subsequent doses should be rescheduled from the date of the replacement injection to maintain the recommended dosing interval. Do not inject a double dose to make up for a missed one.
Overdose
Single doses of up to 6 mg/kg have been administered intravenously in clinical studies without dose-limiting toxicity. In the event of an overdose, the patient should be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment initiated immediately. There is no specific antidote. Contact your regional poison information service or seek emergency medical assistance.
How Otulfi Is Given
Subcutaneous injections of Otulfi are usually given into the upper thighs, abdomen (at least 5 cm away from the navel), upper arms, or buttocks. Injection sites should be rotated between administrations. Do not inject into areas where the skin is tender, bruised, red, hardened, or affected by psoriasis plaques. Each pre-filled syringe is for single use only and should be allowed to reach room temperature (30–60 minutes outside the refrigerator) before injection for a more comfortable experience.
The intravenous induction dose for Crohn’s disease and ulcerative colitis is administered by a healthcare professional over at least one hour in a hospital or infusion clinic. You will be monitored during and after the infusion for potential reactions.
Otulfi must be prescribed and initiated by a physician with experience in diagnosing and treating plaque psoriasis, psoriatic arthritis, Crohn’s disease, or ulcerative colitis. After proper training, maintenance subcutaneous injections can be self-administered at home, but any concerns or adverse reactions should be reported to the treating physician immediately.
What Are the Side Effects of Otulfi?
Like all medicines, Otulfi can cause side effects, although not everyone experiences them. The safety profile of ustekinumab has been characterized in clinical trials enrolling thousands of patients and through extensive post-marketing experience with the reference product Stelara over more than 15 years. The side effect profile of Otulfi is expected to be the same as that of the reference product based on the biosimilar evaluation.
Injection-Site and Infusion-Related Reactions
Local injection-site reactions — including erythema (redness), pain, pruritus (itching), induration (hardening), bruising, and swelling — occur in a significant minority of patients, particularly early in treatment. Most are mild, resolve within a few days, and do not require specific treatment. Allowing the syringe to reach room temperature before injection, rotating sites, and applying a cold pack before or after the injection can help. Intravenous infusion reactions during the induction dose for inflammatory bowel disease are uncommon but may include chills, nausea, chest pain, back pain, flushing, or rarely dyspnea.
Side Effect Frequency Grid
Very Common
May affect more than 1 in 10 people
- Upper respiratory tract infection (including nasopharyngitis and sinusitis)
- Headache
- Fatigue
- Arthralgia (joint pain)
Common
May affect up to 1 in 10 people
- Dental infections
- Dizziness
- Pharyngolaryngeal pain (sore throat)
- Diarrhea
- Nausea
- Vomiting
- Pruritus (itching)
- Back pain
- Myalgia (muscle pain)
- Injection-site reactions (erythema, pain, swelling, bruising, itching, hardening, bleeding, or irritation)
- Asthenia (weakness)
- Depression
Uncommon
May affect up to 1 in 100 people
- Cellulitis (bacterial skin infection)
- Viral upper respiratory tract infection (including shingles/herpes zoster)
- Hypersensitivity reactions (including rash and urticaria)
- Facial palsy
- Nasal congestion
- Pustular psoriasis
- Exfoliative dermatitis
- Acne
- Skin exfoliation (peeling)
Rare
May affect up to 1 in 1,000 people
- Serious hypersensitivity reactions including anaphylaxis and angioedema
- Erythrodermic psoriasis
- Lichenoid dermatitis
- Lupus-like syndrome
- Serious infections (including diverticulitis, sepsis, osteomyelitis)
- Reactivation of latent tuberculosis
- Hypersensitivity vasculitis
Not Known
Frequency cannot be estimated from available data
- Reversible posterior leukoencephalopathy syndrome (RPLS)
- Non-infectious pneumonia (eosinophilic, organizing, or interstitial)
- Stevens-Johnson syndrome / toxic epidermal necrolysis
- DRESS syndrome (drug reaction with eosinophilia and systemic symptoms)
- Cutaneous and systemic lupus erythematosus
- Bullous pemphigoid
Malignancy
An increased risk of malignancy, including non-melanoma skin cancer, has been discussed as a theoretical concern with all immunomodulatory biologics. Large post-marketing registries of Stelara (including PSOLAR and other real-world cohorts) have not identified a clear signal for increased cancer risk with long-term ustekinumab therapy compared with background population rates; however, patients with a personal history of cancer or risk factors should discuss this individually with their doctor. Regular skin examinations are recommended, particularly for patients with a long history of phototherapy or immunosuppressive treatment.
