Frequently Asked Questions About HUMIRA^®

• What is HUMIRA and how does it work?
• How is HUMIRA different from other medications that treat psoriatic arthritis?
• How do I use HUMIRA?
• Can I use HUMIRA if I'm taking other medicines for my psoriatic arthritis or other conditions?
• When should I use HUMIRA?
• How should I store HUMIRA?
• How often and for how long will I have to use HUMIRA?
• Will HUMIRA cure my disease?
• How long before I will start to see and feel improvement?
• What should I do with my used Pen or syringe after I take HUMIRA? Can I reuse the needle?
• What is the most important information I should know about HUMIRA?
• How will I know if I'm allergic to HUMIRA?
• Are there any foods that interact with HUMIRA?
• Can I drink alcohol when using HUMIRA?
• Who shouldn't use HUMIRA?
• What information should I share with my doctor before starting HUMIRA?
• What are the possible side effects with HUMIRA?
• Can I use HUMIRA if I'm pregnant or breast-feeding?
• What else can I do to take care of my disease besides taking medications?

HUMIRA is used to reduce the signs and symptoms of psoriatic arthritis in adults, may prevent further damage to your bones and joints, and may help your ability to perform daily activities. HUMIRA can be used alone or with certain other medicines.

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What is HUMIRA and how does it work?

HUMIRA is a medicine called a TNF blocker, a type of protein that blocks the action of TNF-α, a substance made by your body's immune system. People with psoriatic arthritis (PsA) have too much TNF-α in their bodies. The extra TNF-α can attack normal healthy body tissue and cause inflammation especially in the tissue in your bones, cartilage, and joints. HUMIRA may prevent further damage to the bones and joints of moderate to severe psoriatic arthritis patients, and may help the ability to perform daily activities. HUMIRA can also help improve the skin lesions that often accompany PsA.

How is HUMIRA different from other medications that treat psoriatic arthritis?

HUMIRA is a biologic disease-modifying antirheumatic drug, also called a biologic DMARD, or simply "biologic." Biologics are a class of medications used to treat the signs and symptoms of active psoriatic arthritis, improve physical function and help keep the joint damage from getting worse.

However, HUMIRA can also lower the ability to fight infections.

HUMIRA is a medicine given by injection under the skin. HUMIRA can be injected by you or a caregiver in the convenience of your own home. For PsA, it is injected once every 2 weeks, which may be convenient for your lifestyle.

How do I use HUMIRA?

HUMIRA is a medicine given by injection under the skin, every other week. HUMIRA cannot be taken by mouth. Ask your doctor to show you or a caregiver how to inject HUMIRA.

Make sure you have been instructed by a healthcare provider how to inject HUMIRA before you do it yourself. Your first injection should be given under the supervision of a healthcare professional.

You can call your doctor or 1-800-4HUMIRA (448-6472) if you have questions about giving yourself an injection.

One of the most common side effects with HUMIRA is injection site reactions such as redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. If you have pain, redness, swelling around the injection site that doesn’t go away within a few days or gets worse, call your doctor right away.

Do not inject HUMIRA more often than prescribed.

Signs of a serious allergic reaction include skin rash, swollen face, trouble breathing. Call your doctor right away if you experience any of these symptoms.

Can I use HUMIRA if I'm taking other medicines for my psoriatic arthritis or other conditions?

Yes, you can take other medicines if your doctor has prescribed them, or has told you it's okay to take them while you're taking HUMIRA. It’s important that you tell your doctor about any other medicines you are taking for other conditions (for example, high blood pressure medicine) before you start taking HUMIRA.

You should also tell your doctor about any over-the-counter drugs, painkillers, herbal medicines, and vitamin and mineral supplements you're taking. You should not take HUMIRA with other TNF blockers or with another medication called Kineret^® (anakinra). If you have questions, you should ask your doctor.

HUMIRA is supplied in a single-use, pre-filled syringe or Pen. It should NOT be mixed with any other medication (such as insulin), nor should any other medications be added to the syringe or Pen.

When should I use HUMIRA?

Some patients find it helpful to inject HUMIRA in the morning or at bedtime. However, once you find a time that you prefer, taking the medication at a consistent time can help you remember to take it. It's also a good idea to mark your calendar with the dates of your treatment. This may help you remember when to take it. Always follow your doctor's instructions on when and how often to take HUMIRA.

If you forget to take HUMIRA when you're supposed to, inject the next dose right away. Then take your next dose when your next scheduled dose is due. This will put you back on schedule. If you have any questions, consult your doctor.

Do not inject HUMIRA more often than prescribed.

