HUMIRA Frequently Asked Questions

Whether you have already started on HUMIRA or are considering it, here are some questions you may have. For further assistance, call 1-800-4HUMIRA.

What is HUMIRA?

HUMIRA is a prescription medicine used in adults to help get moderate to severe ulcerative colitis 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.

Safety Considerations

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. Please click here for additional Important Safety Information you should know about HUMIRA and discuss it with your doctor.

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What is HUMIRA and how does it work?

HUMIRA is a medicine called a TNF (tumor necrosis factor) blocker. HUMIRA works by binding TNF and helps block the process of inflammation in the large intestine that is associated with ulcerative colitis. Because TNF blockers, including HUMIRA, affect the immune system, they can lower the ability to fight infections and may cause other serious side effects.

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Can I self-inject HUMIRA?

HUMIRA can be self-injected. However, your first injection should be given under the supervision of a health care professional.

You can 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. 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 may be able to give your injections at home, you should receive training on the right way to prepare and inject HUMIRA. You should also be monitored as required by your doctor.

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, 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.

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When should I use HUMIRA?

HUMIRA can be self-injected. However, your first injection should be given under the supervision of a health care professional.

You can 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. 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 may be able to give your injections at home, you should receive training on the right way to prepare and inject HUMIRA. You should also be monitored as required by your doctor.

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 you are not sure when to inject HUMIRA, or you have any questions, consult your doctor or pharmacist.

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Can I use HUMIRA if I'm taking other medicines for my ulcerative colitis or other conditions?

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).

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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. 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 it 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 as the HUMIRA Pen and prefilled syringe contain glass.

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

The recommended starting dose of HUMIRA for adult patients with ulcerative colitis is 160 mg (milligrams) on day 1 (4 Pens), followed by 80 mg on day 15 (2 Pens). The maintenance dose is 40 mg on day 29 (1 Pen), and 40 mg every other week thereafter. The first dose can be administered as 4 injections in 1 day or as 2 injections per day for 2 consecutive days. Always follow your doctor's instructions about when and how often to take HUMIRA. Your doctor should assess your progress by 8 weeks and decide whether you should continue treatment.

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Will HUMIRA cure my disease?

Unfortunately, there are no current medications available that can cure ulcerative colitis.

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How long before I will start to feel improvement?

In clinical studies, patients were assessed for clinical results after 8 weeks of treatment. Your doctor should assess your progress by 8 weeks and decide whether you should continue treatment.

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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. DO NOT throw the Pen or syringe in the household trash or recycle. Here are some tips that you may find helpful:

Do not dispose of your used sharps container in your household trash unless your community guidelines permit this. Do not recycle your used sharps container.

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

The used alcohol pads, cotton balls, dose trays, and packaging may be placed in your household trash.

Sign up for our no-cost sharps disposal service at myHUMIRA.com or call 1-800-4HUMIRA (1-800-448-6472).

Always keep the sharps container out of the reach of children.

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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.

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.

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

Warning signs 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. Do not continue to use HUMIRA.

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

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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.

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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.

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

HUMIRA affects the immune system and can lower your ability to fight infections like influenza (the flu). According to the US Centers for Disease Control (CDC), the most effective way to prevent the flu is to get an annual vaccination.

There are currently two types of vaccines available for the 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.

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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.

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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.

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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

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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.

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What else can I do to manage my disease besides taking medications?

To better manage your ulcerative colitis, try making changes to your lifestyle and diet, like planning ahead and cutting back on foods that seem to worsen your symptoms. These and other measures may help reduce the severity of symptoms during flare-ups.

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How long has HUMIRA been available to treat moderate to severe ulcerative colitis?

HUMIRA has been available for the treatment of ulcerative colitis since 2012.

HUMIRA is a prescription medicine used in adults to help get moderate to severe ulcerative colitis 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.

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Is it all right to use a Starter Package that is labeled "Crohn's Starter Package" if I was prescribed HUMIRA for ulcerative colitis?

Yes. The dosing and patient instructions for use are the same for ulcerative colitis as they are for Crohn's disease. If you received a Crohn's Disease Starter Package after being prescribed HUMIRA for ulcerative colitis, use it as directed by your doctor.

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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 4 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 for these adults who have lost response to or are unable to tolerate infliximab.
  • 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.

64H-982716


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.

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.

Uses1
Ulcerative Colitis

HUMIRA is a prescription medicine used in adults to help get moderate to severe ulcerative colitis 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.

Crohn's Disease

HUMIRA is a prescription medicine used to reduce signs and symptoms, and to achieve and maintain clinical remission in adults with moderate to severe Crohn’s disease who have not responded well to conventional treatments, and in these adults who have also lost response to or are unable to tolerate infliximab.

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