Effective Date:
February 27, 2024

Teva Pharmaceuticals USA, Inc. or one of its US-based affiliates (“Teva”) maintains this site, www.simlandi.com (the "Site"), for your personal information, education, and communication. While you should feel free to browse the Site, please understand that your access to and use of the Site is subject to the following terms and conditions ("Terms and Conditions") and all applicable laws. By accessing and browsing the Site, you accept, without limitation or qualification, the Terms and Conditions and acknowledge that any other agreements between you and Teva concerning the Site are superseded to the extent they conflict with these Terms and Conditions. Your use of or linking to any content on the Site, except as provided in these Terms and Conditions, is strictly prohibited.

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

You should discuss the potential benefits and risks of SIMLANDI with your doctor. SIMLANDI is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking SIMLANDI if you have any kind of infection unless your doctor says it is okay.

Serious infections have happened in people taking adalimumab products. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi, or bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting SIMLANDI, and check you closely for signs and symptoms of TB during treatment with SIMLANDI, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.
Cancer. For children and adults taking TNF blockers, including SIMLANDI, the chances of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in children, teenagers, and young adults using TNF blockers. Some people have developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death. If using TNF blockers, including SIMLANDI, your chances of getting two types of skin cancer (basal cell and squamous cell) may increase. These types are generally not life-threatening if treated; tell your doctor if you have a bump or open sore that doesn’t heal.

What should I tell my doctor BEFORE starting SIMLANDI?

Tell your doctor about all of your health conditions, including if you:

Have an infection, are being treated for infection, or have symptoms of an infection.
Get a lot of infections or have infections that keep coming back.
Have diabetes.
Have TB or have been in close contact with someone with TB, or were born in, lived in, or traveled where there is more risk for getting TB.
Live or have lived in an area (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections, such as histoplasmosis, coccidioidomycosis, or blastomycosis. These infections may happen or become more severe if you use SIMLANDI. Ask your doctor if you are unsure you have lived in an area where these infections are common.
Have or have had hepatitis B.
Are scheduled for major surgery.
Have or have had cancer.
Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome.
Have or had heart failure.
Have recently received or are scheduled to receive a vaccine. SIMLANDI patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting SIMLANDI.
Are allergic to any SIMLANDI ingredients.
Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.
Have a baby and you were using SIMLANDI during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines.

Also tell your doctor about all the medicines you take. You should not take SIMLANDI with ORENCIA^® (abatacept), KINERET^® (anakinra), REMICADE^® (infliximab), ENBREL^® (etanercept), CIMZIA^® (certolizumab pegol), or SIMPONI^® (golimumab). Tell your doctor if you have ever used RITUXAN^® (rituximab), IMURAN^® (azathioprine), or PURINETHOL^® (mercaptopurine, 6-MP).

What should I watch for AFTER starting SIMLANDI?

SIMLANDI can cause serious side effects, including:

Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
Allergic reactions. Symptoms of a serious allergic reaction include hives; trouble breathing; and swelling of your face, eyes, lips, or mouth.
Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.
Heart failure (new or worsening). Symptoms include shortness of breath, swelling of your ankles or feet, and sudden weight gain.
Immune reactions, including a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go away, shortness of breath, joint pain, or rash on your cheeks or arms that gets worse in the sun.
Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen). These problems can lead to liver failure and death.
Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.

The most common side effects of SIMLANDI include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, and rash. These are not all the possible side effects with SIMLANDI. Tell your doctor if you have any side effect that bothers you or that does not go away.

Remember, tell your doctor right away if you have an infection or symptoms of an infection, including:

Fever, sweats, or chills
Muscle aches
Cough
Shortness of breath
Blood in phlegm
Warm, red, or painful skin or sores on your body
Diarrhea or stomach pain
Burning when you urinate
Urinating more often than normal
Feeling very tired
Weight loss

These are not all the possible side effects of SIMLANDI. For more information, speak with your doctor or pharmacist.

If you have any questions about this information, be sure to discuss them with your healthcare provider.

To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or  www.fda.gov/medwatch.

SIMLANDI is a medicine called a tumor necrosis factor (TNF) blocker

SIMLANDI is given by injection under the skin. SIMLANDI is used to reduce the signs and symptoms of:

moderate to severe rheumatoid arthritis (RA) in adults. SIMLANDI can be used alone, with methotrexate, or with certain other medicines.
moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years and older. SIMLANDI can be used alone or with methotrexate.
psoriatic arthritis (PsA) in adults. SIMLANDI can be used alone or with certain other medicines.
ankylosing spondylitis (AS) in adults.
moderate to severe hidradenitis suppurativa (HS) in adults.
To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
To treat moderate to severe ulcerative colitis (UC) in adults. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate anti-TNF medicines.
To treat moderate to severe chronic plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills)
To treat non-infectious intermediate, posterior, and panuveitis in adults.

Please read the Full Prescribing Information, including BOXED WARNINGS and Medication Guide.

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LEGAL NOTICE AND TERMS OF USE

Effective Date:February 27, 2024

Terms and Conditions

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Effective Date:
February 27, 2024