Yesintek

Yesintek is an interchangeable biosimilar to Stelara used to treat moderate to severe plaque psoriasis, active psoriatic arthritis, and moderately to severely active Crohn's disease or ulcerative colitis.

Yesintek's mechanism of action involves binding specifically to a protein subunit called p40 used by IL-12 and 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, Yesintek reduces inflammation, pain, swelling, and skin symptoms.

Yesintek (ustekinumab-kfce) belongs to the drug class called interleukin inhibitors. It is given as an injection under the skin (subcutaneously) and is also available as a vial for intravenous infusion, which may be used as the initial dose for Crohn's disease and ulcerative colitis.

Yesintek gained FDA approval on November 29, 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.

Yesintek 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 Yesintek 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.

Use Yesintek exactly as your doctor tells you to. Read all the instructions in the Yesintek package insert.

Adults with Crohn's disease and ulcerative colitis will receive the first dose of Yesintek through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider.

• It takes at least 1 hour to receive the full dose of medicine.
• You will then receive Yesintek as an injection under the skin (subcutaneous injection) 8 weeks after the first dose, as described below.

Adults and children 6 years and older with psoriasis or psoriatic arthritis will receive Yesintek as an injection under the skin (subcutaneous injection).

Injecting Yesintek under your skin (subcutaneous injection)

Yesintek is intended for use under the guidance and supervision of your doctor. In children, it is recommended that Yesintek is administered by a healthcare provider.

• If your doctor decides that you or a caregiver may give your injections of Yesintek at home, you should receive training on the right way to prepare and inject Yesintek.
• Your doctor will determine the right dose of Yesintek for you, the amount for each injection, and how often you should receive it.
• Do not try to inject Yesintek yourself until you or your caregiver have been shown how to inject Yesintek by your doctor or nurse.
• Inject Yesintek 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 Yesintek.
• The liquid should look clear and colorless to pale yellow. Do not use it if it is frozen, discolored, cloudy, or has large particles in it.
• Do not shake the prefilled syringe at any time. Shaking can damage the medicine.
• If you receive two 45 mg prefilled syringes for a 90 mg dose, you will need to give two injections, one right after the other.

Be sure to keep all of your scheduled follow-up appointments. Read the detailed Instructions for Use at the end of the Yesintek Medication Guide for instructions about how to prepare and inject a dose, and how to properly throw away used needles and syringes.

The syringe, needle, and vial must never be reused. After the stopper is punctured, Yesintek can become contaminated by harmful bacteria which could cause an infection if re-used. Therefore, throw away any unused portion of Yesintek.

Do not take Yesintek if you are allergic to ustekinumab products, or to any of the inactive ingredients in Yesintek. Ask your doctor if you are not sure.

Before you start treatment, your doctor should evaluate you for tuberculosis. Yesintek should not be given to people with active tuberculosis, and treatment for latent tuberculosis should be started before Yesintek is given.

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

• have any of the infection symptoms or conditions listed above
• have ever had an allergic reaction to an ustekinumab product
• have recently received or are scheduled to receive an immunization (vaccine). People who take Yesintek 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. You should avoid receiving the BCG vaccine during the one year before receiving Yesintek or one year after you stop receiving Yesintek
• have any new or changing lesions within psoriasis areas or on normal skin
• have ever had any type of cancer
• are receiving or have received allergy shots, especially for serious allergic reactions. Allergy shots may not work as well for you during treatment with Yesintek. Yesintek may also increase your risk of having an allergic reaction to an allergy shot
• 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 Yesintek can harm your unborn baby. Tell your doctor if you are pregnant or plan to become pregnant, and you and your doctor should decide together whether you will receive Yesintek.

Data from a pregnancy registry, published studies, and safety reporting have not identified a link between ustekinumab and major birth defects, miscarriage, or other harmful effects on the mother or baby. Inflammatory bowel disease itself carries risks in pregnancy, and more active disease has been linked with preterm delivery, low birth weight, and babies that are small for their gestational age.

