Humira side effect

by Nathan Wei, MD, FACP, FACR

Nathan Wei is a nationally known board-certified rheumatologist and author of the Second Opinion Arthritis Treatment Kit. It's available exclusively at this website... not available in stores.

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Information from Abbott Laboratories

Adalimumab is a type of drug called a “biologic.”

It reduces the effects of a substance in the body called tumor necrosis factor alpha (TNF-alpha). TNF-alpha is involved in inflammatory processes in the body. Adalimumab is indicated for use in rheumatoid arthritis.

Before using adalimumab, tell your doctor if you

• have an active infection or a history of recurrent infections;
• have ever had tuberculosis (TB) or if you have been in close contact with someone who has had tuberculosis;
• have experienced numbness or tingling or have ever had a disease that affects the nervous system such as multiple sclerosis;
• are scheduled to have major surgery;
• are scheduled to receive any vaccinations; or
• have an allergy to latex or rubber (the needle covers on the pre-filled syringes contain latex).

Serious, even fatal, infections have been reported to occur during treatment with adalimumab. Contact your doctor immediately if you develop signs of infection such as fever or chills, sore throat, coughing, congestion, weight loss, night sweats, or other signs of infection; redness, pain, or swelling of a skin wound; or burning or difficult urination.

A tuberculin skin test should be performed before starting treatment with adalimumab. Latent (inactive) tuberculosis infection may become symptomatic due to treatment with adalimumab.

Treatment with an immunosuppressant such as adalimumab may increase the risk of developing certain types of cancer (e.g., lymphoma). Treatment with adalimumab may also increase the risk of developing an autoimmune disorder such as a lupus-like syndrome.

Adalimumab is in the FDA pregnancy category B. This means that it is not expected to be harmful to an unborn baby. Do not use adalimumab without first talking to your doctor if you are pregnant or could become pregnant during treatment.

It is not known whether adalimumab passes into breast milk. Adalimumab should not be used without first talking to your doctor if you are breast-feeding a baby.

Adalimumab is administered as a subcutaneous (under the skin) injection. Do not inject this medication intramuscularly (into a muscle) or intravenously (into a vein) .

Your doctor or nurse will give you detailed instructions on how to inject adalimumab. It can be injected into the abdomen (avoid the area 2 inches around the navel) or front of the thighs. Rotate the injection sites as directed by your doctor. Each new injection should be given at least one inch from the site you used before.

Do not inject the medication into areas where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.

Do not shake the vials or pre-filled syringes of adalimumab.

Inspect the vial or pre-filled syringe of adalimumab before injection. The liquid should be clear and colorless. Do not use the medication if it is cloudy or discolored, or if it has flakes or particles in it.

Each vial or pre-filled syringe of adalimumab is intended for one use only. Throw away any unused portion of the medication. Do not save it for later use, it does not contain a preservative.

It is important to use adalimumab regularly to get the most benefit.

Dispose of all needles and syringes in an appropriate puncture resistant container.

Store adalimumab in the refrigerator (36 to 46 degrees Fahrenheit or 2 to 8 degrees Celsius) in the original container until it is used. Do not allow the product to freeze and do not use it beyond the expiration date. If the medication needs to be transported during travel, store it in a cool carrier with an ice pack and protect it from light.

If you miss a dose of adalimumab, inject the dose as soon as you remember. Then, inject the next dose when the next scheduled dose is due. Do not use a double dose of the medication.

Contact your doctor if an overdose of adalimumab is suspected. An overdose of adalimumab is unlikely to be harmful.

Adalimumab can lower the activity of the immune system making you susceptible to infections. Avoid contact with people who have colds, the flu, or other contagious illnesses and do not receive "live" vaccines during treatment with adalimumab without first talking to your doctor. In addition, avoid contact with individuals who have recently been vaccinated with a live vaccine. There is a chance that the virus can be passed on to you. Contact your doctor immediately if you develop signs of infection.

Patients on TNF blockers are also at increased risk for tuberculosis and opportunistic fungal infections.

Rare side effects including optic neuritis and a multiple sclerosis like syndrome have been reported with TNF inhibitors.

If you experience any of the following serious side effects, stop using adalimumab and seek emergency medical attention or contact your doctor immediately:

• an allergic reaction (difficulty breathing; closing of the throat; swelling of the lips, tongue, or face; or hives);

• numbness, tingling, or weakness

• problems with vision

• dizziness

• chest pain or shortness of breath

• skin rash on the arms or cheeks that is sensitive to the sun

Other less serious side effects may be more likely to occur. Contact your doctor if you develop:

• headache
• nausea
• redness, rash, swelling, itching, or bruising where the injection was given

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

Other medications may interact with adalimumab or affect your condition. Talk to your doctor or pharmacist before taking other prescription or over-the-counter medications, including herbal products, during treatment with adalimumab.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

The most serious adverse reactions have been:

• Serious Infections.

• Neurologic Events.

• Malignancies.

The most common adverse reaction with HUMIRA was injection site reactions. In placebo-controlled trials, 20% of patients treated with HUMIRA developed injection site reactions (erythema and/or itching, hemorrhage, pain or swelling), compared to 14% of patients receiving placebo. Most injection site reactions were described as mild and generally did not necessitate drug discontinuation.

The proportion of patients who discontinued treatment due to adverse events during the double-blind, placebo-controlled portion of Studies I, n, III and IV was 7% for patients taking HUMIRA and 4% for placebo-treated patients. The most common adverse events leading to discontinuation of HUMIRA were clinical flare reaction (0.7%), rash (0.3%) and pneumonia (0.3%).

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