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 arthritis patients by relieving pain, improving joint function, and slowing disease progression.
Humira is a fully human monoclonal antibody, meaning it is manufactured in a laboratory using human proteins, and no animal proteins.
'Biologic' Class of Drugs:
Humira was approved by the U.S. Food and Drug Administration (FDA) in 2002. It is one of several biologic drugs that block TNF-alpha. Humira was the third TNF blocker approved.
Enbrel was the first anti-TNF drug, also referred to as TNF inhibitors or TNF blockers, approved by the FDA in 1998. Enbrel is derived by introducing human DNA into Chinese hamster ovary cells and creating a genetically engineered protein.
Remicade was the second TNF inhibitor approved by the FDA in 1999. Remicade uses human and mouse proteins to create a monoclonal antibody.
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.
Conditions Humira Treats:
Humira has been approved by the FDA 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.
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
- stomach upset or nausea
Because it suppresses the body's inflammation abilities (which fights off infections), 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.
Drugs that Should or Should Not Be Used With Humira:
If you are using Humira, the following drugs may be continued per instructions of your doctor:
Other biologic DMARDs should not be used with Humira.
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.
- Tell your doctor before receiving any vaccines or surgery.
Sources: Zashin, M.D., Scott J.. Arthritis Without Pain. Sarah Allison Publishing Company, 2004.
Humira. Abbott laboratories. 27 Nov 2006.