Antibodies like ustekinumab cross the placenta, particularly in the third trimester, so a baby may be exposed to the medicine before birth. Talk to your doctor and your baby's healthcare provider about what this may mean for your baby.

Breastfeeding

Limited data suggest that ustekinumab is present in human breast milk. There are no data on the effects on milk production, and the effects on a breastfed infant are unknown. Talk to your doctor about the benefits of breastfeeding alongside your need for Yesintek and any possible effects on your baby.

The most common side effects of Yesintek are:

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

Serious side effects and warnings

Yesintek can cause the following serious side effects.

• Serious allergic reactions. Serious allergic reactions, including anaphylaxis and angioedema (swelling under the skin), have been reported with ustekinumab products both in clinical trials and after these medicines were approved. Serious allergic reactions can cause death. One death has been reported in a person who developed chest tightness and shortness of breath during their first infusion. Some serious allergic reactions have happened during the first intravenous dose, which is given in a healthcare setting where staff can treat a reaction straight away. Reactions were uncommon in the Crohn's disease trials, and the people affected were treated with antihistamines or corticosteroids and their symptoms settled within an hour. Stop using Yesintek and get medical help right away if you have any symptoms of a serious allergic reaction, such as: feeling faint or light-headed swelling of your face, eyelids, lips, tongue, or throat chest discomfort or tightness trouble breathing or shortness of breath hives, a skin rash, or flushing. Do not take another dose of Yesintek unless your doctor tells you it is safe to do so.
• Serious infections. Yesintek 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 Yesintek. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Yesintek and during treatment with Yesintek. Your doctor should watch you closely for signs and symptoms of TB while you are being treated with Yesintek. You should not start taking Yesintek if you have any kind of infection unless your doctor says it is okay. Before starting Yesintek, tell your doctor if you: think you have an infection or have symptoms of an infection such as: fever, sweats, or chills muscle aches cough shortness of breath blood in phlegm weight loss warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinating more often than normal 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 TB, or have been in close contact with someone with TB.

After starting Yesintek, call your doctor right away if you have any symptoms of an infection. These may be signs of infections such as chest infections, or skin infections or shingles, that could have serious complications. Yesintek can make you more likely to get infections or make an infection that you have worse.

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 Yesintek may also be more likely to get these infections.

• Cancers. Yesintek 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 Yesintek, tell your doctor if you develop any new skin growths. Your doctor may monitor you more closely if you are over 60 years of age, have taken medicines that suppress the immune system for a long time, or have had PUVA treatment.
• Posterior Reversible Encephalopathy Syndrome (PRES). PRES is a rare condition that affects the brain and can cause death. It has been reported a few days to several months after starting an ustekinumab product, and in a few cases a year or longer afterwards. People recovered with supportive care once the medicine was stopped. Tell your doctor right away if you have any new or worsening medical problems including headaches, confusion, seizures, or vision problems.
• Lung inflammation. Cases of lung inflammation, including interstitial pneumonia, eosinophilic pneumonia, and cryptogenic organizing pneumonia, have happened in some people who receive ustekinumab products such as Yesintek, and may be serious. These have been reported after one to three doses and have sometimes led to respiratory failure and prolonged hospitalization. These lung problems may need to be treated in a hospital. Tell your doctor right away if you become short of breath or develop a cough that doesn't go away.
• Vaccines. Avoid live vaccines while you are being treated with Yesintek. 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 avoid the BCG (Bacillus Calmette-Guérin) vaccine during the one year before starting Yesintek, while you are taking it, and for one year after you stop. Non-live vaccinations received during Yesintek treatment may not produce an immune response strong enough to prevent disease.

These are not all of the possible side effects of Yesintek. 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 Biocon Biologics at 1-833-986-1468.

Your doctor will work out the right dose for you based on your condition and, where relevant, your weight at the time of dosing.

Yesintek dosage for plaque psoriasis

Adults:

• 100 kg or less: 45 mg
• More than 100 kg: 90 mg.

