Eticovo

Eticovo is a prescription medication used to treat inflammatory conditions including moderate to severe rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis in adults. Eticovo is also used to treat juvenile idiopathic arthritis and children with chronic moderate-to-severe plaque psoriasis.

Eticovo belongs to a group of drugs called tumor-necrosis factor (TNF) inhibitors which reduce the effect of TNF in the body and block the damage that too much TNF can cause.

This medication comes in an injectable form in a pre-filled, single-dose syringe in two different concentrations: 2 mg/0.5 ml and 50 mg/1 ml. Eticovo is injected under the skin (subcutaneously), once or twice a week, depending on the diagnosis.

Common side effects include redness or pain at the injection site and upper respiratory infections. 

Eticovo is a prescription medication used to treat:

• moderately to severely active rheumatoid arthritis (RA). Eticovo can be used alone or with a medicine called methotrexate.
• moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in children ages 2 years and older.
• psoriatic arthritis (PsA). Eticovo can be used alone or with methotrexate.
• ankylosing spondylitis (AS).
• chronic moderate to severe plaque psoriasis (PsO) in children 4 years and older and adults who may benefit from taking injections or pills (systemic therapy) or phototherapy (ultraviolet light).

This medication may be prescribed for other uses. Ask your doctor or pharmacist for more information.

Eticovo may cause serious side effects. See the "Eticovo Precautions" section.

Common side effects include:

• 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).

This is not a complete list of Eticovo side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins and herbal supplements. Especially tell your doctor if you take:

• Orencia (abatacept) or Kineret (anakinra). You have a higher chance for serious infections when taking Eticovo with Orencia or Kineret.
• Cyclophosphamide (Cytoxan). You may have a higher chance for getting certain cancers when taking Eticovo with cyclophosphamide.
• Anti-diabetic medicines. If you have diabetes and are taking medication to control your diabetes, your healthcare provider may decide you need less anti-diabetic medicine while taking Eticovo.

Keep a list of all your medications with you to show your healthcare provider and pharmacist each time you get a new medicine. Ask your healthcare provider if you are not sure if your medicine is one listed above.

Eticovo may cause serious side effects, including:

1. Risk of Infection
2. Risk of Cancer

Risk of Infection

Eticovo can lower the ability of your immune system to fight infections. Some people have serious infections while taking Eticovo. These infections include tuberculosis (TB), and infections caused by viruses, fungi, or bacteria that spread throughout their body. Some people have died from these infections.

• Your healthcare provider should test you for TB before starting Eticovo.
• Your healthcare provider should monitor you closely for symptoms of TB during treatment with Eticovo even if you tested negative for TB.
• Your healthcare provider should check you for symptoms of any type of infection before, during, and after your treatment with Eticovo.

You should not start taking Eticovo if you have any kind of infection unless your healthcare provider says it is okay.

Risk of cancer

• There have been cases of unusual cancers, some resulting in death, in children and teenage patients who started using TNF-blocking agents at less than 18 years of age.
• For children, teenagers, and adults taking TNF-blocker medicines, including etanercept products, the chances of getting lymphoma or other cancers may increase.
• People with rheumatoid arthritis, especially those with very active disease, may be more likely to get lymphoma.

Eticovo can cause other serious side effects, including:

• 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).

Do not use Eticovo if you:

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

Medications can interact with certain foods. In some cases, this may be harmful and your doctor may advise you to avoid certain foods. In the case of Eticovo, there are no specific foods that you must exclude from your diet when receiving this medication.

Before taking Eticovo, tell your doctor about all of your medical conditions. Especially tell your doctor if you:

• have an infection. 
• 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.

Other important medical information you should tell your healthcare provider before starting Eticovo, includes if you:

• have or had a nervous system problem such as multiple sclerosis or Guillain-Barré syndrome.
• have or had heart failure.
• are scheduled to have surgery.
• have recently received or are scheduled to receive a vaccine.
• All vaccines should be brought up-to-date before starting Eticovo.
• People taking Eticovo should not receive live vaccines.
• Ask your healthcare provider if you are not sure if you received a live vaccine.
• have been around someone with varicella zoster (chicken pox).
• are pregnant or plan to become pregnant. It is not known if Eticovo will harm your unborn baby. If you took Eticovo during pregnancy, talk to your healthcare provider prior to administration of live vaccines to your infant.
• are breastfeeding or plan to breastfeed. Eticovo can pass into breast milk. Talk to your healthcare provider about the best way to feed your baby while taking Eticovo.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

Tell your doctor if you are pregnant or plan to become pregnant.

It is not known if Eticovo will harm your unborn baby. There are no well-done studies that have been done in humans with Eticovo. In animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

If you took Eticovo during pregnancy, talk to your healthcare provider prior to administration of live vaccines to your infant.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Eticovo can pass into breast milk.

Not enough information is available to fully understand the effects of this medication on the breastfed infant or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Eticovo and any potential adverse effects on the breastfed child from the drug or from the underlying maternal condition.

Talk to your healthcare provider about the best way to feed your baby while taking Eticovo.

Take Eticovo exactly as prescribed.

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.

Take this medication exactly as prescibed by your doctor. Follow the directions on your prescription label carefully. 

Recommended dosage and frequency:

• Adult Rheumatoid Arthritis and Psoriatic Arthritis: 50 mg once weekly with or without methotrexate (MTX)
• Ankylosing Spondylitis: 50 mg once weekly
• Adult Plaque Psoriasis: 50 mg twice weekly for 3 months, followed by 50 mg once weekly
• Pediatric Plaque Psoriasis or Juvenile Idiopathic Arthritis (patients who weigh 63 kg or more): 50 mg once weekly

If you take too much Eticovo, call your healthcare provider or local poison control center, or seek emergency medical attention right away.

• 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.

WARNING: SERIOUS INFECTIONS and MALIGNANCIES

SERIOUS INFECTIONS
Patients treated with etanercept products are at increased risk for developing serious infections that may lead to hospitalization or death [see Warnings and Precautions (5.1) and Adverse Reactions (6)]. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Eticovo should be discontinued if a patient develops a serious infection or sepsis.

Reported infections include:

• Active tuberculosis, including reactivation of latent tuberculosis. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Patients should be tested for latent tuberculosis before Eticovo use and during therapy. Treatment for latent infection should be initiated prior to Eticovo use.

• Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness.

• Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria.

The risks and benefits of treatment with Eticovo should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection.

Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Eticovo, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.

MALIGNANCIES
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including etanercept products.