Instructional Video Transcript

[Text on Screen] Administering with the HUMIRA Pen

HUMIRA® (adalimumab)

SUSAN:

Welcome. This demonstration video offers you help and guidance for injecting with the HUMIRA® (adalimumab) Pen. Watch this video and read the entire Patient Instructions for Use found in your HUMIRA package. Don't try to inject HUMIRA yourself until your doctor has decided you can, and you've been shown the right way to give injections.

[Text on Screen Throughout the Video] Please see Uses and Important Safety Information contained within this video. Please see accompanying full Prescribing Information, including Patient Instructions for Use in the Medication Guide, and discuss it with your doctor.

The maker of HUMIRA – AbbVie – also offers 24-hour injection assistance from on-call registered nurses over the phone. Just call 1-800-4-HUMIRA.

[Text on Screen] 1-800-4-HUMIRA (1-800-448-6472)

Hello, I'm Susan – and today I'm going to show you how to inject HUMIRA. To begin, find a comfortable, well-lit place where you feel relaxed. Let's get started.

[Text on Screen] Gather your supplies

With clean hands, gather these items onto a flat, clean surface with room to work:

  • an alcohol swab
  • a cotton ball or gauze pad

[Text on Screen] Not included in your HUMIRA box

  • a HUMIRA Pen – which you've taken from the refrigerator.

[Text on Screen]

  • Store HUMIRA in the refrigerator until used
  • Do not use HUMIRA if frozen, even if it has been thawed.

Please be sure to have a sharps container available to put your Pen into once you've finished your injection.

[Text on Screen] Check your materials

Now let's check your HUMIRA Pen. Look at the two ends. There's a gray cap (Cap #1) and a plum-colored cap (Cap #2).

  • Hold your Pen with gray Cap #1 pointed down.
  • Look through the window to make sure the amount of liquid in the Pen is at – or close to – the fill line.
  • Now flip your Pen over, so that gray Cap #1 is pointed up.
  • Look through the window again. Check that the liquid is clear and colorless. It's normal to see a few bubbles.
  • But if the Pen does not contain the full amount of liquid, or if the liquid is cloudy, discolored or has flakes or particles in it, don't use the Pen and call your pharmacist.

After you've checked your Pen, wash your hands with soap and water, and dry them well. Now you're ready to choose where to inject.

[Text on Screen] Choose and prepare your injection area

You can inject HUMIRA on the front of your thighs or your lower abdomen, or belly. Avoid injecting within two inches of your belly button. Each new injection should be given at least one inch from an area you've used before. Also, don't inject into skin that is sore, tender, bruised, red, hard, scarred or where you have stretch marks or psoriasis patches or lesions. Don't inject through your clothes.

[Text on Screen] If you have psoriasis, avoid injecting into any raised, thick, red or scaly skin patches or lesions on your skin

[Text on Screen] Preparing and injecting HUMIRA

Once you've chosen your injection area, wipe it with your alcohol swab. Don't touch the area again before giving the injection.
Hold the Pen in the middle with one hand, with the gray cap pointing up, trying not to touch the caps at either end. With your other hand, take the cap straight off. Don't twist it. Make sure the small gray needle cover has come off with the gray cap. Don't try to re-cap the Pen. Don't touch the needle. If you see a few drops of liquid come out of the needle, don't worry – it's normal.

[Text on Screen]

  • Don't twist the plum and gray caps when removing them
  • Don't re-cap the Pen

Now from the bottom of the Pen, pull the plum-colored cap straight off – don't twist it – and throw it away. This will reveal the plum-colored button. Again, don't try to put the cap back on the Pen. Flip the Pen so that the plum-colored button is pointing up. Hold it so that you can see the window.

With your free hand, gently squeeze the area of cleaned skin and hold it firmly.

Place the white end of your Pen straight and flat against the raised area of skin that you're squeezing.

Insert the Pen straight at a 90-degree angle against the injection area.

Press the plum-colored button with your index finger or thumb to begin the injection.

You'll hear a loud click when you press the button. This signals the start of the injection. Press the button while holding the Pen firmly against your skin for 10 seconds to make sure that all the medicine is injected. Watch the window – you'll know the injection is finished when you see the yellow marker has stopped moving.

Pull the Pen away from your skin. Be careful to not touch the needle, which is covered by the white needle sleeve.

[Text on Screen] Don't touch the needle

Now that you've finished the injection, you may see a little bleeding in the injection area. Don't worry – that's normal. Briefly hold a cotton ball or gauze pad over the injection area. Don't rub the injection area.

[Text on Screen] Don't rub the injection area

There might be redness, rash, swelling, itching, or bruising. If it doesn't go away within a few days or gets worse, call your doctor right away.

[Text on Screen and Spoken] Be sure to put the used Pen into an FDA-cleared sharps disposal container right after use, and keep it out of the reach of children. Do not throw away the Pen in your household trash. Do not recycle your used sharps disposal 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.

[Text on Screen and Spoken] For more information about safe sharps disposal, and for specific information about sharps disposal in the state you live in, go to the FDA website at www.fda.gov/safesharpsdisposal.

Congratulations, you've done it! Remember to read the entire Patient Instructions for Use – and call your doctor with any questions about injections.

[Text on Screen and Spoken] Of course, you can also call the AbbVie registered nurses with any questions at 1-800-4-HUMIRA. AbbVie is ready to help at every step of your treatment journey.

[Text on Screen]

  • 1-800-4-HUMIRA (1-800-448-6472)
  • Please see Uses and Important Safety Information contained within this video.
  • Please see accompanying full Prescribing Information, including Patient Instructions for Use in the Medication Guide, and discuss it with your doctor.

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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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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