Amjevita

Amjevita is a new prescription medication used to treat certain kinds of arthritis, ankylosing spondylitis, Crohn's disease, plaque psoriasis, and ulcerative colitis. 

Amjevita belongs to a group of drugs called tumor necrosis factor (TNF) inhibitors which help to reduce inflammation.

This medication comes in an injectable form that is injected just under the skin and is usually administered every other week.

Common side effects of Amjevita include injection site reactions and increased risk of infection. 

Amjevita is a prescription medication used to reduce the signs and symptoms of: 

• Moderate to severe rheumatoid arthritis (RA) in adults
• Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 and up 
• Active psoriatic arthritis (PsA) in adults
• Active ankylosing spondylitis (AS) in adults
• Moderate to severe active Crohn’s disease (CD) in adults
• Moderate to severe active ulcerative colitis (UC) in adults
• Moderate to severe plaque psoriasis (Ps) in adults

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

• Amgen Inc

Serious side effects have been reported with Amjevita. See the “Amjevita Precautions” section.

Common side effects of Amjevita include the following:

• Injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few
• days. Call your doctor right away if you have pain, redness or swelling around the injection site that does not go away within a few days or gets worse.
• Upper respiratory infections (including sinus infections)
• Headaches
• Rash

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

Tell your doctor if you have any side effect that bothers you or that 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)
• Kineret (anakinra)
• Remicade (infliximab)
• Enbrel (etanercept)
• Cimzia (certolizumab pegol)
• Simponi (golimumab)
• Rituxan (rituximab)
• Imuran (azathioprine)
• Purinethol (6-mercaptopurine)
• Live vaccines

This is not a complete list of Amjevita drug interactions. Ask your doctor or pharmacist for more information. 

Serious side effects have been reported with Amjevita including the following: 

• Serious Infections. Serious infections have happened in people taking AMJEVITA. These serious infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Your doctor will examine you for TB and perform a test to see if you have TB. If your doctor feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Amjevita and during treatment with Amjevita. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking Amjevita. People who had a negative TB skin test before receiving Amjevita have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking Amjevita:

  • cough that does not go away
  • weight loss
  • low grade fever
  • loss of body fat and muscle (wasting)

Before starting this medication, tell your doctor if you think you have an infection or have symptoms of an infection. 

• Increased risk for cancer. There have been cases of unusual cancers in children, teenagers, and young adults using TNF-blockers. There is an increase risk for lymphoma which includes hepatosplenic T-cell lymphoma and/or skin cancer. 
  • People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.

• 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 Amjevita. Your doctor should do blood tests before you start treatment, while you are using Amjevita, and for several months after you stop treatment with Amjevita. Tell your doctor if you have any of the following symptoms of a possible hepatitis B infection:

  • muscle aches
  • feeling very tired
  • dark urine
  • skin or eyes look yellow 
  • little or no appetite
  • vomiting
  • clay-colored bowel movements
  • fever
  • chills
  • stomach discomfort
  • skin rash
• Allergic reactions. Allergic reactions can happen in people who use Amjevita. Call your doctor or get medical help right away if you have any of these symptoms of a serious allergic reaction:
  • hives
  • swelling of your face, eyes, lips or mouth
  • trouble breathing

• Nervous system problems. Signs and symptoms of a nervous system problem include: numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.

• Blood problems. Your body may not make enough of the blood cells that help fight infections or help to stop bleeding. Symptoms include a fever that does not go away, bruising or bleeding very easily, or looking very pale.

• New heart failure or worsening of heart failure you already have. Call your doctor right away if you get new or worsening symptoms of heart failure while taking Amjevita, including:
  • shortness of breath
  • swelling of your ankles or feet
  • 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 a rash on your cheeks or arms that gets worse in the sun. Symptoms may improve when you stop Amjevita.

• Liver problems. Liver problems can happen in people who use TNF-blocker medicines. These problems can lead to liver failure and death. Call your doctor right away if you have any of these symptoms:
  feeling very tired

  • skin or eyes look yellow
  • poor appetite or vomiting
  • pain on the right side of your stomach (abdomen)

• Psoriasis. Some people using Amjevita had new psoriasis or worsening of psoriasis they already had. Tell your doctor if you develop red scaly patches or raised bumps that are filled with pus. Your doctor may decide to stop your treatment with Amjevita. 

Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with Amjevita may be stopped.

Amjevita is a medicine that affects your immune system. Amjevita can lower the ability of your immune system to fight infections. Serious infections have happened in people taking Amjevita. 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 Amjevita.
• Your doctor should check you closely for signs and symptoms of TB during treatment with Amjevita.

You should not start taking Amjevita if you have any kind of infection unless your doctor says it is okay.

After starting Amjevita, call your doctor right away if you have an infection, or any sign of an infection. Amejvita can make you more likely to get infections or make any infection that you may have worse.

Do not use this medication if you are allergic to this medication or to any of its ingredients. 

