Amjevita

Dosage Forms And Strengths

AMJEVITA is a clear, colorless to slightly yellow solution available as:

• Prefilled SureClick® Autoinjector Injection: A single-use AMJEVITA prefilled SureClick® autoinjector, containing a 1 mL prefilled glass syringe with a fixed 27 gauge ½ inch needle, providing 40 mg/0.8 mL of AMJEVITA.
• Prefilled Syringe Injection: A single-use, 1 mL prefilled glass syringe with a fixed 29 gauge ½ inch needle, providing 40 mg/0.8 mL of AMJEVITA.
  Injection: A single-use, 1 mL prefilled glass syringe with a fixed 29 gauge ½ inch needle, providing 20 mg/0.4 mL of AMJEVITA.

Storage And Handling

AMJEVITA™ (adalimumab-atto) Injection is supplied as a preservative-free, sterile, clear, colorless to slightly yellow solution for subcutaneous administration. AMJEVITA is supplied in a single-use prefilled syringe (PFS) or single-use prefilled SureClick® autoinjector (AI).

The following packaging configurations are available.

Do not use beyond the expiration date on the container. AMJEVITA must be refrigerated 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.

If needed, for example 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, with protection 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. Do not store AMJEVITA in extreme heat or cold.

Manufactured by:  Amgen Inc. One Amgen Center Drive Thousand Oaks, CA 91320-1799. Revisrd: Sep 2016

Included as part of the PRECAUTIONS section.

• 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. 

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. 

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. 

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.

Some people using adalimumab have developed a rare fast-growing type of lymphoma (cancer), which can be fatal. Adalimumab can also lower blood cells that help your body fight infections and help your blood to clot. Serious and sometimes fatal infections may occur.

Call your doctor at once if you have symptoms such as fever, night sweats, weight loss, feeling full after eating only a small amount, pain in your upper stomach, easy bruising or bleeding, dark urine, or jaundice (yellowing of the skin or eyes).

Use the medicine as soon as you remember, and then go back to your regular injection schedule. Do not use extra medicine to make up the missed dose.

Applies to adalimumab: subcutaneous solution

Along with its needed effects, adalimumab (the active ingredient contained in Amjevita) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking adalimumab:

• Abdominal or stomach fullness
• body aches or pain
• cough or hoarseness
• ear congestion
• gas with abdominal or stomach pain
• lightheadedness
• loss of voice
• lower back or side pain
• muscle aches and pains
• nasal congestion
• pain or tenderness around the eyes or cheekbones
• rapid and sometimes shallow breathing
• shivering
• sunken eyes
• thirst
• trouble sleeping
• warmth on the skin
• wrinkled skin

• Abdominal or stomach pain
• abnormal vaginal bleeding or discharge
• agitation
• arm, back, or jaw pain
• black, tarry stools
• bleeding from the gums or nose
• blindness
• bloating or swelling of the face, arms, hands, lower legs, or feet
• blood in the stool or change in bowel habits
• bloody or cloudy urine
• blurred vision
• broken bones
• change in size, shape, or color of an existing mole
• change in skin color
• chest pain
• chest tightness or heaviness
• chills
• clear or bloody discharge from the nipple
• cold hands and feet
• confusion
• constipation
• cough
• coughing or spitting up blood
• decreased urination
• decreased vision
• depression
• difficult or frequent urination
• difficulty with breathing
• difficulty, burning, or painful urination
• dimpling of the breast skin
• dizziness
• drowsiness
• eye pain
• fainting
• fast, slow, or irregular heartbeat
• fever
• forgetfulness
• frequent urge to urinate
• general feeling of illness
• hair loss
• hallucinations
• headache
• increased thirst
• inverted nipple
• irregular breathing
• irregular pulse
• irritability
• itching or rash
• light colored stools
• loss of appetite
• lump in the breast or under your arm
• lump or swelling in the abdomen or stomach
• mole that leaks fluid or bleeds
• muscle cramps or spasms
• nausea
• new mole
• night sweats
• no blood pressure or pulse
• noisy breathing
• numbness or tingling in your arms, legs, or face
• pain, redness, or swelling in the arms or legs without any injury present
• pale skin
• persistent non-healing sore on your skin
• pink growth
• puffiness or swelling of the eyelids or around the eyes, face, lips, or tongue
• raised, firm, or bright red patch
• redness or swelling of the breast
• seizures
• sharp back pain just below your ribs
• shiny bump on your skin
• slurred speech or problems with swallowing
• sneezing
• sore on the skin of the breast that does not heal
• sore throat
• sores, ulcers, or white spots on the lips or mouth
• spitting up blood
• stiff neck
• stopping of the heart
• sudden high fever or low grade fever for months
• sweating
• swelling of the face, fingers, feet, or lower legs
• swollen glands
• swollen neck veins
• tightness in the chest
• tiredness
• trouble breathing with activity
• trouble thinking
• unconsciousness
• unexplained bruising or bleeding
• unpleasant breath odor
• unusual tiredness or weakness
• unusual weight gain or loss
• visual disturbances
• vomiting
• vomiting of blood or material that looks like coffee grounds
• yellow skin or eyes

• Blistering, peeling, or loosening of the skin
• diarrhea
• joint or muscle pain
• pinpoint red spots on the skin
• red skin lesions, often with a purple center
• red, irritated eyes
• red, scaling, or crusted skin
• unusual bleeding or bruising

Some side effects of adalimumab may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Bladder pain
• bleeding
• burning
• coldness
• discoloration of the skin
• feeling of pressure
• general feeling of discomfort or illness
• hives
• lumps
• numbness
• pounding in the ears
• redness
• scarring
• soreness
• stinging
• swelling
• tenderness
• tingling
• ulceration
• warmth

• Abnormal healing
• decrease in height
• difficulty with moving
• difficulty with swallowing
• difficulty with walking
• dry mouth
• heartburn
• indigestion
• loss of hearing
• loss of strength or energy
• menstrual changes
• muscle or joint stiffness, tightness, or rigidity
• muscle pain or weakness
• pain in the back, ribs, arms, or legs
• shakiness in the legs, arms, hands, and feet
• sores
• stomach pain, fullness, or discomfort
• swelling or redness in the joints
• weakness