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Frequently Asked Questions
About HUMIRA

Whether you have already started on HUMIRA or are considering it, here are some questions you may have.
Take a look below to find some answers to frequently asked questions and discuss your treatment options with your doctor. For further assistance, call 1.800.4HUMIRA.

How can the myHUMIRA support program help me?

Whether you’re just starting HUMIRA or have been continuing on treatment, the myHUMIRA support program offers a range of services and tools to support you at no additional cost. You can choose the services and tools that are most useful to you, including: help with injections, on-call nurse support, medication reminders, the HUMIRA Co-pay Savings Card, and more.

Click here to see how myHUMIRA has helped other real HUMIRA patients like you.

What is HUMIRA and how does it work?

HUMIRA is a medicine called a tumor necrosis factor (TNF) blocker. HUMIRA targets and helps block TNF-alpha. TNF plays a role in the process that causes inflammation. Because TNF blockers, including HUMIRA, affect the immune system, they can lower the ability to fight infections and may cause other serious side effects.

How do I use HUMIRA?

You take HUMIRA by giving yourself an injection under the skin, typically every other week (after your initial starting doses). HUMIRA cannot be taken by mouth. Do not try to inject HUMIRA yourself until you have been shown the right way to give the injections. If your doctor decides that you are able to give your injections at home, you should receive training on the right way to prepare and inject HUMIRA.

Please remember: Your first HUMIRA injection should be given under the supervision of a nurse or health care professional. Always consult with your health care professional before you start taking HUMIRA. You can call your doctor or 1.800.4HUMIRA (1.800.448.6472) 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, or swelling around the injection site that doesn’t go away within a few days or gets worse, call your doctor right away.

Signs of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth. Call your doctor right away if you experience any of these symptoms.

Your doctor will tell you how often to take an injection of HUMIRA. Do not inject HUMIRA more often than prescribed.
If you need additional help with self-injecting, you can view an instructional video.

When should I use HUMIRA?

It may be a good idea to mark your calendar ahead of time with the dates of your HUMIRA 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 as soon as you remember. Then take your next dose when your next scheduled dose is due. This will put you back on schedule. If your're not sure when to inject HUMIRA, call your doctor or pharmacist.

Your doctor will tell you how often to take an injection of HUMIRA. Do not inject HUMIRA more often than prescribed.

Can I use HUMIRA if I'm taking other medicines for my condition?

Yes, you can take certain other medicines if your doctor has prescribed them, or has told you it's okay to take them while you're taking HUMIRA. Tell your doctor about all the medicines you take. You should not take HUMIRA with ORENCIA® (abatacept), KINERET® (anakinra), REMICADE® (infliximab), ENBREL® (etanercept), CIMZIA® (certolizumab pegol), or SIMPONI® (golimumab). Tell your doctor if you have ever used RITUXAN® (rituximab), IMURAN® (azathioprine), or PURINETHOL® (mercaptopurine, 6-MP).

A rare type of cancer called hepatosplenic T-cell lymphoma, often resulting in death, has developed in some people. Most were male teenagers or young men with inflammatory bowel disease who were being treated with another medicine called IMURAN (azathioprine) or PURINETHOL (6‐mercaptopurine, 6‐MP).

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. Do not use HUMIRA if frozen, even if it has been thawed. Refrigerated HUMIRA may be used until the expiration date printed on the prefilled syringe or Pen. 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 Pen and prefilled syringe as they contain glass.

Can I store HUMIRA at room temperature?

If needed, for example when traveling, HUMIRA may be stored at room temperature up to a maximum of 77°F (25°C) for a period of up to 14 days, with protection from light. HUMIRA should be discarded if not used within the 14-day period.

When not traveling, your HUMIRA Pen or prefilled syringe should be stored in a refrigerator at 36°F to 46°F (2°C to 8°C) in its original carton until you are ready to use it.

My HUMIRA carton says that it “may be stored at room temperature.” What is considered room temperature?

Room temperature is up to 77°F (25°C). In addition, the HUMIRA Pen or prefilled syringe should be protected from direct sunlight and stored in its original carton until you are ready to use it. HUMIRA may be stored at room temperature for a period up to 14 days, with protection from light. HUMIRA should be discarded if not used within the 14-day period.

How long can I store my HUMIRA Pen or prefilled syringe at room temperature?

Once you remove your HUMIRA Pen or prefilled syringe from the refrigerator, it must be used within 14 days. If not used within the 14 days, it must be discarded.

Can I put my HUMIRA Pen or prefilled syringe back in the refrigerator after I’ve already taken it out and allowed it to reach room temperature?

No. Once your HUMIRA Pen or prefilled syringe has reached room temperature, it must be used within 14 days. HUMIRA that has reached room temperature must be discarded if it is not used within the 14-day period.

What should I do if I have not used my unrefrigerated HUMIRA Pen or prefilled syringe within the 14-day period?

