Say Hello to Hulio

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Reference: 1. Serrecchia T, Waller KA, Ishikawa T, Muniz R, Varricchione TR. Human factors validation for a rheumatoid arthritis auto-injector for the adalimumab biosimilar FKB327. Int J Hum Factors Ergon. 2020;7(2):144-160.

Important Safety Information

What is the most important information I should know about HULIO^® (adalimumab-fkjp)?

You should discuss the potential benefits and risks of HULIO with your doctor. HULIO is a TNF blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HULIO if you have any kind of infection unless your doctor says it is okay.

Serious infections

Serious infections have happened in people taking adalimumab products. 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 HULIO and check you closely for signs and symptoms of TB during treatment with HULIO, 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 HULIO, 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 HULIO, 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 HULIO?

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 HULIO. Ask your doctor if you are unsure if you have lived in an area where these infections are common.
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. HULIO patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting HULIO
Are allergic to HULIO or to any of its ingredients
Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed
Have a baby and you were using HULIO 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 HULIO 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^® (6-mercaptopurine, 6-MP).

What should I watch for AFTER starting HULIO?

HULIO 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.

The most common side effects of HULIO include injection site reactions (pain, redness, rash, swelling, itching, or bruising), upper respiratory infections (sinus infections), headaches, and rash. These are not all of the possible side effects with HULIO. 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

If you have any questions about this information, be sure to discuss them with your healthcare provider. 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. Please see Prescribing Information and Medication Guide.

APPROVED USES

HULIO is a prescription medicine used:

To reduce the signs and symptoms of:
- Moderate to severe rheumatoid arthritis (RA) in adults. HULIO can be used alone, with methotrexate, or with certain other medicines. HULIO 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. HULIO can be used alone or with methotrexate.
- Psoriatic arthritis (PsA) in adults. HULIO can be used alone or with certain other medicines. HULIO 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 adults.
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. It is not known if adalimumab products are effective in people who stopped responding to or could not tolerate TNF-blocker 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.