Enbrel

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

Enbrel belongs to a group of drugs called tumor-necrosis factor (TNF) inhibitors, which help prevent inflammation.

This medication comes in an injectable form and is injected under the skin (subcutaneously), usually once or twice a week.

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

Enbrel is a prescription medicine used to treat:

• moderately to severely active rheumatoid arthritis (RA). Enbrel can be used alone or with a medicine called methotrexate.
• psoriatic arthritis. Enbrel can be used alone or with methotrexate.
• ankylosing spondylitis (AS).
• chronic moderate to severe plaque psoriasis in adults ages 18 years and older.
• moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in children ages 2 years and older.
• children (ages 4-17) with chronic moderate-to-severe plaque psoriasis.

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

• Amgen USA Inc.

• Immunex Corporation

Enbrel may cause serious side effects. See "Drug Precautions".

Common side effects of Enbrel 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 doesn’t go away or gets worse, call your doctor.
• Upper respiratory infections (sinus infections).
• Headache.

These are not all the side effects with Enbrel. Tell your doctor about any side effect that bothers you or does not go away.

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:

• abatacept (Orencia)
• anakinra (Kineret)
• cyclophosphamide (Cytoxan)
• diabetes medicines

Tell your doctor if you are planning to receive any "live" vaccines such as chickenpox vaccine (Varicella), nasal vaccine for influenza (FluMist), measles, mumps, rubella vaccine (MMR), Polio vaccine, Rotavirus vaccine, Smallpox vaccine, Yellow fever vaccine, BCG vaccine. If you receive a "live vaccine" while taking Enbrel, you may become infected with the bacteria or virus contained in the vaccine.

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

Enbrel can cause serious side effects, including:

• Infections. Enbrel can make you more likely to get infections or make any infection that you have worse. Some people have serious infections while taking Enbrel. 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.You should not start taking Enbrel if you have any kind of infection unless your doctor says it is okay. Call your doctor right away if you have any symptoms of an infection.
  • Your doctor should test you for TB before starting Enbrel .
  • Your doctor should monitor you closely for symptoms of TB during treatment with Enbrel even if you tested negative for TB.
  • Your doctor should check you for symptoms of any type of infection before, during and after your treatment with Enbrel.
• Hepatitis B infection in people who carry the virus in their blood. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use Enbrel. Your doctor may do a blood test before you start treatment with Enbrel and while you use Enbrel.
• 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 doctor 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 Enbrel. If you have heart failure your condition should be watched closely while you take Enbrel. Call your doctor right away if you get new or worsening symptoms of heart failure while taking Enbrel, such as shortness of breath or swelling of your lower legs or feet.
• Psoriasis. Some people using Enbrel developed new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that may be filled with pus. Your doctor may decide to stop your treatment with Enbrel.
• Allergic reactions. Allergic reactions can happen to people who use TNF-blocker medicines. Call your doctor 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.
• Latex Allergy. Certain Enbrel prefilled syringes contain rubber that can cause an allergic reaction in people who are allergic to latex. Tell your doctor if you have a latex allergy.
• Autoimmune reactions, including:
  • Lupus-like syndrome. Symptoms include a rash on your face and arms that gets worse in the sun. Tell your doctor if you have this symptom. Symptoms may go away when you stop using Enbrel.
  • Autoimmune hepatitis. Liver problems can happen in people who use TNF-blocker medicines, including Enbrel. These problems can lead to liver failure and death. Call your doctor 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).
• Unusual cancers 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 Enbrel, the chances of getting lymphoma or other cancers may increase.
  • People with rheumatoid arthritis or psoriasis, especially those with very active disease, may be more likely to get lymphoma.

Medicines 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 Enbrel there are no specific foods that you must exclude from your diet when receiving this medication.

Before starting Enbrel, tell your doctor if you:

• have an infection, are being treated for an infection, or 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
  • 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
• 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 doctor 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 Enbrel. Ask your doctor 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 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
• have been around someone with varicella zoster (chicken pox)
• are allergic to rubber or latex

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

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

The FDA categorizes medications based on safety for use during pregnancy. Five categories - A, B, C, D, and X, are used to classify the possible risks to an unborn baby when a medication is taken during pregnancy.

Enbrel falls into category B. There are no well-done studies that have been done in humans with Enbrel. But in animal studies, pregnant animals were given this medication, and the babies did not show any medical issues related to this medication.

Tell your doctor if you are breastfeeding or planning to breastfeed.

It is not known if Enbrel crosses into human milk. Because many medications can cross into human milk and because of the possibility for serious adverse reactions in nursing infants with use of this medication, a choice should be made whether to stop nursing or stop the use of this medication. Your doctor and you will decide if the benefits outweigh the risk of using Enbrel.

• Enbrel is given as an injection under the skin (subcutaneous or SC).
• If your doctor decides that you or a caregiver can give the injections of Enbrel at home, you or your caregiver should receive training on the right way to prepare and inject Enbrel. Do not try to inject Enbrel until you have been shown the right way by your doctor or nurse.
• Enbrel is available in several forms, single-use prefilled syringes, prefilled autoinjector, and multiple-use vials. Your doctor will prescribe the type that is best for you.
• Your doctor will tell you how often you should use Enbrel. Do not miss any doses of Enbrel. If you forget to use Enbrel, inject your dose as soon as you remember. Then, take your next dose at your regularly scheduled time. In case you are not sure when to inject Enbrel, call your doctor or pharmacist. Do not use Enbrel more often than as directed by your doctor.
• Your child’s dose of Enbrel may depend on his or her weight. Your child’s doctor will tell you which form of Enbrel to use and how much to give your child.

Take Enbrel exactly as prescribed by your doctor. You will receive Enbrel injections at your doctor's office, or you may be instructed to give the injections to yourself at home.

• The recommended dose for adult rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis patients is 50 mg once a week.
• For adult patients with plaque psoriasis, a starting dose of 50 mg twice a week for 3 months is followed with 50 mg once a week for maintenance.

Juvenile idiopathic arthritis and plaque psoriasis in children:

• For children weighing 63 kg (138 pounds) or more, the recommended dose is 50 mg weekly. 
• For children weighing less than 63 kg (138 pounds), the recommended dose is 0.8 mg/kg once a week. 

If you take too much Enbrel call your doctor or local Poison Control Center right away.

• Store Enbrel in the refrigerator at 36° to 46°F (2° to 8°C).
• Do not freeze.
• Do not shake.
• Keep Enbrel in the original carton to protect from light.

Keep this and all medicines out of the reach of children.

WARNINGS:

SERIOUS INFECTIONS

Patients treated with Enbrel are at increased risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids.

Enbrel 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 Enbrel use and during therapy. Treatment for latent infection should be initiated prior to Enbrel 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 Enbrel 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 Enbrel, 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 Enbrel.