Selarsdi

Selarsdi is 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, or who have active psoriatic arthritis. Selarsdi is also approved for moderately to severely active Crohn's disease or ulcerative colitis in adults. It is a biosimilar to Stelara.

Selarsdi (ustekinumab-aekn) binds specifically to a protein subunit called p40 that is used by interleukin-12 (IL-12) and interleukin-23 (IL-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.

For plaque psoriasis and psoriatic arthritis, Selarsdi is given as an injection under the skin (subcutaneously). For Crohn's disease and ulcerative colitis, the first dose is given as an intravenous infusion, followed by injections under the skin.

Selarsdi was FDA-approved on April 16, 2024. Because it is a biosimilar, it is highly similar to Stelara, and there are no clinically meaningful differences between the two in terms of safety, purity, and potency.

Selarsdi is FDA-approved to treat:

• Plaque psoriasis (moderate to severe) in adults and children 6 years and older who are candidates for phototherapy or systemic therapy
• Psoriatic arthritis (active) in adults and children 6 years and older
• Crohn's disease (moderately to severely active) in adults
• Ulcerative colitis (moderately to severely active) in adults.

It is not known if Selarsdi is safe and effective in children with Crohn's disease or ulcerative colitis, or in children under 6 years of age with plaque psoriasis or psoriatic arthritis.

Do not take Selarsdi if you are allergic to ustekinumab or any other ustekinumab product, such as Stelara, Wezlana, Imuldosa, Otulfi, Pyzchiva, Yesintek, Steqeyma, or Starjemza, or if you are allergic to any of the inactive ingredients in Selarsdi.

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

• have recently received or are scheduled to receive an immunization (vaccine), including a BCG (Bacillus Calmette and Guerin) vaccine within the past 12 months
• have an infection, have symptoms of 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
• have skin cancer
• 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. Antibodies like ustekinumab cross the placenta, and transfer increases as pregnancy progresses, peaking during the third trimester, so ustekinumab may be present in babies exposed before birth. Talk to your doctor about what this could mean for your baby, including the timing of your baby's vaccinations.

An observational pregnancy registry run by the Organization of Teratology Information Specialists (OTIS) MotherToBaby in the United States and Canada, which enrolled between 2013 and 2019, did not identify a ustekinumab-associated risk of major birth defects, a pattern of major or minor anomalies, increased risk of miscarriage, or adverse infant outcomes. The registry was small and had methodological limitations, so it cannot rule out a risk.

Breastfeeding

Limited data suggest ustekinumab is present in human breast milk. There is no information on the effects of ustekinumab products on milk production or on the breastfed infant. Talk to your doctor about the best way to feed your baby if you receive this medicine.

The most common side effects of Selarsdi are:

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

Serious side effects and warnings

Get emergency medical help if you have signs of a serious allergic reaction to Selarsdi: feeling faint, swelling of your face, eyelids, tongue, or throat, chest discomfort or tightness, trouble breathing, hives, or a skin rash.

Selarsdi can cause the following serious side effects:

• Serious allergic reactions. Serious allergic reactions, including anaphylaxis and angioedema, have been reported with ustekinumab products in clinical trials and after approval, and death can occur. Reactions have followed both intravenous infusions and injections under the skin. Some serious reactions have happened during the very first intravenous dose, and there has been a fatal case that began with chest tightness and shortness of breath during that first infusion. Stop using Selarsdi and get medical help right away if you develop any signs of a serious allergic reaction. If you have a serious allergic reaction to Selarsdi, you should not receive it again.
• Infections. Selarsdi can lower the ability of your immune system to fight infections, increase your risk of serious infections, and worsen existing infections, such as tuberculosis (TB). Serious bacterial, mycobacterial, fungal, and viral infections have occurred, some needing hospital treatment. These have included pneumonia and other chest infections, cellulitis, diverticulitis, appendicitis, cholecystitis, sepsis, osteomyelitis, gastroenteritis, urinary tract infections, anal abscess, shingles affecting the eye, listeria meningitis, and tuberculosis. Before starting Selarsdi, your doctor will check for TB, and you may need treatment for TB if you are at risk. You should not start taking Selarsdi if you have an infection unless your doctor says it is okay. Symptoms of an infection include: 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 urinating more often than normal shortness of breath blood in phlegm feeling very tired weight loss.
• Serious infections in people with an IL-12 or IL-23 genetic deficiency. 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. People who take Selarsdi may also be more likely to get these infections. In people with this genetic deficiency, the infections reported include widespread infections caused by mycobacteria, including environmental mycobacteria that do not usually cause disease, salmonella infections, and infections following BCG vaccination. It is not known whether people whose IL-12 and IL-23 are blocked by a medicine such as Selarsdi are vulnerable in the same way. Your doctor may order tests such as a tissue culture or a stool culture if you develop an infection.
• Increased cancer risk. Selarsdi decreases the activity of your immune system, and there may be an increase in your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people receiving ustekinumab products who have risk factors for skin cancer have developed certain types of skin cancer, including the rapid appearance of multiple cutaneous squamous cell carcinomas. Everyone taking Selarsdi should be monitored for non-melanoma skin cancer, and your doctor should follow you especially closely if you are over 60 years of age, have had prolonged immunosuppressant therapy, or have a history of PUVA treatment. During your treatment with this medicine, tell your doctor if you develop any new skin growths, or if a mole changes in size or color.
• Posterior Reversible Encephalopathy Syndrome (PRES). A rare condition that affects the brain and can cause death. Symptoms have included headache, seizures, confusion, and vision problems, and have appeared anywhere from a few days to several months after starting treatment, sometimes a year or longer. Tell your doctor right away if you have any of these symptoms. People have recovered with supportive care after ustekinumab was stopped.
• Noninfectious pneumonia. Cases of interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia have been reported with ustekinumab products. Symptoms have included cough, shortness of breath, and lung changes on imaging following one to three doses. Outcomes have included respiratory failure and prolonged hospitalization. People improved when treatment was stopped, and in some cases corticosteroids were given. Tell your healthcare provider right away if you become short of breath or develop a cough that does not go away.

