“HUMIRA ADULT INJECTION VIDEO – SYRINGE” TRANSCRIPT

[Text on Screen] HOW TO INJECT WITH THE HUMIRA PREFILLED SYRINGE

[Text on Screen and Spoken] This demonstration video offers you help and guidance for injecting with the HUMIRA® prefilled syringe. 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 prefilled syringe, 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 syringe in my fridge and call my pharmacy. Now, I’m going to check my syringe. Hold the syringe with the needle pointing down to make sure that the liquid inside is clear and colorless. If it looks 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. And now I’m ready to pick up the syringe. I hold it by its body, making sure that the covered needle is pointing down. Then I check to make sure that the amount of liquid in the syringe is the same dosage that’s been prescribed by my doctor. If it’s not, don’t use it, and call your pharmacist. Holding the syringe in one hand, gently remove the needle cover, careful not to prick yourself or touch the needle with your fingers. Then turn the syringe so that the needle is facing up. Hold it at eye level with one hand, and with your other hand, slowly push the plunger to push the air out through the needle. If you see a drop of liquid at the end of the needle, that’s perfectly normal. All right, 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. Now, hold the body of the syringe between your thumb and index finger, like you’re holding a pencil. You don’t want to pull back on the plunger at any time here. Then, with your other hand, gently squeeze the area of skin you’ve just cleaned and hold it firmly. Make sure you’re holding the syringe at a forty-five degree angle and with a quick, dart-like motion, insert the needle into your squeezed skin. Once the needle is in, let go of your skin and gently pull back the plunger. If you notice any blood in the syringe, it means you’ve entered a blood vessel. If that happens, do not inject. At the same angle, withdraw the needle, place the syringe in your sharps container, and start again with a new syringe. Since no blood appears in my syringe, I’m going to keep going, slowly pushing the plunger all the way in until all the medicine is injected and my syringe is empty. And finally, keeping the syringe at the same angle, I slowly pull the needle out of my skin. Be careful here not to touch the needle and immediately throw away the syringe into a sharps container. Oh, and don’t try to put the cap back on the syringe. Don’t rub the injection site. Instead gently press a 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]: 45°

[Text on Screen] CLEANUP

Use the FDA-cleared sharps container, not your household trash, for your used syringe. 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 syringe 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.

Also, please note that the needle cap of the prefilled syringe contains latex, for those with latex allergies.

[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

Then, prepare the syringe by pulling the needle cover off and slowly pushing the plunger in, to push the air out through the needle.

[Text on Screen] 2: PREPARE

Next, pinch the area of skin that you’ve just cleaned at the injection site.

[Text on Screen] 3: PINCH

Now, push the needle in at a forty-five degree angle, using a quick, short, dart-like motion. And finally, push the plunger all the way while letting go of the pinched skin, until all of the medicine is injected.

[Text on Screen] 4: PUSH

Remember to review the complete 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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