How should I store HUMIRA?

HUMIRA needs to be stored in a refrigerator (2°C-8°C/36°F-46°F) in its original container and protected from light until it's used. HUMIRA should never be put in the freezer or frozen. Refrigerated HUMIRA remains stable until the expiration date printed on the pre-filled syringe or Pen. If you need to take it with you, such as when you're traveling, store it in a cool carrier with an ice pack and protect the prefilled syringe from light. Do not use a Pen or prefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it. Care should be taken to avoid dropping or crushing the product as it contains a glass syringe.

How often and for how long will I have to use HUMIRA?

The recommended dose of HUMIRA for adult patients with psoriatic arthritis is 40mg (milligrams) every other week. Always follow your doctor's instructions about when and how often to take HUMIRA.

Will HUMIRA cure my disease?

Unfortunately, there are no current treatments available that can cure psoriatic arthritis.

How long before I will start to see and feel improvement?

Some patients see results as soon as 2 weeks. Full effect may take up to 3 months. To know it's working, you may notice less pain, swelling, and joint stiffness. You may also notice an increased range of movement.

What should I do with my used Pen or syringe after I take HUMIRA? Can I reuse the needle?

HUMIRA comes in single-dose, pre-filled Pens or in pre-filled syringes. The needle is not removable or reusable.

You should always check with your healthcare provider for instructions on how to properly dispose of used Pens and syringes. You should follow any special state or local laws regarding the proper disposal of Pens and syringes. DO NOT throw the Pen or syringe in the household trash or recycle. Here are some tips that you may find helpful:

Place the used Pens and syringes in a "Sharps" container, which is specially made for disposing of used syringes and needles. Or you can use a hard plastic container with a screw-on cap or metal container with a plastic lid labeled "used syringes." Do not use glass or clear plastic containers. You should always keep the container out of the reach of children.

When the container is about two-thirds full, tape the cap or lid down so it doesn't come off, then dispose of it as instructed by your doctor, nurse, or pharmacist. Do not throw the container in the household trash or recycle. Sign up for our free Sharps disposal service at myHUMIRA.com or call 1-800-4HUMIRA.

Items used in preparation of your injection, such as gauze or cotton balls, may be placed in the trash, unless otherwise instructed by your doctor, nurse, or pharmacist. The dose tray and cover may be recycled.

What is the most important information I should know about HUMIRA?

HUMIRA is a medicine that affects your immune system. HUMIRA can lower the ability of the immune system to fight infections. Serious infections have happened in patients taking HUMIRA. These infections include tuberculosis (TB) and infections caused by viruses, fungi or bacteria that have spread throughout the body. Some patients have died from these infections.

• Your doctor should test you for TB before starting HUMIRA.
• Your doctor should monitor you closely for signs and symptoms of TB during treatment with HUMIRA.

Before starting HUMIRA, tell your doctor if you:

• think you have an infection. You should not start taking HUMIRA if you have any kind of infection.
• are being treated for an infection
• have signs of an infection, such as a fever, cough, or flu-like symptoms
• have any open cuts or sores on your body
• 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 doctor 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). If you do not know if you have lived in an area where histoplasmosis, coccidioidomycosis, or blastomycosis is common, ask your doctor.
• have or have had hepatitis B
• use the medicine Kineret (anakinra). You may have a higher chance for serious infections and a low white blood cell count when taking HUMIRA with Kineret.
• are scheduled to have major surgery

After starting HUMIRA, call your doctor right away if you have an infection, or any sign of an infection, including:

• a fever
• feel very tired
• a cough
• flu-like symptoms
• warm, red, or painful skin
• open cuts or sores on your body

HUMIRA can make you more likely to get infections or make any infection that you may have worse.

Please see "What are the possible side effects with HUMIRA?" for additional information regarding possible side effects. Also, please read the Medication Guide and discuss it with your doctor.

How will I know if I'm allergic to HUMIRA?

Warning signs may include a skin rash, swollen face, or difficulty breathing. If you experience any of these symptoms, call your doctor or seek emergency care immediately.

The needle cover on the pre-filled syringe contains dry natural rubber. Tell your doctor if you have any allergies to rubber or latex.

Are there any foods that interact with HUMIRA?

Studies have not been done to see how HUMIRA interacts with food. If you have questions, talk to your doctor.

Can I drink alcohol when using HUMIRA?

Studies have not been done to see how HUMIRA interacts with alcohol. If you have questions, talk to your doctor.

Who shouldn't use HUMIRA?