Avoid live vaccines while you are being treated with Selarsdi. It may also be risky for your household contacts to receive live vaccines because of the potential risk of virus shedding and transmission to you. Before starting treatment, you should receive all your age-appropriate immunizations as recommended by current immunization guidelines. You should not receive a BCG (Bacillus Calmette and Guerin) vaccine during the year before you start Selarsdi, while you are taking it, or for one year after your last dose. Non-live vaccinations received during Selarsdi treatment may not produce an immune response sufficient to prevent disease.

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.

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 by a healthcare provider as an intravenous infusion or as an injection under the skin (subcutaneous injection). Some people can be taught how to give the subcutaneous injection themselves.

• Adults with Crohn's disease or ulcerative colitis receive the first dose of Selarsdi through a vein in the arm (intravenous infusion) at a healthcare facility. The infusion takes at least 1 hour. You will then receive Selarsdi as an injection under the skin 8 weeks after the first dose, as described below.
• Adults and children 6 years and older with plaque psoriasis or psoriatic arthritis receive Selarsdi as an injection under the skin.

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.

• Selarsdi may be given under the skin of your stomach area (abdomen), buttocks, or upper legs (thighs). A caregiver can give it in the outer area of your upper arms.
• Do not give an injection in an area of skin that is tender, bruised, red, or hard.
• Use a different injection site each time you use Selarsdi.
• If your dose is 90 mg, you may receive either one 90 mg prefilled syringe, or two 45 mg prefilled syringes, or two 45 mg vials. If you receive two 45 mg syringes or vials, give the second injection right after the first, in a different site.
• Selarsdi is not made with natural rubber latex.
• Read the Selarsdi Medication Guide and Instructions for Use for detailed directions on how to prepare and inject a dose and how to throw away (dispose of) used needles, syringes, and vials. Needles, syringes, and vials must never be reused because of the risk of infection. Throw away any unused portion of Selarsdi.

In children 6 years and older, it is recommended that this medicine be administered by a healthcare provider. Children who weigh less than 60 kg receive a weight-based dose measured from a single-dose vial, and a 1 mL syringe with a 27-gauge, half-inch needle is recommended.

Selarsdi dosage

The dosage of Selarsdi is based on body weight and on the condition being treated. Your doctor will determine the right dose for you.

Selarsdi dosage for plaque psoriasis

Adults 100 kg or less: 45 mg by subcutaneous injection initially and 4 weeks later, followed by 45 mg every 12 weeks.

Adults more than 100 kg: 90 mg by subcutaneous injection initially and 4 weeks later, followed by 90 mg every 12 weeks. In people weighing more than 100 kg, 45 mg was also effective, but 90 mg gave greater efficacy.

Children 6 to 17 years, given initially, 4 weeks later, and then every 12 weeks:

• less than 60 kg: 0.75 mg/kg
• 60 kg to 100 kg: 45 mg
• more than 100 kg: 90 mg.

Selarsdi dosage for psoriatic arthritis

Adults: 45 mg by subcutaneous injection initially and 4 weeks later, followed by 45 mg every 12 weeks. Adults who weigh more than 100 kg and who also have moderate to severe plaque psoriasis receive 90 mg initially and 4 weeks later, followed by 90 mg every 12 weeks.

Children 6 to 17 years, given initially, 4 weeks later, and then every 12 weeks:

• less than 60 kg: 0.75 mg/kg
• 60 kg or more: 45 mg
• more than 100 kg with co-existent moderate to severe plaque psoriasis: 90 mg.

