Imbruvica

For the treatment of chronic lymphocytic leukemia, Waldenström's macroglobulinemia, or chronic graft versus host disease, the recommended adult dose of Imbruvica (Ibrutinib) is 420 mg taken by mouth, once daily.

For the treatment of mantle cell lymphoma or marginal zone lymphoma, the recommended adult dose of Imbruvica (Ibrutinib) is 560 mg taken by mouth, once daily.

In order to keep a constant amount of Imbruvica (Ibrutinib) in your body, so it can be most effective, try to take Imbruvica (Ibrutinib) at the same time every day. The capsules should be swallowed whole. Do not crush, chew, or open the capsules.

Imbruvica (Ibrutinib) may be taken with food or on an empty stomach. Avoid grapefruit juice and Seville oranges while you are taking Imbruvica (Ibrutinib).

It is important to drink plenty of fluids while you are taking Imbruvica (Ibrutinib). This will help keep your kidneys working properly and help to keep you hydrated.

Many things can affect the dose of medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take Imbruvica (Ibrutinib) exactly as prescribed by your doctor.

If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store Imbruvica (Ibrutinib) at room temperature, protect it from light and moisture, and keep it out of the reach of children.

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

In addition to its desired action, this medication may cause some adverse effects, notably: it may decrease your appetite; it may cause headaches; it may cause diarrhea; it may cause dizziness - use caution when getting up from a lying or sitting position and use caution if driving; it may cause unusual tiredness; it may cause nausea or, rarely, vomiting; it may reduce your blood clotting ability. Each person may react differently to a treatment. If you think this medication may be causing adverse effects (including those described here, or others), talk to your health care professional. He or she can help you to determine whether or not the medication is the source of the problem.

140 mg capsule
Each hard white gelatin capsule marked with "ibr 140 mg" in black ink contains 140 mg of Imbruvica (Ibrutinib). Nonmedicinal ingredients: croscarmellose sodium, magnesium stearate, microcrystalline cellulose, and sodium lauryl sulfate; capsule and black ink: gelatin, titanium dioxide (E171), iron oxide black (E172), and shellac.

140 mg tablet
Each yellow-green-to-green, round, film-coated tablet, debossed with "ibr" on one side and "140" on the other, contains 140 mg of Imbruvica (Ibrutinib). Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate; film coating: black iron oxide, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.

280 mg tablet
Each purple, oblong, film-coated tablet, debossed with "ibr" on one side and "280" on the other, contains 280 mg of Imbruvica (Ibrutinib). Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate; film coating: black iron oxide, polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, and titanium dioxide.

420 mg tablet
Each yellow-green-to-green, oblong, film-coated tablet, debossed with "ibr" on one side and "420" on the other, contains 420 mg of Imbruvica (Ibrutinib). Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate; film coating: black iron oxide, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide, and yellow iron oxide.

560 mg tablet
Each yellow-to-orange, oblong, film-coated tablet, debossed with "ibr" on one side and "560" on the other, contains 560 mg of Imbruvica (Ibrutinib). Nonmedicinal ingredients: colloidal silicon dioxide, croscarmellose sodium, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, and sodium lauryl sulfate; film coating: polyethylene glycol, polyvinyl alcohol, red iron oxide, talc, titanium dioxide, and yellow iron oxide.

Do not take Imbruvica (Ibrutinib) if you are allergic to Imbruvica (Ibrutinib) or any ingredients of the medication.

There may be an interaction between Imbruvica (Ibrutinib) and any of the following:

• acetylsalicylic acid (Asa)
• Aliskiren
• Amiodarone
• Apalutamide
• Apixaban
• Aprepitant
• "azole" antifungals (e.g., fluconazole, itraconazole, ketoconazole, Voriconazole)
• Baricitinib
• BCG
• Bosentan
• Carbamazepine
• Clopidogrel
• Cobicistat
• conivaptan
• dabigatran
• Deferasirox
• Digoxin
• Diltiazem
• Dipyridamole
• Dronedarone
• echinacea
• Enzalutamide
• Fingolimod
• grapefruit juice
• Heparin
• herbal products that affect blood clotting (e.g., cat's claw, chamomile, Dong Quai, evening primrose, fenugreek, feverfew, garlic, ginger, ginkgo biloba, ginseng, green tea, licorice, turmeric)
• HIV non-nucleoside reverse transcriptase inhibitors (NNRTIs; e.g., efavirenz, etravirine, nevirapine)
• HIV protease inhibitors (e.g., atazanavir, indinavir, ritonavir, saquinavir)
• Leflunomide
• low molecular weight heparins (e.g., Dalteparin, Enoxaparin, Tinzaparin)
• lumacaftor and Ivacaftor
• macrolide antibiotics (e.g., clarithromycin, erythromycin)
• other medications to treat cancer (e.g., Carboplatin, Cladribine, Cyclophosphamide, Doxorubicin, Ifosfamide, Vincristine)
• Mesalamine
• Methotrexate
• mifepristone
• Natalizumab
• non-steroidal anti-inflammatory medications (NSAIDs; e.g., Diclofenac, Ibuprofen, Naproxen)
• Ocrelizumab
• omega-3 fatty acids
• Phenobarbital
• Phenytoin
• Pimecrolimus
• Prasugrel
• primidone
• rifabutin
• rifampin
• Rivaroxaban
• Roflumilast
• Rosuvastatin
• St. John's wort
• Sarilumab
• selective serotonin reuptake inhibitors (SSRIs; e.g., Citalopram, Fluoxetine, Paroxetine, Sertraline)
• serotonin/norepinephrine reuptake inhibitors (SNRIs; e.g., Desvenlafaxine, Duloxetine, Venlafaxine)
• siltuximab
• siponimod
• Stiripentol
• "statin" anti-cholesterol medications (e.g., Atorvastatin, Lovastatin, Simvastatin)
• Tacrolimus (topical)
• Ticagrelor
• Ticlopidine
• Tocilizumab
• Tofacitinib
• certain tyrosine kinase inhibitors (e.g., Ceritinib, Crizotinib, Dabrafenib, Idelalisib, Pazopanib, imatinib)
• upadacitinib
• vaccines
• Verapamil
• vitamin E
• Warfarin

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:

• stop taking one of the medications,
• change one of the medications to another,
• change how you are taking one or both of the medications, or
• leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. Speak to your doctor about how any drug interactions are being managed or should be managed.

Medications other than those listed above may interact with Imbruvica (Ibrutinib). Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the Nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or Allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use Imbruvica (Ibrutinib).

Abnormal heart rhythms: Imbruvica (Ibrutinib) may cause abnormal heart rhythms. If you have heart disease, atrial fibrillation, or flutter, or a history of abnormal heart rhythms, you may be more at risk. Notify your doctor as soon as possible if you develop any symptoms such as a fast or pounding heartbeat, shortness of breath, or dizziness.

Anemia: Imbruvica (Ibrutinib) may cause low levels of red blood cells. If you experience symptoms of reduced red blood cell count (anemia) such as shortness of breath, feeling unusually tired, or pale skin, contact your doctor as soon as possible.

Your doctor will do blood tests regularly to monitor the number of specific types of blood cells, including red blood cells, in your blood.

Birth control: Effective birth control must be used during treatment and for at least 3 months after stopping therapy. If you are using birth control pills or another form of hormonal birth control, you should also use a barrier method such as condoms or diaphragms. Tell your doctor immediately if you become pregnant while using Imbruvica (Ibrutinib).

Men who are taking Imbruvica (Ibrutinib) must also use effective birth control during treatment and for at least 3 months after stopping therapy.

Bleeding: Imbruvica (Ibrutinib) may cause a reduced number of platelets in the blood, which can make it difficult to stop cuts from bleeding. If you notice any signs of bleeding, such as frequent nosebleeds, unexplained bruising, or black and tarry stools, notify your doctor as soon as possible. Your doctor will order routine blood tests to make sure potential problems are caught early. If you have surgery planned, talk to your doctors about taking Imbruvica (Ibrutinib). Your doctor may want you to stop taking Imbruvica (Ibrutinib) temporarily to reduce the risk of bleeding complications of the surgery.

Blood pressure: Imbruvica (Ibrutinib) may cause increased blood pressure. If you have high blood pressure, discuss with your doctor how Imbruvica (Ibrutinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Imbruvica (Ibrutinib), and whether any special monitoring is needed.

Diarrhea and dehydration: Imbruvica (Ibrutinib) causes diarrhea in many patients. Diarrhea causes fluid loss from the body and can complicate cancer treatment. If you experience diarrhea while taking Imbruvica (Ibrutinib), contact your doctor as soon as possible.