You should not use HUMIRA if you have an allergy to HUMIRA or to any of the ingredients in HUMIRA (including sodium phosphate, sodium citrate, citric acid, mannitol, and polysorbate 80). The needle cover on the pre-filled syringe contains dry natural rubber. Tell your doctor if you have any allergies to rubber or latex.

What information should I share with my doctor before starting HUMIRA?

Before starting HUMIRA, tell your doctor about all of your health conditions, including if you:

• have an infection. See "What is the most important information I should know about HUMIRA?"
• have any numbness or tingling or have a disease that affects your nervous system such as multiple sclerosis or Guillain-Barré syndrome.
• have heart failure or other heart conditions. If you have heart failure, it may get worse while you are taking HUMIRA.
• have recently received or are scheduled to receive a vaccine. Patients receiving HUMIRA should not receive live vaccines.
• are allergic to rubber or latex. The needle cover on the prefilled syringe contains dry natural rubber. Tell your doctor if you have any allergies to rubber or latex.
• are allergic to HUMIRA or to any of its ingredients. See "Who shouldn’t use HUMIRA?".
• if you are pregnant, planning to become pregnant, or breastfeeding

Tell your doctor about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements. Especially, tell your doctor if you take Kineret (anakinra). You may have a higher chance for serious infections and a low white blood cell count when taking HUMIRA with Kineret. Also, tell your doctor if you are taking other medicines that suppress the immune system.

Know the medicines you take. Keep a list of your medicines with you to show your doctor and pharmacist each time you get a new medicine.

If you are not sure or have any questions about any of this information, ask your doctor.

What are the possible side effects with HUMIRA?

Serious side effects, which sometimes lead to death, have happened in people taking HUMIRA, including:

• Serious infections See "What is the most important information I should know about HUMIRA?"

Your doctor will examine you for tuberculosis (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 HUMIRA and during treatment with HUMIRA. Even if your TB test is negative your doctor should carefully monitor you for TB infections while you are taking HUMIRA. Patients who had a negative TB skin test before receiving HUMIRA have developed active TB. Tell your doctor if you have any of the following symptoms while taking or after taking HUMIRA:

• cough that does not go away
• low grade fever
• weight loss
• loss of body fat and muscle (wasting)

• Certain types of Cancer.
  • There have been cases of certain kinds of cancer, in patients taking HUMIRA or other TNF blockers.
  • Some patients receiving HUMIRA have developed types of cancer called non-melanoma skin cancer (basal cell cancer and squamous cell cancer of the skin), which are generally not life-threatening if treated. Tell your doctor if you have a bump or open sore that doesn’t heal.
  • Patients with RA, especially more serious RA, may have a higher chance for getting a kind of cancer called lymphoma.
• Allergic reactions. Signs of serious allergic reaction include a skin rash, a swollen face, or trouble breathing.
• Hepatitis B virus reactivation in patients who carry the virus in their blood. In some cases patients have died as a result of hepatitis B virus being reactivated. Your doctor should monitor you carefully during treatment with HUMIRA if you carry the hepatitis B virus in your blood. Tell your doctor if you have any of the following symptoms:
  • feel unwell
  • poor appetite
  • tiredness (fatigue)
  • fever, skin rash, or joint pain
• 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. Symptoms include shortness of breath or swelling of your ankles or feet or 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 go away when you stop HUMIRA.

Call your doctor or get medical care right away if you develop any of the above symptoms. Your treatment with HUMIRA may be stopped.

Common side effects with HUMIRA include:

• Injection site reactions such as redness, rash, swelling, itching, or bruising. These symptoms usually will go away within a few days. If you have pain, redness or swelling around the injection site that doesn’t go away within a few days or gets worse, call your doctor right away.
• Upper respiratory infections (including sinus infections)
• Headaches
• Rash
• Nausea

These are not all the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away. Ask your doctor or pharmacist for more information.

Can I use HUMIRA if I'm pregnant or breast-feeding?

Tell your doctor if you are pregnant, planning to become pregnant, or breastfeeding. HUMIRA should only be used during a pregnancy if needed. Women who are breastfeeding should talk to their doctor about whether or not to use HUMIRA.

Pregnancy Registry: Abbott Laboratories has a registry for pregnant women exposed to HUMIRA. The purpose of this registry is to check the health of the pregnant mother and her child. Talk to your doctor if you are pregnant and contact the registry at 1.877.311.8972.

What else can I do to take care of my disease besides taking medications?

To better manage your PsA, it may be helpful to eat a healthy diet, get adequate rest, and lose any excess weight. It's also a good idea to exercise regularly, which can help build strength, endurance and mobility. Many people find stress management beneficial, too.