Imbruvica 140 mg Tablets

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IMBRUVICA (ibrutinib) tablets for oral administration are available in the following dosage strengths: 140 mg, 280 mg, 420 mg, and 560 mg.

IMBRUVICA® is dosed once a day as either a single 560-mg tablet or four 140-​mg capsules. Talk to your doctor about which dosing option is right for you.

The dose of ibrutinib should be reduced to 140 mg once daily (one capsule) or withheld for up to 7 days. Each film-coated tablet contains 140 mg of ibrutinib.

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IBRUTINIB (eye BROO ti nib) is a medicine that targets proteins in cancer cells and stops the cancer cells from growing. It is used to treat mantle cell lymphoma, chronic lymphocytic leukemia, small lymphocytic lymphoma, marginal zone lymphoma, Waldenstrom macroglobulinemia, and chronic graft-versus-host disease.

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush or chew this medicine. Do not take with grapefruit juice or eat Seville oranges. Take your medicine at regular intervals. Do not take it more often than directed. Do not stop taking except on your doctor’s advice.

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.

What may interact with this medicine?

This medicine may interact with the following medications:

• antiviral medications for HIV or AIDS
• aprepitant
• boceprevir
• calcium channel blockers like diltiazem and verapamil
• certain antibiotics like clarithromycin, erythromycin, and troleandomycin
• certain medicines for fungal infections like fluconazole, ketoconazole, itraconazole, posaconazole, and voriconazole
• certain medicines for seizures like carbamazepine and phenytoin
• cimetidine
• ciprofloxacin
• clotrimazole
• conivaptan
• crizotinib
• cyclosporine
• digoxin
• dronedarone
• enzalutamide
• fluvoxamine
• grapefruit juice or Seville oranges
• idelalisib
• imatinib
• methotrexate
• mitotane
• nefazodone
• rifampin
• St. John’s wort
• tofisopam

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
• low blood counts •  this medicine may decrease the number of white blood cells, red blood cells and platelets. You may be at increased risk for infections and bleeding
• signs or symptoms of bleeding such as bloody or black, tarry stools; red or dark• brown urine; spitting up blood or brown material that looks like coffee grounds; red spots on the skin; unusual bruising or bleeding from the eye, gums, or nose; confusion; trouble speaking or understanding; severe headaches; weakness; or dizziness
• signs and symptoms of a dangerous change in heartbeat or heart rhythm like chest pain; dizziness; fast or irregular heartbeat; palpitations; feeling faint or lightheaded, falls; breathing problems
• signs and symptoms of infection like fever or chills; cough; sore throat; or pain when urinating
• signs and symptoms of kidney injury like trouble passing urine or change in the amount of urine

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

• bone pain
• diarrhea
• mouth sores
• muscle cramps
• muscle pain
• nausea
• tiredness

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