“HUMIRA ADULT INJECTION VIDEO – PEN” TRANSCRIPT

[Text on Screen] HOW TO INJECT WITH THE HUMIRA PEN

[Text on Screen and Spoken] This demonstration video offers you help and guidance for injecting with the HUMIRA® Pen. Watch it 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.

SARAH:

Hi, I’m Sarah. I’ve been taking HUMIRA for a while now. I have to admit: at first I wasn’t so confident about injecting, but with a little help and practice, it’s become part of my routine. And now, here I am, about to show you how. You may think, “Will I get this right?” I’m here to help you with the process. And of course, you should call your doctor with any questions you might have. Even though a healthcare professional will provide your initial instruction, consider this a refresher. Feel free to watch as many times as you like. OK, I’ll break this down into steps for you. I will also give you a recap based on four quick tips found in your HUMIRA package.

[Text on Screen] SETTING UP

After I wash my hands, I’ll gather the items I need and place them on a clean, flat surface. I’ve got my alcohol swab, a cotton ball or gauze pad, a sharps container, and my HUMIRA Pen, which I’ve taken out of the refrigerator. If it’s more comfortable for you, leave HUMIRA at room temperature for fifteen to thirty minutes before injecting. You’ll want to do this in a well-lit place in your home, where you feel relaxed and have some room. I always check to make sure the medicine hasn’t passed the expiration date. And also, make sure that it’s not frozen, even if it’s been thawed, and that it hasn’t been exposed to direct sunlight. If it has, I won’t use it. I’ll use another pen in my fridge and call my pharmacy. Now, I’m going to inspect the pen. There’s a grey cap, number one, and a plum-colored cap, number two. Holding the pen with the grey cap pointing down, I make sure the liquid inside the window is up to or close to the fill line. Then I turn it over so that the grey cap is pointing up, to check that the liquid is clear and colorless. It’s ok to see a few bubbles. But if you don’t see the full amount of liquid, or if the liquid is cloudy, discolored, or has flakes or particles in it, don’t use it and call your pharmacist.

[Text on Screen] CHOOSING THE INJECTION SITE

Right now, I’m going to inject myself on the front of my thigh. The other site you can use is the lower stomach area.

[Text on Screen] INJECTABLE AREAS

If you choose the lower stomach, make sure it’s at least two inches away from the belly button.

[Text on Screen] 2 INCHES

Each new injection should be at least one inch away from the site you chose the time before.

[Text on Screen] A new injection should be at least 1 inch away from the site you chose the time before.

And my doctor said not to inject into skin that is sore, bruised, red, hard, scarred, raised, thick, has scaly patches, lesions, or stretch marks.

[Text on Screen] Do not inject into skin that is sore, bruised, red, hard, scarred, raised, thick, has scaly patches, lesions, or stretch marks.

And to be sure not to inject through clothing.

[Text on Screen] PREPARING FOR THE INJECTION

With clean hands, I wipe the spot I’ll be injecting with an alcohol pad, careful not to touch the area again. Pick up the pen with the grey cap pointing up. I hold the middle of the pen with one hand, so that I’m not touching either of the caps. With my other hand, I’m going to pull that grey cap straight off, without twisting it. The small grey needle cover inside the cap should come off, along with the cap. You don’t want to recap the pen, and be careful not to touch the needle. If a few drops of liquid come out of the needle, no problem. Now, from the bottom of the pen, I pull the plum-colored cap straight off, which will reveal a plum-colored button. I flip the pen so that the plum-colored button is now pointing up and hold it so I can see the window. I’m still not pressing the button just yet. Now, I’m just about ready to inject.

[Text on Screen] INJECTING

If you’re a little nervous, that’s to be expected. I find that taking a deep breath at this point definitely helps me. With my free hand, I’m going to gently squeeze the area of skin that I’ve cleaned and hold it firmly. I’ll place the white end of my pen straight at a ninety-degree angle and flat against my skin. Then I’ll press the plum-colored button. The loud click you’ll hear signals the start of the injection.

[Text on Screen] 90°

[Text on Screen] ((CLICK))

Now I continue pressing the button and holding the pen against my skin for ten seconds, to make sure that all of the medicine is injected.

[Text on Screen counts up from “:01” to “:10”]

I know the injection is finished when the yellow marker in the window has stopped moving. And then, I pull the pen away from my skin. The white needle sleeve will move to cover the needle tip. Make sure you throw away the pen immediately into a sharps container. Don’t rub the injection site. Instead gently press the gauze or cotton ball for ten seconds. There may be a small amount of fluid or a drop of blood, which is normal. At the injection site, there may 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. All right, we’re just about done.

[Text on Screen] CLEANUP

Use the FDA-cleared sharps container, not your household trash, for your used pen. And of course, it’s important to keep the container out of the reach of children. You can request a new sharps disposal container at no additional cost from the HUMIRA sharps disposal service.

[Text on Screen] For a new sharps container, call 1.800.4HUMIRA or visit HUMIRA.com

When the container is about two-thirds full, request a new container. Remember, do not throw away the pen in your household trash and do not recycle your used sharps container. If you don’t use the HUMIRA disposal service, follow your community guidelines.

[Text on Screen and Spoken] For more information about sharps disposal, go to the FDA website: www.fda.gov/safesharpsdisposal.

OK, that’s it. If you have questions at any time, just pick up the phone and talk to a HUMIRA registered nurse or call your doctor.

[Text on Screen] Call a HUMIRA registered nurse at 1.800.4HUMIRA

I find it helpful to use my phone to keep track of my injections. I also make notes in my calendar so I can remember when and where I’ve already injected.

[Text on Screen] Important Information1

[Text on Screen and Spoken] 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.

[Text on Screen and Spoken] 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.

[Text on Screen and Spoken] If you cannot afford your medication, visit www.pparx.org for assistance.

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

[Text on Screen] QUICK RECAP

Even after you’ve learned how to inject from a healthcare professional, it can be hard to remember all the steps when you start doing it at home. A helpful way to remember is by following the four P’s from the Quick Tips guide, which you’ll find inside the HUMIRA package.

First, pick an injection site, and with washed hands, wipe it clean with an alcohol swab.

[Text on Screen] 1: PICK

Next, pull the grey cap and then the plum-colored cap off the pen.

[Text on Screen] 2: PULL

Once you squeeze the area of skin that you’ve just cleaned at the injection site, place the white end of the pen on the raised area of skin at a ninety-degree angle.

[Text on Screen] 3: PLACE

And finally, press the plum-colored button until you hear a loud click, and hold the pen firmly in place for ten seconds.

[Text on Screen] 4: PRESS

Remember to review the full patient instructions for use included inside the HUMIRA package before giving yourself an actual injection. I hope this video helps you become more comfortable with this.

[Text on Screen] HUMIRA adalimumab destination you

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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