adalimumab (Humira)

Rheumatoid arthritis

Humira is indicated for reducing signs and symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in adult patients with moderately to severely active rheumatoid arthritis. HUMIRA can be used alone or in combination with methotrexate or other disease-modifying anti-rheumatic drugs (DMARDs).

Psoriatic arthritis

Humira is indicated for reducing signs and symptoms of active arthritis, inhibiting the progression

of structural damage, and improving physical function in patients with psoriatic arthritis. Humira can be
used alone or in combination with DMARDs.

Ankylosing spondylitis

Humira is indicated for reducing signs and symptoms in patients with active ankylosing spondylitis.

Crohn’s disease

Humira is indicated for reducing signs and symptoms and inducing and maintaining clinical

remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate
response to conventional therapy. Humira is indicated for reducing signs and symptoms and inducing
clinical remission in these patients if they have also lost response to or are intolerant to infliximab.

Plaque psoriasis

Humira is indicated for the treatment of adult patients with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy, and when other systemic therapies are medically less appropriate. Humira should only be administered to patients who will be closely monitored and have regular follow-up visits with a physician.

How does humira work?

Adalimumab is an injectable protein(antibody) that blocks the inflammatory effects of tumor necrosis factor alpha (TNF alpha) in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and Crohn 's disease of the intestine. 

Inflammation is the body's reaction to injury and is a necessary process for the repair of injury. TNF is a protein that the body produces when there is inflammation. TNF promotes inflammation and the signs of inflammation, which, in the case of arthritis, include fever as well as pain, tenderness, and swelling of joints.

In the case of Crohn's disease, the signs of inflammation include fever, abdominal pain, and diarrhea. The unchecked inflammation of rheumatoid arthritis eventually leads to destruction of the joints. The inflammation in Crohn's disease can lead to strictures (narrowing) of the intestine or intestinal perforation.

Adalimumab is a synthetic (man-made) antibody that binds to TNF in the body and thereby blocks the effects of TNF. As a result, inflammation and its consequences in the joints and intestine are reduced. In arthritis, the progressive destruction of the joints is slowed or prevented. Adalimumab is a disease modifying anti-rheumatic drugs (DMARD) because it slows or prevents destruction of joints.

Adalimumab was approved by the FDA in December 2002.

What brand names are available for adalimumab?

Humira

Is adalimumab available as a generic drug?

No

Do I need a prescription for adalimumab?

Yes

Like other drugs that block TNF, use of adalimumab also has been associated with serious infections such as tuberculosis, sepsis (bacteria in the blood) and fungal infections.

Individuals with active infections should not be treated with adalimumab. Adalimumab also may worsen the symptoms of diseases of the nervous system. In studies some patients who used adalimumab or other TNF blocking drugs developed cancer. Since patients with rheumatoid arthritis have a higher rate of cancers than the general population, the connection between cancer and use of adalimumab is unclear.

The most common side effects are:

• headache,
• rash,
• nausea and
• stomach upset.

Adalimumab may cause swelling, redness, pain and itching at the site of injection. Adalimumab suppresses the immune system and is therefore associated with minor infections of the urinary tract, respiratory tract, and sinuses. 

Other side effects of adalimumab include:

• hypersensitivity reactions (including anaphylaxis) and
• reduced levels in the blood of platelets and red cells (aplastic anemia).

Adalimumab may increase the risk of reactivating hepatitis B virus in chronic carriers of the virus.

Humira is administered by subcutaneous injection.

Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis

40 mg every other week. Some patients with RA not receiving methotrexate may benefit from increasing the frequency to 40 mg every week.

Crohn's Disease

Initial dose (Day 1) is 160 mg (four 40 mg injections in one day or two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later (Day 15). Two weeks later (Day 29) begin a maintenance dose of 40 mg every other week.

Plaque Psoriasis

80 mg initial dose, followed by 40 mg every other week starting one week after initial dose.

Adalimumab has not been adequately studied in pregnant women.

Use of adalimumab by nursing mothers has not been adequately evaluated.

What preparations of adalimumab are available?

Prefilled glass syringe: 20 mg/0.4 ml and 40 mg/0.8 ml; Prefilled pen: 40 mg/0.8 ml.

How should I keep adalimumab stored?

Adalimumab should be refrigerated at 2-8 C (36-46 F).