Do not use it and call your pharmacist immediately to let them know that your HUMIRA Pen or prefilled syringe has been stored out of the refrigerator for more than 14 days. Your pharmacist will be able to advise you on how you may obtain a new HUMIRA Pen or prefilled syringe.

Should I record the date when I take my HUMIRA Pen or prefilled syringe out of the refrigerator?

Yes. Record the date when HUMIRA is first removed from the refrigerator in the spaces provided on the carton and dose tray.

Should I inject HUMIRA at room temperature?

If more comfortable, take your HUMIRA Pen or prefilled syringe out of the refrigerator for 15-30 minutes before injecting to allow the liquid to reach room temperature. Do not remove the cap or cover while allowing it to reach room temperature. Do not warm HUMIRA in any other way (for example, do not warm in a microwave or under hot water).

Has HUMIRA changed now that I can leave it at room temperature?

No, the formula of HUMIRA has not changed.

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

Always follow your doctor's instructions about when and how often to take HUMIRA. Do not inject HUMIRA more often than prescribed. If you need additional help with self-injecting, you can view an instructional video.

Will HUMIRA cure my disease?

Unfortunately, there are no current medicines available that can cure your disease.

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

HUMIRA comes in single-use, prefilled Pens or in prefilled syringes. The needle is not removable or reusable. You should always check with your health care 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.

Here are some tips that you may find helpful:

Place your Pen or syringe in an FDA-cleared sharps disposal container right away after use. DO NOT throw away (dispose of) the Pen or syringe in your household trash or recycle the sharps disposal container. If you do not have a sharps disposal container, you may use a household container made of heavy-duty plastic, able to be closed with a tight-fitting, puncture-resistant lid, without sharps being able to come out; upright and stable; leak-resistant; and properly labeled to warn of hazardous waste inside.

You should always keep the sharps container out of the reach of children.

You can sign up to receive sharps containers for HUMIRA Pen or syringe disposal at no additional cost.

When the container is almost full, you should follow your community guidelines for the right way to dispose of your sharps container. For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA's website at http://www.fda.gov/safesharpsdisposal.

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?

You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a tumor necrosis factor (TNF) blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.

Serious infections have happened in people taking HUMIRA. 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 doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA. If your doctor feels you are at risk, you may be treated with medicine for TB.

Cancer. For children and adults taking TNF blockers, including HUMIRA, 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 HUMIRA, 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 doctor if you have a bump or open sore that doesn’t heal.

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.

See more Important Safety Information for HUMIRA.

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

Warning signs of a serious allergic reaction may include hives, swelling of your face, eyes, lips or mouth or trouble breathing. If you experience any of these symptoms, call your doctor or seek emergency care immediately.

The needle cover on the prefilled 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.

Should I get a flu vaccination ("flu shot") if I am taking HUMIRA?

As you may know, HUMIRA affects the immune system and can lower your ability to fight infections like seasonal flu or H1N1. According to the US Centers for Disease Control and Prevention (CDC), the most effective way to prevent the flu is to get an annual vaccination.

There are currently 2 types of vaccines available for H1N1 and the seasonal flu:

  • An injectable form, given with a syringe, does not contain a live form of the virus
  • An intranasal form, which is administered as a mist in your nose, contains a weakened live form of the virus

The intranasal forms are live vaccines, and patients receiving HUMIRA should not receive live vaccines. Always tell any doctor who is treating you about all medications you are taking, including HUMIRA. Consult the doctor who prescribed your HUMIRA before getting any vaccination.

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 prefilled syringe contains dry natural rubber. Tell your doctor if you have any allergies to rubber or latex.

See more Important Safety Information for HUMIRA.

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

Also, see "What is the most important information I should know about HUMIRA?"

Tell your doctor 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, or were born in, lived in, or traveled where there is more risk for getting 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
  • Have or have had hepatitis B
  • Are scheduled for major surgery
  • Have or have had cancer
  • Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome
  • Have or had heart failure
  • Have recently received or are scheduled to receive a vaccine. HUMIRA patients may receive vaccines, except for live vaccines
  • Are allergic to rubber, latex, or any HUMIRA ingredients
  • Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed

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

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?

Also, see "What is the most important information I should know about HUMIRA?"

HUMIRA can cause serious side effects, including:

  • Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
  • Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
  • Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
  • Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
  • Blood problems. 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 rash on your cheeks or arms that gets worse in the sun.
  • Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen).
  • Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.
Common side effects of HUMIRA include injection site reactions (redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nausea. These are not all of the possible side effects with HUMIRA. Tell your doctor if you have any side effect that bothers you or that does not go away.

Remember, call your doctor right away if you have an infection or any signs 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

See more Important Safety Information for HUMIRA.

Can I use HUMIRA if I'm pregnant or breastfeeding?

Tell your doctor if you are pregnant, planning to become pregnant, breastfeeding, or plan to breastfeed. 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. Women and their doctor should decide whether to breastfeed or use HUMIRA. You should not do both.

Your safety is important to us.
Learn about our Important Safety Information.

