Pronunciation: Yes-in-tek
Generic name: ustekinumab-kfce
Dosage form: subcutaneous injection single-dose prefilled syringe (45 mg/0.5 mL or 90 mg/mL), subcutaneous injection single-dose vial (45 mg/0.5 mL), injection for intravenous infusion single-dose vial (130 mg/26 mL)
Drug class: Interleukin inhibitors

Medically reviewed by Carmen Pope, BPharm. Last updated on Dec 4, 2024.

What is Yesintek?

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

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.

Yesintek is given as an injection under the skin (subcutaneously). Yesintek is also available as a vial for intravenous infusion that may be used as the initial dose for Crohn's disease and ulcerative colitis.

Yesintek gained FDA approval on November 29, 2024. Although Yesintek is a biosimilar to Stelara it does not have interchangeability. A biosimilar means the product is approved based on data demonstrating that it is highly similar to an FDA-approved product, known as the reference product (in this case Stelara) and there are no clinically meaningful differences between Yesintek and Stelara regarding safety, tolerability, and immunogenicity.

What is Yesintek used for?

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 (moderate to severe) in adults
• Ulcerative colitis (moderate to severe) in adults.

Yesintek side effects

The most common Yesintek side effects are:

• nasal congestion
• a sore throat
• runny nose
• headaches
• tiredness
• upper respiratory infections, such as a cold or the flu.

Serious side effects and warnings

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

Yesintek can cause the following serious side effects.

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, excessive sweating, 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 than normal
  • shortness of breath
  • feel very tired
  • blood in phlegm
  • 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 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 with 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.

Posterior Reversible Encephalopathy Syndrome (PRES). PRES is a rare condition that affects the brain and can cause death. The cause of PRES is not known. If PRES is found early and treated, most people recover. Tell your doctor right away if you have any new or worsening medical problems including headaches, confusion, seizures, or vision problems.

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 the 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 Yesintek treatment may not elicit an immune response sufficient to prevent disease.

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

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.

Related/similar drugs

Before taking this medicine

Do not take Yesintek if you are allergic to ustekinumab, Selarsdi, Stelara, Wezlana, Imuldosa, Otulfi, Pyzchiva, Yesintek, or any of the inactive ingredients in the Yesintek injection.

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

• 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 not receive 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
• 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
• have skin cancer
• 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. You and your doctor should decide if you will receive Yesintek. 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 Yesintek while you were pregnant, it may affect what vaccinations can be given to your baby.

Breastfeeding

Yesintek 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 Yesintek?

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 of Yesintek, as described below.

Adults with psoriasis or psoriatic arthritis, 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 6 years and older, it is recommended that Yesintek be 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 (subcutaneous injection) 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.

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 of Yesintek, and how to properly throw away (dispose of) used needles and syringes.

The syringe, needle, and vial must never be re-used. 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.

Yesintek dosage

Yesintek is given as a subcutaneous (SC) injection for psoriasis and psoriatic arthritis in adults and children.

Yesintek dosage for psoriasis or psoriatic arthritis

The dosage of Yesintek is based on body weight. Your doctor will determine the right dose for you.

Adult (less than or equal to 100 kg): Yesintek 45 mg SC initially and 4 weeks later, followed by 45 mg administered SC every 12 weeks.

Adult (more than 100 kg): Yesintek 90 mg SC initially and 4 weeks later, followed by 90 mg administered SC every 12 weeks.

Child (aged 6 to 17 years):

• Children 60 kg to 100 kg: Yesintek 45 mg SC initially and 4 weeks later, then every 12 weeks.
• Children over 100 kg: Yesintek 90 mg SC initially and 4 weeks later, then every 12 weeks.

Yesintek dosage for Crohn's disease and ulcerative colitis

The dosage of Yesintek is based on body weight. Your doctor will determine the right dose for you.

• Initial dose for adults (up to 55 kg): 260 mg (2 vials) by intravenous infusion
• Initial dose for adults (greater than 55 kg to 85 kg): 390 mg (3 vials) by intravenous infusion
• Initial dose for adults (greater than 85 kg): 520 mg (4 vials) by intravenous infusion
• Maintenance dose for adults (all weights): 90 mg SC given 8 weeks after the initial intravenous dose, then every 8 weeks thereafter.

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 Yesintek 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 Yesintek?

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 Yesintek.
• 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 Yesintek?

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:

• 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 Yesintek, 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 Yesintek 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.

Yesintek ingredients

Active ingredient: ustekinumab-kfce

Inactive ingredients Single-dose prefilled syringe for subcutaneous use contains histidine, L-histidine monohydrochloride monohydrate, Polysorbate 80, and sucrose. Hydrochloric acid and sodium hydroxide added to adjust the pH. Single-dose vial for subcutaneous use contains histidine, L-histidine hydrochloride monohydrate, Polysorbate 80 and sucrose. Hydrochloric acid and sodium hydroxide added to adjust the pH. Single-dose vial for intravenous infusion contains edetate disodium, histidine, L-histidine hydrochloride monohydrate, methionine, Polysorbate 80, and sucrose. Hydrochloric acid and sodium hydroxide added to adjust the pH.

Available as: Yesintek 45 mg/0.5 mL single-dose prefilled syringe for subcutaneous injection Yesintek 90 mg/mL single-dose prefilled syringe for subcutaneous injection Yesintek 45 mg/0.5 mL single-dose vial for subcutaneous injection Yesintek 130 mg/26 mL (5 mg/mL) solution in a single-dose vial for intravenous infusion.

Who makes Yesintek?

Biocon Biologics Inc. makes Yesintek.

Yesintek Biosimilars

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 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.

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

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