What to Know About Humira (Adalimumab)

Humira (adalimumab) is a biologic drug used in the treatment of rheumatoid arthritis (RA) and some other autoimmune and inflammatory diseases to both manage symptoms and disease progression. It works by blocking the activity of a protein known as tumor necrosis factor-alpha (TNFα)—why Humira, and drugs like it, are called TNF inhibitors or TNF blockers. Humira comes in liquid form and you inject yourself with it at home.

Approved in 2002, Humira was the third TNF inhibitor. Generic forms of Humira are not available. However, several biosimilars are on the market.

Uses

Normally, TNFα helps your immune system fight infection, but in excess amounts, it can cause painful inflammation and severe joint damage—common symptoms of RA, other forms of inflammatory arthritis, and autoimmune diseases. Drugs like Humira have helped a lot of people with these diseases by:

• Relieving pain
• Improving joint function
• Slowing disease progression

Humira is a fully-humanized monoclonal antibody. As with all biologics, it's made from biological material. "Fully humanized" means that it's made from cloned human antibodies (earlier TNF inhibitors use combinations of rodent and human DNA).

Humira is approved by the U.S. Food and Drug Administration (FDA) to treat multiple conditions in adults and children/adolescents.

• Rheumatoid arthritis: Adults with moderately-to-severely active RA
• Ankylosing spondylitis (AS): Adults with active AS
• Psoriatic arthritis (PsA): Adults with active PsA
• Juvenile idiopathic arthritis (JIA): Children age 2 or older with moderately-to-severely active polyarticular JIA
• Plaque psoriasis (Ps): Adults with moderate-to-severe Ps who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate
• Ulcerative colitis (UC): Adults with moderate-to-severe UC who've had an inadequate response to immunosuppressants
• Crohn's disease (CD): Adults with moderate-to-severe CD who've had an inadequate response to conventional therapy or have become unresponsive to infliximab
• Pediatric Crohn's disease: Children age 6 and older with moderate-to-severe CD who've had an inadequate response to corticosteroids or immunomodulators
• Hidradenitis suppurativa (HS): Moderate-to-severe HS in people age 12 and older
• Uveitis (UV): Non-infectious intermediate, posterior, and panuveitis in adults and children age 2 and older

Off-Label

Humira is sometimes used off-label (i.e., for conditions it's not FDA approved to treat), especially for the adolescent forms of adult diseases for which the drug is approved. Safety data are available for children as young as 2.

Other frequent off-label uses include:

• Behçet's disease, especially for ocular (eye) manifestations
• Scleritis
• Sarcoidosis
• Non-infectious ocular inflammation
• Pyoderma gangrenosum
• Other autoimmune diseases, including lupus and Sjögren's syndrome
• Other inflammatory diseases

Humira may also be used off-label as part of an early, aggressive treatment strategy that's common in people with undifferentiated arthritis, a diagnosis that often comes before full-blown RA is apparent.

Before Taking

TNF inhibitors typically are considered second-line treatments. Doctors generally won't prescribe one until you've tried at least one disease-modifying antirheumatic drug (DMARD), such as methotrexate or sulfasalazine. If you can't tolerate a DMARD or it's not effective enough to keep your symptoms under control, you may be given Humira in addition to your current medication or as a replacement for it.

Talk to your doctor about all medications, supplements, and vitamins that you currently take. While some drugs pose minor interaction risks when taken with Humira, others may outright contraindicate use or prompt careful consideration as to whether the pros of treatment outweigh the cons in your case.

Precautions and Contraindications

Humira may not be safe for some people. Before you start taking this drug, let your doctor know if you have:

• A known allergy to adalimumab or any of the drug's ingredients
• An active infection
• Uncontrolled diabetes or another condition that may make you prone to infection
• Active hepatitis B or you are a carrier
• Numbness, tingling
• Multiple sclerosis
• A central nervous system disorder
• Previous heart failure

Animal studies do not link this drug to fetal harm or birth defects. Statistics of human pregnancies and births show a slight increase in the association with birth defects and pre-term delivery; however, this may be due to disease activity rather than the drug.

Still, Humira is not recommended during pregnancy or breastfeeding. It does cross through the placenta and could impact your baby's immune response during the third trimester.

You may need to delay starting Humira if you plan to have surgery or get vaccinations in the near future.

Other TNF Inhibitors

When choosing a biologic TNF inhibitor for you, your doctor may consider Humira or any of the similar drugs on the market, including:

• Cimzia (certolizumab pegol)
• Enbrel (etanercept)
• Remicade (infliximab)
• Simponi (golimumab) 

Biosimilars

Biosimilars are what they sound like—drugs designed to work like the biologics they are based on. A biosimilar can't have any meaningful differences from its reference drug, including (and especially) its level of effectiveness.

