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 virusesfungior bacteria that have spread throughout the body. Some people have died from these infections. Your doctor should test you for TB before starting SIMLANDIand check you closely for signs and symptoms of TB during treatment with SIMLANDIeven if your TB test was negative. If your doctor feels you are at riskyou may be treated with medicine for TB.
- Cancer. For children and adults taking TNF blockersincluding SIMLANDIthe chances of getting lymphoma or other cancers may increase. There have been cases of unusual cancers in childrenteenagersand 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 blockersincluding SIMLANDIyour 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 conditionsincluding if you:
- Have an infectionare being treated for infectionor 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 TBor were born inlived inor 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 infectionssuch as histoplasmosiscoccidioidomycosisor 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 vaccinesexcept for live vaccines. Children should be brought up to date on all vaccines before starting SIMLANDI.
- Are allergic to any SIMLANDI ingredients.
- Are pregnantplanning to become pregnantbreastfeedingor 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® (mercaptopurine6-MP).
What should I watch for AFTER starting SIMLANDI?
SIMLANDI can cause serious side effectsincluding:
- Serious infections. These include TB and infections caused by virusesfungior bacteria. Symptoms related to TB include a coughlow-grade feverweight lossor loss of body fat and muscle.
- Hepatitis B infection in carriers of the virus. Symptoms include muscle achesfeeling very tireddark urineskin or eyes that look yellowlittle or no appetitevomitingclay-colored bowel movementsfeverchillsstomach discomfortand skin rash.
- Allergic reactions. Symptoms of a serious allergic reaction include hives; trouble breathing; and swelling of your faceeyeslipsor mouth.
- Nervous system problems. Signs and symptoms include numbness or tinglingproblems with your visionweakness in your arms or legsand dizziness.
- Blood problems (decreased blood cells that help fight infections or stop bleeding). Symptoms include a fever that does not go awaybruising or bleeding very easilyor looking very pale.
- Heart failure (new or worsening). Symptoms include shortness of breathswelling of your ankles or feetand sudden weight gain.
- Immune reactionsincluding a lupus-like syndrome. Symptoms include chest discomfort or pain that does not go awayshortness of breathjoint painor rash on your cheeks or arms that gets worse in the sun.
- Liver problems. Symptoms include feeling very tiredskin or eyes that look yellowpoor appetite or vomitingand 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 (painrednessrashswellingitchingor bruising)upper respiratory infections (sinus infections)headachesand 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.
Remembertell your doctor right away if you have an infection or symptoms of an infectionincluding:
- Feversweatsor chills
- Muscle aches
- Cough
- Shortness of breath
- Blood in phlegm
- Warmredor 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 informationspeak with your doctor or pharmacist.
If you have any questions about this informationbe sure to discuss them with your healthcare provider.
To report SUSPECTED ADVERSE REACTIONScontact 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 alonewith methotrexateor 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 people 12 years and older.
- 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 intermediateposteriorand panuveitis in adultsand children 2 years of age and older.
Please read the Full Prescribing Informationincluding BOXED WARNINGS and Medication Guide.
