Humira (adalimumab) - What You Need to Know

A Fully-Human Monoclonal Antibody

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Image from Abbott

Humira (adalimumab) 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 -- 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, meaning 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. That distinguished Humira from the monoclonal antibody TNF blocker that was approved before it because its protein composition is derived in part from a non-human (mouse) antibody.

Humira Was Third Biologic Approved for Rheumatoid Arthritis

Humira was initially approved by the U.S. Food and Drug Administration (FDA) in 2002 as a treatment for rheumatoid arthritis. It is one of several biologic drugs that block TNF-alpha. Enbrel (etanercept) was the first anti-TNF drug approved by the FDA for rheumatoid arthritis and certain inflammatory types of arthritis in 1998. Remicade (infliximab) was the second TNF inhibitor to be approved by the FDA in 1999. Simponi (golimumab) was approved by the FDA on April 24, 2009.

  Cimzia (certolizumab pegol) was FDA-approved on May 14, 2009.

Dosing Information

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

Humira was first available in a single use, pre-filled syringe.

A single use, disposable delivery system has also been developed and is known as the Humira Pen.

Indications for Humira

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

The Recommended Dose

The recommended dose of Humira is 40 mg., 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 with Humira.

Who Should Not Take Humira

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

The drug also 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.

Common Side Effects

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. Humira also may 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.

Important Points to Remember About Humira

  • Tell your doctor if you have an active infection.
  • Tell your doctor if you have been infected with Hepatitis B or are a carrier. Humira has been associated with re-activation of Hepatitis B.
  • Tell your doctor if you have numbness, tingling, or have had multiple sclerosis or a central nervous system disorder.
  • Tell your doctor if you have been treated for heart failure.
  • Talk to your doctor 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.

Sources:

Zashin, M.D., Scott J.. Arthritis Without Pain. Sarah Allison Publishing Company, 2004.

Humira. Abbott laboratories. Prescribing Information. Revised 03/2016.
http://www.rxabbvie.com/pdf/humira.pdf

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