You should discuss the potential benefits and risks of HADLIMA with your doctor. HADLIMA is a tumor necrosis factor (TNF) blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HADLIMA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HADLIMA. 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 HADLIMA, and check you closely for signs and symptoms of TB during treatment with HADLIMA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.
You should discuss the potential benefits and risks of HADLIMA with your doctor. HADLIMA is a tumor necrosis factor (TNF) blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HADLIMA if you have any kind of infection unless your doctor says it is okay. Serious infections have happened in people taking HADLIMA. 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 HADLIMA, and check you closely for signs and symptoms of TB during treatment with HADLIMA, even if your TB test was negative. If your doctor feels you are at risk, you may be treated with medicine for TB.
WHAT IS HADLIMA?
HADLIMA is used to reduce the signs and symptoms of or to treat specific autoimmune or autoinflammatory conditions.
It’s a biosimilar to HUMIRA (adalimumab), meaning it’s as safe and effective as HUMIRA.
WHO IS HADLIMA FOR?
- Moderate to severe rheumatoid arthritis (RA) in adults
- Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older
- Psoriatic arthritis (PsA) in adults
- Ankylosing spondylitis (AS) in adults
- Moderate to severe hidradenitis suppurativa (HS) in adults
- Moderate to severe Crohn’s disease (CD) in adults and children 6 years of age and older
- Moderate to severe ulcerative colitis (UC) in adults
- Moderate to severe chronic plaque psoriasis (Ps) in adults
- Non-infectious intermediate, posterior, and panuveitis in adults
See full list of uses below.
WHAT IS A BIOSIMILAR?
A biosimilar is an FDA-approved medication that is highly similar to its originator biologic medication. A biosimilar also has no clinically meaningful differences from the reference product. This means you can expect the same safety and effectiveness from the biosimilar over the course of treatment as you would the reference product.
Biosimilars may be available at a lower cost than the original biologics.
Cost and coverage for a biosimilar is dependent on the terms and conditions of your individual insurance benefit, including any applicable deductible, co-insurance, or co-payment.
How to use HADLIMA: injections, travel tips, storage, and more
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*Not all patients are eligible to use the co-pay savings card. Certain restrictions apply.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about HADLIMA?
You should discuss the potential benefits and risks of HADLIMA with your doctor. HADLIMA is a tumor necrosis factor (TNF) blocker medicine that can lower the ability of your immune system to fight infections. You should not start taking HADLIMA if you have any kind of infection unless your doctor says it is okay.
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 HADLIMA, and check you closely for signs and symptoms of TB during treatment with HADLIMA, 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 HADLIMA, 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 HADLIMA, your chance of getting 2 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 does not heal.
What should I tell my doctor BEFORE starting HADLIMA?
- 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 HADLIMA. Ask your doctor if you are unsure if you have lived in these areas.
- 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. HADLIMA patients may receive vaccines, except for live vaccines. Children should be brought up to date on all vaccines before starting HADLIMA.
- Are allergic to HADLIMA or any of its ingredients.
- Are pregnant, planning to become pregnant, breastfeeding, or planning to breastfeed.
- Have a baby and were using HADLIMA 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 HADLIMA 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 HADLIMA?
- HADLIMA 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.
- Common side effects of HADLIMA include injection site reactions (pain, 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 HADLIMA. 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
HADLIMA is given by injection under the skin.
This is the most important information to know about HADLIMA. For more information, talk to your health care provider.
Please read the accompanying Medication Guide for HADLIMA, including the information about serious infections and cancers, and discuss it with your doctor. The Instructions for Use and Physician Prescribing Information also are available.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit or call 1-800-FDA-1088.
WHAT IS HADLIMA?
- HADLIMA is a prescription medicine used:
- To reduce the signs and symptoms of:
- Moderate to severe rheumatoid arthritis (RA) in adults. HADLIMA can be used alone, with methotrexate, or with certain other medicines.
- Moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2 years of age and older. HADLIMA can be used alone or with methotrexate.
- Psoriatic arthritis (PsA) in adults. HADLIMA can be used alone or with certain other medicines.
- 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 (lasting a long time) plaque psoriasis (Ps) in adults who have the condition in many areas of their body and who may benefit from taking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light alone or with pills).
- To treat non-infectious intermediate (middle part of the eye), posterior (back of the eye), and panuveitis (all parts of the eye) in adults.
- To reduce the signs and symptoms of: