Frequently Asked Questions About HUMIRA^®

• What is HUMIRA and how does it work?
• How is HUMIRA different from other medications that treat Crohn's disease?
• How do I use HUMIRA?
• When should I use HUMIRA?
• Can I use HUMIRA if I'm taking other medicines for my Crohn's disease or other conditions?
• 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 moderate to severe Crohn’s disease in adults who have not responded well to conventional treatments. HUMIRA is also for these adults with moderate to severe Crohn's disease who have lost response to or are unable to tolerate infliximab.

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What is HUMIRA and how does it work?

HUMIRA is part of a class of medications called TNF (tumor necrosis factor) blockers. HUMIRA works by neutralizing TNF-α, a protein in your body that can cause inflammation. HUMIRA blocks TNF-α in your body and helps reduce the inflammation too much TNF-α can cause.

How is HUMIRA different from other medications that treat Crohn's disease?

HUMIRA is a medication that is taken by injection under the skin. And once your doctor shows you how to take HUMIRA, the injections can be taken in the convenience of your own home. After your initial starting doses, you only need to take one injection of HUMIRA every other week.

How do I use HUMIRA?

You take HUMIRA by giving yourself an injection under the skin, once every other week (after your initial starting doses). HUMIRA cannot be taken by mouth. Ask your doctor to show you or a caregiver how to inject HUMIRA. Make sure you have been shown how to inject HUMIRA before you do it yourself.

The 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, and trouble breathing. Call your doctor right away if you experience any of these symptoms.

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 ahead of time 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.

Can I use HUMIRA if I'm taking other medicines for my Crohn's disease 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 also should 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.

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 Crohn's disease is 160mg (milligrams) on day 1, 80mg on day 15, 40mg on day 29, and 40mg every other week thereafter. The first dose can be administered as four injections in one day or as two injections per day for two consecutive days. 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 Crohn's disease.

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

Many people taking HUMIRA saw a significant difference in their symptoms in as little as 4 weeks. However, individual results will vary.

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 no-cost 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 patients 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 Crohn's disease, try making changes to your lifestyle and diet, like planning ahead and cutting back on some foods high in fat or dairy products. These and other measures may help the severity of symptoms during flare-ups.