Before starting Eticovo, be sure to talk to your healthcare provider:
Eticovo may not be right for you. Before starting Eticovo, tell your healthcare provider about all of your medical conditions, including:
Infections. Tell your healthcare provider if you:

• have an infection. See “What is the most important information I should know about Eticovo?”
• are being treated for an infection.
• think you have an infection.
• have symptoms of an infection such as fever, sweats or chills, cough or flu-like symptoms, shortness of breath, blood in your phlegm, weight loss, muscle aches, warm, red or painful areas on your skin, sores on your body, diarrhea or stomach pain, burning when you urinate or urinating more often than normal, and feel very tired.
• have any open cuts on your body.
• get a lot of infections or have infections that keep coming back.
• have diabetes, HIV, or a weak immune system. People with these conditions have a higher chance for infections.
• have TB, or have been in close contact with someone with TB.
• were born in, lived in, or traveled to countries where there is a risk for getting TB. Ask your healthcare provider if you are not sure.
• live, have lived in, or traveled to certain parts of the country (such as the Ohio and Mississippi River valleys, or the Southwest) where there is a greater risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, blastomycosis). These infections may happen or become more severe if you use Eticovo. Ask your healthcare provider if you do not know if you live or have lived in an area where these infections are common.
• have or have had hepatitis B.

• have an infection that has spread through your body (sepsis).

• Eticovo is given as an injection under the skin (subcutaneous or SC).
• If your healthcare provider decides that you or a caregiver can give the injections of Eticovo at home, you or your caregiver should receive training on the right way to prepare and inject Eticovo. Do not try to inject Eticovo until you have been shown the right way by your healthcare provider or nurse.
• Eticovo is available as a single-dose prefilled syringe.
• See the detailed “Instructions for Use” with this Medication Guide for instructions about the right way to store, prepare, and give your Eticovo injections at home.
• Your healthcare provider will tell you how often you should use Eticovo. Do not miss any doses of Eticovo. If you forget to use Eticovo, inject your dose as soon as you remember. Then, take your next dose at your regular(ly) scheduled time. In case you are not sure when to inject Eticovo, call your healthcare provider or pharmacist. Do not use Eticovo more often than as directed by your healthcare provider.
• Your child's dose of Eticovo depends on his or her weight. Your child's healthcare provider will tell you which form of Eticovo to use and how much to give your child.

What are the possible side effects of Eticovo?
Eticovo can cause serious side effects, including:

• See “What is the most important information I should know about Eticovo?”
• Infections. Eticovo can make you more likely to get infections or make any infection that you have worse. Call your healthcare provider right away if you have any symptoms of an infection. See “Before starting Eticovo, be sure to talk to your healthcare provider” for a list of symptoms of infection.
• Previous Hepatitis B infection. If you have been previously infected with the hepatitis B virus (a virus that affects the liver), the virus can become active while you use Eticovo. Your healthcare provider may do a blood test before you start treatment with Eticovo and while you use Eticovo.
• Nervous system problems. Rarely, people who use TNF-blocker medicines have developed nervous system problems such as multiple sclerosis, seizures, or inflammation of the nerves of the eyes. Tell your healthcare provider right away if you get any of these symptoms: numbness or tingling in any part of your body, vision changes, weakness in your arms and legs, and dizziness.
• Blood problems. Low blood counts have been seen with other TNF-blocker medicines. Your body may not make enough of the blood cells that help fight infections or help stop bleeding. Symptoms include fever, bruising or bleeding very easily, or looking pale.
• Heart failure including new heart failure or worsening of heart failure you already have. New or worse heart failure can happen in people who use TNF-blocker medicines like Eticovo. If you have heart failure your condition should be watched closely while you take Eticovo. Call your healthcare provider right away if you get new or worsening symptoms of heart failure while taking Eticovo, such as shortness of breath or swelling of your lower legs or feet.
• Psoriasis. Some people using Eticovo developed new psoriasis or worsening of psoriasis they already had. Tell your healthcare provider if you develop red scaly patches or raised bumps that may be filled with pus. Your healthcare provider may decide to stop your treatment with Eticovo.
• Allergic reactions. Allergic reactions can happen to people who use TNF-blocker medicines. Call your healthcare provider right away if you have any symptoms of an allergic reaction. Symptoms of an allergic reaction include a severe rash, a swollen face, or trouble breathing.
• Autoimmune reactions, including:
  • Lupus-like syndrome. Symptoms include a rash on your face and arms that gets worse in the sun. Tell your healthcare provider if you have this symptom. Symptoms may go away when you stop using Eticovo.
  • Autoimmune hepatitis. Liver problems can happen in people who use TNF-blocker medicines, including Eticovo. These problems can lead to liver failure and death. Call your healthcare provider right away if you have any of these symptoms: feel very tired, skin or eyes look yellow, poor appetite or vomiting, pain on the right side of your stomach (abdomen).
    

• Injection site reactions such as redness, swelling, itching, or pain. These symptoms usually go away within 3 to 5 days. If you have pain, redness, or swelling around the injection site that does not go away or gets worse, call your healthcare provider.
• Upper respiratory infections (sinus infections).

• Store Eticovo in the refrigerator between 36°F to 46°F (2°C to 8°C).
• Store Eticovo in the original carton to protect from light or physical damage.
• If needed, you may store the Eticovo prefilled syringe at room temperature between 73°F to 81°F (23°C to 27°C), 1 time, for up to 2 weeks (14 days).
  • Once Eticovo has reached room temperature, do not put it back in the refrigerator.
• Throw away Eticovo that has been stored at room temperature after 2 weeks (14 days).
• Do not store Eticovo in extreme heat or cold such as in your vehicle's glove box or trunk.
• Do not freeze.
• Do not shake.
• Keep Eticovo and all medicines out of the reach of children.