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Drug Info:

Adalimumab

Brand names: Humira®



Adalimumab Injection

What does adalimumab injection do?

ADALIMUMAB (Humira™) is used to help treat rheumatoid arthritis. Adalimumab may help prevent further damage to your bones and joints, and can decrease arthritis symptoms like joint pain and inflammation. Adalimumab may be used with other drugs used to treat rheumatoid arthritis. Adalimumab is usually given only after an optimal response to other drugs has not been achieved. Adalimumab is not a cure for rheumatoid arthritis. Adalimumab works by blocking a protein in your body called TNF-alpha. This protein can cause inflammation in your joints. Generic adalimumab injection is not yet available.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:
• congestive heart failure
• currently receiving vaccinations
• depressed immune system or other immune disorders
• diabetes
• exposure to tuberculosis
• infection
• multiple sclerosis
• an unusual reaction to adalimumab, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I take this medicine?

Adalimumab is for injection beneath the skin. Follow the directions on the prescription label. You may give adalimumab injections to yourself or receive your injections in a clinic or doctor's office. Your prescriber or health care professional will assist you in preparing and injecting your first dose (or first few doses), then may teach you how to give the injection to yourself. Make sure you or your caregiver understands these instructions. Several educational materials are available from your health care professional to assist you. You may also call the HUMIRA Patient Resource Center at 1—800—4HUMIRA (448—6472) with any questions you may have.

Do not use a pre-filled syringe that has been frozen or exposed to sunlight. The solution in the pre-filled syringe should be clear and colorless. Do not use if the solution has visible particles, flakes, color, or is cloudy. Also, do not use after the expiration date on the syringe.

Usual sites of injection include the abdomen or thighs. Avoid injecting the area that is 2 inches around your belly button. Do not inject tender, bruised, red, stretched, or scarred skin. After inserting the needle into the skin, pull back slightly on the plunger. If blood appears in the syringe, withdraw the needle. Chose a new site and repeat this process with a new syringe (throw away the original syringe and needle). If no blood appears, inject the drug. After injecting the drug, do not rub the site. Slight bleeding may occur. For each injection, chose a new site that is at least 1 inch away from the previous site.

Contact your pediatrician or health care professional regarding the use of this medicine in children. Special care may be needed.

What if I miss a dose?

It is important to receive adalimumab according to the schedule developed by your health care provider. You may want to use a calendar to help you know when your next dose is needed. If you forget to take a dose when you are supposed to, inject a dose right away. Then, give the next dose when your next scheduled dose is due. This will put you back on schedule. Contact your health care professional if you are not sure how you should handle a missed dose. Do not use double or extra doses.

What other medicines can interact with adalimumab?

• anakinra
• etanercept
• infliximab
• vaccines

Tell your prescriber or health care professional about all other medicines that you are taking, including non-prescription medicines, nutritional supplements, or herbal products. Also tell your prescriber or health care professional if you are a frequent user of drinks with caffeine or alcohol, if you smoke, or if you use illegal drugs. These may affect the way your medicine works. Check with your health care professional before stopping or starting any of your medicines.

What do I need to watch for while I take adalimumab?

Visit your prescriber or health care professional for regular checks on your progress. Your symptoms may not improve until 1—2 weeks after the first adalimumab injection. Adalimumab may be given in combination with other agents to treat rheumatoid arthritis such as corticosteroids, anti-inflammatory drugs, methotrexate, and others.

If you get a cold or other infection while receiving adalimumab, call your prescriber or health care professional. Do not treat yourself. Adalimumab may decrease your body's ability to fight infections. Before beginning adalimumab therapy, your prescriber may do a test to see if you have been exposed to tuberculosis.

If you develop persistent fever, cough, weight loss, bruising, bleeding, extreme tiredness or weakness while receiving adalimumab, immediately call your prescriber or health care professional.

If you are going to have surgery or dental work, tell your prescriber or health care professional that you have been taking adalimumab.

What side effects may I notice from taking adalimumab?

