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Imbruvica

Imbruvica

Ibrutinib

Imbruvica (Ibrutinib) belongs to the class of medications called tyrosine kinase inhibitors. Specifically, it is called a Bruton's tyrosine kinase (BTK) inhibitor.

Available form

Capsule, Suspension

Dosage

70mg/ml, 140mg

Manufacturers

Janssen

Generic brand of

Ibrutinib

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Imbruvica information

Dosage

Side Effects

Available Form

Contraindications

Precautions

Warnings

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.

Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes Imbruvica (Ibrutinib). If you are concerned about side effects, discuss the risks and benefits of Imbruvica (Ibrutinib) with your doctor.

The following side effects have been reported by at least 1% of people taking Imbruvica (Ibrutinib). Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

brittle fingernails or toenails
common cold
Constipation
decreased appetite
Diarrhea
dizziness
eye inflammation
fatigue, lack of energy
headache
heartburn
muscle or joint aches
muscle spasms
numbness or tingling in the hands or feet
nausea
rash
sore mouth
stomach pain
trouble sleeping
vomiting
weakness

Although most of the side effects listed below don't happen very often, they could lead to serious problems if you do not seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:

anxiety
blurred vision
Fever
increased blood pressure
increased frequency of common cold, sinus infections
irregular heartbeat or palpitations
mouth sores
persistent or severe diarrhea
shortness of breath
signs of Anemia (low red blood cells; e.g., dizziness, pale skin, unusual tiredness or weakness, shortness of breath)
signs of clotting problems (e.g., unusual nosebleeds, bruising, blood in urine, coughing blood, bleeding gums, cuts that don't stop bleeding)
signs of dehydration (e.g., decreased urine, dry skin, dry and sticky mouth, sleepiness, dizziness, headache, thirst, confusion)
signs of infection (symptoms may include fever or chills, severe diarrhea, shortness of breath, prolonged dizziness, headache, stiff neck, weight loss, or listlessness)
signs of decreased kidney function (e.g., decreased or no urination, nausea, swelling of the ankles, feet or legs, fatigue, confusion)
signs of decreased liver function (e.g., skin or whites of the eyes turning yellow, feeling tired, dark or brown-coloured urine, nausea or vomiting or not wanting to eat)
signs of low potassium levels in the blood (e.g., weakness, fatigue, muscle cramps, irregular heartbeat)
skin infection
symptoms of lung inflammation (e.g., difficulty breathing, persistent cough)
symptoms of increased uric acid in the blood (e.g., red, hot, painful, swollen joints; flank pain; blood in the urine)
symptoms of a urinary tract infection (e.g., pain when urinating, urinating more often than usual, low back or flank pain)
swelling of the hands, ankles, or feet
unusual skin growths or moles, sores that don't heal, changes to skin colour

Stop taking the medication and seek immediate medical attention if any of the following occur:

signs of a serious allergic reaction (e.g., abdominal cramps, difficulty breathing, nausea and vomiting, or swelling of the face and throat)
signs of bleeding in the stomach (e.g., bloody, black, or tarry stools; spitting up of blood; vomiting blood or material that looks like coffee grounds) or unexpected bleeding that lasts a long time and cannot be controlled
signs of sepsis (blood infection; e.g., dizziness or feeling faint, disorientation, diarrhea, nausea, vomiting, slurred speech, severe muscle pain)
signs of serious kidney problems (e.g., decreased or no urination; nausea; swelling of the ankles, legs, or feet; confusion; seizures)
signs of a severe skin reaction such as blistering, peeling, a rash covering a large area of the body, a rash that spreads quickly, or a rash combined with fever or discomfort
signs of Stroke or mini-stroke (e.g., sudden or severe headache; sudden loss of coordination; vision changes; sudden slurring of speech; or unexplained weakness, numbness, or pain in arm or leg)
symptoms of a severe increase in white blood cells (e.g., fever, fainting, bleeding, bruising, weight loss, pain, severe headache, difficulty walking)
symptoms of tumour lysis syndrome (e.g., decreased urination, severe muscle weakness, changed heart rhythm, seizures)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking Imbruvica (Ibrutinib).

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.

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).

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