Children 6 years and older:

• Less than 60 kg: 0.75 mg/kg
• 60 kg to 100 kg: 45 mg
• More than 100 kg: 90 mg.

For both adults and children, Yesintek is given as a subcutaneous injection initially and 4 weeks later, then every 12 weeks.

Yesintek dosage for psoriatic arthritis

Adults:

• 45 mg, regardless of weight
• 90 mg for people who also have moderate to severe plaque psoriasis and weigh more than 100 kg.

Children 6 years and older:

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

For both adults and children, Yesintek is given as a subcutaneous injection initially and 4 weeks later, then every 12 weeks.

Yesintek dosage for Crohn's disease and ulcerative colitis

Adults receive a single intravenous infusion first, based on weight:

• Up to 55 kg: 260 mg (2 vials)
• More than 55 kg to 85 kg: 390 mg (3 vials)
• More than 85 kg: 520 mg (4 vials).

A 90 mg subcutaneous injection is then given 8 weeks after the initial intravenous dose, and every 8 weeks after that, at all weights.

Call your doctor for instructions if you miss a dose.

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

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 during the one year before you start Yesintek, while you are taking it, 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 Yesintek, 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:

• medicines with a narrow safety margin that are broken down by CYP450 liver enzymes, such as warfarin (Coumadin, Jantoven) and cyclosporine (Gengraf, Neoral, Sandimmune). Blocking IL-12 and IL-23 can change how quickly the liver clears these medicines, so your doctor may check your levels or response and adjust your dose when Yesintek is started or stopped
• allergen immunotherapy (allergy shots). Ustekinumab products, including Yesintek, have not been studied in people who have had allergy immunotherapy. Yesintek may reduce how well allergy shots work and may increase the risk of an allergic reaction to them, so caution is advised, particularly where there is a risk of anaphylaxis.

In psoriasis studies, ustekinumab has not been evaluated in combination with medicines that suppress the immune system or with phototherapy. In studies in psoriatic arthritis, Crohn's disease, and ulcerative colitis, taking methotrexate, azathioprine, 6-mercaptopurine, or oral corticosteroids alongside ustekinumab did not appear to change how safe or effective it was.

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 Yesintek vials, prefilled syringes, and prefilled autoinjectors in a refrigerator between 36°F to 46°F (2°C to 8°C). Store vials standing up straight. Store Yesintek 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 and prefilled autoinjectors may also be stored at room temperature up to 86°F (30°C) for a maximum single period of up to 30 days in the original carton to protect from light. Record the date when the syringe or autoinjector is first removed from the refrigerator on the carton in the space provided.

• Once a syringe or autoinjector has been stored at room temperature, it should not be returned to the refrigerator.
• Throw away the syringe or autoinjector if it is not used within 30 days at room temperature.

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

Active ingredient: ustekinumab-kfce

Inactive ingredients

Single-dose prefilled syringe and single-dose vial for subcutaneous use: histidine, L-histidine monohydrochloride monohydrate, polysorbate 80, and sucrose, with hydrochloric acid and sodium hydroxide added to adjust the pH.

Single-dose vial for intravenous infusion: edetate disodium, histidine, L-histidine hydrochloride monohydrate, methionine, polysorbate 80, and sucrose, with hydrochloric acid and sodium hydroxide added to adjust the pH.

Yesintek is available as

Subcutaneous injection:

• Yesintek 45 mg/0.5 mL single-dose prefilled syringe
• Yesintek 90 mg/mL single-dose prefilled syringe
• Yesintek 45 mg/0.5 mL single-dose prefilled autoinjector
• Yesintek 90 mg/mL single-dose prefilled autoinjector
• Yesintek 45 mg/0.5 mL solution in a single-dose vial.

Intravenous infusion:

• Yesintek 130 mg/26 mL (5 mg/mL) solution in a single-dose vial.

Yesintek is made by Biocon Biologics Inc., Bridgewater, 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 Yesintek.

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.

View Selarsdi information in detail.

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.

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.