Adalimumab

What it is used for

IDACIO is a tumor necrosis factor (TNF) blocker indicated for: Rheumatoid Arthritis (RA): reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active RA. Juvenile Idiopathic Arthritis (JIA): reducing signs and symptoms of moderately to severely active polyarticular JIA in patients 2 years of age and older.

Psoriatic Arthritis (PsA): reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active PsA. Ankylosing Spondylitis (AS): reducing signs and symptoms in adult patients with active AS. Crohn’s Disease (CD): treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older.

Ulcerative Colitis (UC): treatment of moderately to severely active ulcerative colitis in adult patients. Limitations of Use: Effectiveness has not been established in patients who have lost response to or were intolerant to TNF blockers. Plaque Psoriasis (Ps): treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

Hidradenitis Suppurativa (HS): treatment of moderate to severe hidradenitis suppurativa in adult patients. Uveitis (UV): treatment of non-infectious intermediate, posterior, and panuveitis in adult patients. Rheumatoid Arthritis IDACIO is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis.

IDACIO can be used alone or in combination with methotrexate or other non-biologic disease-modifying anti-rheumatic drugs (DMARDs). Juvenile Idiopathic Arthritis IDACIO is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age and older.

IDACIO can be used alone or in combination with methotrexate. Psoriatic Arthritis IDACIO is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in adult patients with active psoriatic arthritis. IDACIO can be used alone or in combination with non-biologic DMARDs.

Ankylosing Spondylitis IDACIO is indicated for reducing signs and symptoms in adult patients with active ankylosing spondylitis. Crohn’s Disease IDACIO is indicated for the treatment of moderately to severely active Crohn’s disease in adults and pediatric patients 6 years of age and older. Ulcerative Colitis IDACIO is indicated for the treatment of moderately to severely active ulcerative colitis in adult patients.

Limitations of Use The effectiveness of adalimumab products has not been established in patients who have lost response to or were intolerant to TNF blockers. Plaque Psoriasis IDACIO is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate.

IDACIO should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician. Hidradenitis Suppurativa IDACIO is indicated for the treatment of moderate to severe hidradenitis suppurativa in adult patients. Uveitis IDACIO is indicated for the treatment of non-infectious intermediate, posterior, and panuveitis in adult patients.

The most important thing to know

Adalimumab-aacf is a 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 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 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.

Before starting Adalimumab-aacf, tell your healthcare provider if you: think you have an infection or have symptoms of an infection such as: fever, sweats, or chills muscle aches cough shortness of breath blood in phlegm warm, red, or painful skin or sores on your body diarrhea or stomach pain burning when you urinate or urinate more often than normal feel very tired weight loss are being treated for an infection.

get a lot of infections or have infections that keep coming back. have diabetes 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 healthcare provider 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 Adalimumab-aacf. Ask your healthcare provider if you do not know if you have lived in an area where these infections are common. 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. 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. Cancer For children and adults taking Tumor Necrosis Factor (TNF)-blockers, including Adalimumab-aacf, the chances of getting cancer may increase.

There have been cases of unusual cancers in children, teenagers, and young adults using TNF-blockers. People with rheumatoid arthritis (RA), especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma. If you use TNF blockers including Adalimumab-aacf your chance of getting two types of skin cancer may increase (basal cell cancer and squamous cell cancer of the skin).

These types of cancer are generally not life-threatening if treated. Tell your healthcare provider if you have a bump or open sore that does not heal. Some people receiving TNF blockers including Adalimumab-aacf developed a rare type of cancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death.

Most of these people were male teenagers or young men. Also, most people were being treated for Crohn's disease or ulcerative colitis with another medicine called IMURAN (azathioprine) or PURINETHOL (6-mercaptopurine, 6–MP). What is Adalimumab-aacf? Adalimumab-aacf is a medicine called a Tumor Necrosis Factor (TNF) blocker.

