WEZLANA™ (ustekinumab-auub) is a prescription medicine that affects your immune system. WEZLANA can increase your chance of having serious side effects including:

Serious Infections

WEZLANA may lower your ability to fight infections and may increase your risk of infections. While taking ustekinumab products, some people have serious infections, which may require hospitalization, including tuberculosis (TB), and infections caused by bacteria, fungi, or viruses.

• Your doctor should check you for TB before starting WEZLANA and watch you closely for signs and symptoms of TB during treatment with WEZLANA.
• If your doctor feels that you are at risk for TB, you may be treated for TB before and during treatment with WEZLANA.

You should not start taking WEZLANA if you have any kind of infection unless your doctor says it is okay.

Before starting WEZLANA, 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 urinate more often than normal
  • – feel 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 WEZLANA, 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, or skin infections or shingles that could have serious complications. WEZLANA 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 that can spread throughout the body and cause death. People who take WEZLANA may also be more likely to get these infections.

Cancers

WEZLANA may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your doctor if you have ever had any type of cancer. Some people who had risk factors for skin cancer developed certain types of skin cancers while receiving WEZLANA. Tell your doctor if you have 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: headache, seizures, confusion, and vision problems.

Serious Allergic Reactions

Serious allergic reactions can occur. Stop using WEZLANA and get medical help right away if you have any symptoms of a serious allergic reaction such as: feeling faint, swelling of your face, eyelids, tongue, or throat, chest tightness, or skin rash.

Lung Inflammation

Cases of lung inflammation have happened in some people who receive ustekinumab products and may be serious. These lung problems may need to be treated in a hospital. Tell your doctor right away if you develop shortness of breath or a cough that doesn’t go away during treatment with WEZLANA.

Before receiving WEZLANA, tell your doctor about all of your medical conditions, including if you:

• have any of the conditions or symptoms listed above for serious infections, cancers, or PRES.
• ever had an allergic reaction to ustekinumab products or any of its ingredients. Ask your doctor if you are not sure.
• have recently received or are scheduled to receive an immunization (vaccine). People who take WEZLANA 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 WEZLANA or one year after you stop receiving WEZLANA.
• 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. It is not known if WEZLANA can harm your unborn baby. You and your doctor should decide if you will receive WEZLANA.
• are breastfeeding or plan to breastfeed. WEZLANA can pass into your breast milk.
• talk to your doctor about the best way to feed your baby if you receive WEZLANA.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them to show your doctor and pharmacist when you get a new medicine.

When prescribed WEZLANA:

• Use WEZLANA exactly as your doctor tells you to.
• WEZLANA is intended for use under the guidance and supervision of your doctor. In children 6 years and older, it is recommended that WEZLANA be administered by a healthcare provider. If your doctor decides that you or a caregiver may give your injections of WEZLANA at home, you should receive training on the right way to prepare and inject WEZLANA. Your doctor will determine the right dose of WEZLANA for you, the amount for each injection, and how often you should receive it. Do not try to inject WEZLANA yourself until you or your caregiver have been shown how to inject WEZLANA by your doctor or nurse.

Common side effects of WEZLANA include: nasal congestion, sore throat, and runny nose, upper respiratory infections, fever, headache, tiredness, itching, nausea and vomiting, redness at the injection site, vaginal yeast infections, urinary tract infections, sinus infection, bronchitis, diarrhea, stomach pain, and joint pain. These are not all of the possible side effects with WEZLANA. Tell your doctor about any side effect that you experience. Ask your doctor or pharmacist for more information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit https://www.fda.gov/medwatch or call 1-800-FDA-1088.

Please see the accompanying WEZLANA full Prescribing Information, including Medication Guide.