Adalimumab Injection

Adalimumab injection is available as several different products that are considered to be biologic medications (medications made from living organisms). These biosimilar products are highly similar to adalimumab injection and work the same way as adalimumab injection in the body. Therefore, the term adalimumab injection products will be used to represent these medications in this discussion.

Using adalimumab injection products may decrease your ability to fight infection and increase the chance that you will develop a serious infection, including severe fungal, bacterial, and viral infection that may spread through the body. These infections may need to be treated in a hospital and may cause death. Tell your doctor if you often get any type of infection or if you have or think you may have any type of infection now. This includes minor infections (such as open cuts or sores), infections that come and go (such as cold sores) or chronic infections that do not go away. Also tell your doctor if you have or have ever had any condition that affects your immune system or if you live or have ever lived in areas such as the Ohio or Mississippi river valleys where severe fungal infections are more common. Ask your doctor if you don’t know if these infections are more common in your area. Tell your doctor if you are taking medications that decrease the activity of the immune system.

Your doctor will monitor you for signs of infection during and after your treatment. If you have any of the following symptoms before you begin your treatment or if you experience any of the following symptoms during or shortly after your treatment, call your doctor immediately: weakness; sweating; sore throat; cough; coughing up bloody mucus; fever; weight loss; extreme tiredness; diarrhea; stomach pain; warm, red, or painful skin; painful, difficult, or frequent urination; or other signs of infection.

You may already be infected with tuberculosis (TB; a serious lung infection) or hepatitis B (a virus that affects the liver) but not have any symptoms of the disease. In this case, adalimumab injection products may increase the risk that your infection will become more serious and you will develop symptoms. Your doctor will perform a skin test to see if you have an inactive TB infection and may order a blood test to see if you have an inactive hepatitis B infection. If necessary, your doctor may give you medication to treat this infection before you begin your treatment with adalimumab. Tell your doctor if you have or have ever had TB, if you have lived in or visited a country where TB is common, or if you have been around someone who has or has ever had TB. If you have any of the following symptoms of TB, or if you develop any of these symptoms during your treatment, call your doctor immediately: cough, weight loss, loss of muscle tone, fever, or night sweats. Also call your doctor immediately if you have any of these symptoms of hepatitis B or if you develop any of these symptoms during or after your treatment: excessive tiredness, yellowing of the skin or eyes, loss of appetite, nausea or vomiting, muscle aches, dark urine, clay-colored bowel movements, fever, chills, stomach pain, or rash.

Some children, teenagers, and young adults who received adalimumab injection products or similar medications developed severe or life-threatening cancers including lymphoma (cancer that begins in the cells that fight infection). Some teenage and young adult males who took adalimumab or similar medications developed hepatosplenic T-cell lymphoma (HSTCL), a very serious form of cancer that often causes death within a short period of time. Most of the people who developed HSTCL were being treated for Crohn’s disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) or ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) with adalimumab or a similar medication along with another medication called azathioprine (Imuran) or 6-mercaptopurine (Purinethol). Tell your child’s doctor if your child has ever had any type of cancer. If your child develops any of these symptoms during his or her treatment, call his or her doctor immediately: stomach pain; fever; unexplained weight loss; swollen glands in the neck, underarms, or groin; or easy bruising or bleeding. Talk to your child’s doctor about the risks of giving adalimumab injection products to your child.

Your doctor or pharmacist will give you the manufacturer’s patient information sheet (Medication Guide) when you begin treatment with adalimumab injection and each time you receive the medication. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer’s website to obtain the Medication Guide.

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Talk to your doctor about the risks of using adalimumab injection.

🔔 Why is this medication prescribed?

Adalimumab injection products are used alone or with other medications to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) including the following:

• rheumatoid arthritis (a condition in which the body attacks its own joints, causing pain, swelling, and loss of function) in adults,
• juvenile idiopathic arthritis (JIA; a condition that affects children in which the body attacks its own joints, causing pain, swelling, loss of function, and delays in growth and development) in children 2 years of age and older,
• Crohn’s disease (a condition in which the body attacks the lining of the digestive tract, causing pain, diarrhea, weight loss, and fever) that has not improved when treated with other medications in adults and children 6 years of age and older,
• ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum) when other medications and treatments did not help or could not be tolerated in adults and children 5 years of age and older,
• ankylosing spondylitis (a condition in which the body attacks the joints of the spine and other areas causing pain and joint damage) in adults,
• psoriatic arthritis (a condition that causes joint pain and swelling and scales on the skin) in adults,
• hidradenitis suppurativa (a skin disease that causes pimple-like bumps in the armpits, groin, and anal area) in adults and children 12 years of age and older,
• uveitis (swelling and inflammation of different areas of the eye) in adults and children 2 years of age and older,
• chronic plaque psoriasis (a skin disease in which red, scaly patches form on some areas of the body) in adults.

Adalimumab injection products are in a class of medications called tumor necrosis factor (TNF) inhibitors. They work by blocking the action of TNF, a substance in the body that causes inflammation.

🔔 How should this medicine be used?

Adalimumab injection products come as a solution (liquid) in single-dose, prefilled syringes, prefilled dosing pens, prefilled automatic injection devices, and vials to inject subcutaneously (under the skin). Your doctor will tell you how often to use adalimumab products based on your condition and age. To help you remember to inject adalimumab injection products, mark the days you are scheduled to inject the drug on your calendar. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use adalimumab injection exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

You will receive your first dose of adalimumab injection products in your doctor’s office. After that, you can inject adalimumab injection products yourself or have a friend or relative perform the injections. Before you use adalimumab injection products yourself the first time, read the written instructions that come with it. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject it.

Use each syringe, pen, or automatic injection device only once and inject all the solution in the syringe, pen, or automatic injection device. Even if there is still some solution left in the syringe, pen, or device after you inject, do not inject again. Dispose of used syringes, pens, and devices in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.

If you are using an adalimumab injection product that has been refrigerated, place it on a flat surface without removing the needle cap and allow it warm to room temperature for 15 to 30 minutes before you are ready to inject the medication. Do not try to warm the medication by heating it in a microwave, placing it in hot water, or through any other method.

You can inject adalimumab injection anywhere on the front of your thighs or stomach except your navel and the area 2 inches (5 centimeters) around it. To reduce the chances of soreness or redness, use a different site for each injection. Give each injection at least 1 inch (2.5 centimeters) away from a spot that you have already used. Keep a list of the places where you have given injections so that you will not inject in these places again. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.

Always look at adalimumab injection solution before injecting it. Check that the expiration date has not passed and that the syringe, dosing pen, or automatic injection device contains the correct amount of liquid. Check with the written instructions for use to find out what your adalimumab injection product solution should look like. Do not use a syringe, pen, or device if it is expired, if it does not contain the correct amount of liquid, or if the liquid does not look like it is described in the written instructions for use.

Adalimumab injection products may help control your condition but will not cure it. Continue to use adalimumab injection products even if you feel well. Do not stop using adalimumab injection products without talking to your doctor.