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HUMIRA Pediatric Ulcerative Colitis Dosing and Administration

You may be used to adjusting your routine around the administration of your child’s pediatric ulcerative colitis (UC) treatment. With HUMIRA, you have options.

Your child’s first dose of HUMIRA must be given under the supervision of a health care professional. The first “starter” dose is administered at the doctor’s office. After proper training, your child’s next dose can be administered at home. At-home administration lets you, or your child, administer treatment with HUMIRA in the comfort of your home.

Administering HUMIRA to your child for the first time

It’s natural to feel nervous the first time you administer HUMIRA to your child, but with your HUMIRA Complete Nurse Ambassador, you will be guided every step of the way*.

Watch the video to learn more about administering treatment to your child:

Are you and your child using the HUMIRA syringe?

Are you and your child using the HUMIRA syringe?

*Nurse Ambassadors are provided by AbbVie and do not work under the direction of your health care professional (HCP) or give medical advice. They are trained to direct patients to their HCP for treatment-related advice, including further referrals.

Tips for creating a comfortable treatment environment

Here are some tips that may help both you and your child feel more at ease during treatment:

  • Develop a routine by administering at the same time on the day your child is due for treatment
  • Choose a quiet and calm place to administer treatment
  • Describe to your child where the administration process will take place and how long it will last
  • Try to get your child to focus on something enjoyable, such as a TV show or an upcoming event
  • Project a positive and confident attitude

If you need help with administering treatment, HUMIRA Complete connects you with your own Nurse Ambassador who is available throughout your child's treatment with HUMIRA.

HUMIRA dosing information for pediatric UC

The important difference between your starting and maintenance doses

Starting Doses

  • Administered on Day 1, Day 8, and Day 15

Maintenance Doses

  • Can be administered at home either every week or every other week

Your child’s first dose of HUMIRA must be given under the supervision of a health care professional. Make sure you have been shown how to administer HUMIRA before you give the treatment to your child. Remember to keep your HUMIRA refrigerated in its original container until ready for use.

Getting started with HUMIRA dosing

Recommended dosing by weight for pediatric UC patients

If your child weighs 44 lbs to 87 lbs

Starting dose

Day 1

80 mg (2 Pens)

Day 8

40 mg (1 Pen)

Day 15

40 mg (1 Pen)

Maintenance dose

Beginning on Day 29

20 mg (1 Syringe) every week or
40 mg (1 Pen) every other week

If your child weighs 88 lbs or more

Starting dose

Day 1

160 mg (2 Pens)*

Day 8

80 mg (1 Pen)

Day 15

80 mg (1 Pen)

*Can be given as a single dose in one day or split over 2 consecutive days

Maintenance dose

Beginning on Day 29

40 mg (1 Pen) every week or
80 mg (1 Pen) every other week

Pediatric patients who turn 18 years of age and are well-controlled on their HUMIRA regimen should continue their prescribed dose.

Your doctor will follow up with you on a regular basis. For more information, refer to the Patient Instructions for Use and the Medication Guide located inside your HUMIRA carton and within the Full Prescribing Information.

Your child should continue taking HUMIRA as directed by your doctor. Remember, HUMIRA is a treatment, not a cure. Your doctor can tell you if and when your child should stop taking HUMIRA. If your child experiences any adverse reactions or discomfort when taking HUMIRA, discuss them with their doctor right away.

Common side effects of HUMIRA include administration site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, rash, and nauseaThese are not all of the possible side effects with HUMIRA. Tell your doctor if your child has any side effect that bothers them or that does not go away.

Read about the Important Safety Information for HUMIRA.

Dosing may vary depending on the product, dosage form, and strength that your child’s doctor has prescribed. Always follow the doctor’s instructions about when and how often your child should take HUMIRA. Refer to the Patient Instructions for Use for the HUMIRA Pen or the prefilled syringe and the Medication Guide for more information.

HUMIRA Citrate-free—less pain immediately following injection.*

*Compared to HUMIRA 40 mg/0.8 mL.

The same HUMIRA, redesigned with your child in mind

  • Thinner, 29-gauge needle
  • Larger viewing window
  • Contains less liquid inside with the same amount of active ingredient (adalimumab)
  • Bold, white numbers on caps
  • Needle cover not made with natural rubber latex

HUMIRA Citrate-free is also available as a prefilled syringe.

Has COVID-19 made paying for your medicine a challenge?

AbbVie may be able to help. Call 1.800.4HUMIRA


HUMIRA Use1

HUMIRA is a prescription medicine used to treat moderate to severe ulcerative colitis in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate TNF-blocker medicines.

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, even if your TB test was negative. 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. These infections may happen or become more severe if you use HUMIRA. Ask your doctor if you are unsure if you have lived in these areas
  • 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. Children should be brought up to date on all vaccines before starting HUMIRA
  • Are allergic to rubber, latex, or any HUMIRA ingredients
  • Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
  • Have a baby and you were using HUMIRA during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines

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 (decreased blood cells that help fight infections or stop bleeding). 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). These problems can lead to liver failure and death.
  • 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 (pain, 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 or with methotrexate.
    • 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 hidradenitis suppurativa (HS) in people 12 years and older.
  • To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
  • To treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. 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.
  • To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults and children 2 years of age and older.

US-HUM-210186

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 are having difficulty paying for your medicine, AbbVie may be able to help. Visit AbbVie.com/myAbbVieAssist to learn more.

HUMIRA Use1

HUMIRA is a prescription medicine used to treat moderate to severe ulcerative colitis in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding

IMPORTANT SAFETY INFORMATION1

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

IMPORTANT SAFETY INFORMATION1

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

HUMIRA Use1

HUMIRA is a prescription medicine used to treat moderate to severe ulcerative colitis in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate TNF-blocker medicines.

IMPORTANT SAFETY INFORMATION1

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, even if your TB test was negative. 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

IMPORTANT SAFETY INFORMATION1

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. 

HUMIRA Use1

HUMIRA is a prescription medicine used to treat moderate to severe ulcerative colitis in adults and children 5 years of age and older. It is not known if HUMIRA is effective in people who stopped responding to or could not tolerate TNF-blocker medicines.

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, even if your TB test was negative. 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. These infections may happen or become more severe if you use HUMIRA. Ask your doctor if you are unsure if you have lived in these areas
  • 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. Children should be brought up to date on all vaccines before starting HUMIRA
  • Are allergic to rubber, latex, or any HUMIRA ingredients
  • Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
  • Have a baby and you were using HUMIRA during your pregnancy. Tell your baby’s doctor before your baby receives any vaccines

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 (decreased blood cells that help fight infections or stop bleeding). 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). These problems can lead to liver failure and death.
  • 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 (pain, 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 or with methotrexate.
    • 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 hidradenitis suppurativa (HS) in people 12 years and older.
  • To treat moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older.
  • To treat moderate to severe ulcerative colitis (UC) in adults and children 5 years of age and older. 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.
  • To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults and children 2 years of age and older.

US-HUM-210186