Wezlana
Generic name: ustekinumab-auub
Brand name: Weslana
Drug class: Interleukin inhibitors
What is Wezlana?
Wezlana (ustekinumab-auub) is used to treat certain types of plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Wezlana helps reduce the symptoms of these diseases but does not cure these inflammatory diseases.
Wezlana works by blocking certain proteins in your body called IL-12 (interleukin-12) and IL-23 (interleukin-23) that cause inflammation in these autoimmune conditions. Wezlana is from a class of medicines called interleukin inhibitors.
Wezlana is an interchangeable biosimilar of Stelara (ustekinumab). A biosimilar is a biologic medicine that is a very close copy of the original product, Stelara, which is made by another company. An interchangeable biosimilar may be substituted for the reference product without consulting the prescriber, subject to state laws. This means that Wezlana can be dispensed when the prescription has been written for Stelara, depending on local state laws.
What is Wezlana used for?
Wezlana can be used to treat:
Adults with:
- moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
- active psoriatic arthritis
- moderately to severely active Crohn’s disease and
- moderately to severely active ulcerative colitis.
Patients 6 years of age and older with:
- moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy
- and active psoriatic arthritis.
Wezlana received FDA approval on October 31, 2023, and is a biosimilar to and interchangeable with Stelara.
Wezlana side effects
Common Wezlana side effects
The most common Wezlana side effects are cold symptoms, fever, diarrhea, headache, tiredness, itchy skin, nausea, vomiting, injection site redness, vaginal candidiasis/mycotic infection, bronchitis (cough with mucus, shortness of breath, chest discomfort), urinary tract infection, inflamed sinus, stomach pain, the flu, and upper respiratory tract infection.
Serious Wezlana side effects
Get emergency medical help if you have signs of an allergic reaction to Wezlana hives, chest pain, difficulty breathing, feeling light-headed, or swelling of your face, lips, tongue, or throat.
Serious infections may occur during treatment with Wezlana. Call your doctor right away if you have signs of infection including 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.
Also, 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 seizure (convulsions).
This is not a complete list of Wezlana side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.
Warnings
You should not use Wezlana if you have received a BCG (Bacillus Calmette and Guérin) vaccine within 1 year prior to, during, or 1 year following treatment.
Before you start treatment with this injection, your doctor may perform tests to make sure you do not have tuberculosis.
Serious infections may occur during treatment with Wezlana. 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.
Ustekinumab 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.
Wezlana may decrease 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.
Before taking this medicine
You should not use Wezlana if you:
- are allergic to the active ingredient ustekinumab or any of the inactive ingredients contained in the medicine.
- have active tuberculosis; or
- have received a BCG (Bacillus Calmette and Guérin) vaccine within the past 12 months.
Tell your doctor if you have ever had tuberculosis, if anyone in your household has tuberculosis, or if you have recently traveled to an area where tuberculosis is common.
To make sure Wezlana is safe for you, tell your doctor if you have:
- signs of infection (fever, chills, cough, muscle aches, painful skin sores, diarrhea, pain when you urinate, feeling very tired)
- chronic infections
- new or changing skin lesions
- a latex allergy as the needle cover on the prefilled syringe contains latex
- phototherapy (light therapy)
- allergy shots
- if you recently received or are scheduled to receive any vaccine, people who take this medicine 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.
Some people using this medicine have developed skin cancer (non-melanoma). However, these people may have had a higher risk of skin cancer. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.
Pregnancy
It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. If you are pregnant, your name may be listed on a pregnancy registry to track the effects of ustekinumab on the baby.
Breastfeeding
It may not be safe to breastfeed while using this medicine. It is thought that Wezlana passes into your breast milk in small amounts. Talk to your doctor about the best way to feed your baby if you receive this medicine.
How should I use Wezlana?
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. Wezlana is intended for use under the guidance and supervision of your doctor. Prepare your injection only when you are ready to give it. Do not use if the medicine looks cloudy, has changed colors, or has particles in it. Call your pharmacist for new medicine.