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

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

• are allergic to Amjevita or to any of its ingredients 
• have or have had cancer.
• have any numbness or tingling or have a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome.
• have or had heart failure.
• have diabetes.
• have or have had hepatitis B.
• use the medicine Orencia (abatacept), Kineret (anakinra), Rituxan (rituximab), Imuran (azathioprine), or Purinethol (6-mercaptopurine, 6-MP).
• are scheduled to have major surgery.
• have recently received or are scheduled to receive a vaccine. You may receive vaccines, except for live vaccines while using Amejvita. Children should be brought up to date with all vaccines before starting Amjevita.
• are allergic to rubber or latex. The needle cover on the prefilled syringe contains dry natural rubber. 
• are pregnant or plan to become pregnant. It is not known if Amjevita will harm your unborn baby. Amjevita should only be used during a pregnancy if needed.
• have a baby and you were using Amjevita during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines.
• are breastfeeding or plan to breastfeed. You and your doctor should decide if you will breastfeed or use Amjevita. You should not do both. 

Before starting Amjevita, also tell your doctor if you:

• think you have an infection or have symptoms of infection such as:
  • fever, sweats, or chills 
  • muscle aches
  • cough
  • shortness of breath
  • blood in phlegm
  • diarrhea or stomach pain
  • burning when you urinate or urinate more often than normal
  • feeling tired
  • weight loss
  • warm, red, or painful skin or sores on your body
• are being treated for an infection.
• get a lot of infections or have infections that keep coming back.
• have TB, or have been in close contact with someone with TB.
• were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask your doctor if you are not sure.
• live or have lived in certain parts of the country (such as the Ohio and Mississippi River valleys) where there is an increased risk for getting certain kinds of fungal infections (histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or become more severe if you use Amjevita. Ask your doctor if you do not know if you have lived in an area where these infections are common.

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. 

There is limited data on Amjevita when used during pregnancy. Your doctor will consider the risks versus benefits of using this medication before prescribing it. Amjevita should only be used during pregnancy if needed.

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

You and your doctor should decide if you will breastfeed or use Amjevita. You should not do both. 

Administer Amjevita exactly as prescribed. Do not inject Amjevita more often than you were prescribed.

Amjevita is given by an injection under the skin. Your doctor will tell you how often to take an injection of Amjevita. This is based on your condition to be treated.

• Amjevita is typically administered every other week
• Amjevita can be injected into the thigh, and stomach area (except for a 2 inch area right around the navel)
• Make sure to rotate injection sites and do not give injections into areas where the skin is tender, bruised, red or hard

Make sure you have been shown how to inject Amjevita before you do it yourself. 

Do not miss any doses unless your doctor says it is okay. If you miss a dose, inject a dose as soon as you remember. Then, take your next dose at your regular scheduled time. This will put you back on schedule. In case you are not sure when to inject Amjevita, call your doctor or pharmacist.

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

The dose your doctor recommends may be based on the following:

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender 

Rheumatoid Arthritis, Psoriatic Arthritis, and Ankylosing Spondylitis: 

• The recommended dose of Amjevita is 40 mg administered every other week.
• Some patients with rheumatoid arthritis not receiving methotrexate may benefit receiving 40 mg every week. 

Juvenile Idiopathic Arthritis: 

The recommended dose of Amjevita for patients 4 years of age and older is based on weight.

• 15 kg (33 lbs) to < 30 kg (66 lbs): 20 mg every other week
• ≥ 30 kg (66 lbs): 40 mg every other week

Adult Crohn’s Disease and Ulcerative Colitis: 

• Initial dose (Day 1): 160 mg (four 40 mg injections in one day or two40 mg injections per day for two consecutive days)
• Second dose two weeks later (Day 15): 80 mg
• Two weeks later (Day 29): Begin a maintenance dose of 40 mg every other week.

Ulcerative Colitis only: Only continue Amjevita in patients who have shown evidence of clinical remission by eight weeks (Day 57) of therapy.

Plaque Psoriasis: 

The recommended dose of Amjevita is 80 mg for the initial dose, then followed by 40 mg every other week starting one week after initial dose. 

If you take too much Amjevita, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

If Amjevita is administered by a healthcare provider in a medical setting, it is unlikely that an overdose will occur. However, if an overdose is suspected, seek emergency medical attention.  

• Store Amjevita in the refrigerator at 36°F to 46°F (2°C to 8°C).
• DO NOT FREEZE. Do not use if frozen even if it has been thawed.
• Store in original carton until time of administration to protect from light.
• Do not store Amjevita in extreme heat or cold. 
• Do not use beyond the expiration date on the container.
• Keep this and all medicines out of the reach of children. 

When traveling, Amjevita may be stored at room temperature up to a maximum of 77°F (25°C) for a period of up to 14 days. Keep medication in original carton to protect from light. Amjevita should be discarded if not used within the 14-day period. Record the date when Amjevita is first removed from the refrigerator in the spaces provided on the carton.

Warning: Serious Infections and Malignancy

Serious Infections:

Patients treated with Amjevita are at increased risk for developing serious infections that may lead to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis), and infections due to other opportunistic pathogens.

• Discontinue Amjevita if a patient develops a serious infection or sepsis.
• Perform test for latent TB; if positive, start treatment for TB prior to starting Amjevita.
• Monitor all patients for active TB during treatment, even if initial latent TB test is negative.
• Carefully consider the risks and benefits of treatment with Amjevita prior to initiating therapy in patients with chronic or recurrent infection.

Malignancy:

• Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers including adalimumab products.
• Post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including adalimumab products. These cases have had a very aggressive disease course and have been fatal. The majority of reported cases have occurred in patients with Crohn's disease or ulcerative colitis and the majority were in adolescent and young adult males.