- Serious infections have happened in people taking
adalimumab products. 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, and check you closely for signs and symptoms of TB during
treatment with AMJEVITA, even if your TB test was negative. If your doctor
feels you are at risk, you may be treated with medicine for TB.
- Cancer. For children and adults taking
TNF blockers, including AMJEVITA, the chance of getting lymphoma or other
cancers may increase. There have been cases of unusual cancers in children,
teenagers, and young adults using TNF blockers. Some people have developed a
rare type of cancer called hepatosplenic T-cell lymphoma. This type of
cancer often results in death. If using TNF blockers including AMJEVITA,
your chance of getting two types of skin cancer (basal cell and squamous
cell) may increase. These types are generally not life-threatening if
treated; tell your doctor if you have a bump or open sore that doesn’t heal.
What should I tell my doctor BEFORE starting AMJEVITA?
Tell your doctor about all of your health conditions,
including if you:
- Have an infection, are being treated for infection, or have symptoms of an
infection
- Get a lot of infections or infections that keep coming back
- Have diabetes
- Have TB or have been in close contact with someone with TB, or were born in,
lived in, or traveled where there is more risk for getting TB
- Live or have lived in an area (such as the Ohio and Mississippi River
valleys) where there is an increased risk for getting certain kinds of
fungal infections, such as histoplasmosis, coccidioidomycosis, or
blastomycosis. These infections may happen or become more severe if you use
AMJEVITA. Ask your doctor if you are unsure if you have lived in these areas
- Have or have had hepatitis B
- Are scheduled for major surgery
- Have or have had cancer
- Have numbness or tingling or a nervous system disease such as multiple
sclerosis or Guillain-Barré syndrome
- Have or had heart failure
- Have recently received or are scheduled to receive a vaccine. AMJEVITA
patients may receive vaccines, except for live vaccines. Children should be
brought up to date on all vaccines before starting AMJEVITA
- Are allergic to any AMJEVITA ingredients
- Are pregnant, planning to become pregnant, breastfeeding, or planning to
breastfeed
- Have a baby and you were using AMJEVITA during your pregnancy. Tell your
baby’s doctor before your baby receives any vaccines
Also tell your doctor about all the medicines you take. You
should not take AMJEVITA with ORENCIA® (abatacept),
KINERET® (anakinra), REMICADE® (infliximab),
ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or
SIMPONI® (golimumab). Tell your doctor if you have ever used
RITUXAN® (rituximab), IMURAN® (azathioprine), or
PURINETHOL® (mercaptopurine, 6-MP).
What should I watch for AFTER starting AMJEVITA?
AMJEVITA can cause serious side effects, including:
- Serious infections. These include TB and infections
caused by viruses, fungi, or bacteria. Symptoms related to TB include a
cough, low-grade fever, weight loss, or loss of body fat and muscle.
- Hepatitis B infection in carriers of the virus.
Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes
that look yellow, little or no appetite, vomiting, clay-colored bowel
movements, fever, chills, stomach discomfort, and skin rash.
- Allergic reactions. Symptoms of a serious allergic
reaction include hives, trouble breathing, and swelling of your face, eyes,
lips, or mouth.
- Nervous system problems. Signs and symptoms include
numbness or tingling, problems with your vision, weakness in your arms or
legs, and dizziness.
- Blood problems (decreased blood cells that help fight
infections or stop bleeding). Symptoms include a fever that does not
go away, bruising or bleeding very easily, or looking very pale.
- Heart failure (new or worsening). Symptoms include
shortness of breath, swelling of your ankles or feet, and 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 rash on your cheeks or arms that gets worse in the
sun.
- Liver problems. Symptoms include feeling very
tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on
the right side of your stomach (abdomen). These problems can lead to liver
failure and death.
- Psoriasis (new or worsening). Symptoms include red
scaly patches or raised bumps that are filled with pus.
Call your doctor or get medical care right away if you
develop any of the above symptoms.
The most common side effects of AMJEVITA include
injection site reactions (pain, redness, rash, swelling, itching, or bruising),
upper respiratory infections (sinus infections), headaches, and rash. These are
not all of the possible side effects with AMJEVITA. Tell your doctor if you have
any side effect that bothers you or that does not go away.
Remember, tell your doctor right away if you have an infection or symptoms of an
infection, including:
- Fever, sweats, or chills
- Muscle aches
- Cough
- Shortness of breath
- Blood in phlegm
- Weight loss
- Warm, red, or painful skin or sores on your body
- Diarrhea or stomach pain
- Burning when you urinate
- Urinating more often than normal
- Feeling very tired
If you have any questions about this information, be sure to discuss them with
your healthcare provider. You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
Please see the accompanying AMJEVITA full
Prescribing Information, including Medication Guide.
INDICATIONS
AMJEVITA is a prescription medicine used:
- To reduce the signs and symptoms of:
- Moderate to severe rheumatoid arthritis (RA) in
adults. AMJEVITA can be used alone, with methotrexate, or
with certain other medicines. AMJEVITA may prevent further damage to
your bones and joints and may help your ability to perform daily
activities.
- Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in
children 2 years of age and older. AMJEVITA can be used alone or with methotrexate.
- Psoriatic arthritis (PsA) in adults.
AMJEVITA can be used alone or with certain other medicines. AMJEVITA
may prevent further damage to your bones and joints and may help
your ability to perform daily activities.
- Ankylosing spondylitis (AS) in adults.
- Moderate to severe hidradenitis suppurativa (HS) in adults.
- To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
- To treat moderate to severe ulcerative colitis (UC) in
adults. It is not known if adalimumab products are effective in
people who stopped responding to or could not tolerate TNF-blocker
medicines.
- To treat moderate to severe chronic plaque psoriasis
(PsO) in adults who are ready for systemic therapy or phototherapy,
and are under the care of a doctor who will decide if other systemic
therapies are less appropriate.
- To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and
panuveitis (all parts of the eye) in adults.