Related/similar drugs
Entyvio, Otezla, Cimzia, Taltz, prednisone, methotrexate, methylprednisolone, dexamethasone, hydrocortisone, hydrocortisone topical
What happens if I miss a dose?
Call your doctor for instructions if you miss a dose.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while using Wezlana?
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.
BCG vaccine should not be given for at least 1 year after you receive your last dose of Wezlana.
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 Wezlana?
Other drugs may interact with Wezlana, 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).
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.
Manufacturer
Amgen, Inc., 1 Amgen Center Drive, Thousand Oaks, CA 91320-1799
Wezlana 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 Wezlana.
Stelara (ustekinumab) - Janssen Biotech, Inc.
Formulation type | Strength |
---|---|
Pre-Filled Syringe | 45 mg/0.5 mL |
Pre-Filled Syringe | 90 mg/mL |
Single-Dose Vial | 130 mg/26 mL (5 mg/mL) |
Single-Dose Vial | 45 mg/0.5 mL |
Single-Dose Vial | 90 mg/mL Discontinued |
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.
Wezlana (ustekinumab-auub) - Amgen Inc.
Formulation type | Strength |
---|---|
Pre-Filled Syringe | 45 mg/0.5 mL |
Pre-Filled Syringe | 90 mg/mL |
Single-Dose Vial | 130 mg/26 mL (5 mg/mL) |
Single-Dose Vial | 45 mg/0.5 mL |
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
Imuldosa (ustekinumab-srlf) - Accord BioPharma Inc.
Formulation type | Strength |
---|---|
Pre-Filled Syringe | 45 mg/0.5 mL |
Pre-Filled Syringe | 90 mg/mL |
Single-Dose Vial | 130 mg/26 mL (5 mg/mL) |
View Imuldosa information in detail.
Otulfi (ustekinumab-aauz) - Fresenius Kabi USA, LLC
Formulation type | Strength |
---|---|
Pre-Filled Syringe | 45 mg/0.5 mL |
Pre-Filled Syringe | 90 mg/mL |
Single-Dose Vial | 130 mg/26 mL (5 mg/mL) |
View Otulfi information in detail.
Pyzchiva (ustekinumab-ttwe) - Samsung Bioepis Co., Ltd.
Formulation type | Strength |
---|---|
Pre-Filled Syringe | 45 mg/0.5 mL |
Pre-Filled Syringe | 90 mg/mL |
Single-Dose Vial | 130 mg/26 mL (5 mg/mL) |
View Pyzchiva information in detail.
Selarsdi (ustekinumab-aekn) - Alvotech USA Inc.
Formulation type | Strength |
---|---|
Pre-Filled Syringe | 45 mg/0.5 mL |
Pre-Filled Syringe | 90 mg/mL |
Single-Dose Vial | 130 mg/26 mL (5 mg/mL) |
View Selarsdi information in detail.
Popular FAQ
Do I qualify for the Stelara copay card, how much can I save?
To qualify for the Stelara copay card you must have commercial or private insurance for Stelara, enroll in the Stelara with Me Savings Program, be at least 6 years of age and not use government-funded insurance programs like Medicare or Medicaid. If you are eligible, you pay $5 per dose with a maximum of $9,450 savings per calendar year. Continue reading
What is the mechanism of action of Stelara and how does it work?
Stelara is a biologic medicine that targets proteins, enzymes and other molecules in your body that cause inflammation, pain and destruction. Stelara works by targeting immune system proteins called interleukin (IL)-12 and IL-23 to help lower inflammation. Continue reading
More FAQ
- What are the new drugs for plaque psoriasis?
- What biosimilars have been approved in the United States?
- How quickly or how long before Stelara starts to work?
- How long can you keep Stelara in or out of the fridge?
More about Wezlana (ustekinumab)
- Check interactions
- Compare alternatives
- Side effects
- Dosage information
- During pregnancy
- FDA approval history
- Drug class: interleukin inhibitors
- Breastfeeding
Patient resources
Other brands
Stelara, Imuldosa, Otulfi, Pyzchiva, ... +2 more
Professional resources
Other brands
Related treatment guides
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.