Selarsdi dosage for Crohn's disease and ulcerative colitis

Adults receive a single intravenous infusion to start, with the dose based on body weight:

• 55 kg or less: 260 mg (2 vials)
• more than 55 kg to 85 kg: 390 mg (3 vials)
• more than 85 kg: 520 mg (4 vials).

Maintenance dose for adults, all weights: 90 mg by subcutaneous injection 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

The infusion is given over at least one hour and must be completed within 4 hours of the solution being prepared.

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. In clinical trials, single intravenous doses up to 6 mg/kg were given without dose-limiting toxicity.

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 close 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 in the year before you start Selarsdi, during treatment, or for at least 1 year after your last dose.
• 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.

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:

• medications that suppress the immune system, such as azathioprine (Azasan, Imuran), cyclosporine (Gengraf, Neoral, Sandimmune), methotrexate (Otrexup, Rasuvo, Trexall, Xatmep), 6-mercaptopurine (Purixan), sirolimus (Rapamune), and tacrolimus (Astagraf, Envarsus, Prograf)
• oral steroids such as dexamethasone (Hemady), methylprednisolone (Medrol), and prednisone (Rayos)
• medicines that are broken down by CYP450 enzymes and have a narrow therapeutic index, meaning the difference between an effective dose and a harmful one is small.

Long-term inflammation can lower the activity of CYP450 enzymes. Because Selarsdi reduces inflammation, CYP450 activity may return toward normal when treatment is started or stopped. If you take a medicine with a narrow therapeutic index, your doctor may need to check its level or adjust your dose. A CYP450 interaction effect was not seen in people with Crohn's disease.

Ustekinumab products, including Selarsdi, have not been studied in people who have undergone allergy immunotherapy. Selarsdi may decrease the protective effect of allergen immunotherapy, which may increase the risk of an allergic reaction to a dose of allergen immunotherapy. Caution is advised, particularly in people who have received allergen immunotherapy 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.

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

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

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

Do not use after the expiration date on the carton, syringe, or vial. Keep out of the reach of children.

Active ingredient: ustekinumab-aekn

Inactive ingredients (single-dose prefilled syringe and single-dose vial for subcutaneous use): histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, sucrose, and water for injection.

Inactive ingredients (single-dose vial for intravenous infusion): edetate disodium, histidine, L-histidine monohydrochloride monohydrate, methionine, polysorbate 80, sucrose, and water for injection.

For subcutaneous use, Selarsdi is available as a 45 mg/0.5 mL single-dose prefilled syringe, a 90 mg/mL single-dose prefilled syringe, and a 45 mg/0.5 mL single-dose vial.

For intravenous infusion, Selarsdi is available as a 130 mg/26 mL (5 mg/mL) solution in a single-dose vial.

Selarsdi is manufactured by Alvotech USA Inc., Leesburg, VA (US License No. 2225), and is a product of Iceland. It is marketed in the United States by Teva Pharmaceuticals, Parsippany, NJ.

Biosimilar and interchangeable products are biological products that are highly similar to and have no clinically meaningful differences from the reference product.

Reference products

These are biological products that have already been approved by the FDA, against which biosimilar products are compared. There is 1 for Selarsdi.

Stelara (ustekinumab) - Janssen Biotech, Inc.

View Stelara information in detail.

Stelara interchangeable products

Interchangeable biosimilar products can be dispensed by a pharmacist without the intervention of the prescriber of the reference product.

Pharmacy laws for biosimilar prescribing may vary by state.

Imuldosa (ustekinumab-srlf) - Accord BioPharma Inc.

View Imuldosa information in detail.

Otulfi (ustekinumab-aauz) - Fresenius Kabi USA, LLC

View Otulfi information in detail.

Pyzchiva (ustekinumab-ttwe) - Samsung Bioepis Co., Ltd.

View Pyzchiva information in detail.

Selarsdi (ustekinumab-aekn) - Alvotech USA Inc.

Starjemza (ustekinumab-hmny) - Bio-Thera Solutions, Ltd.

View Starjemza information in detail.

Steqeyma (ustekinumab-stba) - CELLTRION, Inc.

View Steqeyma information in detail.

Wezlana (ustekinumab-auub) - Amgen Inc.

View Wezlana information in detail.

Yesintek (ustekinumab-kfce) - Biocon Biologics Inc.

View Yesintek information in detail.

Stelara biosimilar products

Biosimilar products can only be dispensed in place of the reference product if the healthcare provider specifically prescribes the biosimilar product by name.

Pharmacy laws for biosimilar prescribing may vary by state

Wezlana (ustekinumab-auub) - Amgen Inc.

View Wezlana information in detail.

Yesintek (ustekinumab-kfce) - Biocon Biologics Inc.

View Yesintek information in detail.