What You Need to Know About Humira (Adalimumab)

Adalimumab, more commonly known as Humira, is a biologic drug that works by blocking a protein known as TNF-alpha. Normally, TNF-alpha helps fight infection, but in excess amounts, it can cause painful inflammation and severe joint damage (i.e. common symptoms of rheumatoid arthritis and other forms of inflammatory arthritis). Drugs like Humira have helped many rheumatoid arthritis patients by relieving pain, improving joint function, and slowing disease progression.

Humira is a fully humanized monoclonal antibody. This means that, even though it is made in non-human biologic systems, the actual protein makeup of the drug is identical to that of human antibodies. And this distinguished Humira from the monoclonal antibody TNF blocker that was approved before it—its protein composition was derived in part from a non-human (mouse) antibody.

In 2002, Humira was first approved by the U.S. Food and Drug Administration (FDA) as a treatment for rheumatoid arthritis. It is one of the several biologic drugs that block TNF-alpha, including:

• Enbrel (Etanercept): The first anti-TNF drug approved by the FDA for rheumatoid arthritis and certain inflammatory types of arthritis in 1998.
• Remicade (Infliximab): The second TNF inhibitor to be approved by the FDA in 1999.
• Simponi (Golimumab): Approved by the FDA on April 24, 2009. 
• Cimzia (Certolizumab Pegol): Approved by the FDA on May 14, 2009.

Humira is given by subcutaneous (under the skin) self-injection once every two weeks. Patients may be advised by their doctor to inject it every week if every 14 days is not enough.

It was first available in a single use, pre-filled syringe. A single use, the disposable delivery system has also been developed, known as the Humira Pen.

The recommended dose, however, is 40mg as a subcutaneous self-injection using the pre-filled syringe or Humira pen every other week. Methotrexate, other non-biologic DMARDs, glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), or analgesics (pain medications) may be continued while being treated with Humira. However, other biologic DMARDs should not be used.

More indications have been added for Humira since it was initially approved by the FDA. It may be prescribed to also treat:

• Rheumatoid Arthritis
• Ankylosing Spondylitis
• Psoriatic Arthritis
• Juvenile Idiopathic Arthritis
• Plaque Psoriasis
• Ulcerative Colitis
• Adult and Pediatric Crohn's Disease
• Hidradenitis Suppurativa

Common side effects associated with Humira include:

• Mild injection site reaction
• Rash
• Headache
• Stomach upset or nausea
• Pneumonia

Adverse Reactions

Because it suppresses the immune response in the body which normally fights off infection, Humira has been associated with serious infections, such as tuberculosis, sepsis, and fungal infections. It may also worsen the symptoms of diseases of the nervous system (e.g., demyelinating disorders). In clinical trials, some patients had higher rates of cancer and lymphoma over a period of 24 months.

Who Should Not Take Humira

Humira should not be used by patients with a known allergy to the drug or its components. It is also not to be used by patients who are pregnant or nursing.

The drug should not be prescribed for a patient who has an active infection or patients who are predisposed to infection, including patients with uncontrolled diabetes or patients who have a history of recurring infections.

Tell Your Doctor

• If you have an active infection
• If you have been infected with Hepatitis B or are a carrier (Humira has been associated with reactivation of Hepatitis B)
• If you have numbness, tingling, or multiple sclerosis or a central nervous system disorder
• If you have been treated for heart failure
• Before receiving any vaccines or surgery

To report suspected adverse reactions, you may contact AbbVie Inc.at 1-800-633-9110 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.