Immunogenicity
A small proportion of patients treated with ustekinumab develop anti-drug antibodies (ADAs). The incidence of ADAs across clinical trials has been reported at approximately 3–7%. Patients who develop ADAs tend to have lower serum ustekinumab levels and, in some cases, reduced clinical response. Your doctor may measure drug levels or ADAs if your disease response seems suboptimal or wanes over time.
If you experience any side effects, including those not listed here, tell your doctor or nurse. You can also report suspected side effects to your national pharmacovigilance authority (e.g., the EMA EudraVigilance system in Europe, the FDA MedWatch program in the United States, or the MHRA Yellow Card Scheme in the United Kingdom) to help monitor the ongoing benefit-risk profile of Otulfi.
How Should Otulfi Be Stored?
Proper storage is important to ensure the medicine remains effective and safe to use. Ustekinumab is a protein that can be damaged by heat, freezing, or vigorous shaking.
- Refrigerated storage: Store in a refrigerator at 2°C to 8°C (36°F to 46°F). Do not freeze. If frozen, the product must be discarded.
- Light protection: Keep the pre-filled syringe or vial in the outer carton to protect from light until ready for use.
- Do not shake: Protein products can be destabilized by agitation. Handle the syringe gently.
- Room temperature storage (if needed): If necessary, the pre-filled syringe can be stored at room temperature up to 30°C for a single period of up to 30 days. Record the date of removal from the refrigerator on the carton. Once stored at room temperature, the syringe must never be returned to the refrigerator and must be used or discarded by the end of the 30-day period (or by the labeled expiry date, whichever is earlier).
- Expiry date: Do not use Otulfi after the expiry date stated on the label and carton after “EXP.” The expiry date refers to the last day of that month.
- Inspection before use: Before injecting, visually inspect the solution. It should be clear to slightly opalescent, colorless to light yellow, and free of particles. Do not use if the solution is discolored, cloudy, or contains foreign particles.
- Disposal: Do not dispose of medicines via wastewater or household waste. Used syringes should be placed in a puncture-resistant sharps container. Ask your pharmacist how to dispose of medicines that are no longer required.
- Keep out of sight and reach of children: Always store Otulfi safely away from children.
What Does Otulfi Contain?
Active Substance
The active substance is ustekinumab, a fully human IgG1κ monoclonal antibody produced in a recombinant murine myeloma (Sp2/0) cell line using DNA technology. Otulfi is available in the following presentations:
- 45 mg/0.5 mL solution for injection in pre-filled syringe (90 mg/mL) – for subcutaneous administration
- 90 mg/1 mL solution for injection in pre-filled syringe (90 mg/mL) – for subcutaneous administration
- 45 mg vial for subcutaneous injection (alternative presentation)
- 130 mg/26 mL concentrate for solution for infusion (5 mg/mL) – for intravenous infusion (induction dose in Crohn’s disease and ulcerative colitis)
Inactive Ingredients (Excipients)
The excipients used in Otulfi include:
- L-histidine
- L-histidine hydrochloride monohydrate (pH buffering)
- Polysorbate 80 (stabilizer – may rarely cause allergic reactions)
- Sucrose (stabilizer / tonicity adjuster)
- Water for injections
The concentrate for infusion (130 mg) may also contain EDTA (edetate disodium dihydrate) and L-methionine as stabilizers.
Appearance
The solution in the pre-filled syringe or vial appears clear to slightly opalescent, colorless to light yellow, and may contain a few small translucent or white particles of protein characteristic of the product. These are not an indication of product deterioration.
Pack Sizes
Otulfi is typically supplied in packs containing one pre-filled syringe with a needle safety guard, or one vial. The concentrate for infusion is supplied in single-use vials. Not all pack sizes or presentations may be marketed in every country.
Marketing Authorization Holder and Manufacturer
Otulfi is marketed in the European Union and other regions by Fresenius Kabi Deutschland GmbH (Bad Homburg, Germany), in partnership with mAbxience for its biosimilar development. In the United States, Otulfi is co-marketed by Fresenius Kabi USA. The exact marketing authorization holder and manufacturing site may vary by region; refer to the outer carton and package leaflet for country-specific information.
