Humira: Uses, Side Effects, Dosages, Precautions

Humira (adalimumab) is a biologic drug used in the treatment of rheumatoid arthritis (RA) and some other autoimmune and inflammatory diseases to manage symptoms and disease progression. It's a TNF inhibitor (or TNF blocker) that works by blocking the activity of the tumor necrosis factor-alpha (TNFα) protein. 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—which are common effects 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, 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 for people who have 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.

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:

Biosimilars

Biosimilars are what they sound like—drugs designed to work like the biologics they are based on. A biosimilar shouldn'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 taken by subcutaneous (under the skin) self-injection once every 14 days. If that's not effective enough for reducing your symptoms, 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.

Standard Humira Dosages for Adults
INDICATION	INTRODUCTORY	MAINTENANCE
Rheumatoid arthritis	None	40 mg/14 days
Psoriatic arthritis	None	40 mg/14 days
Ankylosing Spondylitis	None	40 mg/14 days
Crohn's disease	160 mg; 80 mg two weeks later	40 mg/14 days
Ulcerative colitis	160 mg; 80 mg two weeks later	40 mg/14 days
Plaque psoriasis	80 mg; 40 mg a week later	40 mg/14 days
Hidradenitis suppurativa	160 mg; 80 mg two weeks later; 40 mg two weeks after that	40 mg/7 days
Uveitis	80 mg; 40 mg a week later	40 mg/14 days

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 adjusted to your child's new weight.

These listed dosages are recommended by the manufacturer.

Standard Humira Dosages for Children
INDICATION	Body Weight	INTRODUCTORY	MAINTENANCE
Juvenile idiopathic arthritis, pediatric uveitis	Varies	None	22-32 lbs 10 mg/14 days 33-65 lbs 20 mg/14 days 66 lbs and up 40 mg/14 days
Pediatric Crohn's disease	37-87 lbs*	Day 1: 80 mg Day 15: 40 mg	Day 29: 20 mg Repeat every 14 days thereafter
Adolescent hidradenitis suppurativa	66-131 lbs* (over age 12)	Day 1: 80 mg Day 8: 40 mg	Day 22: 40 mg Repeat every 14 days thereafter

*Children exceeding weight ranges can take the adult dose.

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.

Recently, Abbvie has introduced a citrate-free formulation, which has the advantage of being less painful. The needle is thinner and a smaller amount of medication is injected, which can reduce discomfort with the injection.

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

The most common side effects with Humira are mild and 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:

You should also avoid live vaccines while on Humira. Keep in mind that most vaccines are not live vaccines, so you can have most of the recommended immunizations. Speak to your doctor about which vaccines are/are not safe for you while on this drug.

While taking Humira, you can also take methotrexate or other non-biologic DMARDs, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics (pain killers), as directed. However, Humira should not be combined with other biologics.

What to Know About Humira (Adalimumab)

An injectable biologic drug for rheumatoid arthritis