Selarsdi

Pronunciation: seh-LARS-dee
Generic name: ustekinumab-aekn
Dosage form: subcutaneous injection single-dose prefilled syringe (45 mg/0.5 mL or 90 mg/mL).
Drug class: Interleukin inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Apr 22, 2024.

What is Selarsdi?

Selarsdi (ustekinumab-aekn) is an injectable human interleukin-12 and -23 inhibitor which is a biosimilar to Stelara that may be used to treat adults and children aged 6 years and older with:

• moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
• active psoriatic arthritis.

Selarsdi (ustekinumab) binds specifically to a protein subunit called p40 that is used by both interleukin 12 and interleukin 23 cytokines. Interleukins are made by various cells, such as lymphocytes, monocytes, and macrophages, and are involved in inflammatory and immune responses, including inflammation associated with autoimmune conditions. By blocking the activity of IL-12 and IL-23, Selarsdi reduces inflammation, pain, swelling, and skin symptoms.

Although Selarsdi is a biosimilar to Stelara it does not have interchangeability and is not FDA-approved for ulcerative colitis or Crohn’s disease. It is also only available as a prefilled syringe, unlike Stelara which is available as a vial for intravenous infusion. FDA approval of Selarsdi as a biosimilar was based on data from two trials that demonstrated no clinically meaningful differences between Selarsdi and Stelara regarding safety, tolerability, and immunogenicity.

Selarsdi was FDA approved on April 16, 2024. It is given as an injection under the skin (subcutaneously).

Selarsdi side effects

Selarsdi may cause serious side effects, such as serious infections, pneumonia, a syndrome that affects your brain called PRES, and an increased risk of skin cancer (see warnings below). Call your doctor right away if you have signs of 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.

Get emergency medical help if you have signs of an allergic reaction to Selarsdi such as hives, chest pain, difficulty breathing, feeling light-headed, or swelling of your face, lips, tongue, or throat.

Common Selarsdi side effects may include:

• Nasal congestion
• Sore throat
• Runny nose
• Headache
• Tiredness
• An upper respiratory infection, such as a cold or the flu.

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 seizures (convulsions).

These are not all of the possible side effects of Selarsdi. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to Teva Pharmaceuticals at 1-888-483-8279.

Related/similar drugs

Otezla, Sotyktu, prednisone, methotrexate, Humira, Taltz, Enbrel

Warnings

Selarsdi can lower the ability of your immune system to fight infections, increase your risk of severe infections, and worsen existing infections. Some people have serious infections while taking ustekinumab products, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses, and may end up in hospital. Your doctor should check you for TB before starting Selarsdi and you may be treated with medicine for TB before you begin treatment if your doctor feels that you are at risk. Your doctor should watch you closely for signs and symptoms of TB while you are being treated with Selarsdi.

You should not start taking Selarsdi if you have any kind of infection unless your doctor says it is okay. Before starting treatment, tell your doctor if you think you have an infection or have symptoms of an infection such as:

• fever, sweat, or chills
• warm, red, or painful skin or sores on your body
• muscle aches
• diarrhea or stomach pain
• cough
• burning when you urinate or urinate more often
• shortness of breath than normal
• blood in phlegm
• feel very tired
• weight loss
• are being treated for an infection or have any open cuts.
• get a lot of infections or have infections that keep coming back.
• have TB, or have been in close contact with someone with TB.

After starting Selarsdi, call your doctor right away if you have any symptoms of an infection (see above). These may be signs of infections such as chest infections, skin infections, or shingles that could have serious complications.

People who have a genetic problem where their body does not make any IL-12 or IL-23 are at a higher risk for certain serious infections when they take Selarsdi.

Selarsdi decreases 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.

Selarsdi may also 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.

You should not get a live vaccine while being treated with Selarsdi, and it may be risky if your household contacts receive live vaccines because of the potential risk of virus shedding and transmission to you. Before starting treatment, you should receive all age-appropriate immunizations as recommended by current immunization guidelines. You should not use this medicine if you have received a BCG (Bacillus Calmette and Guérin) vaccine within 1 year before, during, or 1 year following treatment. Non-live vaccinations received during Selarsdi treatment may not elicit an immune response sufficient to prevent disease.