Biosimilars for Humira include:

• Abrilada (adalimumab-afzb)
• Amjevita (adalmimumab-atto)
• Cyltezo (adalimumab-adbm)
• Hadlima (adalimumab-bwwd)
• Hulio (adalimumab-fkjp)
• Hyrimoz (adalimumab-adaz)

These drugs are less expensive than biologics. But your pharmacist can't substitute a biosimilar for a biologic—even if your doctor gives them the OK. An entirely new prescription must be written for such a drug.

Biosimilars also exist for Enbrel and Remicade. As of mid-2020, none were available for Simponi and Cimzia.

Dosage

Humira is given by subcutaneous (under the skin) self-injection once every 14 days. If that's not effective enough for RA, your doctor may increase this to once every week.

The drug is available in a single-use, pre-filled syringe or a single-use, disposable injector pen. Available dosages include 10 milligrams (mg), 20 mg, 40 mg, and 80 mg.

For some conditions, Humira has a short-term introductory dosage that's different from the long-term maintenance dosage. Always be sure to carefully follow the instructions from your doctor.



Modifications for Children

Humira dosages for children and adolescents are based on weight. In some cases, the dosage remains the same as for adults. In others, it must be lowered.

Be sure to notify your doctor if your child gains weight or has a growth spurt between refills to ensure the dose is high enough to remain effective.

These listed dosages are recommended by the manufacturer.



How to Take and Store

Injection is fairly simple since the syringe and pen both come pre-filled with the correct dose of Humira.

Your doctor's office should offer you some training on how to inject yourself. The medication should also come with an information packet that instructs you on proper use. AbbVie, the manufacturer, also offers training videos on its website.

Humira needs to be kept cold. It will be delivered to you in an insulated container, and you should put it in the refrigerator immediately (unless you're planning to use it right away). Do not freeze this medication, and don't use it if it's ever been frozen.

The drug needs to be protected from light. Keep it in the original packaging until you're ready to use it.

On injection days, take the medication out of the refrigerator and let it naturally warm up to room temperature. Don't try to warm it up faster.

If you'll be traveling or are otherwise unable to keep your Humira cold, it can be stored at room temperature (up to a maximum of 77 degrees F) for up to two weeks. If it stays unrefrigerated for longer than 14 days or exceeds this temperature, do not use it.

Side Effects

With Humira's pluses, like any drug, come potential negatives. It's important to be aware of what's considered normal and what should prompt you to call your doctor.

Common

Typically mild side effects associated with Humira that are experienced most often include:

• Mild injection site reactions
• Rash
• Headache
• Nausea
• Back pain

This should diminish over time. If they do not or become severe, contact your doctor.

Severe

Less often, more severe side effects can occur. You should call your doctor or get medical help right away if you experience:

• Numbness or tingling
• Vision problems
• Leg weakness
• Chest pain
• Shortness of breath
• Rash that's sensitive to sunlight
• New joint pain
• Signs of infection (e.g., fever, chills, sore throat)
• Unusual bruising or bleeding
• Pale skin
• Dizziness
• Red, scaly patches or pus-filled bumps on your skin

An allergic reaction to a medication can be life-threatening and warrant immediate emergency care. Signs of an allergic reaction can include:

• Hives
• Itching
• Tightening in the throat (difficulty breathing, swallowing)
• Swelling (edema) in your face, legs, or feet

Warnings and Interactions

Humira suppresses your immune system. As with all TNF inhibitors, it comes with two black-box warnings (the FDA's most serious warning type):

• Serious infections: Humira increases your risk of tuberculosis, sepsis, fungal and other infections.
• Certain types of cancer: In clinical trials, some patients had higher rates of cancer and lymphoma over a period of 24 months. Some adolescents and young adults have developed a rare type of lymphoma called hepatosplenic T-cell lymphoma while taking TNF inhibitors.

Humira may also worsen the symptoms of nervous system diseases, including demyelinating disorders. A condition called lupus-like syndrome is also associated with using this drug.

Drug Interactions

Some drugs can cause problems when used together. Because of an increased risk of severe infections, Humira shouldn't be combined with:

• Orencia (abatacept)
• Kineret (anakinra)
• Other TNF inhibitors

You should also avoid live vaccines while on Humira. Instead of avoiding all vaccines, speak to your doctor about which are/are not safe for you while on this drug.