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Drug Notebook

FDA Alerts

Special Alerts:

[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, dypsnea, 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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infliximab
(in FLIX i mab)

What is this medicine?
INFLIXIMAB (in FLIX i mab) is used to treat Crohn's disease and ulcerative colitis. It is also used to treat ankylosing spondylitis, psoriasis, and some forms of arthritis.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

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What is the price of this medication and similar alternatives?

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 09/2009. For the most current and up-to-date pricing information, please visit www.drugstore.com. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Remicade 100MG Solution CENTOCOR1/$671.83 or 3/$1975.5

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What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:

  • allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
  • chest pain
  • fever or chills, usually related to the infusion
  • muscle or joint pain
  • red, scaly patches or raised bumps on the skin
  • signs of infection - fever or chills, cough, sore throat, pain or difficulty passing urine
  • swollen lymph nodes in the neck, underarm, or groin areas
  • unexplained weight loss
  • unusual bleeding or bruising
  • unusually weak or tired
  • yellowing of the eyes or skin

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

  • headache
  • heartburn or stomach pain
  • nausea, vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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How should I use this medicine?
This medicine is for injection into a vein. It is usually given by a health care professional in a hospital or clinic setting.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

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What if I miss a dose?
It is important not to miss your dose. Call your doctor or health care professional if you are unable to keep an appointment.

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What may interact with this medicine?
Do not take this medicine with any of the following medications:

  • anakinra
  • rilonacept

This medicine may also interact with the following medications:

  • vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

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Who should NOT use this medication?

  • Doses >5 mg/kg in patients with moderate or severe heart failure. (See Cardiovascular Effects under Cautions.)
  • Known hypersensitivity to infliximab, murine proteins, or any ingredient in the formulation.

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What should I watch for while using this medicine?
Visit your doctor or health care professional for regular checks on your progress.

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

This medicine may make the symptoms of heart failure worse in some patients. If you notice symptoms such as increased shortness of breath or swelling of the ankles or legs, contact your health care provider right away.

If you are going to have surgery or dental work, tell your health care professional or dentist that you have received this medicine.

If you take this medicine for plaque psoriasis, stay out of the sun. If you cannot avoid being in the sun, wear protective clothing and use sunscreen. Do not use sun lamps or tanning beds/booths.

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What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:

  • diabetes
  • exposure to tuberculosis
  • heart failure
  • hepatitis or liver disease
  • immune system problems
  • infection
  • lung or breathing disease, like COPD
  • multiple sclerosis
  • current or past resident of Ohio or Mississippi river valleys
  • seizure disorder
  • an unusual or allergic reaction to infliximab, mouse proteins, other medicines, foods, dyes, or preservatives
  • pregnant or trying to get pregnant
  • breast-feeding

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Can I stop taking the medication if I feel better?
As a general rule, you should always take your medications exactly as prescribed and do not change the dosage or stop taking the medication without first discussing it with your healthcare provider.

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I am on so many medications; do I have to take them all?
This is called polypharmacy—many different medications being used at the same time by one person. Sometimes, being on multiple medications is acceptable and appropriate but at other times it may be problematic. If you are receiving your medications from multiple physicians you need to ensure that they all know what medications you are taking. The best way to do this is to make a list of all the medications you are currently using, including all nutritional supplements, homeopathic remedies, vitamins and over-the-counter drugs (if possible, also include all the diseases you have been diagnosed with). Give a copy to every doctor who takes care of you so they have it on file, this way they can avoid duplicating medications and perhaps even try to consolidate some. After every doctor's visit remember to update the list accordingly. Also, as much as you possibly can, try to use the same pharmacy to fill all your prescriptions, this way any potential drug interactions can be caught and averted.

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Where can I get more information?
More Information

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