IMULDOSA® (ustekinumab-srlf) injection, for subcutaneous or intravenous use
IMULDOSA® (ustekinumab- srlf) is biosimilar to STELARA® (ustekinumab)

WHAT is IMULDOSA?

IMULDOSA® is a prescription medicine used for the treatment of:

• adults and children 6 years and older with moderate to severe plaque psoriasis who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills)
• adults and children 6 years and older with active psoriatic arthritis
• adults 18 years and older with moderately to severely active Crohn’s disease
• adults 18 years and older with moderately to severely active ulcerative colitis

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about IMULDOSA?

IMULDOSA is a prescription medicine that affects your immune system. IMULDOSA may cause serious side effects including:

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

• Your healthcare provider should check you for TB before starting IMULDOSA and watch you closely for signs and symptoms of TB during treatment with IMULDOSA.
• If your healthcare provider feels that you are at risk for TB, you may be treated for TB before and during treatment with IMULDOSA. You should not start taking IMULDOSA if you have any kind of infection unless your healthcare provider says it is okay.

Tell your healthcare provider right away if you have an infection or have any of the following symptoms:

• 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 IMULDOSA, call your healthcare provider 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. IMULDOSA 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 IMULDOSA may also be more likely to get these infections.

Cancers. IMULDOSA may decrease the activity of your immune system and increase your risk for certain types of cancer. Tell your healthcare provider 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 IMULDOSA. Tell your healthcare provider 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 healthcare provider right away if you have any new or worsening medical problems including: headache, seizures, confusion, or vision problems.

Serious Allergic Reactions including death can occur with IMULDOSA. Stop using 2 | P a g e IMULDOSA 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 discomfort, trouble breathing, or skin rash.

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

Before starting IMULDOSA, tell your healthcare provider 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 IMULDOSA or any of its ingredients. Ask your healthcare provider if you are not sure.
• have recently received or are scheduled to receive an immunization (vaccine). People who take IMULDOSA should not receive live vaccines. Tell your healthcare provider 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 IMULDOSA or one year after you stop receiving IMULDOSA.
• 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 IMULDOSA can harm your unborn baby. You and your healthcare provider should decide if you will receive IMULDOSA.
• received IMULDOSA while you were pregnant. It is important that you tell your baby’s healthcare provider before any vaccinations are given to your baby.
• are breastfeeding or plan to breastfeed. IMULDOSA can pass into your breast milk.
• talk to your healthcare provider about the best way to feed your baby if you receive IMULDOSA

Tell your healthcare provider 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 healthcare provider and pharmacist when you get a new medicine.

When prescribed IMULDOSA:

• Use IMULDOSA exactly as your healthcare provider tells you to.
• IMULDOSA is intended for use under the guidance and supervision of your healthcare provider.
  • In children 6 years and older, it is recommended that IMULDOSA be administered by a healthcare provider. If your healthcare provider decides that you or a caregiver may give your injections of IMULDOSA at home, you should receive training on the right way to prepare and inject IMULDOSA.
  • Your healthcare provider will determine the right dose of IMULDOSA for you, the amount for each injection, and how often you should receive it. Do not try to inject IMULDOSA yourself until you or your caregiver have been shown how to inject IMULDOSA by your healthcare provider.
  • If you inject too much IMULDOSA. Call your healthcare provider right away. The Poison Help Line (1-800-222-1222), or go to the nearest emergency room right away.

The most common side effects of IMULDOSA 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

These are not all the possible side effects of IMULDOSA. Tell your healthcare provider about any side effect that you experience. For additional information, see the full prescribing information or ask your healthcare provider or pharmacist.

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

IMULDOSA is supplied as single-dose prefilled syringes for subcutaneous use in 45 mg/0.5 mL and 90 mg/mL strengths or as a single-dose vial for intravenous infusion in 130 mg/26 mL (5 mg/mL) strength.