Frequently Asked Questions About Otulfi
Otulfi is a biosimilar of ustekinumab used to treat moderate-to-severe plaque psoriasis in adults and children aged 6 years and older, active psoriatic arthritis in adults (alone or in combination with methotrexate), moderately to severely active Crohn’s disease in adults who have not responded to or are intolerant of conventional or anti-TNF therapy, and moderately to severely active ulcerative colitis in adults with similar prior-treatment failures. It works by blocking two key inflammatory proteins, interleukin-12 and interleukin-23, that drive these immune-mediated diseases.
Otulfi is a biosimilar of Stelara (the reference ustekinumab product originally developed by Janssen). This means Otulfi has been approved by regulators as highly similar to Stelara, with no clinically meaningful differences in safety, purity, or efficacy. Otulfi contains the same active substance (ustekinumab), is administered in the same way, and is approved for the same conditions. It offers a more affordable alternative that helps expand access to biologic therapy.
For plaque psoriasis and psoriatic arthritis, Otulfi is given as a subcutaneous injection at Week 0, Week 4, and then every 12 weeks. For Crohn’s disease and ulcerative colitis, the first dose (induction) is a single intravenous infusion given in hospital over at least one hour, followed by a subcutaneous maintenance injection 8 weeks later and every 12 weeks thereafter. Some patients with inflammatory bowel disease who lose response may switch to an every-8-week schedule. After training, many patients can self-administer the subcutaneous injections at home.
Many patients with plaque psoriasis notice significant skin improvement within 2 to 4 weeks of the first injection, with maximum effect typically observed between weeks 12 and 28. In psoriatic arthritis, joint symptom improvement is often seen within 4 to 8 weeks. For Crohn’s disease and ulcerative colitis, a clinical response after the intravenous induction dose is often detectable within 6 to 8 weeks, and many patients achieve remission within 6 months of continuing maintenance therapy. Individual response varies with disease severity, prior therapies, and body weight.
Inactivated vaccines (such as seasonal flu, pneumococcal, COVID-19 mRNA, and recombinant herpes zoster) can generally be given during Otulfi treatment, though the immune response may be somewhat reduced. Live vaccines (including MMR, varicella, yellow fever, BCG, and oral polio or typhoid) must NOT be given during treatment or for at least one year after stopping due to the risk of vaccine-strain infection. Children should complete all recommended live vaccinations before starting Otulfi if possible. Always inform your doctor and any vaccination clinic that you are receiving Otulfi.
There is limited data on ustekinumab use in pregnancy. As a precautionary measure, Otulfi should be avoided during pregnancy unless the clinical benefit clearly outweighs the potential risk to the baby. Ustekinumab is an IgG1 antibody and can cross the placenta, especially in the second and third trimesters, and may affect infant immune development and vaccine responses. Women of childbearing potential should use effective contraception during treatment and for at least 15 weeks after the last dose. Live vaccines should be delayed in infants exposed to ustekinumab during pregnancy for at least 6 months after birth.
Yes, switching from Stelara to Otulfi (or vice versa) is generally considered safe, and a growing body of real-world evidence from similar biosimilar transitions supports this. Regulatory authorities such as the EMA and the FDA’s interchangeability pathway have assessed ustekinumab biosimilars as suitable substitutes for Stelara. However, any switch should be clearly communicated between patient, pharmacist, and treating physician, and the reasons for the switch (often cost or availability) should be discussed. Your doctor will monitor you after the switch to ensure ongoing disease control.
A theoretical increased risk of cancer is discussed for all medicines that modulate the immune system. Large long-term registries of ustekinumab (such as PSOLAR for psoriasis) have not demonstrated a clear increase in malignancy compared with background rates in the population. Non-melanoma skin cancers have been reported, particularly in patients with a long history of phototherapy or immunosuppression. Regular skin checks are recommended. If you have a personal history of cancer, discuss the risks and benefits with your treating physician before starting Otulfi.
References
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This article was written and reviewed by the iMedic Medical Editorial Team, comprising licensed specialist physicians with expertise in dermatology, rheumatology, gastroenterology, and clinical pharmacology.
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