Some people have developed inflammation in their lungs and serious pneumonia during treatment with ustekinumab products. Tell your healthcare provider immediately if you develop shortness of breath or a cough that doesn’t go away, particularly following the first few doses.

Before taking this medicine

Before you receive Selarsdi, tell your doctor about all of your medical conditions, including if you:

• have any of the conditions or symptoms listed in the warning section above
• ever had an allergic reaction to ustekinumab products, including Stelara, Selarsdi, or Wezlana. Ask your doctor if you are not sure.
• have recently received or are scheduled to receive an immunization (vaccine)
• have received a BCG (Bacillus Calmette and Guérin) vaccine within the past 12 months.
• think you have an infection or have symptoms of an infection
• are being treated for an infection or have any open cuts
• get a lot of infections or have infections that keep coming back
• have TB, or have been in close contact with someone with TB.
• have any new or changing lesions within psoriasis areas or on normal skin
• are receiving or have received allergy shots, especially for serious allergic reactions
• receive or have received phototherapy for your psoriasis
• are pregnant or plan to become pregnant
• are breastfeeding or plan to breastfeed.

Pregnancy

It is not known if Selarsdi can harm your unborn baby. You and your doctor should decide if you will receive Selarsdi. 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 Selarsdi while you were pregnant, it may affect what vaccinations can be given to your baby.

Breastfeeding

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

How should I use Selarsdi?

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

• Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. 

Selarsdi is given as an injection under the skin (subcutaneous injection).

• If your doctor decides that you or a caregiver may give your injections at home, you should receive training on the right way to inject Selarsdi.
• It may be given in buttocks, upper legs (thighs), or stomach area (abdomen). A caregiver can give it to you in your upper arms.

• 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 Selarsdi.

• In children 6 years and older, it is recommended that this medicine be administered by a healthcare provider.
• Read the Medication Guide for detailed instructions about how to prepare and inject a dose of Selarsdi, and how to properly throw away (dispose of) used needles and prefilled syringes. The needle and prefilled syringe must never be re-used because of the risk of infection. Throw away any unused portion of Selarsdi.

Selarsdi dosage

For psoriasis and psoriatic arthritis in adults and children, Selarsdi is given as the first subcutaneous injection, then another injection 4 weeks later, and then a dose is given every 12 weeks after that.

• 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.

What happens if I miss a dose?

Call your doctor for instructions if you miss a dose.

What happens if I overdose?

If you inject more Selarsdi than prescribed, call your doctor right away seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while using Selarsdi?

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.

• The BCG vaccine should not be given for at least 1 year after you receive your last dose of Selarsdi.
• 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 Selarsdi?

Other drugs may interact with Selarsdi, 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)
• other medications that are metabolized by CYP450 enzymes, particularly those that have a narrow therapeutic index (such as warfarin and cyclosporin).

Ustekinumab products, including Selarsdi, have not been studied in patients who have undergone allergy immunotherapy. It may decrease the protective effect of allergen immunotherapy (decrease tolerance) which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Caution is advised especially in those who have received allergen immunotherapy, particularly for anaphylaxis.

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

Store Selarsdi prefilled syringes in a refrigerator between 36°F to 46°F (2°C to 8°C). Store it in the original carton to protect it from light until time to use it. Do not freeze and do not shake.

If needed, individual prefilled syringes may also be stored at room temperature up to 30°C (86°F) for a maximum single period of up to 30 days in the original carton to protect from light.

Record the date when the syringe is first removed from the refrigerator on the carton in the space provided. Once a syringe has been stored at room temperature, it should not be returned to the refrigerator. Discard if not used within 30 days.

Do not use after the expiry date. Keep out of the reach of children.

Ingredients

Active ingredient: ustekinumab-aekn

Inactive ingredients: histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and water for injection.

Selarsdi is available as a 45 mg/0.5 mL single-dose prefilled syringe and a 90 mg/mL single-dose prefilled syringe.

Manufacturer

Alvotech and Teva Pharmaceutical Industries.

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Further information

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