Side effects that you should report to your prescriber or health care professional as soon as possible:
• any signs or symptoms of an infection, such as a cough, fever or chills, runny nose, or sore throat
• any signs or symptoms of unusual bruising or bleeding (nose, gums, urine or stool)
• change in vision
• chest pain
• difficulty breathing
• dizziness
• numbness or tingling
• skin rash or hives
• shortness of breath
• thrush
• numbness or tingling
• weakness

Side effects that usually do not require medical attention (report to your prescriber or health care professional if they continue or are bothersome):
• headache
• nausea
• redness, itching, swelling, or bruising at the injection site

Where can I keep my medicine?

Keep out of the reach of children.

Store in the original container and in the refrigerator between 2 and 8 degrees C (36 and 46 degrees F). Do not freeze. The product may be stored in a cool carrier with an ice pack, if needed. Protect from light. Throw away any unused medicine after the expiration date.

The syringe and needle need to be disposed of in a special container. Check with your health care professional for instructions on how to dispose of used vials, needles, and syringes. Do not throw these materials or the special container away in the regular trash or recycling containers. Return the container to your prescriber or health care professional for proper disposal.

Last updated: 1/3/2003 8:54:00 AM

Important Disclaimer: The drug information provided here is for educational purposes only. It is intended to supplement, not substitute for, the diagnosis, treatment and advice of a medical professional. This drug information does not cover all possible uses, precautions, side effects and interactions. It should not be construed to indicate that this or any drug is safe for you. Consult your medical professional for guidance before using any prescription or over the counter drugs.

 
 
Wikipedia: adalimumab
Adalimumab?
Therapeutic monoclonal antibody
Source Human
Target TNF
Identifiers
CAS number 331731-18-1
ATC code L04AA17
PubChem  ?
DrugBank BTD00049
Chemical data
Formula C6428H9912N1694O1987S46 
Mol. mass 144190.3 g/mol
Pharmacokinetic data
Bioavailability 64%
Metabolism  ?
Half life 10-20 days.
Excretion  ?
Therapeutic considerations
Pregnancy cat.

C(AU) B(US)

Legal status

POM(UK) -only(US)

Routes Subcutaneous

Adalimumab (brand name Humira) is the third TNF antagonist, after infliximab and etanercept, to be approved in the U.S. Like infliximab and etanercept, adalimumab binds to TNFα, preventing it from activating TNF receptors; adalimumab was constructed from a fully human monoclonal antibody, while infliximab is a mouse-human chimeric antibody and etanercept is a TNF receptor-IgG fusion protein. TNFα inactivation has proven to be important in downregulating the inflammatory reactions associated with autoimmune diseases. As of February 2007, adalimumab has been approved for the treatment of rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and Crohn's disease, and data have been submitted to the United States Food and Drug Administration (FDA) for expanding the label to include the treatment of plaque psoriasis.

Humira is marketed in both preloaded 0.8 ml syringes and also in preloaded pen devices, both injected subcutaneously, typically by the patient at home. It cannot be administered orally, because the digestive system would destroy the drug.

Humira's manufacturer is Abbott Laboratories.

Lawsuit

In March 2003, British company Cambridge Antibody Technology (CAT), stated its wish to "initiate discussions regarding the applicability of the royalty offset provisions for Humira" Abbott Laboratories in the High Court of London. In November 2004, the trial began. In December 2004, the Judge, The Hon. Mr Justice Laddie, ruled for CAT stating "Abbott was in error when it made its first royalty payment to CAT calculated on the basis that only 2% of the Net Sales was due. It should have calculated on the basis of the full royalty of just over 5% and should have paid and continued to pay CAT accordingly." Abbott later paid CAT $23.7 million.

Safety

According to the product labeling of infliximab, etanercept, and adalimumab, these drugs are in the class of immunosuppressants. After a number of studies and reports of adverse reactions in patients receiving anti-TNF alpha therapy (including serious and sometimes fatal blood disorders, infections and diseases, rare reports of lymphoma and solid tissue cancers, rare reports of serious liver injury, and rare reports of demyelinating central nervous system disorders), the U.S. Food and Drug Administration issued a warning to doctors appearing in the respective product labeling of these drugs instructing them to screen and monitor potential patients more carefully.

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Drug Info. Gold Standard. Copyright © 2008 by Gold Standard. All rights reserved.  Read more
Wikipedia. This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Adalimumab" Read more

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