Adalimumab-aacf is used: To reduce the signs and symptoms of: moderate to severe RA in adults. Adalimumab-aacf can be used alone, with methotrexate, or with certain other medicines. moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years 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. ankylosing spondylitis (AS) in adults. moderate to sever

How to take it

Adalimumab-aacf is given by an injection under the skin. Your healthcare provider will tell you how often to take an injection of Adalimumab-aacf. This is based on your condition to be treated. Do not inject Adalimumab-aacf more often than you were prescribed. See the Instructions for Use inside the carton for complete instructions for the right way to prepare and inject Adalimumab-aacf.

Make sure you have been shown how to inject Adalimumab-aacf before you do it yourself. If you have any questions about giving yourself an injection, you can call your healthcare provider or the patient support program at 1-833-522-4227. Someone you know can also help you with your injection after they have been shown how to prepare and inject Adalimumab-aacf.

Do not try to inject Adalimumab-aacf yourself until you have been shown the right way to give the injections. If your healthcare provider decides that you or a caregiver may be able to give your injections of Adalimumab-aacf at home, you should receive training on the right way to prepare and inject Adalimumab-aacf. Do not miss any doses of Adalimumab-aacf unless your healthcare provider says it is okay.

If you forget to take Adalimumab-aacf, 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 Adalimumab-aacf, call your healthcare provider or pharmacist. If you take more Adalimumab-aacf than you were told to take, call your healthcare provider.

Side effects, and when to stop

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 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 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. New heart failure or worsening of heart failure you already have. Call your healthcare provider right away if you get new worsening symptoms of heart failure while taking Adalimumab-aacf, including: shortness of breath sudden weight gain swelling of your ankles or feet 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. The most common side effects of Adalimumab-aacf include: injection site reactions: redness, rash, swelling, itching, or bruising.

These symptoms usually will go away within a few days. Call your healthcare provider 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. These are not all the p

What to say before you start

Adalimumab-aacf may not be right for you. Before starting Adalimumab-aacf, tell your healthcare provider about all of your medical conditions, including if you: have an infection. 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 recently received or are scheduled to receive a vaccine. You may receive vaccines, except for live vaccines while using Adalimumab-aacf. Children should be brought up to date with all vaccines before starting Adalimumab-aacf. are allergic to Adalimumab-aacf or to any of its ingredients. See the end of this Medication Guide for a list of ingredients in Adalimumab-aacf.

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.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Especially tell your healthcare provider if you use: ORENCIA (abatacept), KINERET (anakinra), REMICADE (infliximab), ENBREL (etanercept), CIMZIA (certolizumab pegol) or SIMPONI (golimumab), because you should not use Adalimumab-aacf while you are also using one of these medicines.

RITUXAN (rituximab). Your healthcare provider may not want to give you Adalimumab-aacf if you have received RITUXAN (rituximab) recently. IMURAN (azathioprine) or PURINETHOL (6–mercaptopurine, 6-MP). Keep a list of your medicines with you to show your healthcare provider and pharmacist each time you get a new medicine.

Storing it

Store Adalimumab-aacf in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC). Store Adalimumab-aacf in the original carton until use to protect it from light. Do not freeze Adalimumab-aacf. Do not use Adalimumab-aacf if frozen, even if it has been thawed. Refrigerated Adalimumab-aacf may be used until the expiration date printed on the Adalimumab-aacf carton.

Pen or prefilled syringe. Do not use Adalimumab-aacf after the expiration date. If needed, for example when you are traveling, you may also store Adalimumab-aacf at room temperature up to 77°F (25°C) for up to 28 days. Store Adalimumab-aacf in the original carton until use, to protect it from light. Throw away Adalimumab-aacf if it has been kept at room temperature and not been used within 28 days.

Record the date you first remove Adalimumab-aacf from the refrigerator in the spaces provided on the carton. Do not store Adalimumab-aacf in extreme heat or cold. Do not use a Pen or prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it. Do not drop or crush Adalimumab-aacf. The prefilled syringe is glass.

Keep Adalimumab-aacf, injection supplies, and all other medicines out of the reach of children.