IMPORTANT SAFETY INFORMATION
ABOUT HUMIRA® (adalimumab)1

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

You should discuss the potential benefits and risks of HUMIRA with your doctor. HUMIRA is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HUMIRA if you have any kind of infection unless your doctor says it is okay.

  • Serious infections have happened in people taking HUMIRA. 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 doctor should test you for TB before starting HUMIRA, and check you closely for signs and symptoms of TB during treatment with HUMIRA. If your doctor feels you are at risk, you may be treated with medicine for TB.

  • Cancer. For children and adults taking TNF blockers, including HUMIRA, 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 HUMIRA, 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 doctor if you have a bump or open sore that doesn’t heal.


What should I tell my doctor BEFORE starting HUMIRA?

Tell your doctor 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, or were born in, lived in, or traveled where there is more risk for getting 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
  • Have or have had hepatitis B
  • Are scheduled for major surgery
  • Have or have had cancer
  • Have numbness or tingling or a nervous system disease such as multiple sclerosis or Guillain-Barré syndrome
  • Have or had heart failure
  • Have recently received or are scheduled to receive a vaccine. HUMIRA patients may receive vaccines, except for live vaccines
  • Are allergic to rubber, latex, or any HUMIRA ingredients
  • Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed

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


What should I watch for AFTER starting HUMIRA?

HUMIRA can cause serious side effects, including:

  • Serious infections. These include TB and infections caused by viruses, fungi, or bacteria. Symptoms related to TB include a cough, low-grade fever, weight loss, or loss of body fat and muscle.
  • Hepatitis B infection in carriers of the virus. Symptoms include muscle aches, feeling very tired, dark urine, skin or eyes that look yellow, little or no appetite, vomiting, clay-colored bowel movements, fever, chills, stomach discomfort, and skin rash.
  • Allergic reactions. Symptoms of a serious allergic reaction include hives, trouble breathing, and swelling of your face, eyes, lips, or mouth.
  • Nervous system problems. Signs and symptoms include numbness or tingling, problems with your vision, weakness in your arms or legs, and dizziness.
  • Blood problems. 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 rash on your cheeks or arms that gets worse in the sun.
  • Liver problems. Symptoms include feeling very tired, skin or eyes that look yellow, poor appetite or vomiting, and pain on the right side of your stomach (abdomen).
  • Psoriasis (new or worsening). Symptoms include red scaly patches or raised bumps that are filled with pus.

Call your doctor or get medical care right away if you develop any of the above symptoms.


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

HUMIRA is given by injection under the skin.


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

 

Uses

 

HUMIRA is a prescription medicine used:

  • To reduce the signs and symptoms of:
    • Moderate to severe rheumatoid arthritis (RA) in adults. HUMIRA can be used alone, with methotrexate, or with certain other medicines. HUMIRA 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. HUMIRA can be used alone, with methotrexate, or with certain other medicines.
    • Psoriatic arthritis (PsA) in adults. HUMIRA can be used alone or with certain other medicines. HUMIRA may prevent further damage to your bones and joints and may help your ability to perform daily activities.
    • Ankylosing spondylitis (AS) in adults.
    • Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in adults who have not responded well to conventional treatments. HUMIRA is also used to reduce signs and symptoms and to achieve clinical remission in these adults who have lost response to or are unable to tolerate infliximab.
    • Moderate to severe Crohn's disease (CD) and to achieve and maintain clinical remission in children 6 years of age and older when certain other treatments have not worked well enough.
  • In adults, to help get moderate to severe ulcerative colitis (UC) under control (induce remission) and keep it under control (sustain remission) when certain other medicines have not worked well enough. It is not known if HUMIRA 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 doctor who will decide if other systemic therapies are less appropriate.

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In This Section


Please see the Full Prescribing Information, including the Medication Guide, for HUMIRA.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

If you cannot afford your medication, contact: www.pparx.org or call the toll-free phone number (1-888-4PPA-NOW) for assistance.

Please see accompanying full Prescribing Information, including Patient Instructions for Use in the Medication Guide and discuss it with your doctor.

Legal Notices/Privacy Policy. Copyright 2013, AbbVie Inc., North Chicago, Illinois, U.S.A. If you have any questions about AbbVie’s HUMIRA.com website that have not been answered click here. This website and the information contained herein is intended for use by US residents only, is provided for informational purposes only and is not intended to replace a discussion with a healthcare provider. All decisions regarding patient care must be made with a healthcare provider and consider the unique characteristics of each patient.

Reference: 1. HUMIRA Injection [package insert]. North Chicago, IL: AbbVie Inc.

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SAFETY CONSIDERATIONS1

Serious infections have happened in people taking HUMIRA. 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. HUMIRA may increase the chance of getting lymphoma, including a rare kind, or other cancers. HUMIRA can cause serious side effects including hepatitis B infection in carriers of the virus, allergic reactions, nervous system problems, blood problems, heart failure, certain immune reactions including a lupus-like syndrome, liver problems, and new or worsening psoriasis.