For Patients & Caregivers

What is the most important information I should know about Adalimumab-aacf?

You should discuss the potential benefits and risks of Adalimumab-aacf with your healthcare provider. Adalimumab-aacf is a TNF blocker medicine that affects your immune system. Adalimumab-aacf can lower the ability of your immune system to fight infections.

• Serious infections have happened in people taking Adalimumab-aacf. 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 healthcare provider should test you for TB before starting Adalimumab-aacf. Your healthcare provider should check you closely for signs and symptoms of TB during treatment with Adalimumab-aacf.
  You should not start taking Adalimumab-aacf if you have any kind of infection unless your healthcare provider says it is okay.
• Cancer. For children and adults taking TNF blockers, including Adalimumab-aacf, 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 Adalimumab-aacf, 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 healthcare provider if you have a bump or open sore that doesn’t heal.

What should I tell my healthcare provider BEFORE starting Adalimumab-aacf?

Tell your healthcare provider 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
• 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 Adalimumab-aacf. Ask your healthcare provider if you are unsure if you have lived in these areas
• Have or have had hepatitis B
• Have or had heart failure
• Have or 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 recently received or are scheduled to receive a vaccine. You may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting Adalimumab-aacf. Are scheduled for major surgery
• Are allergic to Adalimumab-aacf or to any of its ingredients.
• Are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you should take Adalimumab-aacf while you are pregnant or breastfeeding.
• Have a baby and you were using Adalimumab-aacf during your pregnancy. Tell your baby’s healthcare provider before your baby receives any vaccines.

Also tell your healthcare provider about the medications you take. You should not take Adalimumab-aacf with ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab). Tell your healthcare provider if you have ever used RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (mercaptopurine, 6-MP).

What should I watch for AFTER starting Adalimumab-aacf?

After starting Adalimumab-aacf, call your healthcare provider right away if you have an infection, or any sign of an infection. Adalimumab-aacf can make you more likely to get infections or make any infection that you may have worse.

Adalimumab-aacf can cause serious side effects, including:

• Serious infections. Your healthcare provider will examine you for TB and perform a test to see if you have TB. If your healthcare provider feels that you are at risk for TB, you may be treated with medicine for TB before you begin treatment with Adalimumab-aacf and during treatment with Adalimumab-aacf. Even if your TB test is negative your healthcare provider should carefully monitor you for TB infections while you are taking Adalimumab-aacf. People who had a negative TB skin test before receiving adalimumab products have developed active TB. Tell your healthcare provider if you have any of the following symptoms while taking or after taking Adalimumab-aacf:
  • Cough that does not go away
  • Weight loss
  • Low grade fever 
  • Loss of body fat and muscle (wasting)
• Hepatitis B infection in carriers of the virus. If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus can become active while you use Adalimumab-aacf. Your healthcare provider should do blood tests before you start treatment, while you are using Adalimumab-aacf, and for several months after you stop treatment with Adalimumab-aacf. Tell your healthcare provider if you have any of the following symptoms of a possible hepatitis B infection:
  • Muscle aches
  • Feel 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 Adalimumab-aacf. Call your healthcare provider or get medical help right away if you have any of these symptoms of a serious allergic reaction:
  • Hives
  • Trouble breathing
  • Swelling of your face, eyes, lips or mouth
• 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.
• 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 a rash on your cheeks or arms that gets worse in the sun. Symptoms may improve when you stop Adalimumab-aacf.
• Liver problems. Liver problems can happen in people who use TNF-blocker medicines. 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
  • Poor appetite or vomiting
  • Skin or eyes look yellow
  • Pain on the right side of your stomach (abdomen)
• Psoriasis. Some people using adalimumab products had new psoriasis or worsening of psoriasis they already had. Tell your healthcare provider if you develop red scaly patches or raised bumps that are filled with pus. Your healthcare provider may decide to stop your treatment with Adalimumab-aacf.

Call your healthcare provider or get medical care right away if you develop any of the above symptoms. Your treatment with Adalimumab-aacf may be stopped.

Common side effects of Adalimumab-aacf include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all the possible side effects with Adalimumab-aacf. 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

Adalimumab-aacf is given by injection under the skin.

This is the most important information to know about Adalimumab-aacf. For more information, talk to your health care provider.

Uses

Adalimumab-aacf is a prescription medicine used:

• To reduce the signs and symptoms of:
  • Moderate to severe rheumatoid arthritis (RA) in adults. Adalimumab-aacf can be used alone, with methotrexate, or with certain other medicines. Adalimumab-aacf 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. Adalimumab-aacf can be used alone or with methotrexate.
  • Psoriatic arthritis (PsA) in adults. Adalimumab-aacf can be used alone or with certain other medicines. Adalimumab-aacf may prevent further damage to your bones and joints and may help your ability to perform daily activities.
  • Ankylosing spondylitis (AS) in adults.
  • Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa 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-aacf is effective in people who stopped responding to or could not tolerate anti-TNF medicines.
• To treat moderate to severe chronic plaque psoriasis (Ps) in adults who are ready for systemic therapy or phototherapy and are under the care of a healthcare provider 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.

Please see the Full Prescribing Information, including the Medication Guide, for Adalimumab-aacf.