Drowsiness/reduced alertness: Imbruvica (Ibrutinib) may affect the mental or physical abilities needed to drive or operate machinery. Avoid driving, operating machinery, or performing other hazardous tasks until you have determined how Imbruvica (Ibrutinib) affects you.

Hepatitis B reactivation: People who have hepatitis B infection that is dormant may experience the infection returning, causing further liver dysfunction or liver failure. If you have a history of hepatitis B infection, discuss with your doctor how Imbruvica (Ibrutinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this mediation, and whether any special monitoring is needed.

If you experience symptoms of worsening liver function, such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin, contact your doctor immediately.

Increased white blood cells: When you first start to take Imbruvica (Ibrutinib), your blood tests may show a dramatic increase in the number of white blood cells in the body. This is a temporary occurrence and does not necessarily mean that the illness is getting worse. The number of white blood cells should slowly return to normal. Your doctor will monitor the progress of this with blood tests.

Infection: Imbruvica (Ibrutinib) reduces the number of cells that fight infection in the body (white blood cells). If possible, avoid contact with people with contagious infections. Tell your doctor immediately if you notice signs of an infection, such as fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness. Your doctor will do blood tests regularly to monitor the number of specific types of blood cells in your blood.

Interstitial lung disease: Imbruvica (Ibrutinib) may cause lung inflammation. If you notice any new or worsening cough or breathing difficulties, contact your doctor as soon as possible.

Liver function: Liver disease or reduced liver function may cause Imbruvica (Ibrutinib) to build up in the body, causing side effects. If you have liver problems, discuss with your doctor how Imbruvica (Ibrutinib) may affect your medical condition, how your medical condition may affect the dosing and effectiveness of Imbruvica (Ibrutinib), and whether any special monitoring is needed. Your doctor may want to test your liver function regularly with blood tests while you are taking Imbruvica (Ibrutinib).

Contact your doctor immediately if you experience symptoms of liver problems such as fatigue, feeling unwell, loss of appetite, nausea, yellowing of the skin or whites of the eyes, dark urine, pale stools, abdominal pain or swelling, and itchy skin.

Other cancers: People taking Imbruvica (Ibrutinib) have reported a higher number of other cancers such as non-melanoma Skin Cancer. Talk to your doctor about cancer screening and your risk of developing another type of cancer.

Progressive multifocal leukoencephalopathy (PML): There have been reports of PML after using Imbruvica (Ibrutinib). PML is a rare disorder that causes nerve damage in the brain. If you experience memory loss, vision changes, trouble thinking, personality changes, or difficulty walking, contact your doctor immediately.

Tumour lysis syndrome: Imbruvica (Ibrutinib), like many other cancer medications, causes many cancer cells to be suddenly killed when treatment is first started. This can overwhelm the body with waste products from the cells. As a result, the body may not be able to keep up with getting rid of all the waste. When this happens, you may experience nausea, shortness of breath, cloudy urine, or joint pain. This is called tumour lysis syndrome. Your doctor may prescribe some medications to help your body get rid of the waste products. Make sure you understand how to use these medications and report any of these signs or symptoms to your doctor immediately.

Pregnancy: Imbruvica (Ibrutinib) should not be used during pregnancy, as it may harm the developing baby. If you become pregnant while taking Imbruvica (Ibrutinib), contact your doctor immediately.

Breast-feeding: It is not known if Imbruvica (Ibrutinib) passes into breast milk. If you are a breast-feeding mother and are taking Imbruvica (Ibrutinib), it may affect your baby. Because of the risk of serious effects to the baby if it does pass into breast milk, breast-feeding should be discontinued while taking Imbruvica (Ibrutinib).

Children: The safety and effectiveness of using Imbruvica (Ibrutinib) have not been established for children.

Seniors: Seniors may experience a greater number of side effects with Imbruvica (Ibrutinib).

To fully benefit from the effect of this medication, and to limit any adverse reactions, make sure that the health care facility overseeing your treatment has provided you with all the information needed to properly administer this drug. This medication is typically used only once a day. However, your pharmacist may have suggested a different schedule that is more appropriate for you. Take it regularly and continuously to maintain its beneficial effects. Important: Follow the instructions on the label. Do not use more of this product, or more often, than prescribed. The capsule of this medication should not be opened, crushed or chewed. If you forget a dose, take it as soon as you remember, but do not take two doses the same day. This medication may be taken with or without food. Avoid grapefruit and grapefruit juice during your treatment. Grapefruit can seriously affect how this medication works.