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| Other drug names: | A B C D E F G H I J K L M N O P Q R S T U V W X Y Z 0-9 |
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[Posted 09/04/2008] FDA notified healthcare professionals that pulmonary and disseminated histoplasmosis, coccidioidomycosis, blastomycosis and other opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-α blockers (TNF blockers). This has resulted in delays in appropriate treatment, sometimes resulting in death. For patients taking TNF blockers who present with signs and symptoms of possible systemic fungal infection, such as fever, malaise, weight loss, sweats, cough, dyspnea, and/or pulmonary infiltrates, or other serious systemic illness with or without concomitant shock, healthcare professionals should ascertain if patients live in or have traveled to areas of endemic mycoses. For patients at risk of histoplasmosis and other invasive fungal infections, clinicians should consider empiric antifungal treatment until the pathogen(s) are identified. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNF2, http://www.fda.gov/cder/drug/InfoSheets/HCP/TNF_blockersHCP.htm and http://www.fda.gov/bbs/topics/NEWS/2008/NEW01879.html. [Posted 06/03/2008] FDA issued an Early Communication About an Ongoing Safety Review to inform healthcare professionals that the Agency is investigating a possible association between the use of Tumor Necrosis Factor (TNF) blockers and the development of lymphoma and other cancers in children and young adults. FDA is investigating approximately 30 reports of cancer in children and young adults. These reports were submitted to FDA's Adverse Event Reporting System over a ten-year interval, beginning in 1998 through April 29, 2008. These reports describe cancer occurring in children and young adults who began taking TNF blockers (along with other immuno-suppressive medicines such as methotrexate, azathioprine or 6-mercaptopurine), when they were ages 18 or less, to treat juvenile idiopathic arthritis, Crohn's disease or other diseases. Approximately half of the cancers were lymphomas, including both Hodgkin's and non-Hodgkin's lymphoma. Long-term studies are necessary to provide definitive answers about whether TNF blockers increase the occurrence of cancers in children because cancers may take a long time to develop and may not be detected in short-term studies. Until the evaluation is completed, healthcare providers, parents, and caregivers should be aware of the possible risk of lymphoma and other cancers in children and young adults when deciding how to best treat these patients. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#TNF and http://www.fda.gov/cder/drug/early_comm/TNF_blockers.htm. |
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Using adalimumab may decrease your ability to fight infection and increase the chance that you will develop a serious or life-threatening infection. Tell your doctor if you have any type of infection now, including minor infections (such as open cuts or sores), or if you have any signs of infection such as fever, cough, or flu-like symptoms. Also tell your doctor if you have or have ever had infections that come and go (such as cold sores) or chronic infections that do not go away, or if you often get any type of infection such as bladder infections. Also tell your doctor if you have or have ever had hepatitis B (a viral infection that affects the liver). Tell your doctor if you have any condition that affects your immune system or if you are taking medications that suppress the immune system such as azathioprine (Imuran), cyclosporine (Neoral, Sandimmune), sirolimus (Rapamune), and tacrolimus (Prograf). If you experience any of the following symptoms during or shortly after your treatment with adalimumab, call your doctor immediately: sore throat; cough; fever; weight loss; extreme tiredness; flu-like symptoms; warm, red, or painful skin; painful, difficult, or frequent urination; or other signs of infection. Adalimumab may increase the risk that you will get some types of infections that are most common in certain parts of the United States and the world. Tell your doctor all the places you previously lived and all the places you recently visited or plan to visit while using adalimumab. You may already be infected with tuberculosis but not have any symptoms of the disease. In this case, adalimumab may make your infection more serious and cause you to develop symptoms. Tell your doctor if you have or have ever had tuberculosis or have been around someone who has or has ever had tuberculosis. Before you begin your treatment, your doctor will perform a skin test to see if you have tuberculosis. If you do have tuberculosis, your doctor will treat this infection with antibiotics before you begin using adalimumab. Talk to your doctor about the risks of using adalimumab. |
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Adalimumab is used alone or with other medications to relieve the symptoms of certain autoimmune disorders (conditions in which the immune system attacks healthy parts of the body and causes pain, swelling, and damage) including:
Adalimumab is in a class of medications called tumor necrosis factor (TNF) inhibitors. It works by blocking the action of TNF, a substance in the body that causes inflammation.
Adalimumab comes as a solution (liquid) to inject subcutaneously (under the skin). It is usually injected once every other week. If you are using adalimumab to treat Crohn's disease, your doctor may tell you to inject the medication more often at the beginning of your treatment. If you are using adalimumab to treat rheumatoid arthritis, your doctor may tell you to inject the medication once a week. To help you remember to inject adalimumab, mark the days you are scheduled to inject it on your calendar. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use adalimumab exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.
You will receive your first dose of adalimumab in your doctor's office. After that, you can inject adalimumab yourself or have a friend or relative perform the injections. Before you use adalimumab yourself the first time, read the written instructions that come with it. Ask your doctor or pharmacist to show you or the person who will be injecting the medication how to inject it.
Adalimumab comes in prefilled syringes and dosing pens. Use each syringe or pen only once and inject all the solution in the syringe or pen. Even if there is still some solution left in the syringe or pen after you inject, do not inject again. Dispose of used syringes and pens in a puncture-resistant container. Talk to your doctor or pharmacist about how to dispose of the puncture-resistant container.
Be careful not to drop or crush the prefilled syringes or dosing pens. These devices are made of glass or contain glass and may break if they are dropped.
You can inject adalimumab anywhere on the front of your thighs or stomach except your navel and the area 2 inches (5 centimeters) around it. To reduce the chances of soreness or redness, use a different site for each injection. Give each injection at least 1 inch (2.5 centimeters) away from a spot that you have already used. Keep a list of the places where you have given injections so that you will not inject in these places again. Do not inject into an area where the skin is tender, bruised, red, or hard or where you have scars or stretch marks.
Always look at adalimumab solution before injecting it. Check that the expiration date has not passed, that the syringe or dosing pen contains the correct amount of liquid, and that the liquid is clear and colorless. Do not use a syringe or dosing pen if it is expired, if it does not contain the correct amount of liquid, or if the liquid is cloudy or contains flakes.
Adalimumab may help control your condition but will not cure it. Continue to use adalimumab even if you feel well. Do not stop using adalimumab without talking to your doctor.
This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Before using adalimumab,
Unless your doctor tells you otherwise, continue your normal diet.
Inject the missed dose as soon as you remember it. Then inject the next dose on your regularly scheduled day. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use a double dose to make up for a missed one.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Adalimumab may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:
Some side effects can be serious. The following symptoms are uncommon, but if you experience any of them or those listed in the IMPORTANT WARNING section, call your doctor immediately:
Using adalimumab may increase the risk of developing certain types of cancers including lymphoma (a cancer of the lymph system). People who have had severe rheumatoid arthritis for a long time may have a greater than normal chance of developing these cancers even if they do not use adalimumab. Talk to your doctor about the risks of using this medication.
Adalimumab may cause other side effects. Call your doctor if you have any unusual problems while using this medication.
If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it in the refrigerator and protect it from light. Do not freeze it. If you are traveling and need to take adalimumab with you, keep it in a cooler with an ice pack and do not expose it to light. Throw away any medication that is outdated or no longer needed or that has been frozen. Talk to your pharmacist about the proper disposal of your medication.
In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.
Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.
Keep all appointments with your doctor.
Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.
It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.
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Last Reviewed - 02/01/2009
AHFS® Consumer Medication Information. © Copyright, 2009. The American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.
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Page last updated: 16 June 2009 |