TM Owner Samsung Bioepis
Selarsdi 45mg/0.5mL Injection
Global Shipping : Reliable Global Distribution Network
Express Delivery : Priority Shipping for Every Order
Secure Payments : Trusted Payment Protection System
Disclaimer
Secure Handling
24/7 Worldwide Support
Global Access
Worldwide Access to Health
Cold-Chain Expert
Excellence in Cold-Chain
Trusted Supply
Certified Medical Supply
Indications & Clinical Uses
- Selarsdi 45 mg/0.5 mL is an injection containing ustekinumab-aekn, made by Samsung Bioepis as a biosimilar to the reference biologic Stelara (ustekinumab), initially approved by the FDA in 2024.
- It targets interleukin-12 and interleukin-23 to reduce inflammation, and is approved in the United States to treat moderate to severe plaque psoriasis and active psoriatic arthritis in adults and children aged 6 and over, and to treat moderately to severely active Crohn's disease and ulcerative colitis in adults.
- Being a biosimilar, Selarsdi has been shown to work the same way and have no clinically meaningful differences from Stelara, and may be substituted for it depending on state pharmacy substitution laws.
- The lower-dose subcutaneous injections (45 mg or 90 mg) are typically self-administered after training, while the induction dose for Crohn's disease and ulcerative colitis is given as an intravenous infusion (130 mg/26 mL) by a healthcare provider in a clinic or infusion centre; maintenance doses afterward are given subcutaneously.
Side Effects
- There is no boxed warning on the current Selarsdi prescribing information.
- The most commonly reported reactions in psoriasis and psoriatic arthritis trials, each in 3% or more of patients, are nasopharyngitis, upper respiratory tract infection, headache and tiredness; in Crohn's disease maintenance, reactions include nasopharyngitis, injection-site redness and vaginal yeast infection, and in ulcerative colitis maintenance, nasopharyngitis, headache, stomach pain and flu-like illness are common.
- Because Selarsdi suppresses part of the immune system, it can increase the risk of serious infections, including tuberculosis reactivation, so report fever, persistent cough, weight loss or any signs of infection promptly.
- Seek emergency care for symptoms of a severe allergic reaction, such as facial or throat swelling, difficulty breathing, or widespread rash, which can occur during or after an injection or infusion.
- Rarely, a serious brain condition called posterior reversible encephalopathy syndrome (PRES) has been reported, with headache, seizures, confusion and vision changes.
Precautions & Warnings
- Before starting Selarsdi, you should be evaluated for tuberculosis, and any active infection should be treated and resolved first, since ustekinumab products can lower your ability to fight infection.
- Avoid receiving live vaccines, such as BCG, MMR, yellow fever or nasal flu vaccine, while using Selarsdi; tell your healthcare provider about your vaccination history before starting, and children should be brought up to date on all recommended vaccines beforehand.
- Selarsdi can increase the risk of certain skin cancers, so routine skin checks are recommended, particularly with long-term immunosuppressant use or significant past sun exposure.
- Report new or worsening breathing problems, since rare cases of non-infectious pneumonia have occurred.
- Tell your healthcare provider if you are pregnant, planning pregnancy, or breastfeeding, since data on ustekinumab biosimilars in these situations is limited.
- Intravenous Selarsdi is for infusion only and must never be given as a rapid injection or bolus.
Avoid Interactions
- Tell your healthcare provider about all the medicines you take, particularly other biologic medicines for psoriasis, psoriatic arthritis, Crohn's disease or ulcerative colitis, since combining Selarsdi with another biologic immunosuppressant is not recommended because of a higher infection risk.
- Live vaccines should not be given during Selarsdi treatment.
- Ustekinumab may affect how the liver processes certain medicines with a narrow safety margin, such as warfarin, some anti-seizure drugs, cyclosporine and theophylline, cleared through CYP450 enzymes, so monitoring may be needed when Selarsdi is started or stopped in people taking these.
- Clinical studies found no important safety concerns when the reference product was used alongside methotrexate, corticosteroids, or other immunosuppressants, but your healthcare provider will still weigh the added infection risk of combining immune-suppressing treatments.
References
Frequently Asked Questions
Selarsdi (ustekinumab-aekn) is a biosimilar to Stelara used to treat moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease and ulcerative colitis. It is approved for adults, and for psoriasis and psoriatic arthritis in children aged 6 and over. It works by blocking interleukin-12 and interleukin-23, two proteins that drive inflammation.
Selarsdi 45 mg or 90 mg is usually a self-injection under the skin, given after your first doses in a clinic, roughly every 8 to 12 weeks depending on your condition. For Crohn's disease and ulcerative colitis, the first dose is a one-time intravenous infusion given by a healthcare provider, followed by subcutaneous maintenance doses.
Common effects include nasopharyngitis, headache, tiredness, and injection-site redness. Because Selarsdi lowers immune defences, it can raise the risk of serious infections, including tuberculosis, and rarely severe allergic reactions or a brain condition called PRES. Report fever, persistent cough, breathing changes or facial swelling promptly.
Avoid live vaccines, such as MMR, yellow fever or nasal flu vaccine, while using Selarsdi. Avoid starting Selarsdi if you have an active infection or untreated tuberculosis. Tell your healthcare provider about all other biologic medicines, since combining Selarsdi with another immune-suppressing biologic is not recommended because of added infection risk.
Selarsdi is a biosimilar, meaning it is highly similar to the reference biologic Stelara with no clinically meaningful difference in safety or effectiveness. It contains the same active ingredient, ustekinumab. Depending on state law, a pharmacist may be able to substitute Selarsdi for Stelara without contacting the prescriber first.
Store Selarsdi prefilled syringes and vials in a refrigerator between 2 and 8 degrees C, away from light, and do not freeze. If needed, a syringe can be kept at room temperature for up to 30 days; do not put it back in the refrigerator afterward. Never shake Selarsdi.
Trusted & Reliable – Your Partner in Global Distribution.
We provide comprehensive lines of pharmaceutical products to support all your healthcare distribution needs.
