HUMIRA (adalimumab): The Biography Video TranscriptANNCR VO:
The following is a video about HUMIRA (adalimumab) and its use in moderate to severe chronic plaque psoriasis. Please listen to the Safety Considerations at the end of this video.DR. OKUN:
I studied a variety of different areas of medicine in medical school and dermatology was the one that was most interesting to me. I myself had a skin problem when I was younger so I appreciated how important it was to have good healthy skin and how much people who have skin diseases suffer.
The generic name of HUMIRA is adalimumab. Each syllable of the name has particular significance. 'Ada' is unique to the molecule. The 'lim' syllable means that it is targeting a cytokine, in this case tumor necrosis factor or TNF. The 'u' means that it's fully human, and the 'mab' means it's a monoclonal antibody. Put it all together, you get adalimumab.
HUMIRA treats 7 diseases: What all 7 have in common is that all the diseases have overproduction of TNF.
TNF stands for tumor necrosis factor. TNF is a cytokine, a protein produced by the body that stimulates inflammation. If too much TNF is produced underneath the skin, the skin gets red and inflamed and thickened, you get the signs and symptoms of psoriasis.
HUMIRA has the ability to bind specifically to TNF, sort of like a sponge soaking up the excess TNF that's underneath the skin of psoriasis patients, and by not permitting this protein to cause inflammation, it reduces the inflammation that's occurring in the patient's skin.
In our largest clinical trial at month 4 about 7 out of 10 patients experienced at least 75% improvement in their psoriasis - and about 6 out of 10 patients became clear or almost clear. Because HUMIRA blocks TNF-alpha, patients may be at increased risk for serious infections. They need to monitor themselves for fevers, sweats, chills, cough, anything that makes them suspicious that they may be coming down with a serious infection.
HUMIRA is made in a manufacturing facility in Puerto Rico. I've been there once, it's incredible. It's like out of a science fiction movie. Everybody wearing these suits and multiple layers of protection to make sure that nothing gets contaminated. We're talking about manufacturing something that's going to be injected into people's body. We want to be as sure as humanly possible that what is being injected is free of any contaminants. The scientists and technicians who make HUMIRA are devoted to improving the health of patients.
I wake up in the morning thinking about what I can do to improve patients’ health. And before I go to sleep at night, I review what I've done to see if I've made a difference.
AbbVie is a patient-focused organization that is committed to improving the lives of patients. The science and innovation that we’ve done over the past 20 years has led us to HUMIRA which is having a huge impact on the lives of patients. We want to do more, we want to advance on what we've already done and try to come up with better and better therapies in the future.ANNCR VO:
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.
Common side effects of HUMIRA include injection site reactions (such as redness, rash, swelling, itching, or bruising), upper respiratory infections (including sinus infections), headaches, rash, and nausea.
For additional important safety information about HUMIRA, please refer to this Web page.
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
- 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. 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
- 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.
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 certain other medications. 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.
- Moderate to severe hidradenitis suppurativa (HS) in adults.
- 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.
- To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye) and panuveitis (all parts of the eye) (UV) in adults.