"The U.S. Food and Drug Administration today approved Imbruvica (ibrutinib) to treat patients with mantle cell lymphoma (MCL), a rare and aggressive type of blood cancer.
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Read the Patient Information that comes with ARRANON before you or your child start treatment with ARRANON. Read the information you get each time before each treatment with ARRANON. There may be new information. This information does not take the place of talking with the doctor about your or your child's medical condition or treatment. Talk to your or your child's doctor, if you have any questions.
What is the most important information I should know about ARRANON?
ARRANON may cause serious nervous system problems including:
- extreme sleepiness
- numbness and tingling in the hands, fingers, feet, or toes (peripheral neuropathy)
- weakness and paralysis
Call the doctor right away if you or your child has the following symptoms:
- numbness and tingling in the hands, fingers, feet, or toes
- problems with fine motor skills such as buttoning clothes
- unsteadiness while walking
- increased tripping while walking
- weakness when getting out of a chair or walking up stairs
These symptoms may not go away even when treatment with ARRANON is stopped.
What is ARRANON?
ARRANON is an anti-cancer medicine used to treat adults and children who have:
What should you tell the doctor before you or your child starts ARRANON?
Tell the doctor about all health conditions you or your child have, including if you or your child:
- have any nervous system problems.
- have kidney problems.
- are breast-feeding or plan to breast-feed. It is not known whether ARRANON passes through breast milk. You should not breast-feed during treatment with ARRANON.
- are pregnant or plan to become pregnant. ARRANON may harm an unborn baby. You should use effective birth control to avoid getting pregnant. Talk with your doctor about your choices.
Tell the doctor about all the medicines you or your child take, including prescription and nonprescription medicines, vitamins, and herbal supplements.
How is ARRANON given?
ARRANON is an intravenous medicine. This means it is given through a tube in your vein.
What should you or your child avoid during treatment with ARRANON?
- You or your child should not drive or operate dangerous machines. ARRANON may cause sleepiness.
- You or your child should not receive vaccines made with live germs during treatment with ARRANON.
What are the possible side effects of ARRANON?
ARRANON may cause serious nervous system problems. See “What is the most important information I should know about ARRANON?”
ARRANON may also cause:
- decreased blood counts such as low red blood cells, low
white blood cells, and low platelets. Blood tests should be done regularly to
check blood counts. Call the doctor right away if you or your child:
- is more tired than usual, pale, or has trouble breathing
- has a fever or other signs of an infection
- bruises easy or has any unusual bleeding
- stomach area problems such as nausea, vomiting, diarrhea, and constipation
- blurry eyesight
Call your doctor right away if you experience unexplained muscle pain, tenderness, or weakness while taking ARRANON. This is because on rare occasions, muscle problems can be serious.
These are not all the side effects associated with ARRANON. Ask your doctor or pharmacist for more information.
General Advice about ARRANON
This leaflet summarizes important information about ARRANON. If you have questions or problems, talk with your or your child's doctor. You can ask your doctor or pharmacist for information about ARRANON that is written for healthcare providers or it is available at www.GSK.com.
Last reviewed on RxList: 2/15/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Arranon Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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